Implementing a primary care disease management concept for venous leg ulceration: Findings of a mixed-methods process evaluation in the Ulcus Cruris Care trial

Implementing a primary care disease management concept for venous leg ulceration: Findings of a mixed-methods process evaluation in the Ulcus Cruris Care trial | 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 Research Article Implementing a primary care disease management concept for venous leg ulceration: Findings of a mixed-methods process evaluation in the Ulcus Cruris Care trial Regina Poß-Doering, Thomas Fleischhauer, Nina Sander, Gunter Laux, and 3 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8470254/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 25 You are reading this latest preprint version Abstract Background Care analyses show that evidence-based measures such as compression or promotion of mobility are rarely implemented in treatment of Venous leg ulcers (VLU). The Ulcus Cruris Care project designed a disease management concept to support evidence-based VLU treatment in general practices via online training and three e-learning modules for practice teams, software-supported case management, involving non-physician assistants, and promoting patient activation and education. The intervention program was implemented in a multicenter randomized controlled trial. A mixed-methods process evaluation explored intervention fidelity and perceived effects to identify improvement potential. Methods The cross-sectional process evaluation design applied semi-structured guide-based qualitative telephone interviews and a study-specific survey to evaluate the implementation process of the program. Results N = 38 survey questionnaires were completed and n = 27 interviews were conducted (n = 10 general practitioners, n = 10 non-physician assistants, n = 7 patients). Findings indicate high intervention fidelity regarding completion of the online training (100%), the e-learning modules (between 61% and 48%), application of standard operating procedures (100%), patient education material (91%), and case management software (91%). Practice teams and patients positively perceived the role of non-physician assistants as case managers and their involvement in wound treatment and patient education. Overall, the program was perceived as effective in fostering a change in treatment routines towards the regular use of compression therapy as the most effective treatment measure, patient and practice team education, and wound healing. Discussion The intervention program was assumed to lead to more frequent use of compression therapy, faster healing and less use of medical resources. Participants in the process evaluation perceived the intervention program as contribution to a structured, evidence-based VLU treatment, a gain in relevant knowledge for practice teams and patients and more active patient and relative participation. The outcome analysis in the Ulcus Cruris Care trial strengthened these findings and suggested a potential benefit of the intervention. Conclusion Promotion of comprehensive VLU treatment and care in general practices, including a regular use of compression therapy and active patient participation as facilitated by this intervention program appears to be largely suitable for a VLU case management approach. Trial registration : The trial protocol was registered in the German Clinical Trials Register on August 30, 2021 (DRKS00026126). chronic wounds venous leg ulcer case management general practice education Contributions to the Literature Application of chronic wound care concepts still needs encouragement in primary care in Germany. Implementation of an evidence-based care concept that includes compression therapy can promote faster wound healing and improve quality of life. In our multi-faceted program, implementation strategy clusters followed expert recommendations to foster change and train and support care providers and patients alike. Evaluation of the implementation process facilitated insights regarding intervention fidelity and perceived effects and supports assessment of this program as suitable for a broader disease management approach. Background Chronic wounds are considered a worldwide problem. It is estimated that in developed countries about 1–2% of the population will experience a chronic wound during their lifetime. In low income countries, etiologies may be different, yet there is a common denominator which is “impaired healing” [ 1 ]. Venous leg ulcers (VLU) account for about 70% of chronic lower extremity ulcers and about 1% of the population and 3% of people over 80 years of age are presumed to suffer from VLU [ 2 , 3 ]. Due to aging populations, a steadily growing prevalence can be expected [ 4 ]. Thus, lower-extremity ulcerations are very common and have a major impact on public health [ 5 ]. In Germany, about 1.8 million people are affected by VLU [ 6 ], yet standardized pathways for their treatment have hardly been established. Thus, affected patients may suffer chronification, morbidity and considerable impairment of quality of life [ 7 , 8 ]. Compression therapy carried out in accordance with existing guidelines counteracts the venous disease and thus the cause of the wound healing disorder and has a proven effect on wound healing. However, it is implemented in less than 50% of cases and often incorrectly applied [ 9 , 10 ]. Other effective treatment elements such as promoting mobility and exercising are also rarely addressed [ 11 ]. In contrast, modern wound therapeutics are often used for local therapy, even though there is no objective evidence of beneficial effects [ 12 ]. Reasons for wound care deficits are assumed to be ranging from insufficient care provider knowledge regarding compression therapy and its practical application [ 13 , 14 ], to a lack of standardized outpatient care concepts, increasing time pressure in practices [ 15 ], and a passive, uninformed patient role during treatment [ 16 ]. Care providers such as general practitoners (GPs), nursing services and certified wound managers can be involved in VLU treatment. The project Ulcus Cruris Care (UCC) aims to establish a patient-oriented and evidence-based care concept for VLU treatment in general practice by ensuring care coordination and multidisciplinary treatment. Educational interventions were developed to enable GPs and non-physician medical assistants (MA) to fill a central role in VLU management and support patients and relatives in taking an active role in the treatment process. Also, e-learning and computerized case management were integrated. The study hypothesis was that implementation of the concept generally promotes evidence-based treatment and the use of compression therapy, and potentially leads to faster wound healing, improved quality of life for affected patients and reduced utilization of medical resources. After piloting the intervention program [ 17 ], a multicenter cluster-randomized controlled study (RCT) was carried out in general practices. A process evaluation accompanied the implementation process to investigate intervention fidelity, perceived effects, and identify improvement potential for the intervention components. Methods Study design The UCC intervention was developed to foster primary care treatment of VLU. After successful pilot implementation [ 17 ], the intervention was rolled out in a multicenter randomized controlled trial. As a part of the UCC trial [ 18 ], a mixed-methods process evaluation was conducted to evaluate the implementation process of the UCC intervention. For the observational process evaluation, a cross-sectional study design was chosen. A mixed-methods approach was applied with semi-structured guide-based qualitative telephone interviews and an accompanying survey study to evaluate the implementation process of the UCC intervention. Implementation program Following a status quo survey, a multifaceted intervention program for VLU outpatient treatment was developed, piloted, and subsequently implemented as care concept in n = 44 general practices in Germany for a total of n = 53 patients with VLU. The program addresses implementation strategy clusters suggested by the Expert Recommendations for Implementing Change (ERIC) taxonomy [ 19 , 20 ] and comprises five main components: 1) On-demand online training and e-learning courses for GPs and MAs (cluster: Train and Educate Stakeholders); 2) Standard operating procedures (SOP) for evidence-based VLU treatment (cluster: Support Clinicians); 3) Software-supported case management (cluster: Change Infrastructure); 4) Strong involvement of MAs in case management, wound care, and patient education (cluster: Support clinicians; Develop Stakeholder Interrelationships); 5) Printed educational material and e-learning course for patients (cluster: Train and Educate Stakeholders; Engage consumers). The online training and e-learning courses were based on relevant literature and guidelines [ 11 , 21 – 28 ] and focused on VLU pathophysiology and chronic venous insufficiency, effectiveness and practical aspects of evidence-based compression therapy, local wound treatment, and patient education. A previous publication describes the implementation program in detail [ 18 ]. Recruitment An information letter was sent by mail to approximately 800 regional GP practices collaborating with the study center as an invitation to participate in the trial. Interested practices were screened for eligibility by the study team. Inclusion criteria were to meet IT requirements for using the software-supported case management and at least one MA to be routinely involved in chronic wound treatment and care. GP practices with more than 20 VLU patients per year could not participate. A pragmatic sampling strategy was used for the process evaluation. To be eligible for inclusion in the process evaluation, GPs, MAs, and patients had to be adult participants in the RCT intervention group, with good mastery of German. Patients also had to have a diagnosed VLU that had been present for a maximum of 12 months. MAs had to be actively involved in wound care. All patients in the intervention group were invited to participate in both parts of the process evaluation by the intervention group practices and received printed information about the process evaluation and its objectives, and a consent form. If written consent was given, contact details (telephone number and address) were forwarded to the study team. All GPs and MAs from the intervention practices were contacted via telephone by the study team to invite them for participation in the process evaluation. After completing the online practice training and treating at least two study patients, GPs and MAs who were willing to participate received a separate informed consent form. All participants were informed verbally and in writing about content and objectives of the study and gave written consent prior to participating in the process evaluation. Participants could decide whether they participated in the survey, an interview, or in both. Recruitment target was to include 10 GPs, 10 MAs, and 10 patients in the process evaluation. An expense reimbursement of 50€ was offered for participation in an interview and an additional 20€ for filling in the study-specific questionnaires. Integrated into the study protocol of the multicenter RCT, the process evaluation and its data collection instruments received a positive vote from the Heidelberg Ethics Committee (S-608/2021) and the Ethics Committee of the German Medical Association (B-F-2021-101). Data collection For this process evaluation, study-specific survey questionnaires (see Additional file 1) were developed to cover items regarding intervention fidelity (7 items), acceptance and contentedness (18 items), perceived (9 items) as well as non-anticipated effects (2 items), and contextual factors (6 items). Response options were provided on a 5-point Likert scale (rating: 1 = totally disagree; 5 = totally agree), and an optional free text field. A socio-demographic questionnaire was used to collect participant characteristics. The qualitative study used a semi-structured interview guide (see Additional file 2) to explore participant perceptions regarding acceptance of the intervention program, intervention fidelity, and perceived effects. Against the background of questions used in the evaluation of the pilot study [ 17 ], the interprofessional research team (Health Services Research, General practice, Clinical Research) developed interview guides for the three groups (GPs, MAs, patients) in an iterative process by collecting, discussing and subsuming appropriate questions and wording [ 29 ]. All interviews were conducted by junior and senior research team members (NS (f), TF (m)), audio-recorded, pseudonymized and transcribed via the software f4. Interviews were conducted at the workplace or the home office, participants were at home or at their workplace and knew interviewers through study-related conversations. No non-participants were present, no field notes were taken, and transcripts were not returned to participants. Data were organized and managed in MAXQDA Version 2022 (Release 22.7.0; Verbi Software) and stored on secure servers at the Department of Primary Care and Health Services Research, University Hospital Heidelberg, Germany. Data analysis All quantitative and socio-demographic data were analyzed descriptively by three researchers (T.F, R.P.-D., N.S.) using Microsoft Excel software (Version 1808). Means, medians (med), standard deviations, maximum and minimum values, and absolute and relative frequencies were calculated. Verbal Likert scales were numerically recoded from 1 to 5 (totally disagree = 1, somewhat disagree = 2, partially agree = 3, somewhat agree = 4, totally agree = 5). For intervention fidelity, absolute and relative frequencies were calculated. The qualitative data were analyzed inductively using the Framework analysis method [ 30 , 31 ] as a systematic approach to structuring data and enabling cross-category comparisons to identify key messages and potential contrasts [ 30 ]. All qualitative data were analyzed by a junior (Clinical Research) and a senior researcher (Health Services Research). Coding was discussed in the study team (R.P.-D., J.D.S, N.S.) and approximated if divergences occurred. Results All process evaluation data were collected in the intervention group (n = 20 practices) during the UCC intervention phase between May 2023 and February 2024. A total of n = 27 interviews were conducted (n = 10 GPs, n = 10 MAs, n = 7 patients), n = 38 completed survey (n = 12 GPs, n = 15 MAs, n = 11 patients) and n = 30 socio-demographic questionnaires (n = 10 GPs, n = 11 MAs, n = 9 patients) were returned. Interview and survey participants were not necessarily the same individuals. Interview duration was between 08:31 minutes and 54:27 minutes (mean duration: GP = 20:16 minutes, MA = 23:21 minutes, patients = 19:18 minutes; total = 20:58 minutes). Table 1 describes the socio-demographic characteristics of the sample. Table 1 Socio-demographic sample characteristics General practitioners n = 10 Medical assistants n = 11 Patients n = 9 Age mean (range) 54.5 (35–65) 48.1 (30–58) 76.8 (56–85) Sex f (n) 4 11 6 Professional experience in years (range) 25.3 (6–37) 25 (09-535) Specialist in general practice (n) Specialist in internal medicine (n) 8 2 specialized assistance in general practice (n) 8 Working full-time (n) 10 4 1 Working in single practice (n) 6 6 Working in rural area (n) 8 8 Living in rural area (n) 6 The majority of patients were covered by statutory health insurance (n = 8), were no longer employed (n = 8) and almost half of them lived with a partner or relative (n = 4). All GPs stated that they were responsible for diagnosing, determining therapy, counseling and educating VLU patients and that they either engaged in wound care themselves, delegated it to an MA or carried it out as a team. MAs stated that they were involved in both, patient education and wound care and were responsible for applying compression bandages. Most of the practice teams described working regularly with nursing services when caring for VLU patients outside of the study. The results reported below refer to both, the qualitative data and the data from the survey. Included quotes have been translated with due diligence and are presented with an indication of participant group (GP = general practitioner; MA = non-physician assistant) and number of the interview. All findings are presented with regard to the intervention components along the process evaluation target criteria: 1) Intervention fidelity and perceived benefits, and 2) Perceived effects. Intervention fidelity Practice team perceptions All practice teams participating in the process evaluation attended and completed the online training (100%). The three e-learning modules were completed by n = 17 (58,62%), n = 15 (51,72%), and n = 14 (48,28%) GPs, and n = 22 (61,11%), n = 20 (54,05%), and n = 19 (51,35%) MAs in the intervention group. Participating GPs indicated in the survey that they used the provided standard operating procedures (n = 12), the case management software (n = 11), the patient education material (n = 11), and informed about the patient e-learning (n = 7). Two GPs indicated they made all their participating patients aware of this option. Limitations were indicated regarding the patient e-learning in connection to patient age. GPs stated they saw relevance and benefits for the practice team and patient care in completing the online training (webinar), using the standard operating procedures (med 4.5 each), the e-learning modules (med 4.25), the software-supported patient monitoring and the printed patient education material (med 4). One GP commented in a free text field that practice routines might need adaptation to fully make use of all intervention components. In the survey, GPs and MAs were asked to indicate whether they perceived the intervention components as time consuming. Overall, the ratings were high, in particular regarding time required to complete the e-learning, and for patient education (med 3.4 each), with a slightly lower rating for using standard operating procedures and the software-supported patient monitoring (med 3.2 each). Table 2 details the combined GP and MA rating for contentedness with the intervention components. Table 2 GP and MA rating of contentedness with the UCC intervention components (n = 26) Intervention component Median rating Synchronous online training (webinar) 5.0 Standard operating procedures 5.0 E-learning modules 5.0 Software-supported patient monitoring 4.0 Patient education material 4.0 *scale: 1 = totally disagree to 5 = totally agree A comprehensive use of the UCC intervention components was considered sensible by the participants in the interview study, particularly in view of the ageing patient population and thus a potentially increasing number of wounds to be treated. In this context, a need to train social care center staff accordingly was mentioned. The willingness of patients with VLU to actively participate in a structured care program was considered likely. In the interview study, all GPs and MAs reported they took part in the synchronous online training and completed the e-learning. The benefits of the educational formats were considered high, and no suggestions for improving the e-learning and online training were mentioned. In the online training format, exchange with other practices and the inclusion of interesting case studies were highly appreciated. Regarding content, participants in both groups ranked compression therapy and local wound treatment as particularly relevant. GPs also rated the content on patient education as particularly relevant. Interview participants saw a decisive learning effect in content visualization and repetition in the e-learning, and a good opportunity to receive reassurance regarding compression because they had been “not entirely sure whether it always makes sense” (GP04). The flexibility in terms of being able to choose time and place of completing the training was perceived as positive. Particularly the quality of preparation of the evidence-based content, the opportunity to acquire knowledge and the strengthening of the MAs’ independent action were positively emphasized. “So, with this e-learning, it's quite good, also with the videos that you always have there, you perceive it differently than if you just read it through, at least that's how I feel and yes, it's just, it's repetitive, but it's good that you hear it again and again.” (MA04) MAs perceived the structuring of the treatment process, clarity of the documentation, and a reduction in workload as advantages of the UCC case management program. Most MAs found the monitoring function useful for documenting the healing process and enabling a comparison between the individual study visits. Improvement suggestions for the case management software were mentioned neither in the interviews nor in the questionnaires. “Well, after the patient had been here, we just went to the computer and entered it [the data]. I thought that [...] was well guided, so it was actually good for the process. So, you could easily enter it. […]” (MA10) MAs and GPs also stated that they found the SOP for guideline-compliant VLU care supportive and used it because “it was finally documented and clearly stratified [...]” (GP07). One MA and one GP each perceived the SOPs as rather unhelpful. Two practices reported that they had laminated the SOPs for quick and easy use and hung them up clearly visible in the treatment room. Some participants passed on the SOPs to nursing services and social care units so they could also benefit from the knowledge. “[...] I have now also printed this out with these [SOP], […], we now have this as a guide, the others are now also following it”. (GP08) All GPs and almost all MAs reported using the written patient information, handing it out to patients and also passing it on to nursing and social services for their education. Both professional groups shared the view that the structured verbal education together with dissemination of written information was sustainable and effective. GPs stated that they informed patients about the possibility of making use of the on-demand e-learning, yet patients did not engage with it. According to the interviewees and free text fields in the survey questionnaires, this was assumed to be due to advanced patient age, lacking access to a computer or internet, disinterest or low digital competence. Patent perceptions All patients indicated in the survey that they were very content with the treatment of their wound since they had started participation in the UCC intervention, and perceived compression therapy as necessary to support wound healing (med 5 each). They also stated satisfaction with the received information material and its scope (med 4). Usefulness of the printed educational material was rated as high (med 5), and for the e-learning rather low (med 2). Time consumption for going through the educational material was perceived as moderate (med 3). During interviews, patients described that their GPs and MAs provided education, precise treatment and behavioral instructions, and detailed information about compression therapy. They considered compression therapy as very important, but some described individual barriers for its implementation and their own active participation in treatment such as pain, aesthetics and a lack of patience. Some patients mentioned that they were informed by their GPs about the possibility of participating in an e-learning, yet did not engage with it. They indicated a high relevance of verbal and practical education and described it as more important than reading information in e-learning and printed information leaflets, which were seen as potentially useful add-ons. Information on the content of the clinical picture, dressing changes, compression therapy and general measures were considered to be relevant. “[...] I looked at the pictures a bit, but she [the MA] explained it all to me so well in pictures and in practice that I didn't actually need to read it.” (PAT03) Perceived effects Practice team perceptions GPs and MAs were asked to characterize their assessment of intervention program effects in both parts of the evaluation. Table 3 details their corresponding rating of perceived effects on the survey. Table 3 Rating of perceived effects by GPs and MAs (n = 26) Perceived effects Median rating* I feel more competent now in the treatment of VLU patients. 5.0 My knowledge regarding local wound treatment was strengthened. 5.0 My knowledge regarding compression therapy was strengthened. 5.0 The role of the MA as case manager was strengthened. 5.0 Standardizing of treatment processes was improved. 5.0 The interventions contributed to improvements in patient care. 4.0 Patient education was improved. 4.0 Active patient participation in the treatment process was improved. 4.0 Software-supported patient monitoring improved the treatment process. 4.0 *Scale: 1 = totally disagree − 5 = totally agree They indicated that they had gained more confidence in caring for affected patients and ‘take over completely ourselves’ (GP04) instead of delegating the care to a wound manager. Several providers felt that the intervention components had increased their overall competence in care and counseling of VLU patients, improved healing outcomes and reduced wound healing time. They also described several changes in the therapeutic approach to VLU treatment and attributed the changes to an increase in knowledge. Some stated that they had not given sufficient importance to compression therapy and had tended to focus on local wound treatment prior to their participation in UCC. Some mentioned that with the newly gained knowledge and confidence, they now applied compression therapy with greater consistency and perseverance and had learned it was worthwhile to remain patient. They expressed they were convinced that the intervention components enabled them to approach VLU care in a more structured and evidence-based manner. “The treatment is more stringent and you reflect more on what you are doing.”(GP07) “Yes, and I have to say that the wounds heal really quickly, well, from my previous time in another practice, there were also many older people, who had large wounds that almost never healed at all without compression. So that has already shown me a difference.” (MA05) It was also stated that the role of the MA was strengthened, treatment processes were standardized and patients could be more actively integrated into the treatment process. GPs described that they readily delegated certain tasks to reduce their workload and motivate their MAs at the same time by giving them more responsibility. MAs described experiencing more joy in their profession and recognition by carrying more responsibility. Patient perceptions Patients were asked to assess potential effects they might have perceived in the context of participation in the UCC intervention. Table 4 describes their rating of perceived effects as indicated in the survey. Table 4 Patient perceptions regarding effects (n = 11) Item Median rating* Outpatient treatment quality has improved. 5 I feel well informed about my wound now. 5 I participate more actively in my treatment now. 5 I learned to apply a compression bandage correctly. 4 I have learned how to change a dressing by myself. 5 I feel more confident in dealing with my wound. 5 I feel better treated and supported by my GP 5 *Scale: 1 = totally disagree − 5 = totally agree In the interviews, most patients described their experience of a positive development in the treatment provided by their GP practice since participating in the UCC intervention program. They felt positive about the more intensive care provided by the practice team, well informed, better treated and recognized. Several patients mentioned they paid more attention to a balanced diet as a result of the educational counselling of the practice team. It was also reported that the supervising MA provided knowledge about the use of compression therapy, different compression materials, padding and wound cleaning. All patients stated that they felt safer overall in dealing with their wound and well informed. Some patients described they were able to apply the compression bandage themselves or with the support of relatives. “Exactly, we practiced it two or three times, when it was bandaged, she [the MA] said ‘now you try putting the bandage on’, to see if I'm doing everything right and then she gave me some help the first time. And the second time, it worked really well on my own. When she saw that I could do it all by myself, without her help, she knew it would work.” (PAT03) Discussion Findings of this process evaluation indicate a high level of adherence to the intervention and a high level of acceptance regarding the UCC intervention components in all participant groups and confirm earlier findings in the UCC pilot study [ 17 ]. The UCC intervention components were seen as supportive to a structured, evidence-based VLU treatment, facilitated a gain in relevant knowledge for practice teams and patients while they also enabled informed and more active patient and relative participation as intended by the program at the same time. A change in treatment routine towards the regular use of compression therapy as the most effective treatment measure was noted by both, practice teams and patients. Overall, the patient-centered approach found strong acceptance and the UCC interventions were perceived as contributions to improvements in VLU patient care. Practice teams and patients alike positively perceived the strengthened and central role of MAs as case managers and their more intensive involvement in wound treatment and patient education. Overall, these findings are largely in line with the expectations of an initial survey study carried out prior to intervention development [ 32 ], and findings of the process evaluation of the UCC pilot implementation [ 17 ], and the findings of the outcome analysis in the UCC trial [ 33 ]. The UCC program intends to enhance knowledge and practical skills of care providers, and promote informed and active participation of patients to support standardized evidence-based and patient-centered treatment of VLU in GP practices. The transfer of knowledge via the on-demand online format offered great flexibility for practice teams in terms of both, organization and scheduling. The data collected in the process evaluation show that the practice teams gained relevant knowledge by participating in the training offered, and that this increase in competence was reflected in perceived treatment successes. In this context, a rethinking of the role of GP practices towards active treatment of VLU patients as primary care providers and a change in attitude towards compression therapy was also observed. A focus shift from purely local wound treatment to causally oriented treatment with regular application of guideline-compliant compression therapy was also identified. Previous research indicated knowledge deficits regarding compression therapy and its practical application among healthcare professionals [ 9 , 34 – 36 ]. However, it is considered to be the most effective conservative VLU treatment option with the potential of halving healing time when adequately applied [ 37 , 38 ]. Research also points to knowledge gaps, pain and discomfort, and socio-psychological patient factors as determinants for patient adherence to compression therapy [ 39 – 42 ]. Educational interventions can improve patient knowledge and close such gaps, thus improving therapy adherence and wound-related as well as patient-reported outcomes [ 22 , 43 – 45 ]. As intended, the targeted training and educational interventions offered in the UCC program supported patients in taking a more active role in the treatment process and overcoming barriers together with their primary care providers. With regard to a broader implementation of the UCC intervention program, the knowledge transfer format used for practice teams can be recommended since it successfully addressed potential knowledge gaps. For older patients in particular, the on-demand e-learning format offered for voluntary use in the UCC program might be less relevant than engagement in verbal and practical education supported by printed information material. This is supported by the strong patient activation observed in this process evaluation, despite the only sporadic use of the patient e-learning. However, the patient e-learning could be a suitable add-on for patients interested in this format. Follow-up research should therefore include and evaluate this option. In light of scarce resources and an expected increase in multimorbidity and chronic wounds due to aging populations, the strengthening and expansion of the MA role combined with a structured case management approach as used in the UCC program seems to be essential to ensure adequate VLU care in general practice in the future. This approach was strongly advocated by all participants in this process evaluation and is supported by research that indicates that a trustful relationship between nursing staff and patients can foster therapy adherence [ 46 , 47 ]. Strengths and limitations Studies on the care provider and patient perspectives regarding a holistic case management program for VLU in general practice are scarce. The methodological approach in this process evaluation facilitated in-depth analysis of intervention acceptance and perceived effects, both by general practice teams and patients. Conducting the interviews via telephone accommodated for practice team and patient limitations regarding time resources and potential burden. Participants were able to comprehensively describe their perceptions regarding the program and perceived effects. The systematic yet flexible approach to structuring the qualitative data enabled cross-category comparisons, identification of key aspects and potential contrasts. The first author, who was not involved in data collection, analyzed all qualitative data based on initial analysis of n = 15 transcripts by a junior researcher and along consensus processes in the research team, thus ensuring a high degree of objectivity and independence. With a sample size of n = 27 interviews, a high degree of information saturation was achieved. Reporting follows scientifically valid criteria [ 48 ]. Some limitations have to be reported. Statements regarding the intervention program might entail a limited transferability since less motivated practice teams could have reported different perceptions. Transcripts and results were not returned to participants. The use of non-validated study-specific questionnaires with unclear psychometric properties and an incomplete response rate might limit the validity and reliability of the survey data. Ceiling effects and discriminability could not be accounted for. In both parts of the study, the targeted sample size could not be reached. Overconfidence and social desirability bias may have affected the results of the survey and interviews alike. Conclusions The UCC intervention program facilitated a relevant gain in knowledge for practice teams and patients, promoted active patient participation, and a shift away from simple wound dressing changes towards a comprehensive treatment with regular application of compression therapy. The program appears to be suitable for a broader disease management approach. The outcome analysis in the UCC trial will investigate to confirm the perceived effects. Abbreviations GP General practitioner MA non-physician assistant (medical assistant) SOP Standard operating procedures UCC Ulcus Cruris care VLU Venous leg ulcer Declarations Ethics approval and consent to participate: This study was conducted in accordance with the Declaration of Helsinki and received approval from the ethics commission of the Medical Faculty, University Heidelberg, Germany (reference (S-608/2021) and the Ethics Committee of the German Medical Association (B-F-2021-101). Written informed consent was obtained from all subjects involved in the process evaluation. Consent for publication: Not Applicable Availability of data and materials: All data generated and analyzed in this process evaluation are stored on a secure server at the Department of General Practice and Health Services Research, University Hospital Heidelberg, Germany. De-identified sets of these data can be made available by the corresponding author on reasonable request. Competing interests:UCCis a publicly funded research project (funding code: 01VSF19043). J.D.S and J.S share the project management, T.F. is a doctoral student in the project. N.S. wrote her master’s thesis in Clinical Research (Department for Health Sciences, Medicine and Research, University for Continued Education, Krems, Austria) based on 5 GP, 5 MA and 5 patient interviews included in this present study, and supported the UCC project as research assistant. All authors declare no competing interests. The funder had no role in the design of the study, the collection, analyses, or interpretation of data, the writing of the manuscript, or in the decision to publish the results. Funding:The UCC study is funded by the Innovation Committee at the Federal Joint Committee (G-BA), Berlin (01VSF19043). The funder had no role in the design of this study, data collection, data analysis, interpretation, or writing of the paper. Authors’ Contributions: Conceptualization, J.D.S., R.P.-D.,N.S., T.F., G.L., M.W., and J.S.; data curation, T.F. and N.S.; formal analysis, N.S., R.P.-D., T.F., G.L., M.W., and J.D.S.; funding acquisition, G.L., J.S., and J.D.S.; investigation, N.S., T.F., R.P.-D., and J.D.S; methodology, J.D.S., R.P.-D., T.F., N.S., G.L., and M.W.; project administration, T.F., N.S., G.L., M.W., J.S., and J.D.S.; resources, J.S.; supervision, G.L., M.W., J.S., and J.D.S.; validation, R.P.-D., and T.F.; visualization, R.P.-D.; writing—original draft, R.P.-D.; writing, review and editing, R.P.-D., J.D.S., T.F., M.W., N.S., G.L., and J.S. All authors have read and agreed to the published version of the manuscript. R.P.-D. - Regina Poß-Doering; T.F. - Thomas Fleischhauer; N.S. - Nina Sander; G.L. Gunter Laux; M.W. Michel Wensing; J.S. - Joachim Szecsenyi; J.D.S. Jonas D. Senft Acknowledgments We would like to sincerely thank all participants in this process evaluation for their valuable contributions. Also, we thank our student research assistants for transcribing the interviews. References Falanga V, Isseroff RR, Soulika AM, Romanelli M, Margolis D, Kapp S, et al. Chronic wounds. Nat Rev Dis Primers. 2022;8(1):50. Probst S, Weller CD, Bobbink P, Saini C, Pugliese M, Skinner MB, et al. Prevalence and incidence of venous leg ulcers-a protocol for a systematic review. Syst Rev. 2021;10(1):148. Probst S, Saini C, Gschwind G, Stefanelli A, Bobbink P, Pugliese MT, et al. Prevalence and incidence of venous leg ulcers-A systematic review and meta-analysis. Int Wound J. 2023;20(9):3906–21. Franks PJ, Barker J, Collier M, Gethin G, Haesler E, Jawien A, et al. Management of patients with venous leg ulcers: challenges and current best practice. J Wound Care. 2016;25(Sup6):S1–67. Singer AJ, Tassiopoulos A, Kirsner RS. Evaluation and Management of Lower-Extremity Ulcers. N Engl J Med. 2017;377(16):1559–67. Diener H, Debus E, Herberger S, Heyer K, Augustin M, Tigges W, et al. Versorgungssituation gefäßmedizinischer Wunden Deutschland Gefässchirurgie. 2017;8(22):548–57. de la González H, Quintana-Lorenzo ML, Perdomo-Pérez E, Verdú J. Correlation between health-related quality of life and venous leg ulcer's severity and characteristics: a cross-sectional study. Int Wound J. 2017;14(2):360–8. Renner R, Erfurt-Berge C. Depression and quality of life in patients with chronic wounds: ways to measure their influence and their effect on daily life. Chronic Wound Care Manage Res. 2017:143–51. Heyer K, Protz K, Glaeske G, Augustin M. Epidemiology and use of compression treatment in venous leg ulcers: nationwide claims data analysis in Germany. Int Wound J. 2017;14(2):338–43. Rabe E, Hertel S, Bock E, Hoffmann B, Jöckel KH, Pannier F. Therapy with compression stockings in Germany - results from the Bonn Vein Studies. J Dtsch Dermatol Ges. 2013;11(3):257–61. Jull A, Slark J, Parsons J. Prescribed Exercise With Compression vs Compression Alone in Treating Patients With Venous Leg Ulcers: A Systematic Review and Meta-analysis. JAMA Dermatol. 2018;154(11):1304–11. Norman G, Westby MJ, Rithalia AD, Stubbs N, Soares MO, Dumville JC. Dressings and topical agents for treating venous leg ulcers. Cochrane Database Syst Rev. 2018;6(6):Cd012583. Heyer K, Protz K, Augustin M. Compression therapy–cross-sectional observational survey about knowledge and practical treatment of specialised and non‐specialised nurses and therapists. Int Wound J. 2017;14(6):1148–53. Zarchi K, Jemec GB. Delivery of compression therapy for venous leg ulcers. JAMA dermatology. 2014;150(7):730–6. Irving G, Neves AL, Dambha-Miller H, Oishi A, Tagashira H, Verho A, et al. International variations in primary care physician consultation time: a systematic review of 67 countries. BMJ open. 2017;7(10):e017902. Protz K, Heyer K, Dissemond J, Temme B, Münter KC, Verheyen-Cronau I, et al. Compression therapy–current practice of care: level of knowledge in patients with venous leg ulcers. JDDG: J der Deutschen Dermatologischen Gesellschaft. 2016;14(12):1273–82. Fleischhauer T, Poß-Doering R, Sander N, Laux G, Wensing M, Szecsenyi J et al. Pilot Implementation of a Primary Care Disease Management Concept for Venous Leg Ulceration: Results of a Mixed-Methods Process Evaluation. Healthc (Basel). 2024;12(24). Senft JD, Fleischhauer T, Frasch J, van Rees W, Feißt M, Schwill S, et al. Primary care disease management for venous leg ulceration-study protocol for the Ulcus Cruris Care [UCC] randomized controlled trial (DRKS00026126). Trials. 2022;23(1):60. Waltz TJ, Powell BJ, Matthieu MM, Damschroder LJ, Chinman MJ, Smith JL, et al. Use of concept mapping to characterize relationships among implementation strategies and assess their feasibility and importance: results from the Expert Recommendations for Implementing Change (ERIC) study. Implement Sci. 2015;10(1):109. Powell BJ, Waltz TJ, Chinman MJ, Damschroder LJ, Smith JL, Matthieu MM, et al. A refined compilation of implementation strategies: results from the Expert Recommendations for Implementing Change (ERIC) project. Implement Sci. 2015;10(1):21. Rabe E, Földi E, Gerlach H, Jünger M, Lulay G, Miller A, et al. Medical compression therapy of the extremities with medical compression stockings (MCS), phlebological compression bandages (PCB), and medical adaptive compression systems (MAC) S2k guideline of the German Phlebology Society (DGP) in cooperation with the following professional associations: DDG, DGA, DGG, GDL, DGL, BVP. German version. Der Hautarzt. 2021;72:137–52. Bossert J, Vey JA, Piskorski L, Fleischhauer T, Awounvo S, Szecsenyi J, et al. Effect of educational interventions on wound healing in patients with venous leg ulceration: A systematic review and meta-analysis. Int Wound J. 2023;20(5):1784–95. Protz K, Dissemond J, Karbe D, Augustin M, Klein TM. Increasing competence in compression therapy for venous leg ulcers through training and exercise measured by a newly developed score—Results of a randomised controlled intervention study. Wound repair regeneration. 2021;29(2):261–9. Stürmer E, Dissemond J. Evidenz in der lokalen Therapie chronischer Wunden: Was ist gesichert? Aktuelle Dermatologie. 2021;47(07):314–22. Weller CD, Buchbinder R, Johnston RV. Interventions for helping people adhere to compression treatments for venous leg ulceration. Cochrane Database Syst Rev. 2016;3(3):Cd008378. O'Brien J, Finlayson K, Kerr G, Edwards H. Evaluating the effectiveness of a self-management exercise intervention on wound healing, functional ability and health-related quality of life outcomes in adults with venous leg ulcers: a randomised controlled trial. Int Wound J. 2017;14(1):130–7. O'Meara S, Cullum N, Nelson EA, Dumville JC. Compression for venous leg ulcers. Cochrane Database Syst Rev. 2012;11(11):Cd000265. Gallenkemper G. Diagnostik und Therapie des Ulcus cruris venosum. Aktuelle Dermatologie. 2009;35(06):221–4. Helfferich C. Die Qualität qualitativer Daten. Springer; 2011. Gale NK, Heath G, Cameron E, Rashid S, Redwood S. Using the framework method for the analysis of qualitative data in multi-disciplinary health research. BMC Med Res Methodol. 2013;13:117. Ritchie J, editor. Qualitative research practice: A guide for social science students and researchers. 1. publ ed. London : Sage; 2003. Poß-Doering R, Anders C, Fleischhauer T, Szecsenyi J, Senft JD. Exploring healthcare provider and patient perspectives on current outpatient care of venous leg ulcers and potential interventions to improve their treatment: a mixed methods study in the ulcus cruris care project. BMC Prim Care. 2022;23(1):229. Fleischhauer T, Sander N, Feisst M, Awounvo S, Weller L, Poss-Doering R, Laux G, Altiner A, Müller-Bühl U, Szecsenyi J, Senft JD. Treating Venous Leg Ulcers in Primary Care: The Cluster-Randomized Ulcus Cruris Care Trial. Dtsch Arztebl Int. 2025;(Forthcoming):arztebl.m2025.0207. 10.3238/arztebl.m2025.0207 . Epub ahead of print. PMID: 41189454. Protz K, Heyer K, Dörler M, Stücker M, Hampel-Kalthoff C, Augustin M. Compression therapy: scientific background and practical applications. J Dtsch Dermatol Ges. 2014;12(9):794–801. Protz K, Dissemond J, Karbe D, Augustin M, Klein TM. Increasing competence in compression therapy for venous leg ulcers through training and exercise measured by a newly developed score-Results of a randomised controlled intervention study. Wound Repair Regen. 2021;29(2):261–9. Protz K, Reich-Schupke S, Klose K, Augustin M, Heyer K. [Compression devices for decongestion therapy: A cross-sectional observational survey of handling, pressure, and comfort]. Hautarzt. 2018;69(3):232–41. Patton D, Avsar P, Sayeh A, Budri A, O'Connor T, Walsh S, et al. A meta-review of the impact of compression therapy on venous leg ulcer healing. Int Wound J. 2023;20(2):430–47. Shi C, Dumville JC, Cullum N, Connaughton E, Norman G. Compression bandages or stockings versus no compression for treating venous leg ulcers. Cochrane Database Syst Reviews. 2021(7). Gong JM, Du JS, Han DM, Wang XY, Qi SL. Reasons for patient non-compliance with compression stockings as a treatment for varicose veins in the lower limbs: A qualitative study. PLoS ONE. 2020;15(4):e0231218. Chitambira F. Patient perspectives: explaining low rates of compliance to compression therapy. Wound Practice and Research; 2019. Perry C, Atkinson RA, Griffiths J, Wilson PM, Lavallée JF, Cullum N, et al. Barriers and facilitators to use of compression therapy by people with venous leg ulcers: A qualitative exploration. J Adv Nurs. 2023;79(7):2568–84. Weller CD, Richards C, Turnour L, Team V. Patient Explanation of Adherence and Non-Adherence to Venous Leg Ulcer Treatment: A Qualitative Study. Front Pharmacol. 2021;12:663570. Van Hecke A, Grypdonck M, Beele H, Vanderwee K, Defloor T. Adherence to leg ulcer lifestyle advice: qualitative and quantitative outcomes associated with a nurse-led intervention. J Clin Nurs. 2011;20(3–4):429–43. Van Hecke A, Grypdonck M, Defloor T. Interventions to enhance patient compliance with leg ulcer treatment: a review of the literature. J Clin Nurs. 2008;17(1):29–39. Van Hecke A, Verhaeghe S, Grypdonck MHF, Beele H, Flour MLF, Defloor T. Systematic development and validation of a nursing intervention: the case of lifestyle adherence promotion in patients with leg ulcers. J Adv Nurs. 2011;67(3):662–76. Berardinelli D, Conti A, Hasnaoui A, Casabona E, Martin B, Campagna S, et al. Nurse-Led Interventions for Improving Medication Adherence in Chronic Diseases: A Systematic Review. Healthcare. 2024;12(23):2337. Dinç L, Gastmans C. Trust in nurse–patient relationships: A literature review. Nurs Ethics. 2013;20(5):501–16. Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care. 2007;19(6):349–57. Additional Declarations Competing interest reported. UCC is a publicly funded research project (funding code: 01VSF19043). J.D.S and J.S share the project management, T.F. is a doctoral student in the project. N.S. wrote her master’s thesis in Clinical Research (Department for Health Sciences, Medicine and Research, University for Continued Education, Krems, Austria) based on 5 GP, 5 MA and 5 patient interviews included in this present study, and supported the UCC project as research assistant. All authors declare no competing interests. The funder had no role in the design of the study, the collection, analyses, or interpretation of data, the writing of the manuscript, or in the decision to publish the results. 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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-8470254","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":580392633,"identity":"d948e93d-528f-4dcf-a1cc-591144a71b89","order_by":0,"name":"Regina Poß-Doering","email":"data:image/png;base64,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","orcid":"","institution":"University Hospital Heidelberg","correspondingAuthor":true,"prefix":"","firstName":"Regina","middleName":"","lastName":"Poß-Doering","suffix":""},{"id":580392634,"identity":"7032d6f6-2fd5-4bb6-a524-ff03e0701af2","order_by":1,"name":"Thomas Fleischhauer","email":"","orcid":"","institution":"University Hospital Heidelberg","correspondingAuthor":false,"prefix":"","firstName":"Thomas","middleName":"","lastName":"Fleischhauer","suffix":""},{"id":580392635,"identity":"013fe58d-5d28-428e-b08b-8b865abac466","order_by":2,"name":"Nina Sander","email":"","orcid":"","institution":"University Hospital Heidelberg","correspondingAuthor":false,"prefix":"","firstName":"Nina","middleName":"","lastName":"Sander","suffix":""},{"id":580392637,"identity":"8b428752-1b5b-4864-a022-0cea1aaa3f73","order_by":3,"name":"Gunter Laux","email":"","orcid":"","institution":"University Hospital Heidelberg","correspondingAuthor":false,"prefix":"","firstName":"Gunter","middleName":"","lastName":"Laux","suffix":""},{"id":580392638,"identity":"2fa53c34-748f-48fe-9f4d-67aca4c33ef8","order_by":4,"name":"Michel Wensing","email":"","orcid":"","institution":"University Hospital Heidelberg","correspondingAuthor":false,"prefix":"","firstName":"Michel","middleName":"","lastName":"Wensing","suffix":""},{"id":580392642,"identity":"9bf4d3b0-fb3d-4e0f-9265-cbd57c6f0faf","order_by":5,"name":"Joachim Szecsenyi","email":"","orcid":"","institution":"aQua-Institute","correspondingAuthor":false,"prefix":"","firstName":"Joachim","middleName":"","lastName":"Szecsenyi","suffix":""},{"id":580392645,"identity":"b3f7a872-adab-4c80-91e2-4edbb74c3dae","order_by":6,"name":"Jonas D. Senft","email":"","orcid":"","institution":"University Hospital Heidelberg","correspondingAuthor":false,"prefix":"","firstName":"Jonas","middleName":"D.","lastName":"Senft","suffix":""}],"badges":[],"createdAt":"2025-12-29 07:23:48","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-8470254/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-8470254/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":101352185,"identity":"b366929c-56be-4187-84d9-e7315f3eb544","added_by":"auto","created_at":"2026-01-28 19:02:35","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":662962,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-8470254/v1/1cd7541f-beba-43b6-9895-f00c78d48b54.pdf"},{"id":101352184,"identity":"a98bdcf3-4f48-43dd-871a-a3f1507b6cc8","added_by":"auto","created_at":"2026-01-28 19:02:30","extension":"docx","order_by":0,"title":"","display":"","copyAsset":false,"role":"supplement","size":16987,"visible":true,"origin":"","legend":"","description":"","filename":"Additionalfile1.docx","url":"https://assets-eu.researchsquare.com/files/rs-8470254/v1/65aeabd17d1b210e81823cda.docx"},{"id":101352183,"identity":"0d1c987f-84a8-4a9e-86fd-c1105d084902","added_by":"auto","created_at":"2026-01-28 19:02:30","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":15071,"visible":true,"origin":"","legend":"","description":"","filename":"Additionalfile2.docx","url":"https://assets-eu.researchsquare.com/files/rs-8470254/v1/811451f2fc5c331fdc67ec8f.docx"}],"financialInterests":"Competing interest reported. UCC is a publicly funded research project (funding code: 01VSF19043). J.D.S and J.S share the project management, T.F. is a doctoral student in the project. N.S. wrote her master’s thesis in Clinical Research (Department for Health Sciences, Medicine and Research, University for Continued Education, Krems, Austria) based on 5 GP, 5 MA and 5 patient interviews included in this present study, and supported the UCC project as research assistant. All authors declare no competing interests. The funder had no role in the design of the study, the collection, analyses, or interpretation of data, the writing of the manuscript, or in the decision to publish the results.","formattedTitle":"Implementing a primary care disease management concept for venous leg ulceration: Findings of a mixed-methods process evaluation in the Ulcus Cruris Care trial","fulltext":[{"header":"Contributions to the Literature","content":"\u003cul\u003e\n \u003cli\u003eApplication of chronic wound care concepts \u0026nbsp;still needs encouragement in primary care in Germany. Implementation of an evidence-based \u0026nbsp; care concept that includes compression therapy can promote faster wound healing and improve quality of life.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cul\u003e\n \u003cli\u003eIn our multi-faceted program, implementation strategy clusters followed expert recommendations to foster change and train and support care providers and patients alike.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cul\u003e\n \u003cli\u003eEvaluation of the implementation process facilitated insights regarding intervention fidelity and perceived effects and supports assessment of this program as suitable for a broader disease management approach.\u0026nbsp;\u003c/li\u003e\n\u003c/ul\u003e"},{"header":"Background","content":"\u003cp\u003eChronic wounds are considered a worldwide problem. It is estimated that in developed countries about 1\u0026ndash;2% of the population will experience a chronic wound during their lifetime. In low income countries, etiologies may be different, yet there is a common denominator which is \u0026ldquo;impaired healing\u0026rdquo; [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. Venous leg ulcers (VLU) account for about 70% of chronic lower extremity ulcers and about 1% of the population and 3% of people over 80 years of age are presumed to suffer from VLU [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]. Due to aging populations, a steadily growing prevalence can be expected [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. Thus, lower-extremity ulcerations are very common and have a major impact on public health [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eIn Germany, about 1.8\u0026nbsp;million people are affected by VLU [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e], yet standardized pathways for their treatment have hardly been established. Thus, affected patients may suffer chronification, morbidity and considerable impairment of quality of life [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. Compression therapy carried out in accordance with existing guidelines counteracts the venous disease and thus the cause of the wound healing disorder and has a proven effect on wound healing. However, it is implemented in less than 50% of cases and often incorrectly applied [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. Other effective treatment elements such as promoting mobility and exercising are also rarely addressed [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. In contrast, modern wound therapeutics are often used for local therapy, even though there is no objective evidence of beneficial effects [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]. Reasons for wound care deficits are assumed to be ranging from insufficient care provider knowledge regarding compression therapy and its practical application [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e], to a lack of standardized outpatient care concepts, increasing time pressure in practices [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e], and a passive, uninformed patient role during treatment [\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eCare providers such as general practitoners (GPs), nursing services and certified wound managers can be involved in VLU treatment. The project Ulcus Cruris Care (UCC) aims to establish a patient-oriented and evidence-based care concept for VLU treatment in general practice by ensuring care coordination and multidisciplinary treatment. Educational interventions were developed to enable GPs and non-physician medical assistants (MA) to fill a central role in VLU management and support patients and relatives in taking an active role in the treatment process. Also, e-learning and computerized case management were integrated. The study hypothesis was that implementation of the concept generally promotes evidence-based treatment and the use of compression therapy, and potentially leads to faster wound healing, improved quality of life for affected patients and reduced utilization of medical resources. After piloting the intervention program [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e], a multicenter cluster-randomized controlled study (RCT) was carried out in general practices. A process evaluation accompanied the implementation process to investigate intervention fidelity, perceived effects, and identify improvement potential for the intervention components.\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003eStudy design\u003c/p\u003e \u003cp\u003eThe UCC intervention was developed to foster primary care treatment of VLU. After successful pilot implementation [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e], the intervention was rolled out in a multicenter randomized controlled trial. As a part of the UCC trial [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e], a mixed-methods process evaluation was conducted to evaluate the implementation process of the UCC intervention. For the observational process evaluation, a cross-sectional study design was chosen. A mixed-methods approach was applied with semi-structured guide-based qualitative telephone interviews and an accompanying survey study to evaluate the implementation process of the UCC intervention.\u003c/p\u003e \u003cp\u003eImplementation program\u003c/p\u003e \u003cp\u003e Following a status quo survey, a multifaceted intervention program for VLU outpatient treatment was developed, piloted, and subsequently implemented as care concept in n\u0026thinsp;=\u0026thinsp;44 general practices in Germany for a total of n\u0026thinsp;=\u0026thinsp;53 patients with VLU. The program addresses implementation strategy clusters suggested by the Expert Recommendations for Implementing Change (ERIC) taxonomy [\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e, \u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e] and comprises five main components: 1) On-demand online training and e-learning courses for GPs and MAs (cluster: Train and Educate Stakeholders); 2) Standard operating procedures (SOP) for evidence-based VLU treatment (cluster: Support Clinicians); 3) Software-supported case management (cluster: Change Infrastructure); 4) Strong involvement of MAs in case management, wound care, and patient education (cluster: Support clinicians; Develop Stakeholder Interrelationships); 5) Printed educational material and e-learning course for patients (cluster: Train and Educate Stakeholders; Engage consumers). The online training and e-learning courses were based on relevant literature and guidelines [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e, \u003cspan additionalcitationids=\"CR22 CR23 CR24 CR25 CR26 CR27\" citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e] and focused on VLU pathophysiology and chronic venous insufficiency, effectiveness and practical aspects of evidence-based compression therapy, local wound treatment, and patient education. A previous publication describes the implementation program in detail [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eRecruitment\u003c/p\u003e \u003cp\u003eAn information letter was sent by mail to approximately 800 regional GP practices collaborating with the study center as an invitation to participate in the trial. Interested practices were screened for eligibility by the study team. Inclusion criteria were to meet IT requirements for using the software-supported case management and at least one MA to be routinely involved in chronic wound treatment and care. GP practices with more than 20 VLU patients per year could not participate. A pragmatic sampling strategy was used for the process evaluation. To be eligible for inclusion in the process evaluation, GPs, MAs, and patients had to be adult participants in the RCT intervention group, with good mastery of German. Patients also had to have a diagnosed VLU that had been present for a maximum of 12 months. MAs had to be actively involved in wound care. All patients in the intervention group were invited to participate in both parts of the process evaluation by the intervention group practices and received printed information about the process evaluation and its objectives, and a consent form. If written consent was given, contact details (telephone number and address) were forwarded to the study team. All GPs and MAs from the intervention practices were contacted via telephone by the study team to invite them for participation in the process evaluation. After completing the online practice training and treating at least two study patients, GPs and MAs who were willing to participate received a separate informed consent form. All participants were informed verbally and in writing about content and objectives of the study and gave written consent prior to participating in the process evaluation. Participants could decide whether they participated in the survey, an interview, or in both. Recruitment target was to include 10 GPs, 10 MAs, and 10 patients in the process evaluation. An expense reimbursement of 50\u0026euro; was offered for participation in an interview and an additional 20\u0026euro; for filling in the study-specific questionnaires.\u003c/p\u003e \u003cp\u003e Integrated into the study protocol of the multicenter RCT, the process evaluation and its data collection instruments received a positive vote from the Heidelberg Ethics Committee (S-608/2021) and the Ethics Committee of the German Medical Association (B-F-2021-101).\u003c/p\u003e \u003cp\u003eData collection\u003c/p\u003e \u003cp\u003eFor this process evaluation, study-specific survey questionnaires (see Additional file 1) were developed to cover items regarding intervention fidelity (7 items), acceptance and contentedness (18 items), perceived (9 items) as well as non-anticipated effects (2 items), and contextual factors (6 items). Response options were provided on a 5-point Likert scale (rating: 1\u0026thinsp;=\u0026thinsp;totally disagree; 5\u0026thinsp;=\u0026thinsp;totally agree), and an optional free text field. A socio-demographic questionnaire was used to collect participant characteristics. The qualitative study used a semi-structured interview guide (see Additional file 2) to explore participant perceptions regarding acceptance of the intervention program, intervention fidelity, and perceived effects. Against the background of questions used in the evaluation of the pilot study [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e], the interprofessional research team (Health Services Research, General practice, Clinical Research) developed interview guides for the three groups (GPs, MAs, patients) in an iterative process by collecting, discussing and subsuming appropriate questions and wording [\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eAll interviews were conducted by junior and senior research team members (NS (f), TF (m)), audio-recorded, pseudonymized and transcribed via the software f4. Interviews were conducted at the workplace or the home office, participants were at home or at their workplace and knew interviewers through study-related conversations. No non-participants were present, no field notes were taken, and transcripts were not returned to participants. Data were organized and managed in MAXQDA Version 2022 (Release 22.7.0; Verbi Software) and stored on secure servers at the Department of Primary Care and Health Services Research, University Hospital Heidelberg, Germany.\u003c/p\u003e \u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eData analysis\u003c/h2\u003e \u003cp\u003eAll quantitative and socio-demographic data were analyzed descriptively by three researchers (T.F, R.P.-D., N.S.) using Microsoft Excel software (Version 1808). Means, medians (med), standard deviations, maximum and minimum values, and absolute and relative frequencies were calculated. Verbal Likert scales were numerically recoded from 1 to 5 (totally disagree\u0026thinsp;=\u0026thinsp;1, somewhat disagree\u0026thinsp;=\u0026thinsp;2, partially agree\u0026thinsp;=\u0026thinsp;3, somewhat agree\u0026thinsp;=\u0026thinsp;4, totally agree\u0026thinsp;=\u0026thinsp;5). For intervention fidelity, absolute and relative frequencies were calculated. The qualitative data were analyzed inductively using the Framework analysis method [\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e, \u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e] as a systematic approach to structuring data and enabling cross-category comparisons to identify key messages and potential contrasts [\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e]. All qualitative data were analyzed by a junior (Clinical Research) and a senior researcher (Health Services Research). Coding was discussed in the study team (R.P.-D., J.D.S, N.S.) and approximated if divergences occurred.\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003eAll process evaluation data were collected in the intervention group (n\u0026thinsp;=\u0026thinsp;20 practices) during the UCC intervention phase between May 2023 and February 2024. A total of n\u0026thinsp;=\u0026thinsp;27 interviews were conducted (n\u0026thinsp;=\u0026thinsp;10 GPs, n\u0026thinsp;=\u0026thinsp;10 MAs, n\u0026thinsp;=\u0026thinsp;7 patients), n\u0026thinsp;=\u0026thinsp;38 completed survey (n\u0026thinsp;=\u0026thinsp;12 GPs, n\u0026thinsp;=\u0026thinsp;15 MAs, n\u0026thinsp;=\u0026thinsp;11 patients) and n\u0026thinsp;=\u0026thinsp;30 socio-demographic questionnaires (n\u0026thinsp;=\u0026thinsp;10 GPs, n\u0026thinsp;=\u0026thinsp;11 MAs, n\u0026thinsp;=\u0026thinsp;9 patients) were returned. Interview and survey participants were not necessarily the same individuals. Interview duration was between 08:31 minutes and 54:27 minutes (mean duration: GP\u0026thinsp;=\u0026thinsp;20:16 minutes, MA\u0026thinsp;=\u0026thinsp;23:21 minutes, patients\u0026thinsp;=\u0026thinsp;19:18 minutes; total\u0026thinsp;=\u0026thinsp;20:58 minutes). Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e describes the socio-demographic characteristics of the sample.\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\u003eSocio-demographic sample characteristics\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\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eGeneral practitioners n\u0026thinsp;=\u0026thinsp;10\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eMedical assistants n\u0026thinsp;=\u0026thinsp;11\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003ePatients\u003c/p\u003e \u003cp\u003e n\u0026thinsp;=\u0026thinsp;9\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAge mean (range)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e54.5 (35\u0026ndash;65)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e48.1 (30\u0026ndash;58)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e76.8 (56\u0026ndash;85)\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSex f (n)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e11\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eProfessional experience in years (range)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e25.3 (6\u0026ndash;37)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e25 (09-535)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSpecialist in general practice (n)\u003c/p\u003e \u003cp\u003eSpecialist in internal medicine (n)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8\u003c/p\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003especialized assistance in general practice (n)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWorking full-time (n)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWorking in single practice (n)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWorking in rural area (n)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eLiving in rural area (n)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e6\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\u003eThe majority of patients were covered by statutory health insurance (n\u0026thinsp;=\u0026thinsp;8), were no longer employed (n\u0026thinsp;=\u0026thinsp;8) and almost half of them lived with a partner or relative (n\u0026thinsp;=\u0026thinsp;4). All GPs stated that they were responsible for diagnosing, determining therapy, counseling and educating VLU patients and that they either engaged in wound care themselves, delegated it to an MA or carried it out as a team. MAs stated that they were involved in both, patient education and wound care and were responsible for applying compression bandages. Most of the practice teams described working regularly with nursing services when caring for VLU patients outside of the study.\u003c/p\u003e \u003cp\u003eThe results reported below refer to both, the qualitative data and the data from the survey. Included quotes have been translated with due diligence and are presented with an indication of participant group (GP\u0026thinsp;=\u0026thinsp;general practitioner; MA\u0026thinsp;=\u0026thinsp;non-physician assistant) and number of the interview. All findings are presented with regard to the intervention components along the process evaluation target criteria: 1) Intervention fidelity and perceived benefits, and 2) Perceived effects.\u003c/p\u003e\n\u003ch3\u003eIntervention fidelity\u003c/h3\u003e\n\u003cdiv id=\"Sec6\" class=\"Section2\"\u003e \u003ch2\u003ePractice team perceptions\u003c/h2\u003e \u003cp\u003eAll practice teams participating in the process evaluation attended and completed the online training (100%). The three e-learning modules were completed by n\u0026thinsp;=\u0026thinsp;17 (58,62%), n\u0026thinsp;=\u0026thinsp;15 (51,72%), and n\u0026thinsp;=\u0026thinsp;14 (48,28%) GPs, and n\u0026thinsp;=\u0026thinsp;22 (61,11%), n\u0026thinsp;=\u0026thinsp;20 (54,05%), and n\u0026thinsp;=\u0026thinsp;19 (51,35%) MAs in the intervention group.\u003c/p\u003e \u003cp\u003eParticipating GPs indicated in the survey that they used the provided standard operating procedures (n\u0026thinsp;=\u0026thinsp;12), the case management software (n\u0026thinsp;=\u0026thinsp;11), the patient education material (n\u0026thinsp;=\u0026thinsp;11), and informed about the patient e-learning (n\u0026thinsp;=\u0026thinsp;7). Two GPs indicated they made all their participating patients aware of this option. Limitations were indicated regarding the patient e-learning in connection to patient age. GPs stated they saw relevance and benefits for the practice team and patient care in completing the online training (webinar), using the standard operating procedures (med 4.5 each), the e-learning modules (med 4.25), the software-supported patient monitoring and the printed patient education material (med 4). One GP commented in a free text field that practice routines might need adaptation to fully make use of all intervention components.\u003c/p\u003e \u003cp\u003eIn the survey, GPs and MAs were asked to indicate whether they perceived the intervention components as time consuming. Overall, the ratings were high, in particular regarding time required to complete the e-learning, and for patient education (med 3.4 each), with a slightly lower rating for using standard operating procedures and the software-supported patient monitoring (med 3.2 each). Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e details the combined GP and MA rating for contentedness with the intervention components.\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\u003eGP and MA rating of contentedness with the UCC intervention components (n\u0026thinsp;=\u0026thinsp;26)\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=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIntervention component\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMedian rating\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSynchronous online training (webinar)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e5.0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eStandard operating procedures\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e5.0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eE-learning modules\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e5.0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSoftware-supported patient monitoring\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e4.0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePatient education material\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e4.0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"2\"\u003e*scale: 1\u0026thinsp;=\u0026thinsp;totally disagree to 5\u0026thinsp;=\u0026thinsp;totally agree\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eA comprehensive use of the UCC intervention components was considered sensible by the participants in the interview study, particularly in view of the ageing patient population and thus a potentially increasing number of wounds to be treated. In this context, a need to train social care center staff accordingly was mentioned. The willingness of patients with VLU to actively participate in a structured care program was considered likely.\u003c/p\u003e \u003cp\u003eIn the interview study, all GPs and MAs reported they took part in the synchronous online training and completed the e-learning. The benefits of the educational formats were considered high, and no suggestions for improving the e-learning and online training were mentioned. In the online training format, exchange with other practices and the inclusion of interesting case studies were highly appreciated. Regarding content, participants in both groups ranked compression therapy and local wound treatment as particularly relevant. GPs also rated the content on patient education as particularly relevant. Interview participants saw a decisive learning effect in content visualization and repetition in the e-learning, and a good opportunity to receive reassurance regarding compression because they had been \u0026ldquo;not entirely sure whether it always makes sense\u0026rdquo; (GP04). The flexibility in terms of being able to choose time and place of completing the training was perceived as positive. Particularly the quality of preparation of the evidence-based content, the opportunity to acquire knowledge and the strengthening of the MAs\u0026rsquo; independent action were positively emphasized.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;So, with this e-learning, it's quite good, also with the videos that you always have there, you perceive it differently than if you just read it through, at least that's how I feel and yes, it's just, it's repetitive, but it's good that you hear it again and again.\u0026rdquo; (MA04)\u003c/em\u003e\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003eMAs perceived the structuring of the treatment process, clarity of the documentation, and a reduction in workload as advantages of the UCC case management program. Most MAs found the monitoring function useful for documenting the healing process and enabling a comparison between the individual study visits. Improvement suggestions for the case management software were mentioned neither in the interviews nor in the questionnaires.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e \u003cem\u003e\u0026ldquo;Well, after the patient had been here, we just went to the computer and entered it [the\u003c/em\u003e \u003c/p\u003e\u003cp\u003e \u003cem\u003edata]. I thought that [...] was well guided, so it was actually good for the process. So, you could easily enter it. [\u0026hellip;]\u0026rdquo; (MA10)\u003c/em\u003e \u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003e MAs and GPs also stated that they found the SOP for guideline-compliant VLU care supportive and used it because \u0026ldquo;it was finally documented and clearly stratified [...]\u0026rdquo; (GP07). One MA and one GP each perceived the SOPs as rather unhelpful. Two practices reported that they had laminated the SOPs for quick and easy use and hung them up clearly visible in the treatment room. Some participants passed on the SOPs to nursing services and social care units so they could also benefit from the knowledge.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e\u003cem\u003e \u0026ldquo;[...] I have now also printed this out with these [SOP], [\u0026hellip;], we now have this as a guide, the others are now also following it\u0026rdquo;. (GP08)\u003c/em\u003e\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003eAll GPs and almost all MAs reported using the written patient information, handing it out to patients and also passing it on to nursing and social services for their education. Both professional groups shared the view that the structured verbal education together with dissemination of written information was sustainable and effective. GPs stated that they informed patients about the possibility of making use of the on-demand e-learning, yet patients did not engage with it. According to the interviewees and free text fields in the survey questionnaires, this was assumed to be due to advanced patient age, lacking access to a computer or internet, disinterest or low digital competence.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003ePatent perceptions\u003c/h3\u003e\n\u003cp\u003eAll patients indicated in the survey that they were very content with the treatment of their wound since they had started participation in the UCC intervention, and perceived compression therapy as necessary to support wound healing (med 5 each). They also stated satisfaction with the received information material and its scope (med 4). Usefulness of the printed educational material was rated as high (med 5), and for the e-learning rather low (med 2). Time consumption for going through the educational material was perceived as moderate (med 3).\u003c/p\u003e \u003cp\u003e During interviews, patients described that their GPs and MAs provided education, precise treatment and behavioral instructions, and detailed information about compression therapy. They considered compression therapy as very important, but some described individual barriers for its implementation and their own active participation in treatment such as pain, aesthetics and a lack of patience. Some patients mentioned that they were informed by their GPs about the possibility of participating in an e-learning, yet did not engage with it. They indicated a high relevance of verbal and practical education and described it as more important than reading information in e-learning and printed information leaflets, which were seen as potentially useful add-ons. Information on the content of the clinical picture, dressing changes, compression therapy and general measures were considered to be relevant.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e\u003cem\u003e\u0026ldquo;[...] I looked at the pictures a bit, but she [the MA] explained it all to me so well in pictures and in practice that I didn't actually need to read it.\u0026rdquo; (PAT03)\u003c/em\u003e\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003ePerceived effects\u003c/h2\u003e \u003cdiv id=\"Sec9\" class=\"Section3\"\u003e \u003ch2\u003ePractice team perceptions\u003c/h2\u003e \u003cp\u003eGPs and MAs were asked to characterize their assessment of intervention program effects in both parts of the evaluation. Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e details their corresponding rating of perceived effects on the survey.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eRating of perceived effects by GPs and MAs (n\u0026thinsp;=\u0026thinsp;26)\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=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePerceived effects\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMedian rating*\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eI feel more competent now in the treatment of VLU patients.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e5.0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMy knowledge regarding local wound treatment was strengthened.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e5.0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMy knowledge regarding compression therapy was strengthened.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e5.0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eThe role of the MA as case manager was strengthened.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e5.0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eStandardizing of treatment processes was improved.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e5.0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eThe interventions contributed to improvements in patient care.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e4.0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePatient education was improved.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e4.0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eActive patient participation in the treatment process was improved.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e4.0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSoftware-supported patient monitoring improved the treatment process.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e4.0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"2\"\u003e*Scale: 1\u0026thinsp;=\u0026thinsp;totally disagree \u0026minus;\u0026thinsp;5\u0026thinsp;=\u0026thinsp;totally agree\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eThey indicated that they had gained more confidence in caring for affected patients and \u0026lsquo;take over completely ourselves\u0026rsquo; (GP04) instead of delegating the care to a wound manager. Several providers felt that the intervention components had increased their overall competence in care and counseling of VLU patients, improved healing outcomes and reduced wound healing time. They also described several changes in the therapeutic approach to VLU treatment and attributed the changes to an increase in knowledge. Some stated that they had not given sufficient importance to compression therapy and had tended to focus on local wound treatment prior to their participation in UCC. Some mentioned that with the newly gained knowledge and confidence, they now applied compression therapy with greater consistency and perseverance and had learned it was worthwhile to remain patient. They expressed they were convinced that the intervention components enabled them to approach VLU care in a more structured and evidence-based manner.\u003c/p\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;The treatment is more stringent and you reflect more on what you are doing.\u0026rdquo;(GP07)\u003c/em\u003e \u003cdiv class=\"BlockQuote\"\u003e \u003cp\u003e \u003cem\u003e\u0026ldquo;Yes, and I have to say that the wounds heal really quickly, well, from my previous time in another practice, there were also many older people, who had large wounds that almost never healed at all without compression. So that has already shown me a difference.\u0026rdquo; (MA05)\u003c/em\u003e \u003c/p\u003e \u003c/div\u003e \u003c/p\u003e \u003cp\u003eIt was also stated that the role of the MA was strengthened, treatment processes were standardized and patients could be more actively integrated into the treatment process. GPs described that they readily delegated certain tasks to reduce their workload and motivate their MAs at the same time by giving them more responsibility. MAs described experiencing more joy in their profession and recognition by carrying more responsibility.\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e\n\u003ch3\u003ePatient perceptions\u003c/h3\u003e\n\u003cp\u003ePatients were asked to assess potential effects they might have perceived in the context of participation in the UCC intervention. Table\u0026nbsp;\u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e describes their rating of perceived effects as indicated in the survey.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003ePatient perceptions regarding effects (n\u0026thinsp;=\u0026thinsp;11)\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=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eItem\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eMedian rating*\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOutpatient treatment quality has improved.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eI feel well informed about my wound now.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eI participate more actively in my treatment now.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eI learned to apply a compression bandage correctly.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eI have learned how to change a dressing by myself.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eI feel more confident in dealing with my wound.\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eI feel better treated and supported by my GP\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e5\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"2\"\u003e*Scale: 1\u0026thinsp;=\u0026thinsp;totally disagree \u0026minus;\u0026thinsp;5\u0026thinsp;=\u0026thinsp;totally agree\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eIn the interviews, most patients described their experience of a positive development in the treatment provided by their GP practice since participating in the UCC intervention program. They felt positive about the more intensive care provided by the practice team, well informed, better treated and recognized. Several patients mentioned they paid more attention to a balanced diet as a result of the educational counselling of the practice team. It was also reported that the supervising MA provided knowledge about the use of compression therapy, different compression materials, padding and wound cleaning. All patients stated that they felt safer overall in dealing with their wound and well informed. Some patients described they were able to apply the compression bandage themselves or with the support of relatives.\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003e \u003cem\u003e\u0026ldquo;Exactly, we practiced it two or three times, when it was bandaged, she [the MA] said \u0026lsquo;now you try putting the bandage on\u0026rsquo;, to see if I'm doing everything right and then she gave me some help the first time. And the second time, it worked really well on my own. When she saw that I could do it all by myself, without her help, she knew it would work.\u0026rdquo; (PAT03)\u003c/em\u003e \u003c/p\u003e\u003c/div\u003e\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eFindings of this process evaluation indicate a high level of adherence to the intervention and a high level of acceptance regarding the UCC intervention components in all participant groups and confirm earlier findings in the UCC pilot study [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]. The UCC intervention components were seen as supportive to a structured, evidence-based VLU treatment, facilitated a gain in relevant knowledge for practice teams and patients while they also enabled informed and more active patient and relative participation as intended by the program at the same time. A change in treatment routine towards the regular use of compression therapy as the most effective treatment measure was noted by both, practice teams and patients. Overall, the patient-centered approach found strong acceptance and the UCC interventions were perceived as contributions to improvements in VLU patient care. Practice teams and patients alike positively perceived the strengthened and central role of MAs as case managers and their more intensive involvement in wound treatment and patient education. Overall, these findings are largely in line with the expectations of an initial survey study carried out prior to intervention development [\u003cspan citationid=\"CR32\" class=\"CitationRef\"\u003e32\u003c/span\u003e], and findings of the process evaluation of the UCC pilot implementation [\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e], and the findings of the outcome analysis in the UCC trial [\u003cspan citationid=\"CR33\" class=\"CitationRef\"\u003e33\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe UCC program intends to enhance knowledge and practical skills of care providers, and promote informed and active participation of patients to support standardized evidence-based and patient-centered treatment of VLU in GP practices. The transfer of knowledge via the on-demand online format offered great flexibility for practice teams in terms of both, organization and scheduling. The data collected in the process evaluation show that the practice teams gained relevant knowledge by participating in the training offered, and that this increase in competence was reflected in perceived treatment successes. In this context, a rethinking of the role of GP practices towards active treatment of VLU patients as primary care providers and a change in attitude towards compression therapy was also observed. A focus shift from purely local wound treatment to causally oriented treatment with regular application of guideline-compliant compression therapy was also identified. Previous research indicated knowledge deficits regarding compression therapy and its practical application among healthcare professionals [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e, \u003cspan additionalcitationids=\"CR35\" citationid=\"CR34\" class=\"CitationRef\"\u003e34\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e36\u003c/span\u003e]. However, it is considered to be the most effective conservative VLU treatment option with the potential of halving healing time when adequately applied [\u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e37\u003c/span\u003e, \u003cspan citationid=\"CR38\" class=\"CitationRef\"\u003e38\u003c/span\u003e]. Research also points to knowledge gaps, pain and discomfort, and socio-psychological patient factors as determinants for patient adherence to compression therapy [\u003cspan additionalcitationids=\"CR40 CR41\" citationid=\"CR39\" class=\"CitationRef\"\u003e39\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e]. Educational interventions can improve patient knowledge and close such gaps, thus improving therapy adherence and wound-related as well as patient-reported outcomes [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e, \u003cspan additionalcitationids=\"CR44\" citationid=\"CR43\" class=\"CitationRef\"\u003e43\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR45\" class=\"CitationRef\"\u003e45\u003c/span\u003e]. As intended, the targeted training and educational interventions offered in the UCC program supported patients in taking a more active role in the treatment process and overcoming barriers together with their primary care providers. With regard to a broader implementation of the UCC intervention program, the knowledge transfer format used for practice teams can be recommended since it successfully addressed potential knowledge gaps. For older patients in particular, the on-demand e-learning format offered for voluntary use in the UCC program might be less relevant than engagement in verbal and practical education supported by printed information material. This is supported by the strong patient activation observed in this process evaluation, despite the only sporadic use of the patient e-learning. However, the patient e-learning could be a suitable add-on for patients interested in this format. Follow-up research should therefore include and evaluate this option.\u003c/p\u003e \u003cp\u003eIn light of scarce resources and an expected increase in multimorbidity and chronic wounds due to aging populations, the strengthening and expansion of the MA role combined with a structured case management approach as used in the UCC program seems to be essential to ensure adequate VLU care in general practice in the future. This approach was strongly advocated by all participants in this process evaluation and is supported by research that indicates that a trustful relationship between nursing staff and patients can foster therapy adherence [\u003cspan citationid=\"CR46\" class=\"CitationRef\"\u003e46\u003c/span\u003e, \u003cspan citationid=\"CR47\" class=\"CitationRef\"\u003e47\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eStrengths and limitations\u003c/p\u003e \u003cp\u003eStudies on the care provider and patient perspectives regarding a holistic case management program for VLU in general practice are scarce. The methodological approach in this process evaluation facilitated in-depth analysis of intervention acceptance and perceived effects, both by general practice teams and patients. Conducting the interviews via telephone accommodated for practice team and patient limitations regarding time resources and potential burden. Participants were able to comprehensively describe their perceptions regarding the program and perceived effects. The systematic yet flexible approach to structuring the qualitative data enabled cross-category comparisons, identification of key aspects and potential contrasts. The first author, who was not involved in data collection, analyzed all qualitative data based on initial analysis of n\u0026thinsp;=\u0026thinsp;15 transcripts by a junior researcher and along consensus processes in the research team, thus ensuring a high degree of objectivity and independence. With a sample size of n\u0026thinsp;=\u0026thinsp;27 interviews, a high degree of information saturation was achieved. Reporting follows scientifically valid criteria [\u003cspan citationid=\"CR48\" class=\"CitationRef\"\u003e48\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eSome limitations have to be reported. Statements regarding the intervention program might entail a limited transferability since less motivated practice teams could have reported different perceptions. Transcripts and results were not returned to participants. The use of non-validated study-specific questionnaires with unclear psychometric properties and an incomplete response rate might limit the validity and reliability of the survey data. Ceiling effects and discriminability could not be accounted for. In both parts of the study, the targeted sample size could not be reached. Overconfidence and social desirability bias may have affected the results of the survey and interviews alike.\u003c/p\u003e"},{"header":"Conclusions","content":"\u003cp\u003e The UCC intervention program facilitated a relevant gain in knowledge for practice teams and patients, promoted active patient participation, and a shift away from simple wound dressing changes towards a comprehensive treatment with regular application of compression therapy. The program appears to be suitable for a broader disease management approach. The outcome analysis in the UCC trial will investigate to confirm the perceived effects.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eGP\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;General practitioner\u003c/p\u003e\n\u003cp\u003eMA\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;non-physician assistant (medical assistant)\u003c/p\u003e\n\u003cp\u003eSOP \u0026nbsp; Standard operating procedures\u003c/p\u003e\n\u003cp\u003eUCC\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Ulcus Cruris care\u003c/p\u003e\n\u003cp\u003eVLU \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; Venous leg ulcer\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003eEthics approval and consent to participate:\u0026nbsp;This study was conducted in accordance with the Declaration of Helsinki and received approval from the ethics commission of the Medical Faculty, University Heidelberg, Germany (reference (S-608/2021) and the Ethics Committee of the German Medical Association (B-F-2021-101). Written informed consent was obtained from all subjects involved in the process evaluation.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eConsent for publication:\u0026nbsp;Not Applicable\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAvailability of data and materials:\u0026nbsp;All data generated and analyzed in this process evaluation are stored on a secure server at the Department of General Practice and Health Services Research, University Hospital Heidelberg, Germany. De-identified sets of these data can be made available by the corresponding author on reasonable request.\u003c/p\u003e\n\u003cp\u003eCompeting interests:UCCis a publicly funded research project (funding code: 01VSF19043). J.D.S and J.S share the project management, T.F. is a doctoral student in the project. N.S. wrote her master’s thesis in Clinical Research (Department for Health Sciences, Medicine and Research, University for Continued Education, Krems, Austria) based on 5 GP, 5 MA and 5 patient interviews included in this present study, and supported the UCC project \u0026nbsp;as research assistant. All authors declare no competing interests. The funder had no role in the design of the study, the collection, analyses, or interpretation of data, the writing of the manuscript, or in the decision to publish the results.\u003c/p\u003e\n\u003cp\u003eFunding:The UCC study is funded by the Innovation Committee at the Federal Joint Committee (G-BA), Berlin (01VSF19043). The funder had no role in the design of this study, data collection, data analysis, interpretation, or writing of the paper.\u003c/p\u003e\n\u003cp\u003eAuthors’ Contributions:\u0026nbsp;Conceptualization, J.D.S., R.P.-D.,N.S., T.F., G.L., M.W., and J.S.; data curation, T.F. and N.S.; formal analysis, N.S., R.P.-D., T.F., G.L., M.W., and J.D.S.; funding acquisition, G.L., J.S., and J.D.S.; investigation, N.S., T.F., R.P.-D., and J.D.S; methodology, J.D.S., R.P.-D., T.F., N.S., G.L., and M.W.; project administration, T.F., N.S., G.L., M.W., J.S., and J.D.S.; resources, J.S.; supervision, G.L., M.W., J.S., and J.D.S.; validation, R.P.-D., and T.F.; visualization, R.P.-D.; writing—original draft, R.P.-D.; writing, review and editing, R.P.-D., J.D.S., T.F., M.W., N.S., G.L., and J.S. All authors have read and agreed to the published version of the manuscript.\u003c/p\u003e\n\u003cp\u003eR.P.-D. - Regina Poß-Doering; T.F. - Thomas Fleischhauer; N.S. - Nina Sander; G.L. Gunter Laux; M.W. Michel Wensing; J.S. - Joachim Szecsenyi; J.D.S. Jonas D. Senft\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAcknowledgments\u003c/p\u003e\n\u003cp\u003eWe would like to sincerely thank all participants in this process evaluation for their valuable contributions. Also, we thank our student research assistants for transcribing the interviews.\u0026nbsp;\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eFalanga V, Isseroff RR, Soulika AM, Romanelli M, Margolis D, Kapp S, et al. Chronic wounds. Nat Rev Dis Primers. 2022;8(1):50.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eProbst S, Weller CD, Bobbink P, Saini C, Pugliese M, Skinner MB, et al. Prevalence and incidence of venous leg ulcers-a protocol for a systematic review. Syst Rev. 2021;10(1):148.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eProbst S, Saini C, Gschwind G, Stefanelli A, Bobbink P, Pugliese MT, et al. 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Use of concept mapping to characterize relationships among implementation strategies and assess their feasibility and importance: results from the Expert Recommendations for Implementing Change (ERIC) study. Implement Sci. 2015;10(1):109.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePowell BJ, Waltz TJ, Chinman MJ, Damschroder LJ, Smith JL, Matthieu MM, et al. A refined compilation of implementation strategies: results from the Expert Recommendations for Implementing Change (ERIC) project. Implement Sci. 2015;10(1):21.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRabe E, F\u0026ouml;ldi E, Gerlach H, J\u0026uuml;nger M, Lulay G, Miller A, et al. Medical compression therapy of the extremities with medical compression stockings (MCS), phlebological compression bandages (PCB), and medical adaptive compression systems (MAC) S2k guideline of the German Phlebology Society (DGP) in cooperation with the following professional associations: DDG, DGA, DGG, GDL, DGL, BVP. German version. Der Hautarzt. 2021;72:137\u0026ndash;52.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBossert J, Vey JA, Piskorski L, Fleischhauer T, Awounvo S, Szecsenyi J, et al. Effect of educational interventions on wound healing in patients with venous leg ulceration: A systematic review and meta-analysis. Int Wound J. 2023;20(5):1784\u0026ndash;95.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eProtz K, Dissemond J, Karbe D, Augustin M, Klein TM. Increasing competence in compression therapy for venous leg ulcers through training and exercise measured by a newly developed score\u0026mdash;Results of a randomised controlled intervention study. Wound repair regeneration. 2021;29(2):261\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSt\u0026uuml;rmer E, Dissemond J. Evidenz in der lokalen Therapie chronischer Wunden: Was ist gesichert? Aktuelle Dermatologie. 2021;47(07):314\u0026ndash;22.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eWeller CD, Buchbinder R, Johnston RV. Interventions for helping people adhere to compression treatments for venous leg ulceration. Cochrane Database Syst Rev. 2016;3(3):Cd008378.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eO'Brien J, Finlayson K, Kerr G, Edwards H. 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BMC Med Res Methodol. 2013;13:117.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRitchie J, editor. Qualitative research practice: A guide for social science students and researchers. 1. publ ed. London : Sage; 2003.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePo\u0026szlig;-Doering R, Anders C, Fleischhauer T, Szecsenyi J, Senft JD. Exploring healthcare provider and patient perspectives on current outpatient care of venous leg ulcers and potential interventions to improve their treatment: a mixed methods study in the ulcus cruris care project. BMC Prim Care. 2022;23(1):229.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFleischhauer T, Sander N, Feisst M, Awounvo S, Weller L, Poss-Doering R, Laux G, Altiner A, M\u0026uuml;ller-B\u0026uuml;hl U, Szecsenyi J, Senft JD. Treating Venous Leg Ulcers in Primary Care: The Cluster-Randomized Ulcus Cruris Care Trial. Dtsch Arztebl Int. 2025;(Forthcoming):arztebl.m2025.0207. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.3238/arztebl.m2025.0207\u003c/span\u003e\u003cspan address=\"10.3238/arztebl.m2025.0207\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Epub ahead of print. PMID: 41189454.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eProtz K, Heyer K, D\u0026ouml;rler M, St\u0026uuml;cker M, Hampel-Kalthoff C, Augustin M. Compression therapy: scientific background and practical applications. J Dtsch Dermatol Ges. 2014;12(9):794\u0026ndash;801.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eProtz K, Dissemond J, Karbe D, Augustin M, Klein TM. Increasing competence in compression therapy for venous leg ulcers through training and exercise measured by a newly developed score-Results of a randomised controlled intervention study. 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J Adv Nurs. 2011;67(3):662\u0026ndash;76.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBerardinelli D, Conti A, Hasnaoui A, Casabona E, Martin B, Campagna S, et al. Nurse-Led Interventions for Improving Medication Adherence in Chronic Diseases: A Systematic Review. Healthcare. 2024;12(23):2337.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDin\u0026ccedil; L, Gastmans C. Trust in nurse\u0026ndash;patient relationships: A literature review. Nurs Ethics. 2013;20(5):501\u0026ndash;16.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eTong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care. 2007;19(6):349\u0026ndash;57.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-health-services-research","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bhsr","sideBox":"Learn more about [BMC Health Services Research](http://bmchealthservres.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/BHSR/default.aspx","title":"BMC Health Services Research","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"chronic wounds, venous leg ulcer, case management, general practice, education","lastPublishedDoi":"10.21203/rs.3.rs-8470254/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8470254/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eCare analyses show that evidence-based measures such as compression or promotion of mobility are rarely implemented in treatment of Venous leg ulcers (VLU). The Ulcus Cruris Care project designed a disease management concept to support evidence-based VLU treatment in general practices via online training and three e-learning modules for practice teams, software-supported case management, involving non-physician assistants, and promoting patient activation and education. The intervention program was implemented in a multicenter randomized controlled trial. A mixed-methods process evaluation explored intervention fidelity and perceived effects to identify improvement potential.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eThe cross-sectional process evaluation design applied semi-structured guide-based qualitative telephone interviews and a study-specific survey to evaluate the implementation process of the program.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eN\u0026thinsp;=\u0026thinsp;38 survey questionnaires were completed and n\u0026thinsp;=\u0026thinsp;27 interviews were conducted (n\u0026thinsp;=\u0026thinsp;10 general practitioners, n\u0026thinsp;=\u0026thinsp;10 non-physician assistants, n\u0026thinsp;=\u0026thinsp;7 patients). Findings indicate high intervention fidelity regarding completion of the online training (100%), the e-learning modules (between 61% and 48%), application of standard operating procedures (100%), patient education material (91%), and case management software (91%). Practice teams and patients positively perceived the role of non-physician assistants as case managers and their involvement in wound treatment and patient education. Overall, the program was perceived as effective in fostering a change in treatment routines towards the regular use of compression therapy as the most effective treatment measure, patient and practice team education, and wound healing.\u003c/p\u003e\u003ch2\u003eDiscussion\u003c/h2\u003e \u003cp\u003eThe intervention program was assumed to lead to more frequent use of compression therapy, faster healing and less use of medical resources. Participants in the process evaluation perceived the intervention program as contribution to a structured, evidence-based VLU treatment, a gain in relevant knowledge for practice teams and patients and more active patient and relative participation. The outcome analysis in the Ulcus Cruris Care trial strengthened these findings and suggested a potential benefit of the intervention.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003ePromotion of comprehensive VLU treatment and care in general practices, including a regular use of compression therapy and active patient participation as facilitated by this intervention program appears to be largely suitable for a VLU case management approach.\u003c/p\u003e\u003ch2\u003eTrial registration\u003c/h2\u003e \u003cp\u003e: The trial protocol was registered in the German Clinical Trials Register on August 30, 2021 (DRKS00026126).\u003c/p\u003e","manuscriptTitle":"Implementing a primary care disease management concept for venous leg ulceration: Findings of a mixed-methods process evaluation in the Ulcus Cruris Care trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-01-28 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