Construction of an advance care planning communication plan for intensive care unit patients based on the patient- and family-centered care model: a mixed-method study protocol | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Study protocol Construction of an advance care planning communication plan for intensive care unit patients based on the patient- and family-centered care model: a mixed-method study protocol Ruijie Peng, Yan Yang, Shufan Liu, Xumei Jian, Shanshan Zheng, and 4 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4734311/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background The intensive care unit (ICU) has the highest patient mortality rate. Implementing advance care planning (ACP) in the ICU can improve patients’ sense of dignity in medical decision-making and alleviate psychological pressure on family members, although ACP remains a challenging concept. The ACP communication plan, grounded in the patient- and family-centered care (PFCC) model, promotes patient and family involvement in treatment decisions, safeguarding patient autonomy and preventing issues such as discrepancies between treatment intensity and expected prognosis. Methods The exploratory hybrid research protocol will be comprised of four implementation phases. Phase 1 will involve familiarizing the research team with the content and implementation strategies of ACP based on the PFCC model. In Phase 2, interviews regarding ACP will be conducted with ICU patients and their families to acquire a comprehensive understanding of their needs. Phase 3 will involve developing the ACP communication plan document utilizing the PFCC model. Phase 4 will focus on validating the feasibility of the plan through a two-group (control and intervention), single-center, parallel-group randomized controlled trial. Regarding data analysis, the primary and secondary outcome measures will be assessed at baseline, seven days after baseline, and 30 days after baseline. Discussion The implementation of ACP in the ICU is an important part of palliative care, as it ensures patients’ autonomy and allows them to receive treatment consistent with their wishes, which improves quality of life and reduces the financial and psychological burden on families. However, there have been few studies in this area. This study will integrate the PFCC model into a comprehensive ACP communication plan for ICU patients to empower them and their families in the decision-making process. Our sincere aspiration is that this project will enable medical decisions that align with patients’ preferences, ultimately enhancing the mental well-being of patients and their families, as well as alleviating the financial burden they face. Trial registration: Chinese Clinical Trial Register (ChiCTR2400086414). Advance care planning Intensive care unit Patient- and family-centered care model Randomized controlled trial Protocol Figures Figure 1 Figure 2 BACKGROUND The intensive care unit (ICU), a centralized treatment center for critically ill patients, has the highest mortality rate among all inpatient departments [ 1 ]. According to relevant surveys, 20 to 30% of patients in Western countries are transferred to the ICU during their final month of life [ 2 ]. In China, the mortality rate of ICU patients has been reported to be as high as 42%, and it has continued to increase [ 3 ]. Studies have indicated that before death, 50% of patients experience moderate to severe pain, significantly impacting their quality of life [ 4 ]. The condition of ICU patients is characterized as complex and variable, with recent research focusing on the quality of care provided throughout their lifespan [ 5 ]. Surveys have indicated that when critically ill, 95% of ICU patients are unable to articulate their preferences for end-of-life treatment [ 6 ]. With the increasing importance of ICU patients’ autonomy and decision-making power, unilateral medical decision-making has failed to fulfill the needs of patients and their families in treatment decision-making. The rapidly changing condition of ICU patients frequently leaves both family members and patients feeling perplexed [ 7 ]. Relevant studies have shown that after receiving advance care planning (ACP) communication, most patients choose to spend their final stage at home rather than being sent to the ICU by their families for treatments that are deemed meaningless and painful [ 8 ]. Therefore, it is of immense significance to formulate medical and nursing plans that align with the preferences of ICU patients and their families prior to patients’ loss of decision-making capacity and communication abilities. ACP involves patients expressing their future treatment wishes to family members and medical staff while they are awake and able to communicate [ 9 , 10 ]. Implementing advance medical care planning can facilitate effective communication between doctors, nurses, patients, and their families. Developing medical care plans in advance can prompt patients and family members to consider clinical treatment decisions. This practice also contributes to ensuring patient autonomy and aligning their acceptance with their treatment preferences. Additionally, it enhances patients’ sense of participation in treatment decision-making, alleviates the financial and psychological burden on patients and families, and effectively prevents unnecessary medical interventions [ 9 , 11 ]. Since the 1990s, ACP has gained widespread promotion and support in developed countries, including the United States, Australia, New Zealand, and Canada. Ongoing promotion of ACP has been supported by relevant studies, which have confirmed that ACP significantly reduces psychological stress in patients and their families. Moreover, ACP has been found to enhance quality of life and medical satisfaction during the advanced stages of illness [ 12 – 15 ]. However, the implementation of ACP has primarily focused on oncology, with limited studies conducted in the ICU setting. Moreover, the impact of complex ACP interventions on ICU patients remains unclear [ 16 ]. The patient- and family-centered care (PFCC) model is a method for planning, implementing, and evaluating healthcare that respects and responds to the unique needs of each family (see Fig. 1 ) [ 17 ]. Over the past decade, the PFCC model has gained global attention, particularly its implementation in ICU treatment, which has progressively encompassed the entire ICU population [ 18 ]. Studies have consistently demonstrated that family members’ involvement in ward rounds enhances their comprehension of the patient’s disease and increases satisfaction in both patients and their families. Furthermore, relevant studies have continuously reported that the PFCC model plays an active role in alleviating post-intensive care syndrome, enhancing patients’ quality of life, reducing caregiver burden, and improving the overall quality of care [ 19 ]. The aim of this study is to integrate the PFCC model into ACP practice. By gaining a deeper understanding of the communication needs of patients and their families regarding ACP and incorporating these needs into the plan, the study seeks to develop a comprehensive communication plan that caters to the diverse needs of ICU patients and their families. This integration aims to enhance the clinical applicability of ACP in the ICU setting. Figure 1 . Framework of the patient- and family-centered care model STUDY PURPOSE AND OBJECTIVES This study aims to investigate the attitudes and needs of ICU patients and their families regarding ACP and to assess the feasibility of implementing ACP in the ICU. The specific goals of this study are as follows: To explore the attitudes of ICU patients and their families toward ACP and examine the factors influencing the implementation of ACP. To design an ACP communication plan suitable for the ICU setting. To conduct a preliminary verification of the feasibility of implementing ACP in the ICU. METHODS AND ANALYSIS This study will be a two-group, single-center, parallel-group, mixed-method research project that focuses on the design and application of an ACP communication plan for ICU patients based on the PFCC model. The study will be divided into four phases and will follow the SPIRIT guidelines [ 20 ]. The research will be conducted by a multidisciplinary team composed of ICU doctors, nurses, and ACP professional researchers, all of whom will be required to undergo systematic training. Figure 2 illustrates the division of this study into four independent and interrelated phases. Phase 1 will involve reviewing relevant literature to understand the research content and strategy of randomized controlled trials (RCTs) related to ACP. In Phase 2, qualitative interviews will be conducted to gain a deeper understanding of the attitudes and needs of ICU patients and their families regarding ACP. Phase 3 will focus on designing and determining an ACP communication program for ICU patients using the Delphi method, followed by feasibility verification through an RCT in Phase 4. The study will be carried out in the Department of Critical Care Medicine at a Class A tertiary hospital in China. Data collection is scheduled to commence in July 2024, with the study expected to be completed by the end of 2025. Figure 2 . Flow chart of the study Phase 1: Literature review This study will follow the scoping review guidelines published by the Joanna Briggs Institute (JBI) [ 21 ]. Comprehensive searches will be conducted across 10 databases, including www.cnki.net , WanFang Date, VIP, SinoMed, Web of Science, PubMed, Cochrane Library, Embase, PsycINFO, and CINAHL, using both subject headings and free-text keywords. The inclusion criteria for this study will be based on the “participants, concept, and context” principle, as follows: the participants will be patients aged ≥ 18 years old with chronic conditions, such as cardiovascular, cerebrovascular, and respiratory diseases, as well as cancer; the concept will involve advance medical care planning; and the context will be communication related to advance care planning. Studies will be excluded if they are duplicate publications, are in non-Chinese or non-English languages, or do not involve RCTs. The retrieved literature will then be classified based on the description of the interventions, providing a reference and guidance for the design of the ACP communication plan and the preliminary framework. Phase 2: Qualitative interviews In this phase, semi-structured interviews will be conducted with patients and their families in the ICU. The interviews will consist of both focus-group discussions and individual, in-depth interviews. The objectives will be to comprehensively understand the perceptions and needs of patients and their families regarding ACP, identify implementation issues and influencing factors in ICU patients with chronic diseases, and establish a program framework for reference. The interviews will take place at a tertiary hospital located in Guizhou Province, China. The timing, duration, and location of the interviews will be determined according to the participants’ preferences. Participant recruitment The participants will be selected through purposive sampling at a tertiary general hospital located in Guizhou Province, China, and the interviews will be conducted based on predetermined sampling criteria. Efforts will be made to select interviewees representing various education levels and economic statuses to enhance the representativeness of the sample until data saturation is achieved. In the case that no new themes arise during data analysis, two additional samples will be included to determine the final sample size. Inclusion criteria The inclusion criteria for patients will be as follows: (1) ICU patients aged ≥ 18 years old; (2) ICU stay > 24 hours; (3) patients with chronic diseases (e.g., renal failure, chronic heart failure, chronic obstructive pulmonary disease, etc.); (4) assessment of suitability by the attending doctor for interview participation; and (5) voluntary participation in this study and signed informed consent form. The inclusion criteria for family members will be as follows: (1) family members aged ≥ 18 years; and (2) core family members of the patient who have provided informed consent to participate in the study. Data collection and analysis The data collection process will primarily involve introducing the research purpose to the interviewees and utilizing a voice recorder for on-site recording. After obtaining informed consent from the patients and their families, the time and place of the interviews will be determined. During the interviews, interviewees will be encouraged to freely express their genuine emotions and verbally provide any non-conforming information. To ensure data accuracy, two researchers will independently transcribe the recordings into textual format within 24 hours of conducting the interviews. Colaizzi’s phenomenological seven-step analysis method will be employed to organize, analyze, and summarize the qualitative interview data from patients and their families, which will then be entered into Nvivo12 software for data management and analysis [ 22 ]. Phase 3: Developing an ACP communication plan for ICU patients utilizing the PFCC model By integrating the findings from the qualitative interviews and the literature review, the ACP communication plan for ICU patients will be developed based on the PFCC model. The research team will engage in discussions based on the content of the communication plan. Following the team member meeting discussions, an intervention communication plan will be formulated, which will encompass determining the purpose, content, communication timing and format, communicators, and relevant observation indicators. Inquiry letter to Delphi experts To ensure the scientific rigor and effectiveness of the communication plan, 15 experts will be invited to participate in two rounds of expert consultation focusing on plan design, content, communication guidance, and other relevant aspects [ 23 ]. The experts’ opinions will be collected and used to enhance the plan, resulting in the final version. Expert selection criteria The inclusion criteria for the experts will be as follows: (1) must be from fields such as hospice care and the ICU; (2) a minimum of 10 to 30 years of working experience will be required; and (3) must have professional titles of Deputy, Senior, or higher. Data collection and analysis Expert consultation questionnaires will be administered either face-to-face or via email, with a time gap of two to three weeks between each round. The intervention plan will be revised in accordance with the experts’ opinions in the second round, continuing until a basic consensus among the experts is reached. Experts’ level of expertise An authority coefficient (Cr) ≥ 0.70 is considered an acceptable value, while a higher authority coefficient indicates more reliable research results. The Cr value in this study will depend on the experts’ judgment basis for the consulted content (Ca) and their familiarity with the assessment content (Cs). The experts’ judgments will be based on practical experience, theoretical analysis, references to domestic and foreign literature, and intuition. The expert authority coefficient will be calculated using the formula Cr = (Ca + Cs) / 2 [ 23 ]. Expert opinion consistency level The level of consistency among the expert opinions will be represented by the coefficient of variation (CV). A smaller value indicates a higher level of coordination among the expert opinions. Generally, a CV value of ≤ 0.25 is considered acceptable [ 23 ]. Expert opinion importance level: The level of importance assigned to each indicator in the plan will be expressed as the mean (M), and the mean should be ≥ 3.5 [ 23 ]. Indicator deletion criteria If the average importance assignment value is 0.25, indicators will be deleted to prevent the removal of important indicators [ 23 ]. If only one of the conditions is not met, the research team will evaluate the indicators based on their scientific and comprehensive nature, feasibility, and other principles. The final decision will be made through discussion. Phase 4: Validate feasibility through an RCT In this phase, an RCT will be conducted to answer the following three research questions: Is ACP feasible for patients with chronic diseases in the ICU? What is the best time to provide ACP for patients with chronic diseases in the ICU? Will ACP increase the pain of patients and their families? Participation and recruitment The study population will be comprised of 52 patients admitted to the adult ICU and their respective families [ 24 ]. The recruitment of study participants will be carried out in two comprehensive ICUs located within a tertiary general hospital in Guizhou Province, China. Patients who meet the inclusion criteria will be directly screened by the research team in accordance with the predefined inclusion and exclusion criteria. The researchers will communicate face-to-face with patients and their families to obtain informed consent and administer baseline surveys. Inclusion criteria The inclusion criteria for patients will be as follows: (1) aged ≥ 18 years old; (2) ICU stay > 24 hours; (3) patients with chronic diseases (e.g., renal failure, chronic heart failure, chronic obstructive pulmonary disease, etc.); (4) deemed capable by the attending physician of participating in the interviews; and (5) voluntary participation in the study and signed informed consent form. The inclusion criteria for family members will be as follows: (1) aged ≥ 18 years old; and (2) members of the patient’s core family who provided informed consent to participate in the study. Exclusion criteria Patients will be excluded from the trial if they: (1) have signed advance directives; and (2) have impaired consciousness or are unable to express their thoughts clearly. Adult family members will be excluded from the trial if they: (1) have mental disorders or diseases; (2) have visual or auditory impairments; and (3) are unable to express their thoughts. Dropout criteria The criteria for dropping out of the study will be as follows: (1) participants who dropped out midway; and (2) patients whose condition worsened or who died during the intervention period. Randomization and blinding This study will employ a randomized controlled design. Random numbers will be generated using SPSS 29.0, and the participants will be evenly allocated into either the control group or the intervention group to ensure equal sample sizes [ 25 ]. Allocation concealment will be achieved by placing random allocation plans in sealed envelopes. Blinding will be implemented for both the participants and the data collectors. Control treatment The participants in the control group will receive standard care, which will include appropriate management of clinical symptoms, pain, daily living activities, and exercise, as well as proper adherence to patient placement and physician instructions. The medical staff will provide care to the patients’ family members based on individual patients’ needs, condition, and level of acceptance. The researchers will conduct regular follow-up communication and provide verbal education to the participants. Additionally, questionnaires will be administered to the participants on the day of enrollment, seven days after enrollment, and 30 days after enrollment. Intervention duration and termination The participants in the intervention group will begin the intervention on the first day of enrollment. In the event that the intervention is suspended due to illness or personal reasons caused by the patient or family members, whether to terminate the intervention or consider it as a dropout will be determined based on the specific circumstances. If a participant withdraws from the study, s/he will be considered as having dropped out in the pre-intervention phase. A multidisciplinary collaborative intervention and implementation team for chronic disease patients in the ICU will establish an ACP communication plan, including ICU medical staff, rehabilitation therapists, psychotherapists, ICU managers, and graduate students. Before the project begins, all team members will receive training on the purpose and aims of the study, their role in the project, and the work they will undertake. The division of tasks among team members is outlined in Table 1 . Table 1 Formation and division of labor of the ACP communication team members Personnel Division of Labor ICU Director Responsible for guiding and coordinating to ensure smooth progress of the study Chief Nurse Responsible for managing and coordinating the work of the ACP communication team members Nurses 1 and 2 Responsible for training and guiding the ACP communication team members and recruiting patients and their families who meet the inclusion criteria Nurses 3 and 4 Responsible for collecting and organizing communication materials and following up on transferred patients Nurses 5 and 6 Responsible for collecting problems in the intervention process, and then coordinating and rectifying them Research Assistant Responsible for data analysis, liaising and coordinating with various departments, data review, tracking of patients’ whereabouts, and ensuring timely and effective implementation of communication plans ICU = intensive care unit; ACP = advance care planning. Intervention phase In addition to routine care, the intervention group will be introduced to the ACP communication plan based on the PFCC model. The ACP communication process will involve step-by-step discussions on topics such as ICU-related treatment, ACP-related knowledge, and the significance of ACP implementation. These communication sessions will be conducted over the course of one week. Surveys will be administered to both groups at the time of enrollment, seven days after enrollment, and 30 days after enrollment to assess outcomes. Detailed information regarding the intervention plan can be found in Table 2 . Table 2 Grouping methods and intervention timing Timepoints Groups Participants Control Group Usual Nurse Intervention Group Usual Nurse + ACP Communication T0 Demographics, (1), (2), (3), (4) Demographics, (1), (2), (3), (4) Patients and main family members T1 Usual nurse Usual nurse + ACP communication Patients and main family members T2 (1), (2), (3), (4) (1), (2), (3), (4) Patients and main family members T3 (1), (2), (3), (4) (1), (2), (3), (4) Patients and main family members T0 = first day of enrollment; T1 = five to six days after enrollment; T2 = one day after the end of the intervention; T3 = 30 days after the end of the intervention. (1) End-of-Life Treatment Intention Questionnaire; (2) Willingness Consistency Questionnaire; (3) ACP Readiness Scale for Chronically Ill Patients (patient participants only); (4) Project Satisfaction Survey. Outcomes and measurements For the primary outcome, the feasibility analysis will include an assessment of the patient enrollment rate, consent rate, loss to follow-up rate, and phase completion rate. The secondary outcomes will include the following: End-of-Life Treatment Intention Questionnaire [ 26 ] (for patient participants): The questionnaire has demonstrated a strong internal consistency, with a Cronbach’s α coefficient of 0.791. The survey primarily consists of the following key questions: (1) Are you willing to participate in discussions regarding end-of-life treatment wishes? (2) If you had to make a choice for the future, what would be your preference? (3) In the event that your disease continues to worsen and your life is at risk, what actions would you like your doctor to take? Willingness Consistency Questionnaire [ 26 ] (for patient participants): The questionnaire has demonstrated strong internal consistency, with a Cronbach’s α coefficient of 0.791. It primarily consists of the following key question: If your condition becomes severe or you fall into a coma, and life-saving measures are required to maintain your life, would you be willing to accept interventions such as cardiopulmonary resuscitation, mechanical ventilation, gastrointestinal nutrition, blood transfusion, surgery, hemodialysis, vasopressor drugs, transfer to the intensive care unit (ICU), intravenous nutrition, and analgesics? ACP Readiness Scale for Chronically Ill Patients [ 27 ] (for patient participants): This scale will be used as the primary measurement tool to evaluate patients’ readiness for advance care planning encompassing three key aspects: (1) attitudes toward advance care planning; (2) beliefs about readiness; and (3) motivation for participating in advance care planning. The scale employs a 5-point rating system, with scores ranging from 22 to 110. A higher total score indicates a greater level of preparedness for advance care planning. The score ranges are as follows: 22–43 for a low level, 44–65 for a lower-middle level, 66–87 for an upper-middle level, and 88–110 for a high level of readiness. The scale has exhibited strong internal consistency, with a total Cronbach’s α coefficient of 0.923. Project Satisfaction Survey (for patient participants): This survey primarily includes the following questions: (1) Did you find the project meaningful? (2) How do you feel after participating in the project? (3) Would you recommend this project to others? (4) What are your suggestions and opinions on this project? End-of-life Treatment Intention Questionnaire [ 26 ] (for family member participants): The questionnaire has demonstrated strong internal consistency, with a Cronbach’s α coefficient of 0.757. It primarily includes the following key questions: (1) Do you want the patient to participate in discussions about end-of-life care wishes? (2) If the patient had to make a decision for the future, what do you think their preference would be? (3) If the patient’s condition worsens and his/her life is at risk, who would you prefer to be their doctor? Willingness Consistency Questionnaire [ 26 ] (for family member participants): The questionnaire has exhibited strong internal consistency, with a Cronbach’s α coefficient of 0.804. This questionnaire primarily focuses on whether the family member would be willing to have the patient undergo various life-sustaining interventions, such as cardiopulmonary resuscitation, mechanical ventilation, gastrointestinal nutrition, blood transfusion, surgery, hemodialysis, vasopressors, transfer to the intensive care unit (ICU), intravenous nutrition, gastrointestinal nutrition, and analgesics, if his/her condition became severe or s/he fell into a coma. Project Satisfaction Survey (for family member participants): This survey primarily comprises the following key questions: (1) Did you consider the project to be meaningful? (2) How do you feel about your participation in the project? (3) Would you recommend this project to others? (4) What are your suggestions and opinions regarding this project? Data management and monitoring Data management and monitoring responsibilities will be undertaken by the coordinating investigator site’s clinical trial unit. The trial will strictly adhere to national and international standards for good clinical practice, ensuring compliance with regulatory and ethical requirements. Any serious adverse events, whether related or unrelated, that affect the participants (including family members) will be meticulously collected and documented in reliable source documents. Regular monitoring will be conducted to ensure the study’s quality and regulatory compliance. It is important to note that the monitoring personnel will not be involved in the research activities. The ethics committee has granted approval for supervision, including the verification of the investigators’ and research team members’ qualifications and the monitoring of document integrity and appropriateness. Data analysis This study will utilize EpiData 3.1 software for data entry, with two individuals performing the task. Following data correction, the imported dataset will be analyzed using SPSS 29.0. Normally distributed measurement data will be expressed as mean ± standard deviation. Group t-tests will be employed to compare the sample means of the two groups, while count data will be presented as percentages. The chi-squared test (χ2) will be used to compare the two groups of binary count data. Median and interquartile ranges (M [P25-P75]) will be utilized to describe rank or non-normally distributed data, and the rank sum test will be employed to compare the two groups. Two-sided tests will be used in all analyses. For the analysis of discrete repeated-measurement longitudinal data, such as decision certainty and end-of-life treatment intentions, generalized estimated equations will be applied. Statistical significance will be determined at a significance level of p < 0.05. DISCUSSION The ICU is an area where all types of critically ill patients and patients with multi-system failure are concentrated for strict monitoring and rescue treatment [ 28 ]. The advancement and development of ICU medical technology not only brings the hope of continued life to patients but also increases patients’ pain and the financial burden on their families [ 6 , 7 ]. For many terminally ill patients with no therapeutic benefits, their lives are only temporarily prolonged. As an important part of palliative care, the implementation of ACP in the ICU is conducive to ensuring patients’ autonomy and allowing them to receive treatment consistent with their wishes, thereby improving patients’ final quality of life and reducing the financial and psychological burden on their families [ 29 ]. Therefore, it is particularly important to promote ACP in the ICU, but there are no relevant reports on this subject at this time to the best of the researchers’ knowledge. Due to critical illness or prolonged sedative use, the majority of ICU patients lose their capacity for treatment decision-making, leaving only a small proportion with decision-making ability [ 30 ]. Consequently, it is necessary for family members to be involved in making decisions on their behalf. Building upon this foundation, the study will integrate the PFCC model to develop a comprehensive ACP communication plan for ICU patients. This approach of discussing ACP in a systematic manner aims to empower patients and their families by providing them with a prominent role in the entire communication process. Given the complex and dynamic nature of ICU patients’ conditions, the needs of family members likewise evolves accordingly. This study will involve conducting multiple family meetings to promptly ascertain any changes in patients’ expressed preferences. Our sincere aspiration is that our project will enable medical decisions that align with patients’ preferences, ultimately enhancing the mental well-being of patients and their families, as well as alleviating the financial burden they face. Abbreviations ACP advance care planning Ca consulted content Cr authority coefficient Cs assessment content CV coefficient of variation ICU intensive care unit M mean FCC patient- and family-centered care RCT randomized controlled trial Declarations Ethics and consent to participate This study protocol (V.1.0, July 11, 2023) has been approved by the Biomedical Research Ethics Committee of the Affiliated Hospital of Zunyi Medical University (approval number: KLL-2023-090). Written informed consent was obtained from all participants / participants’ legal guardians / next of kin for their participation in this study. The results of this study will be distributed through peer-reviewed journals. Consent for publication Not applicable. Availability of data and materials Not applicable. Competing interests The researchers have read and understand BMJ’s policy on the declaration of competing interests and declare that they have no competing interests. Funding This study is supported by a research grant from the Zunyi Science and Technology Bureau of Guizhou Province (Zunyi Kehe HZ Zi [2022]197). Authors’ contributions YY initiated the research conception and design of the ACP communication program for ICU patients based on the PFCC model design concept, and was responsible for funding applications and coordinating the investigators. YY, RP, LS, and XJ made major contributions to the conception and design of the research project and co-wrote the grant application. RP, RD, and CL were responsible for the revision of the grant application and quality control of the project’s implementation process. RP and YY co-wrote the manuscript. RP, XJ, SL, YY, RD, and CL critically reviewed the manuscript for important intellectual content. All authors read and approved the final manuscript. Acknowledgements We would like to thank our patients, caregivers, and healthcare team, without whom this work would not have been possible. Disclaimer The funding source had no role in the design of the study and will not have any role during the execution, analyses, interpretation of the data, or decision to submit the results. Patient and public involvement Patients and/or the public were not involved in the design, conduct, reporting, or dissemination plans of the current research. Patient consent for publication Not applicable. Provenance and peer review Not commissioned; externally peer reviewed. Trial status ChiCTR.gov Identifier: ChiCTR2400086414 Recruitment Status: Recruiting. Trial Registration Date: July 1, 2024. Date Recruitment Began: July 2, 2024. Estimated Primary Completion Date: March 2025. Estimated Study Completion Date: December 2025. References Tongyang Y. Study on the current status and influencing factors of patients’ death quality from the perspective of ICU nurses in a tertiary hospital in Zunyi City. Zunyi Medical University; 2021. Romano M. 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ATS Sch. 2024;5(1):53–70. Additional Declarations No competing interests reported. Cite Share Download PDF Status: Posted 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. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4734311","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Study protocol","associatedPublications":[],"authors":[{"id":334893881,"identity":"1b876e50-d64b-4563-8f04-1c17dae9ad81","order_by":0,"name":"Ruijie Peng","email":"","orcid":"","institution":"Affiliated Hospital of Zunyi Medical University","correspondingAuthor":false,"prefix":"","firstName":"Ruijie","middleName":"","lastName":"Peng","suffix":""},{"id":334893882,"identity":"5dff235c-58c3-4f8f-a5d9-a62c91d62b42","order_by":1,"name":"Yan Yang","email":"","orcid":"","institution":"Affiliated Hospital of Zunyi Medical University","correspondingAuthor":false,"prefix":"","firstName":"Yan","middleName":"","lastName":"Yang","suffix":""},{"id":334893883,"identity":"1a5cbe24-bba1-4a2c-9b5a-f86bc90d91bc","order_by":2,"name":"Shufan Liu","email":"","orcid":"","institution":"Affiliated Hospital of Zunyi Medical University","correspondingAuthor":false,"prefix":"","firstName":"Shufan","middleName":"","lastName":"Liu","suffix":""},{"id":334893884,"identity":"8fbbfb5a-40a7-4859-a319-c2244e58cd77","order_by":3,"name":"Xumei Jian","email":"","orcid":"","institution":"Affiliated Hospital of Zunyi Medical University","correspondingAuthor":false,"prefix":"","firstName":"Xumei","middleName":"","lastName":"Jian","suffix":""},{"id":334893885,"identity":"111d5df8-991f-4bb1-9299-da401a3fb716","order_by":4,"name":"Shanshan Zheng","email":"","orcid":"","institution":"Affiliated Hospital of Zunyi Medical 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08:38:55","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4734311/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4734311/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":62064530,"identity":"e34065f2-0a0b-428f-8551-789eedf1cb24","added_by":"auto","created_at":"2024-08-09 00:33:11","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":133422,"visible":true,"origin":"","legend":"\u003cp\u003eFramework of the patient- and family-centered care model\u003c/p\u003e","description":"","filename":"floatimage1.png","url":"https://assets-eu.researchsquare.com/files/rs-4734311/v1/e32f810774860683b46cf4ee.png"},{"id":62064531,"identity":"34944db1-8592-4410-833a-9f309f25301e","added_by":"auto","created_at":"2024-08-09 00:33:11","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":237364,"visible":true,"origin":"","legend":"\u003cp\u003eFlow chart of the study\u003c/p\u003e","description":"","filename":"floatimage2.png","url":"https://assets-eu.researchsquare.com/files/rs-4734311/v1/3471132b99d1143d8df578ec.png"},{"id":67449991,"identity":"1fee56f5-1322-4761-816b-54f55888be15","added_by":"auto","created_at":"2024-10-25 07:31:49","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":924544,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4734311/v1/85a0dd43-d03e-479a-b70d-8e5dbbab52c4.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Construction of an advance care planning communication plan for intensive care unit patients based on the patient- and family-centered care model: a mixed-method study protocol","fulltext":[{"header":"BACKGROUND","content":"\u003cp\u003eThe intensive care unit (ICU), a centralized treatment center for critically ill patients, has the highest mortality rate among all inpatient departments [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. According to relevant surveys, 20 to 30% of patients in Western countries are transferred to the ICU during their final month of life [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. In China, the mortality rate of ICU patients has been reported to be as high as 42%, and it has continued to increase [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. Studies have indicated that before death, 50% of patients experience moderate to severe pain, significantly impacting their quality of life [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. The condition of ICU patients is characterized as complex and variable, with recent research focusing on the quality of care provided throughout their lifespan [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]. Surveys have indicated that when critically ill, 95% of ICU patients are unable to articulate their preferences for end-of-life treatment [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. With the increasing importance of ICU patients\u0026rsquo; autonomy and decision-making power, unilateral medical decision-making has failed to fulfill the needs of patients and their families in treatment decision-making. The rapidly changing condition of ICU patients frequently leaves both family members and patients feeling perplexed [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. Relevant studies have shown that after receiving advance care planning (ACP) communication, most patients choose to spend their final stage at home rather than being sent to the ICU by their families for treatments that are deemed meaningless and painful [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. Therefore, it is of immense significance to formulate medical and nursing plans that align with the preferences of ICU patients and their families prior to patients\u0026rsquo; loss of decision-making capacity and communication abilities.\u003c/p\u003e \u003cp\u003eACP involves patients expressing their future treatment wishes to family members and medical staff while they are awake and able to communicate [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. Implementing advance medical care planning can facilitate effective communication between doctors, nurses, patients, and their families. Developing medical care plans in advance can prompt patients and family members to consider clinical treatment decisions. This practice also contributes to ensuring patient autonomy and aligning their acceptance with their treatment preferences. Additionally, it enhances patients\u0026rsquo; sense of participation in treatment decision-making, alleviates the financial and psychological burden on patients and families, and effectively prevents unnecessary medical interventions [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eSince the 1990s, ACP has gained widespread promotion and support in developed countries, including the United States, Australia, New Zealand, and Canada. Ongoing promotion of ACP has been supported by relevant studies, which have confirmed that ACP significantly reduces psychological stress in patients and their families. Moreover, ACP has been found to enhance quality of life and medical satisfaction during the advanced stages of illness [\u003cspan additionalcitationids=\"CR13 CR14\" citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. However, the implementation of ACP has primarily focused on oncology, with limited studies conducted in the ICU setting. Moreover, the impact of complex ACP interventions on ICU patients remains unclear [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe patient- and family-centered care (PFCC) model is a method for planning, implementing, and evaluating healthcare that respects and responds to the unique needs of each family (see Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e) [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]. Over the past decade, the PFCC model has gained global attention, particularly its implementation in ICU treatment, which has progressively encompassed the entire ICU population [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. Studies have consistently demonstrated that family members\u0026rsquo; involvement in ward rounds enhances their comprehension of the patient\u0026rsquo;s disease and increases satisfaction in both patients and their families. Furthermore, relevant studies have continuously reported that the PFCC model plays an active role in alleviating post-intensive care syndrome, enhancing patients\u0026rsquo; quality of life, reducing caregiver burden, and improving the overall quality of care [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]. The aim of this study is to integrate the PFCC model into ACP practice. By gaining a deeper understanding of the communication needs of patients and their families regarding ACP and incorporating these needs into the plan, the study seeks to develop a comprehensive communication plan that caters to the diverse needs of ICU patients and their families. This integration aims to enhance the clinical applicability of ACP in the ICU setting.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eFigure \u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. Framework of the patient- and family-centered care model\u003c/p\u003e \u003cdiv id=\"Sec2\" class=\"Section2\"\u003e \u003ch2\u003eSTUDY PURPOSE AND OBJECTIVES\u003c/h2\u003e \u003cp\u003eThis study aims to investigate the attitudes and needs of ICU patients and their families regarding ACP and to assess the feasibility of implementing ACP in the ICU. The specific goals of this study are as follows:\u003c/p\u003e \u003cp\u003e \u003col\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eTo explore the attitudes of ICU patients and their families toward ACP and examine the factors influencing the implementation of ACP.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eTo design an ACP communication plan suitable for the ICU setting.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eTo conduct a preliminary verification of the feasibility of implementing ACP in the ICU.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003c/ol\u003e \u003c/p\u003e \u003c/div\u003e"},{"header":"METHODS AND ANALYSIS","content":"\u003cp\u003eThis study will be a two-group, single-center, parallel-group, mixed-method research project that focuses on the design and application of an ACP communication plan for ICU patients based on the PFCC model. The study will be divided into four phases and will follow the SPIRIT guidelines [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]. The research will be conducted by a multidisciplinary team composed of ICU doctors, nurses, and ACP professional researchers, all of whom will be required to undergo systematic training. Figure\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e illustrates the division of this study into four independent and interrelated phases. Phase 1 will involve reviewing relevant literature to understand the research content and strategy of randomized controlled trials (RCTs) related to ACP. In Phase 2, qualitative interviews will be conducted to gain a deeper understanding of the attitudes and needs of ICU patients and their families regarding ACP. Phase 3 will focus on designing and determining an ACP communication program for ICU patients using the Delphi method, followed by feasibility verification through an RCT in Phase 4. The study will be carried out in the Department of Critical Care Medicine at a Class A tertiary hospital in China. Data collection is scheduled to commence in July 2024, with the study expected to be completed by the end of 2025.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eFigure \u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e. Flow chart of the study\u003c/p\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003ePhase 1: Literature review\u003c/h2\u003e \u003cp\u003eThis study will follow the scoping review guidelines published by the Joanna Briggs Institute (JBI) [\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]. Comprehensive searches will be conducted across 10 databases, including \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e\u003ca href=\"http://www.cnki.net\" target=\"_blank\"\u003ewww.cnki.net\u003c/a\u003e\u003c/span\u003e\u003cspan address=\"http://www.cnki.net\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e, WanFang Date, VIP, SinoMed, Web of Science, PubMed, Cochrane Library, Embase, PsycINFO, and CINAHL, using both subject headings and free-text keywords. The inclusion criteria for this study will be based on the \u0026ldquo;participants, concept, and context\u0026rdquo; principle, as follows: the participants will be patients aged\u0026thinsp;\u0026ge;\u0026thinsp;18 years old with chronic conditions, such as cardiovascular, cerebrovascular, and respiratory diseases, as well as cancer; the concept will involve advance medical care planning; and the context will be communication related to advance care planning. Studies will be excluded if they are duplicate publications, are in non-Chinese or non-English languages, or do not involve RCTs. The retrieved literature will then be classified based on the description of the interventions, providing a reference and guidance for the design of the ACP communication plan and the preliminary framework.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003ePhase 2: Qualitative interviews\u003c/h2\u003e \u003cp\u003eIn this phase, semi-structured interviews will be conducted with patients and their families in the ICU. The interviews will consist of both focus-group discussions and individual, in-depth interviews. The objectives will be to comprehensively understand the perceptions and needs of patients and their families regarding ACP, identify implementation issues and influencing factors in ICU patients with chronic diseases, and establish a program framework for reference. The interviews will take place at a tertiary hospital located in Guizhou Province, China. The timing, duration, and location of the interviews will be determined according to the participants\u0026rsquo; preferences.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003eParticipant recruitment\u003c/h2\u003e \u003cp\u003eThe participants will be selected through purposive sampling at a tertiary general hospital located in Guizhou Province, China, and the interviews will be conducted based on predetermined sampling criteria. Efforts will be made to select interviewees representing various education levels and economic statuses to enhance the representativeness of the sample until data saturation is achieved. In the case that no new themes arise during data analysis, two additional samples will be included to determine the final sample size.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003eInclusion criteria\u003c/h2\u003e \u003cp\u003eThe inclusion criteria for patients will be as follows: (1) ICU patients aged\u0026thinsp;\u0026ge;\u0026thinsp;18 years old; (2) ICU stay\u0026thinsp;\u0026gt;\u0026thinsp;24 hours; (3) patients with chronic diseases (e.g., renal failure, chronic heart failure, chronic obstructive pulmonary disease, etc.); (4) assessment of suitability by the attending doctor for interview participation; and (5) voluntary participation in this study and signed informed consent form. The inclusion criteria for family members will be as follows: (1) family members aged\u0026thinsp;\u0026ge;\u0026thinsp;18 years; and (2) core family members of the patient who have provided informed consent to participate in the study.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eData collection and analysis\u003c/h2\u003e \u003cp\u003eThe data collection process will primarily involve introducing the research purpose to the interviewees and utilizing a voice recorder for on-site recording. After obtaining informed consent from the patients and their families, the time and place of the interviews will be determined. During the interviews, interviewees will be encouraged to freely express their genuine emotions and verbally provide any non-conforming information. To ensure data accuracy, two researchers will independently transcribe the recordings into textual format within 24 hours of conducting the interviews. Colaizzi\u0026rsquo;s phenomenological seven-step analysis method will be employed to organize, analyze, and summarize the qualitative interview data from patients and their families, which will then be entered into Nvivo12 software for data management and analysis [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e].\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003ePhase 3: Developing an ACP communication plan for ICU patients utilizing the PFCC model\u003c/h2\u003e \u003cp\u003eBy integrating the findings from the qualitative interviews and the literature review, the ACP communication plan for ICU patients will be developed based on the PFCC model. The research team will engage in discussions based on the content of the communication plan. Following the team member meeting discussions, an intervention communication plan will be formulated, which will encompass determining the purpose, content, communication timing and format, communicators, and relevant observation indicators.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec10\" class=\"Section2\"\u003e \u003ch2\u003eInquiry letter to Delphi experts\u003c/h2\u003e \u003cp\u003eTo ensure the scientific rigor and effectiveness of the communication plan, 15 experts will be invited to participate in two rounds of expert consultation focusing on plan design, content, communication guidance, and other relevant aspects [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]. The experts\u0026rsquo; opinions will be collected and used to enhance the plan, resulting in the final version.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eExpert selection criteria\u003c/h2\u003e \u003cp\u003e \u003cul\u003e \u003cli\u003e \u003cp\u003eThe inclusion criteria for the experts will be as follows: (1) must be from fields such as hospice care and the ICU; (2) a minimum of 10 to 30 years of working experience will be required; and (3) must have professional titles of Deputy, Senior, or higher.\u003c/p\u003e \u003c/li\u003e \u003c/ul\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003eData collection and analysis\u003c/h2\u003e \u003cp\u003eExpert consultation questionnaires will be administered either face-to-face or via email, with a time gap of two to three weeks between each round. The intervention plan will be revised in accordance with the experts\u0026rsquo; opinions in the second round, continuing until a basic consensus among the experts is reached.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003eExperts\u0026rsquo; level of expertise\u003c/h2\u003e \u003cp\u003eAn authority coefficient (Cr)\u0026thinsp;\u0026ge;\u0026thinsp;0.70 is considered an acceptable value, while a higher authority coefficient indicates more reliable research results. The Cr value in this study will depend on the experts\u0026rsquo; judgment basis for the consulted content (Ca) and their familiarity with the assessment content (Cs). The experts\u0026rsquo; judgments will be based on practical experience, theoretical analysis, references to domestic and foreign literature, and intuition. The expert authority coefficient will be calculated using the formula Cr = (Ca\u0026thinsp;+\u0026thinsp;Cs) / 2 [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e].\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003e\u003cb\u003eExpert opinion consistency level\u003c/b\u003e\u003c/h2\u003e \u003cp\u003eThe level of consistency among the expert opinions will be represented by the coefficient of variation (CV). A smaller value indicates a higher level of coordination among the expert opinions. Generally, a CV value of \u0026le;\u0026thinsp;0.25 is considered acceptable [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e].\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003eExpert opinion importance level:\u003c/h2\u003e \u003cp\u003eThe level of importance assigned to each indicator in the plan will be expressed as the mean (M), and the mean should be \u0026ge;\u0026thinsp;3.5 [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e].\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec16\" class=\"Section2\"\u003e \u003ch2\u003eIndicator deletion criteria\u003c/h2\u003e \u003cp\u003eIf the average importance assignment value is \u0026lt;\u0026thinsp;3.5 and the CV is \u0026gt;\u0026thinsp;0.25, indicators will be deleted to prevent the removal of important indicators [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]. If only one of the conditions is not met, the research team will evaluate the indicators based on their scientific and comprehensive nature, feasibility, and other principles. The final decision will be made through discussion.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec17\" class=\"Section2\"\u003e \u003ch2\u003ePhase 4: Validate feasibility through an RCT\u003c/h2\u003e \u003cp\u003eIn this phase, an RCT will be conducted to answer the following three research questions:\u003c/p\u003e \u003cp\u003e \u003col\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eIs ACP feasible for patients with chronic diseases in the ICU?\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eWhat is the best time to provide ACP for patients with chronic diseases in the ICU?\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eWill ACP increase the pain of patients and their families?\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003c/ol\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec18\" class=\"Section2\"\u003e \u003ch2\u003eParticipation and recruitment\u003c/h2\u003e \u003cp\u003eThe study population will be comprised of 52 patients admitted to the adult ICU and their respective families [\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e]. The recruitment of study participants will be carried out in two comprehensive ICUs located within a tertiary general hospital in Guizhou Province, China. Patients who meet the inclusion criteria will be directly screened by the research team in accordance with the predefined inclusion and exclusion criteria. The researchers will communicate face-to-face with patients and their families to obtain informed consent and administer baseline surveys.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec19\" class=\"Section2\"\u003e \u003ch2\u003eInclusion criteria\u003c/h2\u003e \u003cp\u003eThe inclusion criteria for patients will be as follows: (1) aged\u0026thinsp;\u0026ge;\u0026thinsp;18 years old; (2) ICU stay\u0026thinsp;\u0026gt;\u0026thinsp;24 hours; (3) patients with chronic diseases (e.g., renal failure, chronic heart failure, chronic obstructive pulmonary disease, etc.); (4) deemed capable by the attending physician of participating in the interviews; and (5) voluntary participation in the study and signed informed consent form. The inclusion criteria for family members will be as follows: (1) aged\u0026thinsp;\u0026ge;\u0026thinsp;18 years old; and (2) members of the patient\u0026rsquo;s core family who provided informed consent to participate in the study.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec20\" class=\"Section2\"\u003e \u003ch2\u003eExclusion criteria\u003c/h2\u003e \u003cp\u003ePatients will be excluded from the trial if they: (1) have signed advance directives; and (2) have impaired consciousness or are unable to express their thoughts clearly. Adult family members will be excluded from the trial if they: (1) have mental disorders or diseases; (2) have visual or auditory impairments; and (3) are unable to express their thoughts.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec21\" class=\"Section2\"\u003e \u003ch2\u003eDropout criteria\u003c/h2\u003e \u003cp\u003eThe criteria for dropping out of the study will be as follows: (1) participants who dropped out midway; and (2) patients whose condition worsened or who died during the intervention period.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec22\" class=\"Section2\"\u003e \u003ch2\u003eRandomization and blinding\u003c/h2\u003e \u003cp\u003eThis study will employ a randomized controlled design. Random numbers will be generated using SPSS 29.0, and the participants will be evenly allocated into either the control group or the intervention group to ensure equal sample sizes [\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e]. Allocation concealment will be achieved by placing random allocation plans in sealed envelopes. Blinding will be implemented for both the participants and the data collectors.\u003c/p\u003e \u003cdiv id=\"Sec23\" class=\"Section3\"\u003e \u003ch2\u003eControl treatment\u003c/h2\u003e \u003cp\u003eThe participants in the control group will receive standard care, which will include appropriate management of clinical symptoms, pain, daily living activities, and exercise, as well as proper adherence to patient placement and physician instructions. The medical staff will provide care to the patients\u0026rsquo; family members based on individual patients\u0026rsquo; needs, condition, and level of acceptance. The researchers will conduct regular follow-up communication and provide verbal education to the participants. Additionally, questionnaires will be administered to the participants on the day of enrollment, seven days after enrollment, and 30 days after enrollment.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec24\" class=\"Section2\"\u003e \u003ch2\u003e\u003cb\u003eIntervention duration and termination\u003c/b\u003e\u003c/h2\u003e \u003cp\u003eThe participants in the intervention group will begin the intervention on the first day of enrollment. In the event that the intervention is suspended due to illness or personal reasons caused by the patient or family members, whether to terminate the intervention or consider it as a dropout will be determined based on the specific circumstances. If a participant withdraws from the study, s/he will be considered as having dropped out in the pre-intervention phase. A multidisciplinary collaborative intervention and implementation team for chronic disease patients in the ICU will establish an ACP communication plan, including ICU medical staff, rehabilitation therapists, psychotherapists, ICU managers, and graduate students. Before the project begins, all team members will receive training on the purpose and aims of the study, their role in the project, and the work they will undertake. The division of tasks among team members is outlined in Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eFormation and division of labor of the ACP communication team members\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"2\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePersonnel\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eDivision of Labor\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eICU Director\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eResponsible for guiding and coordinating to ensure smooth progress of the study\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eChief Nurse\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eResponsible for managing and coordinating the work of the ACP communication team members\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNurses 1 and 2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eResponsible for training and guiding the ACP communication team members and recruiting patients and their families who meet the inclusion criteria\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNurses 3 and 4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eResponsible for collecting and organizing communication materials and following up on transferred patients\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNurses 5 and 6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eResponsible for collecting problems in the intervention process, and then coordinating and rectifying them\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eResearch Assistant\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eResponsible for data analysis, liaising and coordinating with various departments, data review, tracking of patients\u0026rsquo; whereabouts, and ensuring timely and effective implementation of communication plans\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eICU\u0026thinsp;=\u0026thinsp;intensive care unit; ACP\u0026thinsp;=\u0026thinsp;advance care planning.\u003c/p\u003e \u003cdiv id=\"Sec25\" class=\"Section3\"\u003e \u003ch2\u003eIntervention phase\u003c/h2\u003e \u003cp\u003eIn addition to routine care, the intervention group will be introduced to the ACP communication plan based on the PFCC model. The ACP communication process will involve step-by-step discussions on topics such as ICU-related treatment, ACP-related knowledge, and the significance of ACP implementation. These communication sessions will be conducted over the course of one week. Surveys will be administered to both groups at the time of enrollment, seven days after enrollment, and 30 days after enrollment to assess outcomes. Detailed information regarding the intervention plan can be found in Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eGrouping methods and intervention timing\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"4\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eTimepoints\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003eGroups\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003eParticipants\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eControl Group\u003c/p\u003e \u003cp\u003eUsual Nurse\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eIntervention Group\u003c/p\u003e \u003cp\u003eUsual Nurse\u0026thinsp;+\u0026thinsp;ACP Communication\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eT0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eDemographics, (1), (2), (3), (4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eDemographics, (1), (2), (3), (4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003ePatients and main family members\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eT1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eUsual nurse\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003eUsual nurse\u0026thinsp;+\u0026thinsp;ACP communication\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003ePatients and main family members\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eT2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e(1), (2), (3), (4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e(1), (2), (3), (4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003ePatients and main family members\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eT3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e(1), (2), (3), (4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e(1), (2), (3), (4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003ePatients and main family members\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eT0\u0026thinsp;=\u0026thinsp;first day of enrollment; T1\u0026thinsp;=\u0026thinsp;five to six days after enrollment; T2\u0026thinsp;=\u0026thinsp;one day after the end of the intervention; T3\u0026thinsp;=\u0026thinsp;30 days after the end of the intervention. (1) End-of-Life Treatment Intention Questionnaire; (2) Willingness Consistency Questionnaire; (3) ACP Readiness Scale for Chronically Ill Patients (patient participants only); (4) Project Satisfaction Survey.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec26\" class=\"Section3\"\u003e \u003ch2\u003eOutcomes and measurements\u003c/h2\u003e \u003cp\u003eFor the primary outcome, the feasibility analysis will include an assessment of the patient enrollment rate, consent rate, loss to follow-up rate, and phase completion rate.\u003c/p\u003e \u003cp\u003eThe secondary outcomes will include the following:\u003c/p\u003e \u003cp\u003e \u003col\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eEnd-of-Life Treatment Intention Questionnaire [\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e] (for patient participants): The questionnaire has demonstrated a strong internal consistency, with a Cronbach\u0026rsquo;s α coefficient of 0.791. The survey primarily consists of the following key questions: (1) Are you willing to participate in discussions regarding end-of-life treatment wishes? (2) If you had to make a choice for the future, what would be your preference? (3) In the event that your disease continues to worsen and your life is at risk, what actions would you like your doctor to take?\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eWillingness Consistency Questionnaire [\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e] (for patient participants): The questionnaire has demonstrated strong internal consistency, with a Cronbach\u0026rsquo;s α coefficient of 0.791. It primarily consists of the following key question: If your condition becomes severe or you fall into a coma, and life-saving measures are required to maintain your life, would you be willing to accept interventions such as cardiopulmonary resuscitation, mechanical ventilation, gastrointestinal nutrition, blood transfusion, surgery, hemodialysis, vasopressor drugs, transfer to the intensive care unit (ICU), intravenous nutrition, and analgesics?\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eACP Readiness Scale for Chronically Ill Patients [\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e] (for patient participants): This scale will be used as the primary measurement tool to evaluate patients\u0026rsquo; readiness for advance care planning encompassing three key aspects: (1) attitudes toward advance care planning; (2) beliefs about readiness; and (3) motivation for participating in advance care planning. The scale employs a 5-point rating system, with scores ranging from 22 to 110. A higher total score indicates a greater level of preparedness for advance care planning. The score ranges are as follows: 22\u0026ndash;43 for a low level, 44\u0026ndash;65 for a lower-middle level, 66\u0026ndash;87 for an upper-middle level, and 88\u0026ndash;110 for a high level of readiness. The scale has exhibited strong internal consistency, with a total Cronbach\u0026rsquo;s α coefficient of 0.923.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eProject Satisfaction Survey (for patient participants): This survey primarily includes the following questions: (1) Did you find the project meaningful? (2) How do you feel after participating in the project? (3) Would you recommend this project to others? (4) What are your suggestions and opinions on this project?\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eEnd-of-life Treatment Intention Questionnaire [\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e] (for family member participants): The questionnaire has demonstrated strong internal consistency, with a Cronbach\u0026rsquo;s α coefficient of 0.757. It primarily includes the following key questions: (1) Do you want the patient to participate in discussions about end-of-life care wishes? (2) If the patient had to make a decision for the future, what do you think their preference would be? (3) If the patient\u0026rsquo;s condition worsens and his/her life is at risk, who would you prefer to be their doctor?\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eWillingness Consistency Questionnaire [\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e] (for family member participants): The questionnaire has exhibited strong internal consistency, with a Cronbach\u0026rsquo;s α coefficient of 0.804. This questionnaire primarily focuses on whether the family member would be willing to have the patient undergo various life-sustaining interventions, such as cardiopulmonary resuscitation, mechanical ventilation, gastrointestinal nutrition, blood transfusion, surgery, hemodialysis, vasopressors, transfer to the intensive care unit (ICU), intravenous nutrition, gastrointestinal nutrition, and analgesics, if his/her condition became severe or s/he fell into a coma.\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003cspan\u003e \u003cli\u003e \u003cp\u003eProject Satisfaction Survey (for family member participants): This survey primarily comprises the following key questions: (1) Did you consider the project to be meaningful? (2) How do you feel about your participation in the project? (3) Would you recommend this project to others? (4) What are your suggestions and opinions regarding this project?\u003c/p\u003e \u003c/li\u003e \u003c/span\u003e \u003c/ol\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec27\" class=\"Section3\"\u003e \u003ch2\u003eData management and monitoring\u003c/h2\u003e \u003cp\u003eData management and monitoring responsibilities will be undertaken by the coordinating investigator site\u0026rsquo;s clinical trial unit. The trial will strictly adhere to national and international standards for good clinical practice, ensuring compliance with regulatory and ethical requirements. Any serious adverse events, whether related or unrelated, that affect the participants (including family members) will be meticulously collected and documented in reliable source documents. Regular monitoring will be conducted to ensure the study\u0026rsquo;s quality and regulatory compliance. It is important to note that the monitoring personnel will not be involved in the research activities. The ethics committee has granted approval for supervision, including the verification of the investigators\u0026rsquo; and research team members\u0026rsquo; qualifications and the monitoring of document integrity and appropriateness.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv id=\"Sec28\" class=\"Section2\"\u003e \u003ch2\u003eData analysis\u003c/h2\u003e \u003cp\u003eThis study will utilize EpiData 3.1 software for data entry, with two individuals performing the task. Following data correction, the imported dataset will be analyzed using SPSS 29.0. Normally distributed measurement data will be expressed as mean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation. Group t-tests will be employed to compare the sample means of the two groups, while count data will be presented as percentages. The chi-squared test (χ2) will be used to compare the two groups of binary count data. Median and interquartile ranges (M [P25-P75]) will be utilized to describe rank or non-normally distributed data, and the rank sum test will be employed to compare the two groups. Two-sided tests will be used in all analyses. For the analysis of discrete repeated-measurement longitudinal data, such as decision certainty and end-of-life treatment intentions, generalized estimated equations will be applied. Statistical significance will be determined at a significance level of \u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05.\u003c/p\u003e \u003c/div\u003e"},{"header":"DISCUSSION","content":"\u003cp\u003eThe ICU is an area where all types of critically ill patients and patients with multi-system failure are concentrated for strict monitoring and rescue treatment [\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e]. The advancement and development of ICU medical technology not only brings the hope of continued life to patients but also increases patients\u0026rsquo; pain and the financial burden on their families [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e, \u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. For many terminally ill patients with no therapeutic benefits, their lives are only temporarily prolonged. As an important part of palliative care, the implementation of ACP in the ICU is conducive to ensuring patients\u0026rsquo; autonomy and allowing them to receive treatment consistent with their wishes, thereby improving patients\u0026rsquo; final quality of life and reducing the financial and psychological burden on their families [\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e]. Therefore, it is particularly important to promote ACP in the ICU, but there are no relevant reports on this subject at this time to the best of the researchers\u0026rsquo; knowledge.\u003c/p\u003e \u003cp\u003eDue to critical illness or prolonged sedative use, the majority of ICU patients lose their capacity for treatment decision-making, leaving only a small proportion with decision-making ability [\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e]. Consequently, it is necessary for family members to be involved in making decisions on their behalf. Building upon this foundation, the study will integrate the PFCC model to develop a comprehensive ACP communication plan for ICU patients. This approach of discussing ACP in a systematic manner aims to empower patients and their families by providing them with a prominent role in the entire communication process. Given the complex and dynamic nature of ICU patients\u0026rsquo; conditions, the needs of family members likewise evolves accordingly. This study will involve conducting multiple family meetings to promptly ascertain any changes in patients\u0026rsquo; expressed preferences. Our sincere aspiration is that our project will enable medical decisions that align with patients\u0026rsquo; preferences, ultimately enhancing the mental well-being of patients and their families, as well as alleviating the financial burden they face.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"9.388335704125177%\" valign=\"top\"\u003e\n \u003cp\u003eACP\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"90.61166429587482%\" valign=\"top\"\u003e\n \u003cp\u003eadvance care planning\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"9.388335704125177%\" valign=\"top\"\u003e\n \u003cp\u003eCa\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"90.61166429587482%\" valign=\"top\"\u003e\n \u003cp\u003econsulted content\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"9.388335704125177%\" valign=\"top\"\u003e\n \u003cp\u003eCr\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"90.61166429587482%\" valign=\"top\"\u003e\n \u003cp\u003eauthority coefficient\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"9.388335704125177%\" valign=\"top\"\u003e\n \u003cp\u003eCs\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"90.61166429587482%\" valign=\"top\"\u003e\n \u003cp\u003eassessment content\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"9.388335704125177%\" valign=\"top\"\u003e\n \u003cp\u003eCV\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"90.61166429587482%\" valign=\"top\"\u003e\n \u003cp\u003ecoefficient of variation\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"9.388335704125177%\" valign=\"top\"\u003e\n \u003cp\u003eICU\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"90.61166429587482%\" valign=\"top\"\u003e\n \u003cp\u003eintensive care unit\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"9.388335704125177%\" valign=\"top\"\u003e\n \u003cp\u003eM\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"90.61166429587482%\" valign=\"top\"\u003e\n \u003cp\u003emean\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"9.388335704125177%\" valign=\"top\"\u003e\n \u003cp\u003eFCC\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"90.61166429587482%\" valign=\"top\"\u003e\n \u003cp\u003epatient- and family-centered care\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"9.388335704125177%\" valign=\"top\"\u003e\n \u003cp\u003eRCT\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"90.61166429587482%\" valign=\"top\"\u003e\n \u003cp\u003erandomized controlled trial\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study protocol (V.1.0, July 11, 2023) has been approved by the Biomedical Research Ethics Committee of the Affiliated Hospital of Zunyi Medical University (approval number: KLL-2023-090). Written informed consent was obtained from all participants / participants\u0026rsquo; legal guardians / next of kin for their participation in this study. The results of this study will be distributed through peer-reviewed journals.\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\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe researchers have read and understand BMJ\u0026rsquo;s policy on the declaration of competing interests and declare that they have no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study is supported by a research grant from the Zunyi Science and Technology Bureau of Guizhou Province (Zunyi Kehe HZ Zi [2022]197).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026rsquo; contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eYY initiated the research conception and design of the ACP communication program for ICU patients based on the PFCC model design concept, and was responsible for funding applications and coordinating the investigators. YY, RP, LS, and XJ made major contributions to the conception and design of the research project and co-wrote the grant application. RP, RD, and CL were responsible for the revision of the grant application and quality control of the project\u0026rsquo;s implementation process. RP and YY co-wrote the manuscript. RP, XJ, SL, YY, RD, and CL critically reviewed the manuscript for important intellectual content. All authors read and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe would like to thank our patients, caregivers, and healthcare team, without whom this work would not have been possible.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDisclaimer\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe funding source had no role in the design of the study and will not have any role during the execution, analyses, interpretation of the data, or decision to submit the results.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePatient and public involvement\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePatients and/or the public were not involved in the design, conduct, reporting, or dissemination plans of the current research.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePatient consent for publication\u003c/strong\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eProvenance and peer review\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot commissioned; externally peer reviewed.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial status\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eChiCTR.gov Identifier: ChiCTR2400086414\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eRecruitment Status: Recruiting.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTrial Registration Date: July 1, 2024.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eDate Recruitment Began: July 2, 2024.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eEstimated Primary Completion Date: March 2025.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eEstimated Study Completion Date: December 2025.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eTongyang Y. Study on the current status and influencing factors of patients\u0026rsquo; death quality from the perspective of ICU nurses in a tertiary hospital in Zunyi City. Zunyi Medical University; 2021.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRomano M. Facilitating supportive care in cardiac intensive care units. Curr Opin Support Palliat Care. 2020;14(1):19\u0026ndash;24.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eYu L, Zhixia Y, Li I. Research progress on death with dignity for terminally ill patients in ICU. Milit Nurs. 2016;33(7):40\u0026ndash;2.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eConnors AF, Desbiens NA, Fulkerson WJ, et al. A controlled trial to improve care for seriously ill hospitalized patients: the study to understand prognoses and preferences for outcomes and risks of treatments (SUPPORT). JAMA. 1995;274(20):1591\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eQiqi N, Yiyu Z. The research hotspots of critical care nursing in recent 5 years based on PubMed database. Chin J Emerg Crit Care Nurs. 2023;4(02):167\u0026ndash;72.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHongjun Z, Tao L. Analysis of ethical issues in ICU treatment practice. Med Phil. 2022;43(01):28\u0026ndash;33.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eYaodan Z, Huan L, Aipin D, et al. A qualitative study on the factors influencing clinical treatment decision-making among family members of ICU patients. Mod Med J. 2020;48(11):1428\u0026ndash;32.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSkorstengaard MH, Jensen AB, Andreassen P, et al. Advance care planning and place of death, hospitalisation and actual place of death in lung, heart and cancer disease: a randomised controlled trial. BMJ Support Palliat Care. 2020;10(4):e37.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eYeyin Q, Jianghui Z, Jiarui M, et al. Recent advances in intervention model of advance care planning for patients with advanced cancer. Chin Gen Pract. 2019;22(21):2524\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJohnson S, Clayton J, Butow PN, et al. Advance care planning in patients with incurable cancer: study protocol for a randomised controlled trial. BMJ Open. 2016;6(12):e12387.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKhandelwal N, Kross EK, Engelberg RA, et al. Estimating the effect of palliative care interventions and advance care planning on ICU utilization: a systematic review. Crit Care Med. 2015;43(5):1102\u0026ndash;11.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eZhijian D. The experience of advanced cancer patients and their relatives in advance care planning: a qualitative study. Zunyi Medical University; 2021.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eShoubi W, Jianghui Z, Liuliu C, et al. Influencing factors of participation in advance care planning among elderly with mild cognitive impairment: a qualitative research. Chin Nurs Res. 2020;34(01):24\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eXiaoming S, Man Y, Yun Z, et al. Effects of advance care planning on fatigue symptom and psychological condition among patients with chronic heart failure. Chin J Pract Nurs. 2022;38(2):81\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBeibei L, Feng L, Shufang Z, et al. Research progress on acceptance of advance care planning in the elderly. J Nurs Sci. 2021;36(7):110\u0026ndash;12.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eZhiiian D, Xiangying C, Liu Y, et al. The experience of cancer patients and their relatives in advance care planning: a meta-synthesis of qualitative research. Chin J Nurs. 2020;55(12):1864\u0026ndash;70.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAbukari AS, Schmollgruber S. Concepts of family-centered care at the neonatal and paediatric intensive care unit: a scoping review. J Pediatr Nurs. 2023;71:e1\u0026ndash;10.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJacob M, Horton C, Rance-Ashley S, et al. Needs of patients\u0026rsquo; family members in an intensive care unit with continuous visitation. Am J Crit Care. 2016;25(2):118\u0026ndash;25.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eQin H, Wenping X. Practice of regularly scheduled and appointment-based visitation in neurological ICU. J Nurs Sci. 2013;28(20):21\u0026ndash;3.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChan AW, Tetzlaff JM, Gotzsche PC, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLockwood C, Dos SK, Pap R. Practical guidance for knowledge synthesis: scoping review methods. Asian Nurs Res (Korean Soc Nurs Sci). 2019;13(5):287\u0026ndash;94.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChenxi T. Construction of two cancers screening intervention program for women based on health belief model. Cent South Univ. 2023.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eShuzhi P, Peng Z, Shuzhen X. Evaluation system of chronic disease self-management capacity established based on the Delphi expert inquiry method. Guangxi Med J. 2023;45(14):1780\u0026ndash;4.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJun W, Qiongya S, Yuepei X et al. The principle and implementation of confidence interval of effect size. Psychol: Tech Applic. 2019;7:284\u0026thinsp;\u0026ndash;\u0026thinsp;96.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLiu X, Long J, Chang Y, et al. Application of the whole-course care model (IWF/C Care) for postintensive care syndrome based on an early warning system in critically ill patients: a randomised controlled trial study protocol. BMJ Open. 2023;13(7):e73035.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eYeyin Q, Jianghui Z, Jiarui M, et al. Construction and feasibility study of the intervention model of advance care planning for patients with advanced cancer. Chin J Pract Nurs. 2020;36(28):2179\u0026ndash;86.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eXinru W, Yu S. Development and validation of advance care planning readiness scale. Chin Nurs Manag. 2019;19(6):861\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eXiao X, Keping T, Xiaohong Z, et al. The research progress of end-of-life decisions among ICU patients. Chin Nurs Manag. 2017;17(2):271\u0026ndash;5.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eJones C, Griffiths RD, Humphris G, et al. Memory, delusions, and the development of acute posttraumatic stress disorder-related symptoms after intensive care. Crit Care Med. 2001;29(3):573\u0026ndash;80.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eConroy M, McCallister J, Gustin J. Entrustment decision making in the intensive care unit: it\u0026rsquo;s about more than the learner. ATS Sch. 2024;5(1):53\u0026ndash;70.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"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":"Advance care planning, Intensive care unit, Patient- and family-centered care model, Randomized controlled trial, Protocol","lastPublishedDoi":"10.21203/rs.3.rs-4734311/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4734311/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eThe intensive care unit (ICU) has the highest patient mortality rate. Implementing advance care planning (ACP) in the ICU can improve patients\u0026rsquo; sense of dignity in medical decision-making and alleviate psychological pressure on family members, although ACP remains a challenging concept. The ACP communication plan, grounded in the patient- and family-centered care (PFCC) model, promotes patient and family involvement in treatment decisions, safeguarding patient autonomy and preventing issues such as discrepancies between treatment intensity and expected prognosis.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eThe exploratory hybrid research protocol will be comprised of four implementation phases. Phase 1 will involve familiarizing the research team with the content and implementation strategies of ACP based on the PFCC model. In Phase 2, interviews regarding ACP will be conducted with ICU patients and their families to acquire a comprehensive understanding of their needs. Phase 3 will involve developing the ACP communication plan document utilizing the PFCC model. Phase 4 will focus on validating the feasibility of the plan through a two-group (control and intervention), single-center, parallel-group randomized controlled trial. Regarding data analysis, the primary and secondary outcome measures will be assessed at baseline, seven days after baseline, and 30 days after baseline.\u003c/p\u003e\u003ch2\u003eDiscussion\u003c/h2\u003e \u003cp\u003eThe implementation of ACP in the ICU is an important part of palliative care, as it ensures patients\u0026rsquo; autonomy and allows them to receive treatment consistent with their wishes, which improves quality of life and reduces the financial and psychological burden on families. However, there have been few studies in this area. This study will integrate the PFCC model into a comprehensive ACP communication plan for ICU patients to empower them and their families in the decision-making process. Our sincere aspiration is that this project will enable medical decisions that align with patients\u0026rsquo; preferences, ultimately enhancing the mental well-being of patients and their families, as well as alleviating the financial burden they face.\u003c/p\u003e\u003ch2\u003eTrial registration:\u003c/h2\u003e \u003cp\u003eChinese Clinical Trial Register (ChiCTR2400086414).\u003c/p\u003e","manuscriptTitle":"Construction of an advance care planning communication plan for intensive care unit patients based on the patient- and family-centered care model: a mixed-method study protocol","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-08-09 00:33:06","doi":"10.21203/rs.3.rs-4734311/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"
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