Implementation and Sustainability Factors of Two Early-Stage Breast Cancer Conversation Aids in Diverse Practices

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Yen, Catherine H. Saunders, Glyn Elwyn, and 14 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-91143/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 10 May, 2021 Read the published version in Implementation Science → Version 1 posted You are reading this latest preprint version Abstract Background Conversation aids can facilitate shared decision making and improve patient-centered outcomes. However, there are few examples of sustained use of conversation aids in routine care due to numerous barriers at clinical and organizational levels. We explored strategies that will promote the sustained use of two early-stage breast cancer conversation aids. We examined any differences in experiences and opinions between the two conversation aids and across socioeconomic strata. Methods We nested this study within a randomized controlled trial evaluating two early-stage breast cancer surgery treatment conversation aids, one text-based and one picture-based, across four health systems with socioeconomically diverse patient populations. We conducted semi-structured interviews with a sample of patient participants, purposively sampled across conversation aid assignment and socioeconomic status (SES), and collected observations and field-notes. We also interviewed trial surgeons and other stakeholders. We conducted a framework analysis of all interviews, notes, and observations with two independent coders using the NOrmalization MeAsure Development through Normalization Process Theory. We also conducted an inductive analysis. We conducted additional sub-analyses based on which conversation aid was used/received and patient SES. Results We conducted 73 semi-structured interviews with 43 patients, 16 surgeons, and 14 stakeholders like nurses, cancer center directors, and electronic health record (EHR) experts. Patients and surgeons felt the conversation aids should be used in breast cancer care in the future and were open to various methods of giving and receiving the conversation aid (EHR, email, patient portal, before consultation). Patients of higher SES were more likely to note the conversation aids influenced their treatment discussion, while patients of lower SES noted more influence on their decision making. Intervention surgeons reported using the conversation aids did not lengthen their typical consultation time. Most intervention surgeons felt using the conversation aids was similar to their usual care after using it a few times, and most patients felt it appeared part of their normal routine. Conclusions Key factors that will help guide the future sustained implementation of the conversation aids include adapting to existing clinical workflows, flexibility of use, patient characteristics and communication preferences. Trial registration NCT03136367 at ClinicalTrials.gov Health Policy Health Economics & Outcomes Research Breast cancer Conversation aids two early-stage diverse practices electronic health record (EHR) Contributions To The Literature Both surgeons and patients, regardless of conversation aid used and socioeconomic status, recommended the early-stage breast cancer conversation aids be used in future breast cancer care. Normalization Process Theory (focused on health professionals’ perspectives) can feasibly be used to analyze the patient perspective about the sustainable implementation of conversation aids into clinically diverse practices. Tailoring the use of conversation aids to existing clinical workflows, flexibly of use, and taking into account patient characteristics and preferences, like health literacy, can facilitate sustained implementation. 1. Introduction Conversation aids help patients compare treatment options using evidence-based information to support them and their families in making a decision that is aligned with their preferences and values.[ 1 – 3 ] However, sustained implementation of these conversation aids in clinical care is complex.[ 4 – 13 ] Clinical barriers can include a lack of training on the conversation aids, clinician indifference on using them, lack of trust in the content of the conversation aids, and possible disruption of established clinic behaviors and workflows.[ 5 ] While training is recognized by clinic staff as an important way to promote shared decision making and the use of conversation aids, a common barrier to implementation is the lack of appropriate training on how best to use and integrate the conversation aids.[ 4 , 5 , 14 ] In breast cancer care, clinicians tend to feel they communicate well with their patients and are reluctant to modify aspects of their usual care.[ 15 ] Clinicians also worry that it takes too much time to use a conversation aid and engage in shared decision making.[ 14 , 16 ] Buy-in at the clinic level, led by clinical champions, can reinforce the sustainability of an implemented conversation aid.[ 17 ] Despite the multiple barriers that exist, tailoring to the individual needs of clinics can ensure better sustainability of an implemented conversation aid.[ 18 ] System level barriers can include a lack of prioritizing implementation efforts and incentivization for clinicians and clinic staff.[ 5 – 7 ] An organization’s willingness to adhere to guidelines promotes the implementation of conversation aids.[ 19 ] Patients with early-stage breast cancer are faced with a preference sensitive decision about their treatment options, mastectomy or breast conserving surgery with radiation.[ 20 , 21 ] Patients of lower socioeconomic status (SES) who have early-stage breast cancer often have poorer communication with their doctors and health outcomes.[ 22 – 26 ] Given evidence of the effectiveness of conversation aids, it is imperative to understand the factors and facilitators for routine implementation and sustainability of conversation aids in diverse clinical contexts for early-stage breast cancer, and particularly for patients of lower SES.[ 27 , 28 ] While implementation and sustainability of conversation aids in routine clinical care has been evaluated in some contexts, the patient perspective has been notably absent in evaluation.[ 27 , 29 – 32 ] In this study, we aimed to explore strategies that promote the conversation aids’ sustained use and dissemination using a theoretical implementation model. We also aimed to distinguish any differences in experiences and opinions between the two conversation aids and across varied socioeconomic strata. 2. Methods This qualitative study uses data collected from a parent study, What Matters Most.[ 33 ] The protocol for the parent study is published elsewhere.[ 34 ] What Matters Most was a three-arm, multi-site, parallel randomized controlled trial of two early-stage breast cancer conversation aids across SES. We randomized surgeons to a text-based conversation aid (n = 4), picture-based conversation aid (n = 6), or usual care (n = 6). Intervention surgeons were trained to use the conversation aid during the surgical consultation. Patients who provided consent at each site were assigned to their surgeon’s corresponding intervention. Research staff at each site were responsible for giving the paper-based conversation aid to eligible patients prior to their surgical consultation. In this qualitative study, we conducted semi-structured interviews with What Matters Most patient participants, trial surgeons, and other relevant stakeholders to explore how two conversation aids can be implemented and sustained in diverse contexts in the future. All methods and results are reported using the COnsolidated criteria for REporting Qualitative (COREQ) research checklist (see Appendix , Fig. 1 ).[ 35 ] 2.1 Interventions The Option Grid conversation aid for early-stage breast cancer presents evidence-based information on breast conserving surgery (BCS) with radiation and mastectomy in a comparative table.[ 36 ] The Picture Option Grid conversation aid includes the same information as the Option Grid, but uses pictures and fewer words. The Picture Option Grid was iteratively designed and developed using a Community Based Participatory Research approach.[ 28 , 37 ] Pictures have been shown to improve comprehension of health information when closely linked with text or spoken words, and this relationship may be enhanced for individuals with lower health literacy.[ 38 – 42 ] The Picture Option Grid was designed for use with all patients diagnosed with early-stage breast cancer during the surgical consultation, but particularly for patients with lower health literacy and lower SES. Both interventions are paper-based with a sixth grade readability level. 2.2 Setting and participants We recruited participants for interviews across seven clinics at four NCI-designated cancer centers in the United States with diverse patient populations. Three sites had urban and ethnically diverse populations, and one site had a rural, mostly white population. Two urban sites were specifically selected for recruiting patients of lower SES. Table 1 in the appendix summarizes usual care characteristics for each site. We interviewed: All What Matters Most trial participating surgeons after trial involvement (n = 16). Prior to starting the trial, all surgeons underwent training using videos and role-plays that included information about the trial protocol, shared decision making, and communication skills. Training also included teaching how to use the conversation aid during the surgical encounter if the surgeon was randomized to using one of the two conversation aids. A purposive sample of trial patient participants in intervention arms who agreed to be contacted for a 3-month post-operative interview. Family of invited patient participants were allowed to join the patient’s interview if they were involved in the surgical consultation when the intervention was used. Please see the parent trial protocol for participant inclusion criteria.[ 34 ] Clinical and non-clinical stakeholders, including nurse practitioners, nurses, physician assistants, social workers, administrators, and electronic health record (EHR) specialists. Most interviewed clinical stakeholders and one non-clinical stakeholder were part of integrating the trial activities in the clinics where they worked. Some non-clinical stakeholders, in administration, provided initial support for the conversation aids’ use as well. We planned to collect up to 60 patient interviews and 40 surgeon and stakeholder interviews.[ 34 ] We discussed data saturation as a core group (M-AD, RWY, CHS, DS, GE) as interviews were occurring, and with the broader parent trial team and stakeholders to reach consensus on when to stop conducting interviews. Retrospectively, we conducted a saturation test using Guest and colleagues’ approach to assess and report thematic saturation in qualitative research (p < 0.05).[ 43 ] 2.3 Theoretical framework and interview guides We developed semi-structured interview guides in partnership with the parent trial’s surgeon, patient, and professional stakeholders as part of a Community Based Participatory Research approach.[ 28 ] There were separate interview guides for the patients, intervention surgeons, usual care surgeons, clinical stakeholders, and non-clinical stakeholders (See Appendix , Fig. 2 ). In designing the interview guides, we targeted a 30-minute interview duration. We piloted all interview guides with team members, including patient partners (breast cancer survivors), and made necessary revisions before starting data collection. Revisions included making sure the interview flowed smoothly and reducing repetition. We developed the guides using the constructs and components of Normalization Process Theory (NPT). NPT is a framework that was developed to understand how complex interventions become implemented in routine healthcare settings using four theoretical constructs to contextualize implementation mechanisms.[ 44 , 45 ] NPT has reliably been used to evaluate implementation and sustainability of similar conversation aids like Option Grid in the past. However, NPT has not been used to analyze the patient perspective on implementation and sustainability.[ 29 – 32 ] NPT’s four theoretical constructs include: 1) Coherence: processes of individual and communal sense-making of a complex intervention regarding its use and value; 2) Cognitive participation: processes that promote or hinder users’ buy-in and commitment to the intervention; 3) Collective action: processes that determine whether the intervention is being used by all as intended; and 4) Reflexive monitoring: processes of communal and individual appraisal of the effect of the intervention.[ 46 ] We also developed the interview guides with a few hypotheses in mind, although not typically required in qualitative research. Rather, we used these hypotheses as probes used during the semi-structured interviews to explore their role in sustained use of the conversation aids. Our first hypothesis was that pre-visit planning, minimal clinician training, flexibility of use, and integration into the workflow and EHR would facilitate future sustained use. Our second hypothesis was that successful use by patients and families will be determined by the perceived acceptability of the intervention and integration into workflows. For full hypotheses, refer to the parent trial protocol.[ 34 ] 2.4 Procedure 2.4.1 Patient interviews Research staff at each site conducted the semi-structured interviews with patients. All interviewers were female and ranged in education from a bachelor’s degree to a master’s degree. Two study members (RWY and M-AD) trained research staff at each site in semi-structured interview techniques, such as probing and redirection, before conducting interviews. Research staff approached previously-consented parent trial patient participants via phone call or in-person at a patient’s follow-up appointment in the clinic three months after the patient’s surgery. Research staff made no more than five attempts to contact participants to schedule an interview. After each research team member conducted their first interview, two members of the research team (RWY and M-AD) reviewed the transcript and gave feedback to the interviewer on their interview techniques. Research staff conducted interviews over the phone or in-person depending on the interview participant’s preference and availability. Apart from recruiting the participants into the parent trial, there was no established relationship between the interviewers and the interview participants. We ensured interview participants had a copy of the conversation aid they used in the trial before the interviews were conducted. All patient participants were compensated for their time with a $30 gift card. No repeat interviews were carried out. Interview field notes were not taken. 2.4.2 Surgeon and stakeholder interviews Surgeons consented to be contacted for the post-trial interview prior to the recruitment of patients for the study. Stakeholders consented to the interview after being contacted post-trial. We chose a researcher external to What Matters Most (RF), a female PhD candidate with a master's degree, to conduct the surgeon and stakeholder interviews to minimize positive response bias. The researcher conducted the interviews over the phone. All surgeon and stakeholder interview participants consented to their interview being audio-recorded. Surgeon and stakeholder interviews were aware that the interviewer was outside of the parent trial. 2.4.3 Observations and field notes Research staff at each site were trained in ethnographically informed methods prior to recruiting participants for the broader study. Research staff collected observational information from each site using an Observation Grid (See Appendix , Fig. 3 ). The Observation Grid included sections on identifying materials in the clinics and chatter from clinic staff and patients about the study or the materials associated with the study. Additionally, research staff were encouraged to ask clinic staff questions about the study and the conversation aids. Lastly, research staff were encouraged to write down their thoughts about what they observed and questions or concerns raised from the observational data in a weekly email to the study coordinator (RWY) throughout parent trial recruitment. 2.5 Data management and analysis 2.5.1 Data management Interview audio-recordings were transcribed verbatim by a HIPAA-compliant professional transcription service, Civicom Inc. For interviews that were conducted without a recording, the interviewer took in-depth notes on the interview guide for coding and analysis. The transcripts were not returned to participants for comments or corrections. While we did not check with the interview participants themselves, we confirmed our findings with the parent trial’s stakeholders, patient partners, and Community Advisory Board. 2.5.2 Analysis We used a hybrid approach to our analysis, including framework and inductive analyses. Our main analysis was guided by NPT, however, we conducted an inductive analysis to allow for new codes to emerge. We also conducted additional sub-analyses based on conversation aid used (Picture Option Grid versus Option Grid) and participant SES. For this sub-study, we stratified patients according to higher or lower SES by using their reported income level and number of dependents to calculate if they were above or below the 138% federal poverty level in the year of recruitment.[ 47 ] If income was not available, we used health insurance as a proxy where no insurance or government insurance without supplemental indicated lower SES, and private insurance or government insurance with supplemental indicated higher SES. We conducted χ 2 tests and two-sample t-tests to determine if there were significant differences between those who declined versus not when approached. We analyzed all interview transcripts, field notes, and observations using NPT through the lens of the NOrmalization MeAsure Development (NoMAD) instrument. The NoMAD instrument is a 20-item list organized by NPT constructs (see Appendix , Fig. 4 ).[ 48 , 49 ] NoMAD uses NPT constructs and components to assess participants’ opinions about how an intervention impacts their work and whether the intervention can be integrated and routinely used in their practice. The NoMAD items that correspond to NPT are composed of “I” statements like, “I can see the potential value of Option Grid/Picture Option Grid for my work”. Given NoMAD was not originally designed to evaluate implementation from the patient’s perspective, we adapted it for patient interviews. We adapted NoMAD to include the patient perspective by looking at the definition NoMAD provides for each NPT component and construct (for health professionals) and adapting item wording to focus on the patient experience. Adaptation occurred through collaboration between the two coders and arbitration by the senior author. See Appendix Table 2 for NoMAD’s definitions of each NPT construct and component for this study, including our addition of the patient perspective. Two researchers (DS and RWY) purposively selected six interview transcripts that were evenly divided between the type of interview (patient, surgeon, stakeholder) and coded them using both the NPT framework and descriptive codes to develop the codebook. The coders shared the codebook with two other team members (M-AD and GE) before continuing coding. One researcher coded a 20% purposive sample of the interviews (RWY) selected across types of interview (patient, surgeon, stakeholder) and study site. Another researcher (DS) coded all interview transcriptions, observations, and notes. Where there was disagreement between coders, a third individual helped the primary coders reach consensus (M-AD). All coding was conducted using ATLAS.ti. A research collaborator outside of What Matters Most with experience in NPT (PS) convened with the two coders to help determine the major and minor themes that emerged from the data once coding was completed. 3. Results 3.1 Participant characteristics Patients Forty-three of 76 patients approached (56.6%) agreed to be interviewed. Those who declined were more likely to be Hispanic, Spanish-speaking, have less education, and be of lower SES. Eighteen of the patients interviewed received the Option Grid in their surgical encounters, and 25 patients received the Picture Option Grid. Over half of patients were White, non-Hispanic and spoke primarily English. About a quarter of the patients were Black, non-Hispanic, and all others were either Hispanic or Asian. Fifty-one percent of patients had a 2-year college degree or higher. Approximately three quarters of the patients were considered higher SES. Please see Table 1 for detailed patient participant characteristics, stratified by consent status. Imbalances in intervention received and socioeconomic status categories are consistent with the larger trial data. Surgeons and stakeholders All trial surgeons (n = 16) participated in the interviews (five used Option Grid, six used Picture Option Grid, and five used usual care). The surgeons were majority female (81%), had an average of 23 years since graduating medical school, and an average of 10 years working at their current site. All surgeons had interest in shared decision making prior to the study. See Table 2 . Thirty other stakeholders were contacted for an interview, of which 14 were interviewed. These 14 stakeholders included three nurse practitioners, three nurses, one physician assistant, one social worker, and six other non-clinical stakeholders that serve in administration or EHR-related roles. 3.2 Setting and interview characteristics Forty-nine interviews were conducted over the phone, 19 in clinic, and 5 in other locations (e.g., office). Four interviewees declined to be recorded, so the interviewer took detailed notes. One patient recording was lost due to technical difficulties. The average length of interviews for patients, surgeons, and stakeholders was 24, 27, and 20 minutes respectively. Please see Table 3 in the appendix for the average length of interviews stratified by site and interviewee type. No individuals other than the interviewer and participant were present for the interviews. 3.3 Major themes according to NPT construct Table 3 summarizes the major themes for patients and surgeons organized by the four NPT constructs. The following sections describe the major themes in more detail. 3.3.1 Major themes related to coherence - “What is the work?” Regardless of SES and intervention received, when asked, most patients felt the conversation aids were easier to understand and more concise compared to other breast cancer materials they had received as part of their cancer care (Differentiation). “ It was more concise. Other materials I received, you had to read through a whole bunch of things before you could get to the end and decide." - Patient, Option Grid, Lower SES For most intervention surgeons, the use of the conversation aids felt similar to their usual care (Differentiation). However, for both interventions, about half of surgeons thought the conversation aids disrupted the flow of their usual conversation. For both interventions, half of the intervention surgeons and three other stakeholders felt that the conversation aids would be particularly helpful for patients with low health literacy or other associated factors like lower health literacy and limited formal education (Internalization). " When you're sitting there and actually showing them the picture and they can visualize what you're telling them, it does help, especially in our patient population where they don't necessarily understand everything we are saying to them ." - Clinical stakeholder 3.3.2 Major themes related to cognitive participation - “Who does the work?” For both interventions, approximately one-third of patients thought email or the patient portal would hypothetically be a helpful way to receive the conversation aid. Patients were open to various methods of receiving the conversation aids (email, mail, patient portal), but almost all highlighted the importance of paper-based versions (Enrollment). Regardless of SES or intervention received, almost all patients recommended that others like them use the conversation aids. They felt the conversation aids should be used in breast cancer care in the future (Legitimation). " I would give it to me on paper, but I would also send it to my email - it doesn’t have to be one way. It could be two ways, it could be three ways. " - Patient, Picture Option Grid, Higher SES Half of the surgeons thought it would be helpful if patients received the conversation aids prior to their surgical consultation. For both interventions and including usual care, about half of surgeons felt integrating the conversation aids in the electronic health record and/or the patient portal would be helpful (Enrollment). Most surgeons recommended that others like them should use the conversation aids (Legitimation). " I think having something beforehand, even if it’s just a heads-up, would be helpful. " - Surgeon, Option Grid 3.3.3 Major themes related to collective action - “How does the work get done?” Regardless of SES or intervention received, over half of patients thought their surgeons used the conversation aid with ease and it appeared part of their normal routine (Interactional workability). “... because it flowed into our appointment so seamlessly. It definitely seemed like part of how [the surgeon] would present the information. ” - Patient, Picture Option Grid, Higher SES Most intervention surgeons had to use the conversation aid a few times before using it with ease. After a few uses, they felt the conversation aid was part of their normal routine (Interactional workability). For both interventions, all surgeons thought the training on shared decision making and how to use their assigned intervention was sufficient and did not recommend any changes (Skillset workability). " Well, it became pretty much second-hand for me actually. I got really used to using it. It just became part of my routine. " - Surgeon, Picture Option Grid 3.3.4 Major themes related to reflexive monitoring (“How is the work understood?”) For both interventions, over half of patients felt the conversation aid affected their treatment decision (Systemization). " I had a lumpectomy instead of a mastectomy because the information contained in the grid helped me understand that I didn’t need one [mastectomy]. " - Patient, Picture Option Grid, Higher SES Surgeons understood the conversation aids were designed to help structure their conversation with eligible patients and help them make a treatment decision. For both interventions, all surgeons felt that the time it took to use the conversation aid did not change the typical time they spend with patients in the surgical consultation (Individual appraisal). "... as I got faster, I got more used to it. It did help the rhythm. At first, it took me a little bit longer than I think it would’ve been, but not much. Then at the end, I think it ultimately helped structure things. It might have made things as efficient or more efficient. " - Surgeon, Option Grid See Table 4 in the appendix for a detailed analysis including major and minor themes from all types of stakeholders (patients, surgeons, other stakeholders) according to NPT constructs and components. 3.4 Comparing major themes by participant SES Patients of higher SES, for both interventions, were more likely to find the conversation aid easier to understand than materials they had received before. They found the conversation aid concise and understood it was designed to help them compare their treatment options (Coherence). For patients of lower SES in the Picture Option Grid group who found the conversation aid easy to understand, all found the pictures played a significant role in their understanding (Coherence). Patients of lower SES who received Picture Option Grid and patients of higher SES who received Option Grid had a preference for paper-based conversation aids. Patients of higher SES reported more willingness to hypothetically receive the conversation aid ahead of their appointment (for example, through the patient portal) compared to patients of lower SES, who were more likely to mention that receiving it directly from their surgeon would be best (Cognitive participation). Patients of higher SES, for both interventions, mentioned more often that the conversation aid affected the discussion with their surgeon compared to patients of lower SES were more likely to mention it influenced their treatment decision (Reflexive monitoring). " I interacted with the piece of paper a hundred times more than I would with the downloaded file if somebody had just sent that to me to look at before my appointment. " - Patient, Option Grid, Higher SES " I’d say it really influenced it [my decision]. " - Patient, Option Grid, Lower SES " I would recommend it to everybody. " - Patient, Option Grid, Lower SES Table 5 in the appendix features a detailed analysis comparing both major and minor themes by participant SES. Tables 6 and 7 in the appendix include a detailed analysis with both major and minor themes comparing SES for each intervention. 3.5 Comparing major themes by intervention Patients who received Picture Option Grid reported more willingness to hypothetically receive the conversation aid in advance of their appointment. Patients who received Option Grid were more likely to mention that receiving the conversation aid from their surgeon, and paper-based, would be best (Cognitive participation). Patients who received Option Grid found that using the conversation aid did not feel awkward (Collective action). Patients who received Option Grid were slightly more likely to feel the conversation aid influenced their discussion with their surgeon (Reflexive monitoring). " Completely influenced [my decision] " - Patient, Option Grid, Higher SES " It needs to be something they can see online in MyChart. It should also be in a doctor’s office so that a woman can, you know, ‘Let me read this’. " - Patient, Picture Option Grid, Lower SES All surgeons who used Option Grid felt using the conversation aid did not feel different from their usual practice compared to only half of surgeons who used Picture Option Grid (Coherence). Surgeons who used Picture Option Grid were more likely to mention the conversation aid should be given at the surgical consultation, as was done in the RCT. They were also more comfortable with their nurse or other qualified clinic personnel giving the conversation aid (Cognitive participation). Surgeons who used Picture Option Grid found they were able to integrate the conversation aid into their normal practice, especially after a few uses (Collective action). Some Picture Option Grid surgeons found the pictures not helpful, but most had no concerns with patients using the conversation aid. " Well, it became pretty much second-hand for me actually. I got really used to using it so I don’t know. It just became part of my routine. " - Surgeon, Picture Option Grid Table 8 in the appendix includes a detailed analysis comparing both major and minor themes by intervention used or received. 4. Discussion 4.1 Main findings In this study, the future implementation of the early-stage breast cancer Option Grid conversation aids across diverse practices shows promise for sustainability. Key facilitators include adapting the conversation aids to existing clinical workflows, using them in an adaptable manner that fits best with a surgeon’s typical consultation, and taking into account patient characteristics and communication preferences. No major barriers were reported by patients, surgeons, or stakeholders in sustainably implementing these conversation aids in diverse practices. Over half of patients thought their surgeons used the conversation aids as part of their usual care. Almost all recommended others like them use the conversation aids. Patients of higher SES were more likely to note the conversation aids influenced their treatment discussion, while patients of lower SES noted more influence on their decision making. Patients were open to receiving the conversation aids in various ways (EHR, patient portal, email, prior to appointment). For all intervention surgeons, using the conversation aids did not change the typical time they spent with their patients. Most intervention surgeons felt using the conversation aids was similar to their usual care. It felt part of their normal routine and took a few times before using the conversation aid with ease. Most surgeons recommended other surgeons like them use these conversation aids with their patients in the future. Overall, there were no noted major downsides to using the conversation aids in clinical practice, thus facilitating future adoption and potential sustainability of these conversation aids in diverse clinical settings. 4.2 Strengths and limitations A strength of our study is the large number of interviews conducted with a diverse group of stakeholders. We had diversity in type of interviewee (patient, surgeon, stakeholder) and in demographics (race, SES, health literacy). Another strength is the involvement of a researcher not affiliated with the What Matters Most project to conduct the interviews with the surgeons and stakeholders to minimize positive response bias. Using NPT with multiple perspectives provided a holistic picture of the implementation and sustainability factors of the conversation aids. As a novel approach, we also used NPT with a patient perspective as it is equally important to understand the patient’s experiences and opinions regarding the implementation of conversation aids with diverse patient groups. One potential limitation is that we originally designed the interview guides primarily guided by NPT and its constructs and components. However, in analysis, we primarily used the NoMAD’s definition of NPT’s constructs and components. Therefore, there may be slight differences in interpretation. Another limitation is the discrepancy in patient interview lengths across the sites potentially resulting in some sites having more representation than others. However, the same training materials, training protocols, and transcript review mechanisms were used across all sites to promote consistency and quality control. There were also significant differences between patients who agreed to the interview compared to those who declined which might limit the generalizability of our findings. Decliners were more likely to be Hispanic, Spanish-speaking, have less education, and be of lower SES. Further, our results should be interpreted with caution as we conducted an implementation and sustainability assessment using an implementation framework in a comparative effectiveness trial.[ 50 ] Since surgeons and clinical staff were not asked to routinely integrate these conversation aids in their clinical practices, we cannot expect that the opinions and thoughts generated from these interviews were always directly related to implementation and sustainability factors, since the context of use was not an implementation study but a randomized controlled trial. 4.3 Results in context Our findings align with existing evidence, including in early stage breast cancer, that it takes flexibility of use and a few tries for a clinician to become comfortable using a conversation aid.[ 15 , 51 ] A major component of integrating a conversation aid into a workflow is encounter duration. While previous barriers to implementation have noted surgeons’ concern regarding conversation aids increasing encounter duration, our findings align with a previous study suggesting that surgeons did not report an impact of the conversation aids on the length of their regular consultation.[ 52 ] Surgeons who were able to integrate the conversation aid in their daily clinical practice commented that the conversation aid was very similar to their usual consultation content, also seen in a similar study on contraceptive counseling.[ 17 ] Some patients, surgeons, and stakeholders were interested in integrating the conversation aids in the EHR. However, the sample was divided with emphasis on the importance of paper-based conversation aids. Our findings align with Politi et al.’s study that examined clinicians’ use of tools where there is no “one-size-fits-all” approach to implementing conversation aids, with variation in patient preferences in format and clinicians’ opinions about conversation aids.[ 53 ] Our results coincide with another study on a different surgical conversation aid that most patients mentioned the best place to use the conversation aids was during the surgical consultation.[ 54 ] However, as also seen in Bunzli’s study, patients mentioned that receiving the conversation aid beforehand would be helpful in some circumstances provided the patient already knew their diagnosis.[ 54 ] Patients also noted that the conversation aids covered relevant content and the information provided was helpful and served as a helpful starting point. Our findings that patients felt the conversation aids covered relevant content and served as a starting point coincides with Bozic’s study findings on orthopaedic surgery decision and communication aids.[ 55 ] According to patients and surgeons who liked using the conversation aids, they mentioned that Picture Option Grid appeared particularly powerful with the inclusion of images. Research shows that pictures in health communication may help better facilitate knowledge for disadvantaged patients than words alone.[ 38 – 42 ] A systematic review showed pictures in health information moderately improved knowledge and recall, but largely increased knowledge for lower health literacy populations.[ 56 ] It is imperative to address patients with lower health literacy or other health inequities by developing and using conversation aids that address their needs.[ 57 ] Individual patient characteristics and the health system that they are familiar interacting with is an important determination for which conversation aid will be most helpful. 4.4 Implications Barriers to implementing similar conversation aids continue to exist despite a general understanding that these conversation aids are helpful for patients.[ 58 – 60 ] We found in our study that individual patient characteristics, like health literacy level and communication preferences, is important in determining which conversation aid will be most appropriate to use. However, clinicians' discretion may not suffice, in which case, patients should be offered a choice between the two conversation aids or given both. Healthcare professionals’ willingness to use and confidence in the conversation aid is a facilitator to implementation. Those willing to integrate a conversation aid must do so by adapting it to their existing workflow and clinical environment to ensure sustained implementation. With a small learning curve and adjustment to workflow, surgeons we interviewed said that using the conversation aid did not seem to extend the consultation time, and they reported no major downsides to using them. This study exemplifies that commonly noted barriers to implementation and sustainability can be overcome with enough willingness to improve healthcare delivery from the patient, clinical, and organizational standpoints. 5. Conclusion This study is novel in our effort to understand the experiences and opinions of implementation and sustainability factors of two conversation aids for early-stage breast cancer with multiple stakeholder perspectives, including the patient perspective. We found that in order to successfully implement and ensure sustainability, the conversation aids must be skillfully adapted to clinical workflows and integrated flexibly in health professionals’ usual care. Individual patient characteristics, like health literacy and existing knowledge about breast cancer, and communication preferences are an important factor in determining which conversation aid to use. However, we also recommend that patients are given a choice between the two or given both. Patients and surgeons agreed that the conversation aids should be used in breast cancer care in the future and were open to various methods of giving and receiving the conversation aid, allowing for adaptability of future implementation efforts. In this study, the future implementation of the early-stage breast cancer Option Grid conversation aids across diverse clinical practices shows promise for sustainability. Declarations Ethics approval and consent to participate Ethics approval for this study was provided by the Dartmouth Committee for the Protection of Human Subjects on June 8, 2017. Montefiore Medical Center provided an authorization agreement to rely on Dartmouth’s approval on September 8, 2017. Ethics approval was provided by Washington University in St. Louis Institutional Review Board on May 9, 2017. New York University School of Medicine provided ethics approval on August 29, 2017. Consent for publication Not applicable Availability of data and materials The dataset analyzed during the current study is not publicly available due to the protection of the human subjects involved in the qualitative interviews. A deidentified copy of the dataset is available from the corresponding author on reasonable request. Competing interests Glyn Elwyn has edited and published books that provide royalties on sales by the publishers: the books include Shared Decision Making (Oxford University Press) and Groups (Radcliffe Press). Glyn Elwyn’s academic interests are focused on shared decision making and coproduction. He owns copyright in measures of shared decision making and care integration, namely collabo RATE, integ RATE (measure of care integration), conside RATE (patient experience of care in serious illness), coope RATE (measure of goal setting), tole RATE (clinician attitude to shared decision making), Observer OPTION-5, and Observer OPTION-12 (observer measures of shared decision making). He has in the past provided consultancy for organizations, including: 1) Emmi Solutions, LLC who developed patient decision support tools; 2) National Quality Forum on the certification of decision support tools; 3) Washington State Health Department on the certification of decision support tools; 4) SciMentum LLC, Amsterdam (workshops for shared decision making). He is the Founder and Director of &think LLC, which owns the registered trademark for Option GridsTM patient decision aids; Founder and Director of SHARP NETWORK LLC, a provider of training for shared decision making. He provides advice in the domain of shared decision making and patient decision aids to: 1) Access Community Health Network, Chicago (Adviser to Federally Qualified Medical Centers); 2) EBSCO Health for Option GridsTM patient decision aids (consultant); 3) Bind on Demand Health Insurance (consultant); 4) PatientWisdom Inc (adviser); 5) abridge AI Inc (Chief Clinical Research Scientist). Glyn Elwyn and Marie-Anne Durand have developed the Option Grid conversation aids, which are licensed to EBSCO Health. They receive consulting income from EBSCO Health, and may receive royalties in the future. Marie-Anne Durand was a consultant for ACCESS Community Health Network until 2019. From 2014-2018, Dr. Karen Sepucha received salary support as a member of the scientific advisory board for Healthwise, a not-for-profit foundation that develops and distributes patient education and decision support materials. Catherine Hylas Saunders holds copyright in the consideRATE suite of tools. No other competing interests declared. Funding The research reported in this manuscript is funded through a Patient-Centered Outcomes Research Institute (PCORI) Award (1511-32875). The statements presented in this manuscript are solely the responsibility of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI), its Board of Governors or Methodology Committee. The study funder has no role in any aspects of the set up or execution of the study or manuscript. Study sponsor Trustees of Dartmouth College Office of Sponsored Projects, 11 Rope Ferry Road #6210, Hanover, NH, 03755, [email protected] The study sponsor has no role in any aspects of the set up or execution of the study or manuscript. Authors’ Contributions Danielle Schubbe: Methodology, Formal analysis, Investigation, Data curation, Writing - original draft, Visualization; Renata W Yen: Conceptualization, Methodology, Formal analysis, Investigation, Resources, Data curation, Writing - review & editing, Supervision, Project administration; Catherine H Saunders: Investigation, Writing - review & editing; Glyn Elwyn: Conceptualization, Methodology, Writing - review & editing, Supervision, Funding acquisition; Rachel Forcino : Investigation, Writing - review & editing; James O’Malley: Conceptualization, Writing - review & editing; Mary Politi: Conceptualization, Resources, Writing - review & editing; Julie Margenthaler: Resources, Writing - review & editing; Robert J. Volk: Writing - review & editing; Karen Sepucha: Writing - review & editing; Elissa Ozanne: Writing - review & editing; Sanja Percac-Lima: Writing - review & editing; Ann Bradley: Investigation, Writing - review & editing; Courtney Goodwin: Investigation, Writing - review & editing; Maria van den Muijsenbergh: Supervision, Writing - review & editing; Annemijn Aarts: Supervision, Writing - review & editing; Peter Scalia: Formal analysis, Writing - review & editing; Marie-Anne Durand: Conceptualization, Methodology, Investigation, Resources, Writing - review & editing, Supervision, Project administration, Funding acquisition Acknowledgments We want to thank all patients, surgeons, and stakeholders who took part in the interviews for this study. We also want to thank our trial’s Community Advisory Board, Data Safety and Monitoring Board, and Trial Steering Group for their monitoring and guidance. References Stacey D, Légaré F, Lewis K, Barry MJ, Bennett CL, Eden KB, et al. 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Available from: http://dx.doi.org/10.1111/j.1369-7625.2007.00477.x Tables Table 1 Patient participant characteristics, stratified by interview status Characteristic Interviewed (n = 43) Declined Interview (n = 33) p-value* Age, mean (SD) 56.6 (12.0) 62.4 (13.7) 0.05 Race/Ethnicity, n (%) 0.04 Black, non-Hispanic 10 (23) 8 (24) Hispanic 2 (5) 9 (27) Asian 3 (7) 1 (3) White, non-Hispanic 28 (65) 15 (45) Primary Language, n (%) 0.01 English 41 (95) 24 (73) Spanish 1 (2) 8 (24) Mandarin 1 (2) 1 (3) Education, n (%) 0.03 Never attended high school 1 (2) 3 (9) Some high school 0 (0) 6 (18) High school diploma (or equivalent) 11 (26) 6 (18) Some college 9 (21) 5 (15) 2-year degree 6 (14) 6 (18) 4-year degree or higher 16 (37) 7 (21) SES, n (%)** 0.01 Higher SES 32 (74) 15 (45) Lower SES 11 (26) 18 (55) *Chi-square tests used for categorical and dichotomous variables, t-tests used for continuous variables. Statistical tests had a null hypothesis of no difference in the distribution of the variables between interviewees and non-interviewees. **Patients were considered lower SES if they were below 138% of the Federal Poverty Level based on income and household size for the calendar year they were enrolled in the trial. Table 2 Select characteristics of participating surgeons (n = 16) Characteristic Arm, n (%) Option Grid 5 (31%) Picture Option Grid 6 (38%) Usual Care 5 (31%) Female Sex, n (%) 13 (81%) Years since graduating medical school, m (range) 23 years (10–44) Years at current site, m (range) 10 (< 1 to 30) Interest in SDM before trial 16 (100%) Table 3 Summary of major themes by NPT construct NPT Construct Major themes Coherence Patients thought the Option Grids were easier to understand and more concise than other breast cancer materials. Using the Option Grids felt like usual care for surgeons. Cognitive participation Patients and surgeons recommended using Option Grids and were open to receiving and using them in various ways. Collective action Surgeons (after a few uses) and patients perceived the Option Grids were a part of a normal work routine. Reflexive monitoring Surgeons did not feel the Option Grids increased their consultation time. Supplementary Files Appendixfigure1COREQchecklist.pdf COREQ research checklist Appendixfigure2.pdf Interview guides Appendixfigure3.pdf Observation Grid Appendixfigure4.pdf NoMAD instrument APPENDIX.docx Cite Share Download PDF Status: Published Journal Publication published 10 May, 2021 Read the published version in Implementation Science → Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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Yen","email":"","orcid":"","institution":"The Dartmouth Institute for Health Policy and Clinical Practice","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Renata","middleName":"W.","lastName":"Yen","suffix":""},{"id":3483593,"identity":"d849f385-da01-4dba-b258-72291d8ab621","order_by":2,"name":"Catherine H. 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James O’Malley","email":"","orcid":"","institution":"The Dartmouth Institute for Health Policy and Clinical Practice","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"A.","middleName":"James","lastName":"O’Malley","suffix":""},{"id":3483597,"identity":"9290d765-80af-4acd-96b3-93307bee9b6f","order_by":6,"name":"Mary C. Politi","email":"","orcid":"","institution":"Washington University School of Medicine in St Louis Department of Surgery","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Mary","middleName":"C.","lastName":"Politi","suffix":""},{"id":3483598,"identity":"07beb35b-23ce-4d15-9384-6e7169a3f6cb","order_by":7,"name":"Julie Margenthaler","email":"","orcid":"","institution":"Washington University School of Medicine in St Louis Department of Surgery","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Julie","middleName":"","lastName":"Margenthaler","suffix":""},{"id":3483599,"identity":"2bd9aea8-02c7-4577-a5cc-b2207f660410","order_by":8,"name":"Robert J. Volk","email":"","orcid":"","institution":"The University of Texas MD Anderson Cancer Center Division of Cancer Prevention and Population Sciences","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Robert","middleName":"J.","lastName":"Volk","suffix":""},{"id":3483600,"identity":"ef653bce-f696-41ec-9136-7266da2b81af","order_by":9,"name":"Karen Sepucha","email":"","orcid":"","institution":"Massachusetts General Hospital Division of General Internal Medicine","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Karen","middleName":"","lastName":"Sepucha","suffix":""},{"id":3483601,"identity":"2b650b8b-56fe-43f6-a9cf-29129b0bc9ac","order_by":10,"name":"Elissa Ozanne","email":"","orcid":"","institution":"University of Utah Health","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Elissa","middleName":"","lastName":"Ozanne","suffix":""},{"id":3483602,"identity":"6b819228-81b0-49b8-85bc-e11923cb24bd","order_by":11,"name":"Sanja Percac-Lima","email":"","orcid":"","institution":"Massachusetts General Hospital Chelsea Healthcare Center","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Sanja","middleName":"","lastName":"Percac-Lima","suffix":""},{"id":3483603,"identity":"81828e36-f12b-429c-901b-03cc9b87e61e","order_by":12,"name":"Ann Bradley","email":"","orcid":"","institution":"The Dartmouth Institute for Health Policy and Clinical Practice","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Ann","middleName":"","lastName":"Bradley","suffix":""},{"id":3483604,"identity":"8dcdc004-8284-46f1-ac49-d6fb5822c777","order_by":13,"name":"Courtney Goodwin","email":"","orcid":"","institution":"Washington University in St Louis Department of Surgery","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Courtney","middleName":"","lastName":"Goodwin","suffix":""},{"id":3483605,"identity":"3ea8f4d9-45be-4733-a4ab-9ef65505adf1","order_by":14,"name":"Maria van den Muijsenbergh","email":"","orcid":"","institution":"Radboudumc","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Maria","middleName":"van den","lastName":"Muijsenbergh","suffix":""},{"id":3483606,"identity":"f77a32f1-b580-48c9-b8d8-a6cd8256df3f","order_by":15,"name":"Johanna WM Aarts","email":"","orcid":"","institution":"Amsterdamumc","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Johanna","middleName":"WM","lastName":"Aarts","suffix":""},{"id":3483607,"identity":"e95cd52d-e524-4549-85b6-9dfe46fba1a1","order_by":16,"name":"Peter Scalia","email":"","orcid":"","institution":"The Dartmouth Institute for Health Policy and Clinical Practice","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Peter","middleName":"","lastName":"Scalia","suffix":""},{"id":3483608,"identity":"03ee287a-3deb-4a7a-84e8-7f254456f93d","order_by":17,"name":"Marie-Anne Durand","email":"data:image/png;base64,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","orcid":"https://orcid.org/0000-0002-8173-1993","institution":"Université Toulouse III Paul Sabatier, Toulouse, France","correspondingAuthor":true,"submittingAuthor":false,"prefix":"","firstName":"Marie-Anne","middleName":"","lastName":"Durand","suffix":""}],"badges":[],"createdAt":"2020-10-11 20:31:01","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-91143/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-91143/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s13012-021-01115-1","type":"published","date":"2021-05-10T21:05:03+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":13604875,"identity":"3a446fc6-dc7d-47d5-8426-9f6ca84fe97e","added_by":"auto","created_at":"2021-09-17 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20:51:03","extension":"pdf","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":1636014,"visible":true,"origin":"","legend":"Interview guides","description":"","filename":"Appendixfigure2.pdf","url":"https://assets-eu.researchsquare.com/files/rs-91143/v1/40725f17a87696ea99295b87.pdf"},{"id":3033239,"identity":"4a6ac6eb-7235-4159-8d7a-8638e9bf3c42","added_by":"auto","created_at":"2020-10-16 20:51:04","extension":"pdf","order_by":3,"title":"","display":"","copyAsset":false,"role":"supplement","size":58155,"visible":true,"origin":"","legend":"Observation Grid","description":"","filename":"Appendixfigure3.pdf","url":"https://assets-eu.researchsquare.com/files/rs-91143/v1/09e06c8010c415d4d1e4444f.pdf"},{"id":3033240,"identity":"3f8cd805-8b57-4799-a399-4c3374ebca0c","added_by":"auto","created_at":"2020-10-16 20:51:04","extension":"pdf","order_by":4,"title":"","display":"","copyAsset":false,"role":"supplement","size":186833,"visible":true,"origin":"","legend":"NoMAD instrument","description":"","filename":"Appendixfigure4.pdf","url":"https://assets-eu.researchsquare.com/files/rs-91143/v1/4e6957edecf487332166fb3f.pdf"},{"id":3033241,"identity":"9ebe141f-ed53-40e2-a66d-77cdba04ea07","added_by":"auto","created_at":"2020-10-16 20:51:04","extension":"docx","order_by":5,"title":"","display":"","copyAsset":false,"role":"supplement","size":38799,"visible":true,"origin":"","legend":"","description":"","filename":"APPENDIX.docx","url":"https://assets-eu.researchsquare.com/files/rs-91143/v1/bdbdd138bd241084f702dd8d.docx"}],"financialInterests":"","formattedTitle":"\u003cp\u003eImplementation and Sustainability Factors of Two Early-Stage Breast Cancer Conversation Aids in Diverse Practices\u003c/p\u003e","fulltext":[{"header":"Contributions To The Literature ","content":"\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003eBoth surgeons and patients, regardless of conversation aid used and socioeconomic status, recommended the early-stage breast cancer conversation aids be used in future breast cancer care.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eNormalization Process Theory (focused on health professionals\u0026rsquo; perspectives) can feasibly be used to analyze the patient perspective about the sustainable implementation of conversation aids into clinically diverse practices.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eTailoring the use of conversation aids to existing clinical workflows, flexibly of use, and taking into account patient characteristics and preferences, like health literacy, can facilitate sustained implementation.\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ul\u003e"},{"header":"1. Introduction","content":" \u003cp\u003eConversation aids help patients compare treatment options using evidence-based information to support them and their families in making a decision that is aligned with their preferences and values.[\u003cspan additionalcitationids=\"CR2\" citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e] However, sustained implementation of these conversation aids in clinical care is complex.[\u003cspan additionalcitationids=\"CR5 CR6 CR7 CR8 CR9 CR10 CR11 CR12\" citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e] Clinical barriers can include a lack of training on the conversation aids, clinician indifference on using them, lack of trust in the content of the conversation aids, and possible disruption of established clinic behaviors and workflows.[\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e] While training is recognized by clinic staff as an important way to promote shared decision making and the use of conversation aids, a common barrier to implementation is the lack of appropriate training on how best to use and integrate the conversation aids.[\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]\u003c/p\u003e \u003cp\u003eIn breast cancer care, clinicians tend to feel they communicate well with their patients and are reluctant to modify aspects of their usual care.[\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e] Clinicians also worry that it takes too much time to use a conversation aid and engage in shared decision making.[\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e] Buy-in at the clinic level, led by clinical champions, can reinforce the sustainability of an implemented conversation aid.[\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e] Despite the multiple barriers that exist, tailoring to the individual needs of clinics can ensure better sustainability of an implemented conversation aid.[\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e] System level barriers can include a lack of prioritizing implementation efforts and incentivization for clinicians and clinic staff.[\u003cspan additionalcitationids=\"CR6\" citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e] An organization\u0026rsquo;s willingness to adhere to guidelines promotes the implementation of conversation aids.[\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]\u003c/p\u003e \u003cp\u003ePatients with early-stage breast cancer are faced with a preference sensitive decision about their treatment options, mastectomy or breast conserving surgery with radiation.[\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e, \u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e] Patients of lower socioeconomic status (SES) who have early-stage breast cancer often have poorer communication with their doctors and health outcomes.[\u003cspan additionalcitationids=\"CR23 CR24 CR25\" citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e] Given evidence of the effectiveness of conversation aids, it is imperative to understand the factors and facilitators for routine implementation and sustainability of conversation aids in diverse clinical contexts for early-stage breast cancer, and particularly for patients of lower SES.[\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e, \u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e] While implementation and sustainability of conversation aids in routine clinical care has been evaluated in some contexts, the patient perspective has been notably absent in evaluation.[\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e, \u003cspan additionalcitationids=\"CR30 CR31\" citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e]\u003c/p\u003e \u003cp\u003eIn this study, we aimed to explore strategies that promote the conversation aids\u0026rsquo; sustained use and dissemination using a theoretical implementation model. We also aimed to distinguish any differences in experiences and opinions between the two conversation aids and across varied socioeconomic strata.\u003c/p\u003e "},{"header":"2. Methods","content":"\u003cp\u003eThis qualitative study uses data collected from a parent study, What Matters Most.[\u003cspan class=\"CitationRef\"\u003e33\u003c/span\u003e] The protocol for the parent study is published elsewhere.[\u003cspan class=\"CitationRef\"\u003e34\u003c/span\u003e] What Matters Most was a three-arm, multi-site, parallel randomized controlled trial of two early-stage breast cancer conversation aids across SES. We randomized surgeons to a text-based conversation aid (n\u0026thinsp;=\u0026thinsp;4), picture-based conversation aid (n\u0026thinsp;=\u0026thinsp;6), or usual care (n\u0026thinsp;=\u0026thinsp;6). Intervention surgeons were trained to use the conversation aid during the surgical consultation. Patients who provided consent at each site were assigned to their surgeon\u0026rsquo;s corresponding intervention. Research staff at each site were responsible for giving the paper-based conversation aid to eligible patients prior to their surgical consultation.\u003c/p\u003e\n\u003cp\u003eIn this qualitative study, we conducted semi-structured interviews with What Matters Most patient participants, trial surgeons, and other relevant stakeholders to explore how two conversation aids can be implemented and sustained in diverse contexts in the future. All methods and results are reported using the COnsolidated criteria for REporting Qualitative (COREQ) research checklist (see \u003cspan class=\"InternalRef\"\u003eAppendix\u003c/span\u003e, Fig.\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e).[\u003cspan class=\"CitationRef\"\u003e35\u003c/span\u003e]\u003c/p\u003e\n\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\n\u003ch2\u003e2.1 Interventions\u003c/h2\u003e\n\u003cp\u003eThe Option Grid conversation aid for early-stage breast cancer presents evidence-based information on breast conserving surgery (BCS) with radiation and mastectomy in a comparative table.[\u003cspan class=\"CitationRef\"\u003e36\u003c/span\u003e] The Picture Option Grid conversation aid includes the same information as the Option Grid, but uses pictures and fewer words. The Picture Option Grid was iteratively designed and developed using a Community Based Participatory Research approach.[\u003cspan class=\"CitationRef\"\u003e28\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e37\u003c/span\u003e] Pictures have been shown to improve comprehension of health information when closely linked with text or spoken words, and this relationship may be enhanced for individuals with lower health literacy.[\u003cspan class=\"CitationRef\"\u003e38\u003c/span\u003e\u0026ndash;\u003cspan class=\"CitationRef\"\u003e42\u003c/span\u003e] The Picture Option Grid was designed for use with all patients diagnosed with early-stage breast cancer during the surgical consultation, but particularly for patients with lower health literacy and lower SES. Both interventions are paper-based with a sixth grade readability level.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec4\" class=\"Section2\"\u003e\n\u003ch2\u003e2.2 Setting and participants\u003c/h2\u003e\n\u003cp\u003eWe recruited participants for interviews across seven clinics at four NCI-designated cancer centers in the United States with diverse patient populations. Three sites had urban and ethnically diverse populations, and one site had a rural, mostly white population. Two urban sites were specifically selected for recruiting patients of lower SES. Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e in the \u003cspan class=\"InternalRef\"\u003eappendix\u003c/span\u003e\u0026nbsp;summarizes usual care characteristics for each site.\u003c/p\u003e\n\u003cdiv id=\"Sec4\" class=\"Section2\"\u003e\n\u003cp\u003eWe interviewed:\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003eAll What Matters Most trial participating surgeons after trial involvement (n\u0026thinsp;=\u0026thinsp;16). Prior to starting the trial, all surgeons underwent training using videos and role-plays that included information about the trial protocol, shared decision making, and communication skills. Training also included teaching how to use the conversation aid during the surgical encounter if the surgeon was randomized to using one of the two conversation aids.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eA purposive sample of trial patient participants in intervention arms who agreed to be contacted for a 3-month post-operative interview. Family of invited patient participants were allowed to join the patient\u0026rsquo;s interview if they were involved in the surgical consultation when the intervention was used. Please see the parent trial protocol for participant inclusion criteria.[\u003cspan class=\"CitationRef\"\u003e34\u003c/span\u003e]\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eClinical and non-clinical stakeholders, including nurse practitioners, nurses, physician assistants, social workers, administrators, and electronic health record (EHR) specialists. Most interviewed clinical stakeholders and one non-clinical stakeholder were part of integrating the trial activities in the clinics where they worked. Some non-clinical stakeholders, in administration, provided initial support for the conversation aids\u0026rsquo; use as well.\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eWe planned to collect up to 60 patient interviews and 40 surgeon and stakeholder interviews.[\u003cspan class=\"CitationRef\"\u003e34\u003c/span\u003e] We discussed data saturation as a core group (M-AD, RWY, CHS, DS, GE) as interviews were occurring, and with the broader parent trial team and stakeholders to reach consensus on when to stop conducting interviews. Retrospectively, we conducted a saturation test using Guest and colleagues\u0026rsquo; approach to assess and report thematic saturation in qualitative research (p\u0026thinsp;\u0026lt;\u0026thinsp;0.05).[\u003cspan class=\"CitationRef\"\u003e43\u003c/span\u003e]\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec5\" class=\"Section2\"\u003e\n\u003ch2\u003e2.3 Theoretical framework and interview guides\u003c/h2\u003e\n\u003cp\u003eWe developed semi-structured interview guides in partnership with the parent trial\u0026rsquo;s surgeon, patient, and professional stakeholders as part of a Community Based Participatory Research approach.[\u003cspan class=\"CitationRef\"\u003e28\u003c/span\u003e] There were separate interview guides for the patients, intervention surgeons, usual care surgeons, clinical stakeholders, and non-clinical stakeholders (See \u003cspan class=\"InternalRef\"\u003eAppendix\u003c/span\u003e, Fig.\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e). In designing the interview guides, we targeted a 30-minute interview duration. We piloted all interview guides with team members, including patient partners (breast cancer survivors), and made necessary revisions before starting data collection. Revisions included making sure the interview flowed smoothly and reducing repetition.\u003c/p\u003e\n\u003cp\u003eWe developed the guides using the constructs and components of Normalization Process Theory (NPT). NPT is a framework that was developed to understand how complex interventions become implemented in routine healthcare settings using four theoretical constructs to contextualize implementation mechanisms.[\u003cspan class=\"CitationRef\"\u003e44\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e45\u003c/span\u003e] NPT has reliably been used to evaluate implementation and sustainability of similar conversation aids like Option Grid in the past. However, NPT has not been used to analyze the patient perspective on implementation and sustainability.[\u003cspan class=\"CitationRef\"\u003e29\u003c/span\u003e\u0026ndash;\u003cspan class=\"CitationRef\"\u003e32\u003c/span\u003e] NPT\u0026rsquo;s four theoretical constructs include: 1) Coherence: processes of individual and communal sense-making of a complex intervention regarding its use and value; 2) Cognitive participation: processes that promote or hinder users\u0026rsquo; buy-in and commitment to the intervention; 3) Collective action: processes that determine whether the intervention is being used by all as intended; and 4) Reflexive monitoring: processes of communal and individual appraisal of the effect of the intervention.[\u003cspan class=\"CitationRef\"\u003e46\u003c/span\u003e]\u003c/p\u003e\n\u003cp\u003eWe also developed the interview guides with a few hypotheses in mind, although not typically required in qualitative research. Rather, we used these hypotheses as probes used during the semi-structured interviews to explore their role in sustained use of the conversation aids. Our first hypothesis was that pre-visit planning, minimal clinician training, flexibility of use, and integration into the workflow and EHR would facilitate future sustained use. Our second hypothesis was that successful use by patients and families will be determined by the perceived acceptability of the intervention and integration into workflows. For full hypotheses, refer to the parent trial protocol.[\u003cspan class=\"CitationRef\"\u003e34\u003c/span\u003e]\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec6\" class=\"Section2\"\u003e\n\u003ch2\u003e2.4 Procedure\u003c/h2\u003e\n\u003cdiv id=\"Sec7\" class=\"Section3\"\u003e\n\u003ch2\u003e2.4.1 Patient interviews\u003c/h2\u003e\n\u003cp\u003eResearch staff at each site conducted the semi-structured interviews with patients. All interviewers were female and ranged in education from a bachelor\u0026rsquo;s degree to a master\u0026rsquo;s degree. Two study members (RWY and M-AD) trained research staff at each site in semi-structured interview techniques, such as probing and redirection, before conducting interviews.\u003c/p\u003e\n\u003cp\u003eResearch staff approached previously-consented parent trial patient participants via phone call or in-person at a patient\u0026rsquo;s follow-up appointment in the clinic three months after the patient\u0026rsquo;s surgery. Research staff made no more than five attempts to contact participants to schedule an interview. After each research team member conducted their first interview, two members of the research team (RWY and M-AD) reviewed the transcript and gave feedback to the interviewer on their interview techniques. Research staff conducted interviews over the phone or in-person depending on the interview participant\u0026rsquo;s preference and availability. Apart from recruiting the participants into the parent trial, there was no established relationship between the interviewers and the interview participants. We ensured interview participants had a copy of the conversation aid they used in the trial before the interviews were conducted. All patient participants were compensated for their time with a $30 gift card. No repeat interviews were carried out. Interview field notes were not taken.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec8\" class=\"Section3\"\u003e\n\u003ch2\u003e2.4.2 Surgeon and stakeholder interviews\u003c/h2\u003e\n\u003cp\u003eSurgeons consented to be contacted for the post-trial interview prior to the recruitment of patients for the study. Stakeholders consented to the interview after being contacted post-trial. We chose a researcher external to What Matters Most (RF), a female PhD candidate with a master's degree, to conduct the surgeon and stakeholder interviews to minimize positive response bias. The researcher conducted the interviews over the phone. All surgeon and stakeholder interview participants consented to their interview being audio-recorded. Surgeon and stakeholder interviews were aware that the interviewer was outside of the parent trial.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec9\" class=\"Section3\"\u003e\n\u003ch2\u003e2.4.3 Observations and field notes\u003c/h2\u003e\n\u003cp\u003eResearch staff at each site were trained in ethnographically informed methods prior to recruiting participants for the broader study. Research staff collected observational information from each site using an Observation Grid (See \u003cspan class=\"InternalRef\"\u003eAppendix\u003c/span\u003e, Fig.\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e3\u003c/span\u003e). The Observation Grid included sections on identifying materials in the clinics and chatter from clinic staff and patients about the study or the materials associated with the study. Additionally, research staff were encouraged to ask clinic staff questions about the study and the conversation aids. Lastly, research staff were encouraged to write down their thoughts about what they observed and questions or concerns raised from the observational data in a weekly email to the study coordinator (RWY) throughout parent trial recruitment.\u003c/p\u003e\n\u003c/div\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec10\" class=\"Section2\"\u003e\n\u003ch2\u003e2.5 Data management and analysis\u003c/h2\u003e\n\u003cdiv id=\"Sec11\" class=\"Section3\"\u003e\n\u003ch2\u003e2.5.1 Data management\u003c/h2\u003e\n\u003cp\u003eInterview audio-recordings were transcribed verbatim by a HIPAA-compliant professional transcription service, Civicom Inc. For interviews that were conducted without a recording, the interviewer took in-depth notes on the interview guide for coding and analysis. The transcripts were not returned to participants for comments or corrections. While we did not check with the interview participants themselves, we confirmed our findings with the parent trial\u0026rsquo;s stakeholders, patient partners, and Community Advisory Board.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec12\" class=\"Section3\"\u003e\n\u003ch2\u003e2.5.2 Analysis\u003c/h2\u003e\n\u003cp\u003eWe used a hybrid approach to our analysis, including framework and inductive analyses. Our main analysis was guided by NPT, however, we conducted an inductive analysis to allow for new codes to emerge. We also conducted additional sub-analyses based on conversation aid used (Picture Option Grid versus Option Grid) and participant SES. For this sub-study, we stratified patients according to higher or lower SES by using their reported income level and number of dependents to calculate if they were above or below the 138% federal poverty level in the year of recruitment.[\u003cspan class=\"CitationRef\"\u003e47\u003c/span\u003e] If income was not available, we used health insurance as a proxy where no insurance or government insurance without supplemental indicated lower SES, and private insurance or government insurance with supplemental indicated higher SES. We conducted \u003cem\u003e\u0026chi;\u003c/em\u003e\u003csup\u003e2\u003c/sup\u003e tests and two-sample t-tests to determine if there were significant differences between those who declined versus not when approached.\u003c/p\u003e\n\u003cp\u003eWe analyzed all interview transcripts, field notes, and observations using NPT through the lens of the NOrmalization MeAsure Development (NoMAD) instrument. The NoMAD instrument is a 20-item list organized by NPT constructs (see \u003cspan class=\"InternalRef\"\u003eAppendix\u003c/span\u003e, Fig.\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e4\u003c/span\u003e).[\u003cspan class=\"CitationRef\"\u003e48\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e49\u003c/span\u003e] NoMAD uses NPT constructs and components to assess participants\u0026rsquo; opinions about how an intervention impacts their work and whether the intervention can be integrated and routinely used in their practice. The NoMAD items that correspond to NPT are composed of \u0026ldquo;I\u0026rdquo; statements like, \u0026ldquo;I can see the potential value of Option Grid/Picture Option Grid for my work\u0026rdquo;. Given NoMAD was not originally designed to evaluate implementation from the patient\u0026rsquo;s perspective, we adapted it for patient interviews. We adapted NoMAD to include the patient perspective by looking at the definition NoMAD provides for each NPT component and construct (for health professionals) and adapting item wording to focus on the patient experience. Adaptation occurred through collaboration between the two coders and arbitration by the senior author. See \u003cspan class=\"InternalRef\"\u003eAppendix\u0026nbsp;\u003c/span\u003eTable\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e for NoMAD\u0026rsquo;s definitions of each NPT construct and component for this study, including our addition of the patient perspective.\u003c/p\u003e\n\u003cp\u003eTwo researchers (DS and RWY) purposively selected six interview transcripts that were evenly divided between the type of interview (patient, surgeon, stakeholder) and coded them using both the NPT framework and descriptive codes to develop the codebook. The coders shared the codebook with two other team members (M-AD and GE) before continuing coding. One researcher coded a 20% purposive sample of the interviews (RWY) selected across types of interview (patient, surgeon, stakeholder) and study site. Another researcher (DS) coded all interview transcriptions, observations, and notes. Where there was disagreement between coders, a third individual helped the primary coders reach consensus (M-AD). All coding was conducted using ATLAS.ti. A research collaborator outside of What Matters Most with experience in NPT (PS) convened with the two coders to help determine the major and minor themes that emerged from the data once coding was completed.\u003c/p\u003e\n\u003c/div\u003e\n\u003c/div\u003e"},{"header":"3. Results","content":"\u003cdiv id=\"Sec14\" class=\"Section2\"\u003e\n\u003ch2\u003e3.1 Participant characteristics\u003c/h2\u003e\n\u003cp\u003e\u003cem\u003ePatients\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eForty-three of 76 patients approached (56.6%) agreed to be interviewed. Those who declined were more likely to be Hispanic, Spanish-speaking, have less education, and be of lower SES. Eighteen of the patients interviewed received the Option Grid in their surgical encounters, and 25 patients received the Picture Option Grid. Over half of patients were White, non-Hispanic and spoke primarily English. About a quarter of the patients were Black, non-Hispanic, and all others were either Hispanic or Asian. Fifty-one percent of patients had a 2-year college degree or higher. Approximately three quarters of the patients were considered higher SES. Please see Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e for detailed patient participant characteristics, stratified by consent status. Imbalances in intervention received and socioeconomic status categories are consistent with the larger trial data.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eSurgeons and stakeholders\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eAll trial surgeons (n\u0026thinsp;=\u0026thinsp;16) participated in the interviews (five used Option Grid, six used Picture Option Grid, and five used usual care). The surgeons were majority female (81%), had an average of 23\u0026nbsp;years since graduating medical school, and an average of 10\u0026nbsp;years working at their current site. All surgeons had interest in shared decision making prior to the study. See Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e.\u003c/p\u003e\n\u003cp\u003eThirty other stakeholders were contacted for an interview, of which 14 were interviewed. These 14 stakeholders included three nurse practitioners, three nurses, one physician assistant, one social worker, and six other non-clinical stakeholders that serve in administration or EHR-related roles.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec15\" class=\"Section2\"\u003e\n\u003ch2\u003e3.2 Setting and interview characteristics\u003c/h2\u003e\n\u003cp\u003eForty-nine interviews were conducted over the phone, 19 in clinic, and 5 in other locations (e.g., office). Four interviewees declined to be recorded, so the interviewer took detailed notes. One patient recording was lost due to technical difficulties. The average length of interviews for patients, surgeons, and stakeholders was 24, 27, and 20 minutes respectively. Please see Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e3\u003c/span\u003e in the \u003cspan class=\"InternalRef\"\u003eappendix\u003c/span\u003e\u0026nbsp;for the average length of interviews stratified by site and interviewee type. No individuals other than the interviewer and participant were present for the interviews.\u003c/p\u003e\n\n\u003cdiv id=\"Sec16\" class=\"Section2\"\u003e\n\u003ch2\u003e3.3 Major themes according to NPT construct\u003c/h2\u003e\n\u003cp\u003eTable\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e3\u003c/span\u003e summarizes the major themes for patients and surgeons organized by the four NPT constructs.\u003c/p\u003e\n\u003cp\u003eThe following sections describe the major themes in more detail.\u003c/p\u003e\n\u003cdiv id=\"Sec17\" class=\"Section3\"\u003e\n\u003ch2\u003e3.3.1 Major themes related to coherence - \u0026ldquo;What is the work?\u0026rdquo;\u003c/h2\u003e\n\u003cp\u003eRegardless of SES and intervention received, when asked, most patients felt the conversation aids were easier to understand and more concise compared to other breast cancer materials they had received as part of their cancer care (Differentiation).\u003c/p\u003e\n\u003cp\u003e\u0026ldquo;\u003cem\u003eIt was more concise. Other materials I received, you had to read through a whole bunch of things before you could get to the end and decide.\"\u003c/em\u003e - Patient, Option Grid, Lower SES\u003c/p\u003e\n\u003cp\u003eFor most intervention surgeons, the use of the conversation aids felt similar to their usual care (Differentiation). However, for both interventions, about half of surgeons thought the conversation aids disrupted the flow of their usual conversation. For both interventions, half of the intervention surgeons and three other stakeholders felt that the conversation aids would be particularly helpful for patients with low health literacy or other associated factors like lower health literacy and limited formal education (Internalization).\u003c/p\u003e\n\u003cp\u003e\"\u003cem\u003eWhen you're sitting there and actually showing them the picture and they can visualize what you're telling them, it does help, especially in our patient population where they don't necessarily understand everything we are saying to them\u003c/em\u003e.\" - Clinical stakeholder\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec18\" class=\"Section3\"\u003e\n\u003ch2\u003e3.3.2 Major themes related to cognitive participation - \u0026ldquo;Who does the work?\u0026rdquo;\u003c/h2\u003e\n\u003cp\u003eFor both interventions, approximately one-third of patients thought email or the patient portal would hypothetically be a helpful way to receive the conversation aid. Patients were open to various methods of receiving the conversation aids (email, mail, patient portal), but almost all highlighted the importance of paper-based versions (Enrollment). Regardless of SES or intervention received, almost all patients recommended that others like them use the conversation aids. They felt the conversation aids should be used in breast cancer care in the future (Legitimation).\u003c/p\u003e\n\u003cp\u003e\"\u003cem\u003eI would give it to me on paper, but I would also send it to my email - it doesn\u0026rsquo;t have to be one way. It could be two ways, it could be three ways.\u003c/em\u003e\" - Patient, Picture Option Grid, Higher SES\u003c/p\u003e\n\u003cp\u003eHalf of the surgeons thought it would be helpful if patients received the conversation aids prior to their surgical consultation. For both interventions and including usual care, about half of surgeons felt integrating the conversation aids in the electronic health record and/or the patient portal would be helpful (Enrollment). Most surgeons recommended that others like them should use the conversation aids (Legitimation).\u003c/p\u003e\n\u003cp\u003e\"\u003cem\u003eI think having something beforehand, even if it\u0026rsquo;s just a heads-up, would be helpful.\u003c/em\u003e\" - Surgeon, Option Grid\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec19\" class=\"Section3\"\u003e\n\u003ch2\u003e3.3.3 Major themes related to collective action - \u0026ldquo;How does the work get done?\u0026rdquo;\u003c/h2\u003e\n\u003cp\u003eRegardless of SES or intervention received, over half of patients thought their surgeons used the conversation aid with ease and it appeared part of their normal routine (Interactional workability).\u003c/p\u003e\n\u003cp\u003e\u0026ldquo;...\u003cem\u003ebecause it flowed into our appointment so seamlessly. It definitely seemed like part of how [the surgeon] would present the information.\u003c/em\u003e\u0026rdquo; - Patient, Picture Option Grid, Higher SES\u003c/p\u003e\n\u003cp\u003eMost intervention surgeons had to use the conversation aid a few times before using it with ease. After a few uses, they felt the conversation aid was part of their normal routine (Interactional workability). For both interventions, all surgeons thought the training on shared decision making and how to use their assigned intervention was sufficient and did not recommend any changes (Skillset workability).\u003c/p\u003e\n\u003cp\u003e\"\u003cem\u003eWell, it became pretty much second-hand for me actually. I got really used to using it. It just became part of my routine.\u003c/em\u003e\" - Surgeon, Picture Option Grid\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec20\" class=\"Section3\"\u003e\n\u003ch2\u003e3.3.4 Major themes related to reflexive monitoring (\u0026ldquo;How is the work understood?\u0026rdquo;)\u003c/h2\u003e\n\u003cp\u003eFor both interventions, over half of patients felt the conversation aid affected their treatment decision (Systemization).\u003c/p\u003e\n\u003cp\u003e\"\u003cem\u003eI had a lumpectomy instead of a mastectomy because the information contained in the grid helped me understand that I didn\u0026rsquo;t need one [mastectomy].\u003c/em\u003e\" - Patient, Picture Option Grid, Higher SES\u003c/p\u003e\n\u003cp\u003eSurgeons understood the conversation aids were designed to help structure their conversation with eligible patients and help them make a treatment decision. For both interventions, all surgeons felt that the time it took to use the conversation aid did not change the typical time they spend with patients in the surgical consultation (Individual appraisal).\u003c/p\u003e\n\u003cp\u003e\"...\u003cem\u003eas I got faster, I got more used to it. It did help the rhythm. At first, it took me a little bit longer than I think it would\u0026rsquo;ve been, but not much. Then at the end, I think it ultimately helped structure things. It might have made things as efficient or more efficient.\u003c/em\u003e\" - Surgeon, Option Grid\u003c/p\u003e\n\u003cp\u003eSee Table\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e4\u003c/span\u003e in the \u003cspan class=\"InternalRef\"\u003eappendix\u0026nbsp;\u003c/span\u003efor a detailed analysis including major and minor themes from all types of stakeholders (patients, surgeons, other stakeholders) according to NPT constructs and components.\u003c/p\u003e\n\u003c/div\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec21\" class=\"Section2\"\u003e\n\u003ch2\u003e3.4 Comparing major themes by participant SES\u003c/h2\u003e\n\u003cp\u003ePatients of higher SES, for both interventions, were more likely to find the conversation aid easier to understand than materials they had received before. They found the conversation aid concise and understood it was designed to help them compare their treatment options (Coherence). For patients of lower SES in the Picture Option Grid group who found the conversation aid easy to understand, all found the pictures played a significant role in their understanding (Coherence). Patients of lower SES who received Picture Option Grid and patients of higher SES who received Option Grid had a preference for paper-based conversation aids. Patients of higher SES reported more willingness to hypothetically receive the conversation aid ahead of their appointment (for example, through the patient portal) compared to patients of lower SES, who were more likely to mention that receiving it directly from their surgeon would be best (Cognitive participation). Patients of higher SES, for both interventions, mentioned more often that the conversation aid affected the discussion with their surgeon compared to patients of lower SES were more likely to mention it influenced their treatment decision (Reflexive monitoring).\u003c/p\u003e\n\u003cp\u003e\"\u003cem\u003eI interacted with the piece of paper a hundred times more than I would with the downloaded file if somebody had just sent that to me to look at before my appointment.\u003c/em\u003e\" - Patient, Option Grid, Higher SES\u003c/p\u003e\n\u003cp\u003e\"\u003cem\u003eI\u0026rsquo;d say it really influenced it [my decision].\u003c/em\u003e\" - Patient, Option Grid, Lower SES\u003c/p\u003e\n\u003cp\u003e\"\u003cem\u003eI would recommend it to everybody.\u003c/em\u003e\" - Patient, Option Grid, Lower SES\u003c/p\u003e\n\u003cp\u003eTable\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e5\u003c/span\u003e in the \u003cspan class=\"InternalRef\"\u003eappendix\u003c/span\u003e\u0026nbsp;features a detailed analysis comparing both major and minor themes by participant SES. Tables\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e6\u003c/span\u003e and \u003cspan class=\"InternalRef\"\u003e7\u003c/span\u003e in the \u003cspan class=\"InternalRef\"\u003eappendix\u003c/span\u003e\u0026nbsp;include a detailed analysis with both major and minor themes comparing SES for each intervention.\u003c/p\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec22\" class=\"Section2\"\u003e\n\u003ch2\u003e3.5 Comparing major themes by intervention\u003c/h2\u003e\n\u003cp\u003ePatients who received Picture Option Grid reported more willingness to hypothetically receive the conversation aid in advance of their appointment. Patients who received Option Grid were more likely to mention that receiving the conversation aid from their surgeon, and paper-based, would be best (Cognitive participation). Patients who received Option Grid found that using the conversation aid did not feel awkward (Collective action). Patients who received Option Grid were slightly more likely to feel the conversation aid influenced their discussion with their surgeon (Reflexive monitoring).\u003c/p\u003e\n\u003cp\u003e\"\u003cem\u003eCompletely influenced [my decision]\u003c/em\u003e\" - Patient, Option Grid, Higher SES\u003c/p\u003e\n\u003cp\u003e\"\u003cem\u003eIt needs to be something they can see online in MyChart. It should also be in a doctor\u0026rsquo;s office so that a woman can, you know, \u0026lsquo;Let me read this\u0026rsquo;.\u003c/em\u003e\" - Patient, Picture Option Grid, Lower SES\u003c/p\u003e\n\u003cp\u003eAll surgeons who used Option Grid felt using the conversation aid did not feel different from their usual practice compared to only half of surgeons who used Picture Option Grid (Coherence). Surgeons who used Picture Option Grid were more likely to mention the conversation aid should be given at the surgical consultation, as was done in the RCT. They were also more comfortable with their nurse or other qualified clinic personnel giving the conversation aid (Cognitive participation). Surgeons who used Picture Option Grid found they were able to integrate the conversation aid into their normal practice, especially after a few uses (Collective action). Some Picture Option Grid surgeons found the pictures not helpful, but most had no concerns with patients using the conversation aid.\u003c/p\u003e\n\u003cp\u003e\"\u003cem\u003eWell, it became pretty much second-hand for me actually. I got really used to using it so I don\u0026rsquo;t know. It just became part of my routine.\u003c/em\u003e\" - Surgeon, Picture Option Grid\u003c/p\u003e\n\u003cp\u003eTable\u0026nbsp;\u003cspan class=\"InternalRef\"\u003e8\u003c/span\u003e in the \u003cspan class=\"InternalRef\"\u003eappendix\u003c/span\u003e\u0026nbsp;includes a detailed analysis comparing both major and minor themes by intervention used or received.\u003c/p\u003e\n\u003c/div\u003e"},{"header":"4. Discussion","content":" \u003cdiv id=\"Sec24\" class=\"Section2\"\u003e \u003ch2\u003e4.1 Main findings\u003c/h2\u003e \u003cp\u003eIn this study, the future implementation of the early-stage breast cancer Option Grid conversation aids across diverse practices shows promise for sustainability. Key facilitators include adapting the conversation aids to existing clinical workflows, using them in an adaptable manner that fits best with a surgeon\u0026rsquo;s typical consultation, and taking into account patient characteristics and communication preferences. No major barriers were reported by patients, surgeons, or stakeholders in sustainably implementing these conversation aids in diverse practices.\u003c/p\u003e \u003cp\u003eOver half of patients thought their surgeons used the conversation aids as part of their usual care. Almost all recommended others like them use the conversation aids. Patients of higher SES were more likely to note the conversation aids influenced their treatment discussion, while patients of lower SES noted more influence on their decision making. Patients were open to receiving the conversation aids in various ways (EHR, patient portal, email, prior to appointment). For all intervention surgeons, using the conversation aids did not change the typical time they spent with their patients. Most intervention surgeons felt using the conversation aids was similar to their usual care. It felt part of their normal routine and took a few times before using the conversation aid with ease. Most surgeons recommended other surgeons like them use these conversation aids with their patients in the future. Overall, there were no noted major downsides to using the conversation aids in clinical practice, thus facilitating future adoption and potential sustainability of these conversation aids in diverse clinical settings.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec25\" class=\"Section2\"\u003e \u003ch2\u003e4.2 Strengths and limitations\u003c/h2\u003e \u003cp\u003eA strength of our study is the large number of interviews conducted with a diverse group of stakeholders. We had diversity in type of interviewee (patient, surgeon, stakeholder) and in demographics (race, SES, health literacy). Another strength is the involvement of a researcher not affiliated with the What Matters Most project to conduct the interviews with the surgeons and stakeholders to minimize positive response bias. Using NPT with multiple perspectives provided a holistic picture of the implementation and sustainability factors of the conversation aids. As a novel approach, we also used NPT with a patient perspective as it is equally important to understand the patient\u0026rsquo;s experiences and opinions regarding the implementation of conversation aids with diverse patient groups.\u003c/p\u003e \u003cp\u003eOne potential limitation is that we originally designed the interview guides primarily guided by NPT and its constructs and components. However, in analysis, we primarily used the NoMAD\u0026rsquo;s definition of NPT\u0026rsquo;s constructs and components. Therefore, there may be slight differences in interpretation. Another limitation is the discrepancy in patient interview lengths across the sites potentially resulting in some sites having more representation than others. However, the same training materials, training protocols, and transcript review mechanisms were used across all sites to promote consistency and quality control. There were also significant differences between patients who agreed to the interview compared to those who declined which might limit the generalizability of our findings. Decliners were more likely to be Hispanic, Spanish-speaking, have less education, and be of lower SES. Further, our results should be interpreted with caution as we conducted an implementation and sustainability assessment using an implementation framework in a comparative effectiveness trial.[\u003cspan citationid=\"CR50\" class=\"CitationRef\"\u003e50\u003c/span\u003e] Since surgeons and clinical staff were not asked to routinely integrate these conversation aids in their clinical practices, we cannot expect that the opinions and thoughts generated from these interviews were always directly related to implementation and sustainability factors, since the context of use was not an implementation study but a randomized controlled trial.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec26\" class=\"Section2\"\u003e \u003ch2\u003e4.3 Results in context\u003c/h2\u003e \u003cp\u003eOur findings align with existing evidence, including in early stage breast cancer, that it takes flexibility of use and a few tries for a clinician to become comfortable using a conversation aid.[\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e, \u003cspan citationid=\"CR51\" class=\"CitationRef\"\u003e51\u003c/span\u003e] A major component of integrating a conversation aid into a workflow is encounter duration. While previous barriers to implementation have noted surgeons\u0026rsquo; concern regarding conversation aids increasing encounter duration, our findings align with a previous study suggesting that surgeons did not report an impact of the conversation aids on the length of their regular consultation.[\u003cspan citationid=\"CR52\" class=\"CitationRef\"\u003e52\u003c/span\u003e]\u003c/p\u003e \u003cp\u003eSurgeons who were able to integrate the conversation aid in their daily clinical practice commented that the conversation aid was very similar to their usual consultation content, also seen in a similar study on contraceptive counseling.[\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e] Some patients, surgeons, and stakeholders were interested in integrating the conversation aids in the EHR. However, the sample was divided with emphasis on the importance of paper-based conversation aids. Our findings align with Politi et al.\u0026rsquo;s study that examined clinicians\u0026rsquo; use of tools where there is no \u0026ldquo;one-size-fits-all\u0026rdquo; approach to implementing conversation aids, with variation in patient preferences in format and clinicians\u0026rsquo; opinions about conversation aids.[\u003cspan citationid=\"CR53\" class=\"CitationRef\"\u003e53\u003c/span\u003e]\u003c/p\u003e \u003cp\u003eOur results coincide with another study on a different surgical conversation aid that most patients mentioned the best place to use the conversation aids was during the surgical consultation.[\u003cspan citationid=\"CR54\" class=\"CitationRef\"\u003e54\u003c/span\u003e] However, as also seen in Bunzli\u0026rsquo;s study, patients mentioned that receiving the conversation aid beforehand would be helpful in some circumstances provided the patient already knew their diagnosis.[\u003cspan citationid=\"CR54\" class=\"CitationRef\"\u003e54\u003c/span\u003e] Patients also noted that the conversation aids covered relevant content and the information provided was helpful and served as a helpful starting point. Our findings that patients felt the conversation aids covered relevant content and served as a starting point coincides with Bozic\u0026rsquo;s study findings on orthopaedic surgery decision and communication aids.[\u003cspan citationid=\"CR55\" class=\"CitationRef\"\u003e55\u003c/span\u003e]\u003c/p\u003e \u003cp\u003eAccording to patients and surgeons who liked using the conversation aids, they mentioned that Picture Option Grid appeared particularly powerful with the inclusion of images. Research shows that pictures in health communication may help better facilitate knowledge for disadvantaged patients than words alone.[\u003cspan additionalcitationids=\"CR39 CR40 CR41\" citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e] A systematic review showed pictures in health information moderately improved knowledge and recall, but largely increased knowledge for lower health literacy populations.[\u003cspan citationid=\"CR56\" class=\"CitationRef\"\u003e56\u003c/span\u003e] It is imperative to address patients with lower health literacy or other health inequities by developing and using conversation aids that address their needs.[\u003cspan citationid=\"CR57\" class=\"CitationRef\"\u003e57\u003c/span\u003e] Individual patient characteristics and the health system that they are familiar interacting with is an important determination for which conversation aid will be most helpful.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec27\" class=\"Section2\"\u003e \u003ch2\u003e4.4 Implications\u003c/h2\u003e \u003cp\u003eBarriers to implementing similar conversation aids continue to exist despite a general understanding that these conversation aids are helpful for patients.[\u003cspan additionalcitationids=\"CR59\" citationid=\"CR58\" class=\"CitationRef\"\u003e58\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR60\" class=\"CitationRef\"\u003e60\u003c/span\u003e] We found in our study that individual patient characteristics, like health literacy level and communication preferences, is important in determining which conversation aid will be most appropriate to use. However, clinicians' discretion may not suffice, in which case, patients should be offered a choice between the two conversation aids or given both. Healthcare professionals\u0026rsquo; willingness to use and confidence in the conversation aid is a facilitator to implementation. Those willing to integrate a conversation aid must do so by adapting it to their existing workflow and clinical environment to ensure sustained implementation. With a small learning curve and adjustment to workflow, surgeons we interviewed said that using the conversation aid did not seem to extend the consultation time, and they reported no major downsides to using them. This study exemplifies that commonly noted barriers to implementation and sustainability can be overcome with enough willingness to improve healthcare delivery from the patient, clinical, and organizational standpoints.\u003c/p\u003e \u003c/div\u003e "},{"header":"5. Conclusion","content":" \u003cp\u003eThis study is novel in our effort to understand the experiences and opinions of implementation and sustainability factors of two conversation aids for early-stage breast cancer with multiple stakeholder perspectives, including the patient perspective. We found that in order to successfully implement and ensure sustainability, the conversation aids must be skillfully adapted to clinical workflows and integrated flexibly in health professionals\u0026rsquo; usual care. Individual patient characteristics, like health literacy and existing knowledge about breast cancer, and communication preferences are an important factor in determining which conversation aid to use. However, we also recommend that patients are given a choice between the two or given both. Patients and surgeons agreed that the conversation aids should be used in breast cancer care in the future and were open to various methods of giving and receiving the conversation aid, allowing for adaptability of future implementation efforts. In this study, the future implementation of the early-stage breast cancer Option Grid conversation aids across diverse clinical practices shows promise for sustainability.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eEthics approval for this study was provided by the Dartmouth Committee for the Protection of Human Subjects on June 8, 2017. Montefiore Medical Center provided an authorization agreement to rely on Dartmouth\u0026rsquo;s approval on September 8, 2017. Ethics approval was provided by Washington University in St. Louis Institutional Review Board on May 9, 2017. New York University School of Medicine provided ethics approval on August 29, 2017.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe dataset analyzed during the current study is not publicly available due to the protection of the human subjects involved in the qualitative interviews. A deidentified copy of the dataset is available from the corresponding author on reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cp\u003eGlyn Elwyn has edited and published books that provide royalties on sales by the publishers: the books include \u003cem\u003eShared Decision Making \u003c/em\u003e(Oxford University Press) and \u003cem\u003eGroups \u003c/em\u003e(Radcliffe Press). Glyn Elwyn\u0026rsquo;s academic interests are focused on shared decision making and coproduction. He owns copyright in measures of shared decision making and care integration, namely \u003cstrong\u003ecollabo\u003c/strong\u003eRATE, \u003cstrong\u003einteg\u003c/strong\u003eRATE (measure of care integration), \u003cstrong\u003econside\u003c/strong\u003eRATE (patient experience of care in serious illness), \u003cstrong\u003ecoope\u003c/strong\u003eRATE (measure of goal setting), \u003cstrong\u003etole\u003c/strong\u003eRATE (clinician attitude to shared decision making), Observer OPTION-5, and Observer OPTION-12 (observer measures of shared decision making). He has in the past provided consultancy for organizations, including: 1) Emmi Solutions, LLC who developed patient decision support tools; 2) National Quality Forum on the certification of decision support tools; 3) Washington State Health Department on the certification of decision support tools; 4) SciMentum LLC, Amsterdam (workshops for shared decision making). He is the Founder and Director of \u0026amp;think LLC, which owns the registered trademark for Option GridsTM patient decision aids; Founder and Director of \u003cstrong\u003eSHARP\u003c/strong\u003eNETWORK LLC, a provider of training for shared decision making. He provides advice in the domain of shared decision making and patient decision aids to: 1) Access Community Health Network, Chicago (Adviser to Federally Qualified Medical Centers); 2) EBSCO Health for Option GridsTM patient decision aids (consultant); 3) Bind on Demand Health Insurance (consultant); 4) PatientWisdom Inc (adviser); 5) abridge AI Inc (Chief Clinical Research Scientist).\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eGlyn Elwyn and Marie-Anne Durand have developed the Option Grid conversation aids, which are licensed to EBSCO Health. They receive consulting income from EBSCO Health, and may receive royalties in the future. Marie-Anne Durand was a consultant for ACCESS Community Health Network until 2019.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eFrom 2014-2018, Dr. Karen Sepucha received salary support as a member of the scientific advisory board for Healthwise, a not-for-profit foundation that develops and distributes patient education and decision support materials.\u003c/p\u003e\n\u003c/li\u003e\n\u003cli\u003e\n\u003cp\u003eCatherine Hylas Saunders holds copyright in the consideRATE suite of tools.\u003c/p\u003e\n\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eNo other competing interests declared.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe research reported in this manuscript is funded through a Patient-Centered Outcomes Research Institute (PCORI) Award (1511-32875). The statements presented in this manuscript are solely the responsibility of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute (PCORI), its Board of Governors or Methodology Committee.\u003c/p\u003e\n\u003cp\u003eThe study funder has no role in any aspects of the set up or execution of the study or manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStudy sponsor\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTrustees of Dartmouth College Office of Sponsored Projects, 11 Rope Ferry Road #6210, Hanover, NH, 03755, \u003ca href=\"mailto:[email protected]\"\[email protected]\u003c/a\u003e\u003c/p\u003e\n\u003cp\u003eThe study sponsor has no role in any aspects of the set up or execution of the study or manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026rsquo; Contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDanielle Schubbe:\u003c/strong\u003e Methodology, Formal analysis, Investigation, Data curation, Writing - original draft, Visualization; \u003cstrong\u003eRenata W Yen:\u003c/strong\u003e Conceptualization, Methodology, Formal analysis, Investigation, Resources, Data curation, Writing - review \u0026amp; editing, Supervision, Project administration;\u003cstrong\u003e Catherine H Saunders:\u003c/strong\u003e Investigation, Writing - review \u0026amp; editing; \u003cstrong\u003eGlyn Elwyn: \u003c/strong\u003eConceptualization, Methodology, Writing - review \u0026amp; editing, Supervision, Funding acquisition; \u003cstrong\u003eRachel Forcino\u003c/strong\u003e: Investigation, Writing - review \u0026amp; editing; \u003cstrong\u003eJames O\u0026rsquo;Malley:\u003c/strong\u003e Conceptualization, Writing - review \u0026amp; editing; \u003cstrong\u003eMary Politi: \u003c/strong\u003eConceptualization, Resources, Writing - review \u0026amp; editing; \u003cstrong\u003eJulie Margenthaler:\u003c/strong\u003e Resources, Writing - review \u0026amp; editing; \u003cstrong\u003eRobert J. Volk:\u003c/strong\u003e Writing - review \u0026amp; editing; \u003cstrong\u003eKaren Sepucha:\u003c/strong\u003e Writing - review \u0026amp; editing; \u003cstrong\u003eElissa Ozanne:\u003c/strong\u003e Writing - review \u0026amp; editing; \u003cstrong\u003eSanja Percac-Lima:\u003c/strong\u003e Writing - review \u0026amp; editing; \u003cstrong\u003eAnn Bradley:\u003c/strong\u003e Investigation, Writing - review \u0026amp; editing; \u003cstrong\u003eCourtney Goodwin:\u003c/strong\u003e Investigation, Writing - review \u0026amp; editing; \u003cstrong\u003eMaria van den Muijsenbergh:\u003c/strong\u003e Supervision, Writing - review \u0026amp; editing; \u003cstrong\u003eAnnemijn Aarts: \u003c/strong\u003eSupervision, Writing - review \u0026amp; editing; \u003cstrong\u003ePeter Scalia: \u003c/strong\u003eFormal analysis, Writing - review \u0026amp; editing; \u003cstrong\u003eMarie-Anne Durand:\u003c/strong\u003e Conceptualization, Methodology, Investigation, Resources, Writing - review \u0026amp; editing, Supervision, Project administration, Funding acquisition\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgments\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe want to thank all patients, surgeons, and stakeholders who took part in the interviews for this study. We also want to thank our trial\u0026rsquo;s Community Advisory Board, Data Safety and Monitoring Board, and Trial Steering Group for their monitoring and guidance.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eStacey D, L\u0026eacute;gar\u0026eacute; F, Lewis K, Barry MJ, Bennett CL, Eden KB, et al. Decision aids for people facing health treatment or screening decisions [Internet]. Cochrane Database of Systematic Reviews. 2017. Available from: http://dx.doi.org/10.1002/14651858.cd001431.pub5\u003c/li\u003e\n\u003cli\u003eScalia P, Durand M-A, Berkowitz JL, Ramesh NP, Faber MJ, Kremer JAM, et al. The impact and utility of encounter patient decision aids: Systematic review, meta-analysis and narrative synthesis [Internet]. Patient Education and Counseling. 2019. p. 817\u0026ndash;41. 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Available from: https://idp.springer.com/authorize/casa?redirect_uri=https://link.springer.com/article/10.1007/s11606-019-05239-5\u0026amp;casa_token=TO9sxsqsQpwAAAAA:0r1cHVbmOZ8AbTI4FuxdtiHCtUl6M5UepEj4tj398MLWlneDlJ5hTCeuyse8T48MieyNPzL6C5YKnokmMw\u003c/li\u003e\n\u003cli\u003eO\u0026rsquo;Brien MA, Charles C, Lovrics P, Wright FC, Whelan T, Simunovic M, et al. Enablers and barriers to using patient decision aids in early stage breast cancer consultations: a qualitative study of surgeons\u0026rsquo; views. Implement Sci [Internet]. 2014;9:174. Available from: http://dx.doi.org/10.1186/s13012-014-0174-0\u003c/li\u003e\n\u003cli\u003eMyckatyn TM, Parikh RP, Lee C, Politi MC. Challenges and Solutions for the Implementation of Shared Decision-making in Breast Reconstruction. Plast Reconstr Surg Glob Open [Internet]. 2020;8:e2645. Available from: http://dx.doi.org/10.1097/GOX.0000000000002645\u003c/li\u003e\n\u003cli\u003eMunro S, Manski R, Donnelly KZ, Agusti D, Stevens G, Banach M, et al. Investigation of factors influencing the implementation of two shared decision-making interventions in contraceptive care: a qualitative interview study among clinical and administrative staff. Implement Sci [Internet]. 2019;14:95. Available from: http://dx.doi.org/10.1186/s13012-019-0941-z\u003c/li\u003e\n\u003cli\u003eStacey D, Vandemheen KL, Hennessey R, Gooyers T, Gaudet E, Mallick R, et al. Implementation of a cystic fibrosis lung transplant referral patient decision aid in routine clinical practice: an observational study. Implement Sci [Internet]. 2015;10:17. Available from: http://dx.doi.org/10.1186/s13012-015-0206-4\u003c/li\u003e\n\u003cli\u003eKlaassen LA, Friesen-Storms JHHM, Bours GJJW, Dirksen CD, Boersma LJ, Hoving C. Perceived facilitating and limiting factors for healthcare professionals to adopting a patient decision aid for breast cancer aftercare: A cross-sectional study. Patient Educ Couns [Internet]. 2020;103:145\u0026ndash;51. Available from: http://dx.doi.org/10.1016/j.pec.2019.07.024\u003c/li\u003e\n\u003cli\u003ePDQ Adult Treatment Editorial Board. Breast Cancer Treatment (Adult) (PDQ\u0026reg;): Patient Version. PDQ Cancer Information Summaries [Internet]. Bethesda (MD): National Cancer Institute (US); 2019. Available from: https://www.ncbi.nlm.nih.gov/pubmed/26389406\u003c/li\u003e\n\u003cli\u003eTreatment of Early-Stage Breast Cancer. JAMA [Internet]. American Medical Association; 1991 [cited 2020 Aug 9];265:391\u0026ndash;5. Available from: https://jamanetwork.com/journals/jama/article-abstract/384776\u003c/li\u003e\n\u003cli\u003eWheeler SB, Reeder-Hayes KE, Carey LA. Disparities in breast cancer treatment and outcomes: biological, social, and health system determinants and opportunities for research. Oncologist [Internet]. 2013;18:986\u0026ndash;93. Available from: http://dx.doi.org/10.1634/theoncologist.2013-0243\u003c/li\u003e\n\u003cli\u003eHurd TC, James T, Foster JM. Factors that affect breast cancer treatment: underserved and minority populations. Surg Oncol Clin N Am [Internet]. 2005;14:119\u0026ndash;30, vii. Available from: http://dx.doi.org/10.1016/j.soc.2004.08.001\u003c/li\u003e\n\u003cli\u003eChen JY, Diamant AL, Thind A, Maly RC. Determinants of breast cancer knowledge among newly diagnosed, low-income, medically underserved women with breast cancer [Internet]. Cancer. 2008. p. 1153\u0026ndash;61. Available from: http://dx.doi.org/10.1002/cncr.23262\u003c/li\u003e\n\u003cli\u003eMcVea KL, Minier WC, Johnson Palensky JE. Low-income women with early-stage breast cancer: physician and patient decision-making styles. Psycho-Oncology: Journal of the Psychological, Social and Behavioral Dimensions of Cancer [Internet]. Wiley Online Library; 2001;10:137\u0026ndash;46. Available from: https://onlinelibrary.wiley.com/doi/abs/10.1002/pon.503\u003c/li\u003e\n\u003cli\u003ePolacek GNLJ, Ramos MC, Ferrer RL. Breast cancer disparities and decision-making among U.S. women. Patient Educ Couns [Internet]. 2007;65:158\u0026ndash;65. Available from: http://dx.doi.org/10.1016/j.pec.2006.06.003\u003c/li\u003e\n\u003cli\u003eHsu C, Liss DT, Westbrook EO, Arterburn D. Incorporating patient decision aids into standard clinical practice in an integrated delivery system. Med Decis Making [Internet]. 2013;33:85\u0026ndash;97. Available from: http://dx.doi.org/10.1177/0272989X12468615\u003c/li\u003e\n\u003cli\u003eDurand M-A, Alam S, Grande SW, Elwyn G. \u0026ldquo;Much clearer with pictures\u0026rdquo;: using community-based participatory research to design and test a Picture Option Grid for underserved patients with breast cancer. Available from: http://bmjopen.bmj.com/\u003c/li\u003e\n\u003cli\u003eScalia P, Elwyn G, Durand M-A. \u0026ldquo;Provoking conversations\u0026rdquo;: case studies of organizations where Option Grid\u003csup\u003eTM\u003c/sup\u003e decision aids have become \u0026ldquo;normalized\u0026rdquo; [Internet]. BMC Medical Informatics and Decision Making. 2017. Available from: http://dx.doi.org/10.1186/s12911-017-0517-2\u003c/li\u003e\n\u003cli\u003eLloyd A, Joseph-Williams N, Edwards A, Rix A, Elwyn G. Patchy \u0026ldquo;coherence\u0026rdquo;: using normalization process theory to evaluate a multi-faceted shared decision making implementation program (MAGIC). 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Available from: https://play.google.com/store/books/details?id=EQSIAwAAQBAJ\u003c/li\u003e\n\u003cli\u003eDurand MA, Yen RW, O\u0026rsquo;Malley AJ, Schubbe D, Politi MC, Saunders CH, Dhage S, Rosenkranz K, Margenthaler J, Tosteson ANA, Crayton E, Jackson S, Bradley A, WallingL, Marx CM, Volk RJ, Sepucha K, Ozanne E, Percac-Lima S, Bergin E, Goodwin C, MillerC, Harris C, Barth RJ Jr, Aft R, Feldman S, Cyr AE, Angeles CV, Jiang S, Elwyn G. What Matters Most: Randomized Controlled Trial of Breast Cancer Surgery Conversation Aids Across Socioeconomic Strata. Cancer. 2020;In Press.\u003c/li\u003e\n\u003cli\u003eDurand M-A, Yen RW, O\u0026rsquo;Malley AJ, Politi MC, Dhage S, Rosenkranz K, et al. What matters most: protocol for a randomized controlled trial of breast cancer surgery encounter decision aids across socioeconomic strata. BMC Public Health [Internet]. 2018;18:241. Available from: http://dx.doi.org/10.1186/s12889-018-5109-2\u003c/li\u003e\n\u003cli\u003eTong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care [Internet]. 2007;19:349\u0026ndash;57. Available from: http://dx.doi.org/10.1093/intqhc/mzm042\u003c/li\u003e\n\u003cli\u003eElwyn G, Lloyd A, Joseph-Williams N, Cording E, Thomson R, Durand M-A, et al. Option Grids: shared decision making made easier. Patient Educ Couns [Internet]. 2013;90:207\u0026ndash;12. Available from: http://dx.doi.org/10.1016/j.pec.2012.06.036\u003c/li\u003e\n\u003cli\u003eAlam S, Elwyn G, Percac-Lima S, Grande S, Durand M-A. Assessing the acceptability and feasibility of encounter decision aids for early stage breast cancer targeted at underserved patients [Internet]. BMC Medical Informatics and Decision Making. 2016. Available from: http://dx.doi.org/10.1186/s12911-016-0384-2\u003c/li\u003e\n\u003cli\u003eSudore RL, Schillinger D. Interventions to Improve Care for Patients with Limited Health Literacy. J Clin Outcomes Manag [Internet]. NIH Public Access; 2009;16:20\u0026ndash;9. Available from: http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=PMC2799039\u003c/li\u003e\n\u003cli\u003eLevie WH, Lentz R. Effects of text illustrations: A review of research. Educational Communication \u0026amp; Technology [Internet]. Springer US; 1982;30:195\u0026ndash;232. Available from: https://link.springer.com/article/10.1007/BF02765184\u003c/li\u003e\n\u003cli\u003eAlberto PA, Fredrick L, Hughes M, Cihak D. Components of Visual Literacy: 2007;22:234\u0026ndash;43. Available from: http://dx.doi.org/10.1177/10883576070220040501\u003c/li\u003e\n\u003cli\u003eAustin PE, Matlack R 2nd, Dunn KA, Kesler C, Brown CK. Discharge instructions: do illustrations help our patients understand them? Ann Emerg Med [Internet]. 25:317\u0026ndash;20. Available from: http://RY2UE4EK7D.search.serialssolutions.com/?sid=OVID:Ovid+MEDLINE%28R%29+%3C1988+to+1995%3E\u0026amp;genre=article\u0026amp;id=pmid:7532382\u0026amp;id=doi:\u0026amp;issn=0196-0644\u0026amp;volume=25\u0026amp;issue=3\u0026amp;spage=317\u0026amp;pages=317-20\u0026amp;date=1995\u0026amp;title=Annals+of+Emergency+Medicine\u0026amp;atitle=Discharge+instructions%3A+do+illustrations+help+our+patients+understand+them%3F.\u0026amp;aulast=Austin\u0026amp;pid=%3Cauthor%3EAustin+PE%3C%2Fauthor%3E\u0026amp;%3CAN%3E7532382%3C%2FAN%3E\u0026amp;ui=7532382\u003c/li\u003e\n\u003cli\u003eHill B, Perri-Moore S, Kuang J, Bray BE, Ngo L, Doig A, et al. Automated pictographic illustration of discharge instructions with Glyph: impact on patient recall and satisfaction. J Am Med Inform Assoc [Internet]. 23:1136\u0026ndash;42. Available from: http://RY2UE4EK7D.search.serialssolutions.com/?sid=OVID:Ovid+MEDLINE%28R%29+%3CAugust+Week+3+2017+-+December+Week+3+2017%3E\u0026amp;genre=article\u0026amp;id=pmid:27234601\u0026amp;id=doi:10.1093%2Fjamia%2Focw019\u0026amp;issn=1067-5027\u0026amp;volume=23\u0026amp;issue=6\u0026amp;spage=1136\u0026amp;pages=1136-1142\u0026amp;date=2016\u0026amp;title=Journal+of+the+American+Medical+Informatics+Association\u0026amp;atitle=Automated+pictographic+illustration+of+discharge+instructions+with+Glyph%3A+impact+on+patient+recall+and+satisfaction.\u0026amp;aulast=Hill\u0026amp;pid=%3Cauthor%3EHill+B%3C%2Fauthor%3E\u0026amp;%3CAN%3E27234601%3C%2FAN%3E\u0026amp;ui=27234601\u003c/li\u003e\n\u003cli\u003eGuest G, Namey E, Chen M. A simple method to assess and report thematic saturation in qualitative research. PLoS One [Internet]. 2020;15:e0232076. Available from: http://dx.doi.org/10.1371/journal.pone.0232076\u003c/li\u003e\n\u003cli\u003eMay CR, Finch T, Ballini L, MacFarlane A, Mair F, Murray E, et al. Evaluating complex interventions and health technologies using normalization process theory: development of a simplified approach and web-enabled toolkit [Internet]. BMC Health Services Research. 2011. Available from: http://dx.doi.org/10.1186/1472-6963-11-245\u003c/li\u003e\n\u003cli\u003eMay CR, Mair F, Finch T, MacFarlane A, Dowrick C, Treweek S, et al. Development of a theory of implementation and integration: Normalization Process Theory. Implement Sci [Internet]. 2009;4:29. Available from: http://dx.doi.org/10.1186/1748-5908-4-29\u003c/li\u003e\n\u003cli\u003eMay C, Finch T, Mair F, Ballini L, Dowrick C, Eccles M, et al. Understanding the implementation of complex interventions in health care: the normalization process model. BMC Health Serv Res [Internet]. 2007;7:148. Available from: http://dx.doi.org/10.1186/1472-6963-7-148\u003c/li\u003e\n\u003cli\u003eof Health USD, Services H. Prior HHS poverty guidelines and Federal Register references. Available from: https://aspe.hhs.gov/prior-hhs-poverty-guidelines-and-federal-register-references\u003c/li\u003e\n\u003cli\u003eRapley T, Girling M, Mair FS, Murray E, Treweek S, McColl E, et al. Improving the normalization of complex interventions: part 1 - development of the NoMAD instrument for assessing implementation work based on normalization process theory (NPT) [Internet]. BMC Medical Research Methodology. 2018. Available from: http://dx.doi.org/10.1186/s12874-018-0590-y\u003c/li\u003e\n\u003cli\u003eFinch TL, Girling M, May CR, Mair FS, Murray E, Treweek S, et al. Improving the normalization of complex interventions: part 2 - validation of the NoMAD instrument for assessing implementation work based on normalization process theory (NPT) [Internet]. BMC Medical Research Methodology. 2018. Available from: http://dx.doi.org/10.1186/s12874-018-0591-x\u003c/li\u003e\n\u003cli\u003eHerrmann A, Mansfield E, Hall AE, Sanson-Fisher R, Zdenkowski N. Wilfully out of sight? A literature review on the effectiveness of cancer-related decision aids and implementation strategies. BMC Med Inform Decis Mak [Internet]. 2016;16:36. Available from: http://dx.doi.org/10.1186/s12911-016-0273-8\u003c/li\u003e\n\u003cli\u003eFay M, Grande SW, Donnelly K, Elwyn G. Using Option Grids: steps toward shared decision-making for neonatal circumcision. Patient Educ Couns [Internet]. 2016;99:236\u0026ndash;42. Available from: http://dx.doi.org/10.1016/j.pec.2015.08.025\u003c/li\u003e\n\u003cli\u003eElwyn G, Rasmussen J, Kinsey K, Firth J, Marrin K, Edwards A, et al. On a learning curve for shared decision making: Interviews with clinicians using the knee osteoarthritis Option Grid. J Eval Clin Pract [Internet]. 2018;24:56\u0026ndash;64. Available from: http://dx.doi.org/10.1111/jep.12665\u003c/li\u003e\n\u003cli\u003ePoliti MC, Adsul P, Kuzemchak MD, Zeuner R, Frosch DL. Clinicians\u0026rsquo; perceptions of digital vs. paper-based decision support interventions. J Eval Clin Pract [Internet]. 2015;21:175\u0026ndash;9. Available from: http://dx.doi.org/10.1111/jep.12269\u003c/li\u003e\n\u003cli\u003eBunzli S, Nelson E, Scott A, French S, Choong P, Dowsey M. Barriers and facilitators to orthopaedic surgeons\u0026rsquo; uptake of decision aids for total knee arthroplasty: a qualitative study. BMJ Open [Internet]. 2017;7:e018614. Available from: http://dx.doi.org/10.1136/bmjopen-2017-018614\u003c/li\u003e\n\u003cli\u003eBozic KJ, Chenok KE, Schindel J, Chan V, Huddleston JI 3rd, Braddock C 3rd, et al. Patient, surgeon, and healthcare purchaser views on the use of decision and communication aids in orthopaedic surgery: a mixed methods study. BMC Health Serv Res [Internet]. 2014;14:366. Available from: http://dx.doi.org/10.1186/1472-6963-14-366\u003c/li\u003e\n\u003cli\u003eSchubbe D, Scalia P, Yen RW, Saunders CH, Cohen S, Elwyn G, et al. Using pictures to convey health information: A systematic review and meta-analysis of the effects on patient and consumer health behaviors and outcomes. Patient Educ Couns [Internet]. 2020; Available from: http://dx.doi.org/10.1016/j.pec.2020.04.010\u003c/li\u003e\n\u003cli\u003eMcCaffery KJ, Holmes-Rovner M, Smith SK, Rovner D, Nutbeam D, Clayman ML, et al. Addressing health literacy in patient decision aids. BMC Med Inform Decis Mak [Internet]. 2013;13 Suppl 2:S10. Available from: http://dx.doi.org/10.1186/1472-6947-13-S2-S10\u003c/li\u003e\n\u003cli\u003eBhavnani V, Fisher B. Patient factors in the implementation of decision aids in general practice: a qualitative study. Health Expect [Internet]. 2010;13:45\u0026ndash;54. Available from: http://dx.doi.org/10.1111/j.1369-7625.2009.00556.x\u003c/li\u003e\n\u003cli\u003eO\u0026rsquo;Donnell S, Cranney A, Jacobsen MJ, Graham ID, O\u0026rsquo;Connor AM, Tugwell P. Understanding and overcoming the barriers of implementing patient decision aids in clinical practice. J Eval Clin Pract [Internet]. 2006;12:174\u0026ndash;81. Available from: http://dx.doi.org/10.1111/j.1365-2753.2006.00613.x\u003c/li\u003e\n\u003cli\u003eSilvia KA, Ozanne EM, Sepucha KR. Implementing breast cancer decision aids in community sites: barriers and resources. Health Expect [Internet]. 2008;11:46\u0026ndash;53. Available from: http://dx.doi.org/10.1111/j.1369-7625.2007.00477.x\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Tables","content":"\u003cdiv class=\"gridtable\"\u003e\n\u003ctable id=\"Tab1\" border=\"1\"\u003e\u003ccaption\u003e\n\u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\n\u003cdiv class=\"CaptionContent\"\u003e\n\u003cp\u003ePatient participant characteristics, stratified by interview status\u003c/p\u003e\n\u003c/div\u003e\n\u003c/caption\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eCharacteristic\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eInterviewed\u003c/p\u003e\n\u003cp\u003e(n\u0026thinsp;=\u0026thinsp;43)\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eDeclined Interview\u003c/p\u003e\n\u003cp\u003e(n\u0026thinsp;=\u0026thinsp;33)\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003ep-value*\u003c/p\u003e\n\u003c/th\u003e\n\u003c/tr\u003e\n\u003c/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eAge, mean (SD)\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e56.6 (12.0)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e62.4 (13.7)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.05\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eRace/Ethnicity, n (%)\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.04\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eBlack, non-Hispanic\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e10 (23)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e8 (24)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eHispanic\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e2 (5)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e9 (27)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eAsian\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e3 (7)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1 (3)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eWhite, non-Hispanic\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e28 (65)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e15 (45)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003ePrimary Language, n (%)\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.01\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eEnglish\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e41 (95)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e24 (73)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eSpanish\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1 (2)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e8 (24)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eMandarin\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1 (2)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1 (3)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eEducation, n (%)\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.03\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eNever attended high school\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e1 (2)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e3 (9)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eSome high school\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0 (0)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e6 (18)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eHigh school diploma (or equivalent)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e11 (26)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e6 (18)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eSome college\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e9 (21)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e5 (15)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e2-year degree\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e6 (14)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e6 (18)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e4-year degree or higher\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e16 (37)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e7 (21)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eSES, n (%)**\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e0.01\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eHigher SES\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e32 (74)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e15 (45)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eLower SES\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e11 (26)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e18 (55)\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd colspan=\"4\" align=\"left\"\u003e\n\u003cp\u003e*Chi-square tests used for categorical and dichotomous variables, t-tests used for continuous variables. Statistical tests had a null hypothesis of no difference in the distribution of the variables between interviewees and non-interviewees.\u003c/p\u003e\n\u003cp\u003e**Patients were considered lower SES if they were below 138% of the Federal Poverty Level based on income and household size for the calendar year they were enrolled in the trial.\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003c/div\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cdiv id=\"Sec10\" class=\"Section2\"\u003e\n\u003cdiv id=\"Sec12\" class=\"Section3\"\u003e\n\u003cdiv class=\"gridtable\"\u003e\n\u003ctable id=\"Tab3\" border=\"1\"\u003e\u003ccaption\u003e\n\u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e\n\u003cdiv class=\"CaptionContent\"\u003e\n\u003cp\u003eSelect characteristics of participating surgeons (n\u0026thinsp;=\u0026thinsp;16)\u003c/p\u003e\n\u003c/div\u003e\n\u003c/caption\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eCharacteristic\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\u0026nbsp;\u003c/th\u003e\n\u003c/tr\u003e\n\u003c/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eArm, n (%)\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\u0026nbsp;\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eOption Grid\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e5 (31%)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ePicture Option Grid\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e6 (38%)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eUsual Care\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e5 (31%)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eFemale Sex, n (%)\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e13 (81%)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eYears since graduating medical school, m (range)\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e23\u0026nbsp;years (10\u0026ndash;44)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eYears at current site, m (range)\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e10 (\u0026lt;\u0026thinsp;1 to 30)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e\u003cstrong\u003eInterest in SDM before trial\u003c/strong\u003e\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003e16 (100%)\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003c/div\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003c/div\u003e\n\u003c/div\u003e\n\u003cdiv class=\"gridtable\"\u003e\n\u003ctable id=\"Tab5\" border=\"1\"\u003e\u003ccaption\u003e\n\u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e\n\u003cdiv class=\"CaptionContent\"\u003e\n\u003cp\u003eSummary of major themes by NPT construct\u003c/p\u003e\n\u003c/div\u003e\n\u003c/caption\u003e\n\u003cthead\u003e\n\u003ctr\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eNPT Construct\u003c/p\u003e\n\u003c/th\u003e\n\u003cth align=\"left\"\u003e\n\u003cp\u003eMajor themes\u003c/p\u003e\n\u003c/th\u003e\n\u003c/tr\u003e\n\u003c/thead\u003e\n\u003ctbody\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eCoherence\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ePatients thought the Option Grids were easier to understand and more concise than other breast cancer materials. Using the Option Grids felt like usual care for surgeons.\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eCognitive participation\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003ePatients and surgeons recommended using Option Grids and were open to receiving and using them in various ways.\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eCollective action\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eSurgeons (after a few uses) and patients perceived the Option Grids were a part of a normal work routine.\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003ctr\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eReflexive monitoring\u003c/p\u003e\n\u003c/td\u003e\n\u003ctd align=\"left\"\u003e\n\u003cp\u003eSurgeons did not feel the Option Grids increased their consultation time.\u003c/p\u003e\n\u003c/td\u003e\n\u003c/tr\u003e\n\u003c/tbody\u003e\n\u003c/table\u003e\n\u003c/div\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Breast cancer, Conversation aids, two early-stage, diverse practices, electronic health record (EHR)","lastPublishedDoi":"10.21203/rs.3.rs-91143/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-91143/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground\u003c/strong\u003e\u003c/p\u003e\u003cp\u003eConversation aids can facilitate shared decision making and improve patient-centered outcomes. However, there are few examples of sustained use of conversation aids in routine care due to numerous barriers at clinical and organizational levels. We explored strategies that will promote the sustained use of two early-stage breast cancer conversation aids. We examined any differences in experiences and opinions between the two conversation aids and across socioeconomic strata. \u003c/p\u003e\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e\u003c/p\u003e\u003cp\u003eWe nested this study within a randomized controlled trial evaluating two early-stage breast cancer surgery treatment conversation aids, one text-based and one picture-based, across four health systems with socioeconomically diverse patient populations. We conducted semi-structured interviews with a sample of patient participants, purposively sampled across conversation aid assignment and socioeconomic status (SES), and collected observations and field-notes. We also interviewed trial surgeons and other stakeholders. We conducted a framework analysis of all interviews, notes, and observations with two independent coders using the NOrmalization MeAsure Development through Normalization Process Theory. We also conducted an inductive analysis. We conducted additional sub-analyses based on which conversation aid was used/received and patient SES. \u003c/p\u003e\u003cp\u003e\u003cstrong\u003eResults\u003c/strong\u003e\u003c/p\u003e\u003cp\u003eWe conducted 73 semi-structured interviews with 43 patients, 16 surgeons, and 14 stakeholders like nurses, cancer center directors, and electronic health record (EHR) experts. Patients and surgeons felt the conversation aids should be used in breast cancer care in the future and were open to various methods of giving and receiving the conversation aid (EHR, email, patient portal, before consultation). Patients of higher SES were more likely to note the conversation aids influenced their treatment discussion, while patients of lower SES noted more influence on their decision making. Intervention surgeons reported using the conversation aids did not lengthen their typical consultation time. Most intervention surgeons felt using the conversation aids was similar to their usual care after using it a few times, and most patients felt it appeared part of their normal routine. \u003c/p\u003e\u003cp\u003e\u003cstrong\u003eConclusions\u003c/strong\u003e\u003c/p\u003e\u003cp\u003eKey factors that will help guide the future sustained implementation of the conversation aids include adapting to existing clinical workflows, flexibility of use, patient characteristics and communication preferences.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eTrial registration\u003c/strong\u003e\u003c/p\u003e\u003cp\u003eNCT03136367 at ClinicalTrials.gov\u003c/p\u003e","manuscriptTitle":"Implementation and Sustainability Factors of Two Early-Stage Breast Cancer Conversation Aids in Diverse Practices","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2020-10-16 20:49:02","doi":"10.21203/rs.3.rs-91143/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"66d51ff4-53cd-4967-8793-045c58994ad1","owner":[],"postedDate":"October 16th, 2020","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[{"id":797713,"name":"Health Policy"},{"id":797714,"name":"Health Economics \u0026 Outcomes Research"}],"tags":[],"updatedAt":"2021-07-27T21:05:03+00:00","versionOfRecord":{"articleIdentity":"rs-91143","link":"https://doi.org/10.1186/s13012-021-01115-1","journal":{"identity":"implementation-science","isVorOnly":false,"title":"Implementation Science"},"publishedOn":"2021-05-10 21:05:03","publishedOnDateReadable":"May 10th, 2021"},"versionCreatedAt":"2020-10-16 20:49:02","video":"","vorDoi":"10.1186/s13012-021-01115-1","vorDoiUrl":"https://doi.org/10.1186/s13012-021-01115-1","workflowStages":[]},"version":"v1","identity":"rs-91143","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-91143","identity":"rs-91143","version":["v1"]},"buildId":"7rjqhiLT3MXkJMwkYKINL","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}