Developing an Evidence‐Based and Patient‐Centred Care Concept to Address Deficits in German Primary Care of Venous Leg Ulcers: Results of an Expert Survey Within the ULCUS CRURIS CARE Project

ABSTRACT

Venous leg ulcers (VLU) account for the majority of chronic wounds, with an estimated rise in prevalence due to demographic change. Care often does not comply with evidence, and patients remain passive and uninformed. To support general practice VLU care, the ‘UlcusCrurisCare’ (UCC) project developed a multimodal intervention comprising provider training, software‐supported case management and standardised patient education. Experts from the medical community (physicians, nurses, association of medical assistants), health insurance and patient representatives provided their assessment of barriers in VLU care, requirements for intervention components and their expected effects. Semi‐structured interviews and questionnaires were used at two measuring points. Qualitative data analysis was based on the Theoretical Domains Framework. Quantitative data were analysed descriptively. Ten experts named a lack of knowledge and application regarding compression therapy, reluctance to assume role as primary care provider, and inadequate remuneration as barriers for evidence‐based VLU care. To effectively address these barriers, interventions are required to foster the use of compression therapy and patient education. A multimodal approach such as pursued in UCC is expected to effectively address deficits in VLU care at general practitioner level by promoting provider knowledge about evidence‐based treatment and supporting patient adherence.

Key Messages.

• The ‘UlcusCrurisCare’ (UCC) project developed a multimodal intervention comprising provider training, software‐supported case management and standardised patient education to support VLU care in general practices.

• Experts viewed a lack of knowledge and application regarding compression therapy, reluctance of general practitioner practices to act as primary care provider, and inadequate remuneration as current barriers for evidence‐based VLU care.

• Interventions are required to foster the use of compression therapy and patient education.

• The multimodal approach pursued in UCC is expected to effectively address deficits in VLU care at general practitioner level by promoting provider knowledge about evidence‐based treatment and supporting patient adherence.

Abbreviations

GP

General practitioner

MA

Medical Assistant

MAC

Medical Adaptive Compression system

SOP

Standard Operating Procedure

UCC

Ulcus Cruris Care

VLU

Venous leg ulcer

1. Introduction

Venous leg ulcers (VLUs) are the most common type of chronic wound of the lower limbs [1, 2]. Their prevalence increases with age [3], and is expected to rise further due to rising life expectancy, placing a considerable burden on healthcare systems and the quality of life of affected patients [4, 5]. Compression therapy is the cornerstone of causal treatment for VLU, as it treats the underlying venous hypertension that impedes wound healing [6]. Its high efficacy in VLU treatment and prevention has been scientifically confirmed [7, 8, 9, 10, 11], which is why its regular use can be considered key to improving VLU care. Despite its status in VLU treatment, compression therapy is only used in 30%–40% of patients [12, 13, 14, 15, 16, 17]. Without appropriate causal therapy, there is a high risk of chronicity and deterioration in the quality of life of affected patients [18, 19, 20, 21]. The reasons for this care deficit are multifactorial. On the one hand, knowledge about compression therapy and its practical application among healthcare providers and patients is demonstrably insufficient [22, 23]. While the majority of VLU patients are cared for by general practitioners (GPs) as their primary care provider [4, 23], there are no standardised care concepts for outpatient care of VLU, and GP practice teams are facing increasing time and resource pressures [24, 25]. Lastly, patients tend to take a passive and uninformed role in their treatment, although their active participation in treatment is crucial for adherence and thus wound healing [26, 27]. The Ulcus Cruris Care (UCC) project aimed to develop an evidence‐based and patient‐centred care concept for the treatment of VLU by general practices. To this end, a multimodal intervention was designed comprising online training for general practice teams, software supported documentation and monitoring, and training materials for patient education. In order to refine the intervention for a potential transfer into standard care, a pilot study [28] with accompanying process evaluation [29] was conducted prior to testing the intervention in a randomised controlled trial [30]. Within the process evaluation and along the trial, assessments from experts of various interest groups with chronic wound care experience were captured. This expert survey aimed at exploring the state of VLU care in Germany, perceived requirements for interventions to address barriers for evidence‐based treatment and their assumed effects on VLU care from expert perspective. The results of this study could help to inform the planning and designing of targeted interventions or political decisions not only for GP‐centred VLU care in Germany, but also for regional contexts in which similar care structures and care deficits exist.

2. Methods

2.1. Study Design

Qualitative semi‐structured, guide‐based expert interviews were conducted, supplemented by a study‐specific quantitative questionnaire and a sociodemographic questionnaire at two measuring points. By synergistically integrating quantitative and qualitative data, this approach enables in‐depth insights into the perceptions of individuals on interventions or implementation programmes [31]. The COREQ checklist served as a reporting guideline for this study [32].

2.2. Context—UCC Implementation Program

A multimodal implementation programme for outpatient VLU care in general practices was designed. The programme is based on clusters for implementation strategies proposed in the ERIC taxonomy (Expert Recommendations for Implementing Change) [33] and comprises five components: (1) On‐demand online training and eLearning courses for general practitioners (GPs) and medical assistants (MAs) (cluster: Train and Educate Stakeholders); (2) Standard operating procedures (SOPs) for evidence‐based VLU treatment (cluster: Support Clinicians); (3) Software‐supported wound documentation and monitoring (cluster: Change Infrastructure); (4) Verbal and written information and eLearning course for patients (cluster: Engage consumers/Train and Educate Stakeholders); and (5) Strong involvement of MAs as case managers in wound care and patient education (cluster: Develop Stakeholder Interrelationships/Support clinicians (revise professional roles)). Online training and eLearning focused on the pathophysiology of VLU, the effectiveness and practical aspects of compression therapy, approaches to local wound treatment and recommendations for standardised patient education. Videos, graphics, illustrations, tables and overviews were used to visualise the learning content.

2.3. Study Population, Recruiting and Sampling

The target group were experts from the medical profession, nursing, association of medical assistants, health insurance and patient representatives, which were identified as interest groups with a particular stake in chronic wound care. Potentially eligible participants were selected based on a web search and had to have designated practical, scientific or administrative expertise within the field of chronic wound care (medical profession, association of medical assistants, nursing profession, health insurance) or patient counselling (patient representatives from a self‐help service). One to two participants per interest group were to be recruited to cover the relevant spectrum and achieve an adequate degree of thematic saturation. Following a purposive sampling strategy, participants who were considered information‐rich for the phenomenon under study were intentionally selected and recruited. This sampling approach emphasises the depth and relevance of insights rather than a high sample size to claim statistical representativeness [34]. Hence, a sample size of n = 10 was aimed for. Potential participants were approached by the study team via email or phone if contact details were available on the web and were sent an information leaflet, a consent form and questionnaires along with a return envelope if they agreed to participate. No expense allowance was paid for participation in the study.

2.4. Data Collection

The expert interviews were conducted by two experienced interviewers with backgrounds in health sciences, health services research, and clinical research between August and December 2021 and between January and March 2024 either from the workplace or home office. All participants provided their written consent to participate in the study prior to data collection. Nine of the ten interviews were conducted by telephone, and one was conducted via Cisco Webex (with video). Based on the research questions, the research team developed interview guides and a non‐validated study‐specific questionnaire in an iterative process of collecting, discussing and agreeing on suitable questions and wording. Another questionnaire was used to record the socio‐demographic characteristics of the participants. After a pilot survey, minor adjustments were made to the survey instruments. All interviews were conducted in German, digitally recorded and transcribed verbatim. All data collected was pseudonymised and stored electronically on secure servers.

2.5. Data Analysis

MAXQDA 2020 (version 20.2.2) software was used to organise and code interview transcripts. The qualitative data were analysed by two experienced members of the research team. In phase one, the categories “Current state of VLU care” and “Requirements for interventions” were formed a priori deductively, based on the research questions. Subsequently, the category “contextual factors of implementation” was derived inductively, which reflects the determinants of intervention implementation. Based on the assumption that the implementation of evidence‐based interventions depends on behavioural factors, the domains “knowledge” and “skills” (combined into one category), “social/professional role and identity” and “environmental context and resources” of the Theoretical Domains Framework (TDF) [35] were included in the qualitative data analysis. The TDF consolidates 33 behavioural models and theories, assigns them to a framework of 14 theoretical domains, and thus enables a theory‐based categorisation of behavioural factors [36]. In a final phase, the influencing factors identified inductively in the data were assigned to corresponding domains of the TDF. To achieve a high degree of intercoder congruence, coding was discussed and agreed upon in regular meetings within the research team. Table 1 shows the coding system and the categorisation into main and subcategories. To establish the link between TDF domains and UCC implementation strategies, the three categories of the COM‐B model were used as a reference [37], thereby accounting for the interconnectedness of the TDF and COM‐B [38].

TABLE 1.

Consented coding system and categorisation into main and subcategories.

Main categories		Inductive subcategories
Current state of VLU care (based on the TDF)		Knowledge and Skills a
		Social/professional role and identity
		Environmental context and resources
Requirements for interventions	Training of GP practice teams	Format/eLearning
		Contents
		Modular structure
		Outpatient care services
		Expected effects
	Patient education and written patient information	eLearning
		Active role/personal responsibility
		Contents
		Role of relatives
		Expected effects
	Software for wound documentation and monitoring	Requirements
		Expected effects
	SOPs	Requirements
		Expected effects
	Strong involvement of MAs as Case Managers	Qualification
		Responsibilities
		Case Management
		Expected effects
Miscellaneous		—

Abbreviations: GP, General practitioner; MAs, Medical Assistants; SOP, Standard Operating Procedure; TDF, Theoretical Domains Framework.

^a ‘Knowledge’ and ‘Skills’ are separate domains of the TDF but were combined for this analysis due to their thematic proximity.

Descriptive analyses of the questionnaires were performed using Microsoft Excel (version 2301). Using a 5‐point Likert scale (from 1 = strongly disagree to 5 = strongly agree), mean values, medians, standard deviations, and absolute and relative frequencies were calculated. Questionnaire items representing the same thematic construct were summarised into key statements to support the interview statements.

3. Results

Experts' assessments of the current state of VLU care in Germany, requirements for intervention components and their expected effects on VLU care are reported primarily based on qualitative data and supplemented by questionnaire data where applicable. Quotes from the qualitative data are presented in pseudonymised form (E = expert; interview number). Figure 1 provides an overview of the theoretical‐analytical approach and the results of the expert survey.

FIGURE 1.

Theorising‐analytical approach and results of the expert survey. GP, General practitioner; MAs, Medical Assistants; SOP, Standard Operating Procedure; TDF, Theoretical Domains Framework; VLU, Venous leg ulcer.

The COM‐B model states that behaviour (B) only occurs when a person has the capability (C), the opportunity (O) and the motivation (M) to do so [37]. If one or more of these three conditions is missing, the desired behaviour will not occur at all or will only occur unreliably. Effective interventions therefore target one or more of these conditions. COM‐B and the TDF complement each other in explaining and analysing behavioural change [38]. The TDF serves as a ‘hinge’ between theory and practice and operates on a more detailed level (domain), while COM‐B describes the fundamental, systemic influencing factors. The domains of the TDF can be clearly assigned to the three COM‐B categories, enabling a structured, theory‐based analysis of behavioural barriers and facilitators. Considering the three major TDF domains referred to for explaining the current state of VLU care, the UCC intervention aims to cover all three conditions of the COM‐B wheel. To increase capability (C) of providers and patients, increasing their knowledge and skills and thus overall competence in VLU care could be achieved by a structured training program (1) and verbal and written patient education (4). To increase GP practice teams’ motivation (M) to assume a role as the primary care provider for VLU patients (Social/professional role and identity), rationalising and standardising care processes for practice teams could be achieved by means of SOPs (2) and software support (3) to facilitate decision‐making, documentation and monitoring in GP practices. To foster patients’ willingness (M) to take an active role in their treatment (Social/professional role and identity), educating them verbally and via written information material (4) could raise their awareness for the importance of compression therapy and adherence. To address environmental and contextual factors regarding available resources and reimbursement of VLU care (O), a strong involvement of and delegation of competencies to qualified MAs (5) could improve the ratio between resources consumed for and remuneration of VLU care. It is important to note that the COM‐B components influence each other: more opportunity can increase motivation, and increased capabilities, for example, acquired through training, can increase motivation to treat VLU patients as the primary care provider.

3.1. Participant Characteristics

Between August and December 2021, and January and March 2024, a total of n = 10 experts were interviewed and n = 10 socio‐demographic and study‐specific questionnaires were completed, corresponding to a response rate of 100%. Table 2 describes the socio‐demographic characteristics of the sample. Interview duration was between 14:43 and 78:38 min (average 41:09 min).

TABLE 2.

Participant characteristics.

	Experts (n = 10)
Age mean (Standard deviation)	45 (9.5)
Female (%)	4 (40)
Interest group n (%)
Medical profession	3 (30)
Association of medical assistants	1 (10)
Nursing	2 (20)
Health insurance	2 (20)
Patient representatives	2 (20)
Years in current occupation (Standard deviation)	17.4 (9.9)
Full‐time employment (%)	8 (80)
Part‐time employment (%)	2 (20)

3.2. State of VLU Care in Germany

3.2.1. Knowledge and Skills

All interviewees identified deficits and a need for improvement in VLU care in Germany.

Wounds are a very special topic where, in recent years or decades, a great deal of expertise and experience has simply been lost. (E10)

They unanimously noted a ‘training deficit’ (E08) among healthcare providers, particularly regarding compression therapy, which would often be applied incorrectly or not used at all.

We all notice that, especially in wound management, care is suboptimal, and compression therapies are often not applied adequately or completely, and I believe that we simply have a training deficit here. (E03)/… we always need diagnostics and causal therapy first, and that's where the problem lies. (E09).

One participant reported that most care providers were unaware of modern compression devices such as medical adaptive compression systems (MAC), ulcer stocking systems and multi‐component compression systems which were estimated to be superior to traditional compression devices, for example, compression bandages, and therefore preferable

Historically, Germany has always been a bit of a short‐stretch bandage country. I would say they've been out of fashion for 20 years. No one can apply them [correctly, Author's note] anymore. (E09).

Constant innovations in local wound treatment were reported to shift the focus from compression therapy to local wound treatment with modern wound dressings which were considered subordinate for achieving wound healing in VLU.

But what is the wound dressing supposed to do if venous return to the heart is impaired? If a wound does not heal, it is never, and I mean never, the fault of the wound dressing. (E09).

3.2.2. Social/Professional Role and Identity of GP Practices in VLU Care

Some participants described that GPs referred VLU patients to other healthcare providers instead of treating them themselves:

That [the VLU patient] gets sent away to specialist practices, or at best, briefly to the hospital, but the main thing is that I don't have to touch patients. So, I give them a referral slip and that's that. (E04).

This was assumed to be due to a high complexity of VLU treatment and deficits in knowledge and practical skills of the practice teams, particularly regarding compression therapy. This gap was attributed to insufficient coverage of VLU and compression therapy in medical school and vocational training (‘neither doctors nor medical assistants learn anything about wound care during their studies…’ (E09)) and insufficient practical experience in compression therapy due to frequent delegation to nursing services or relatives:

A parallel development is that general practitioners simply delegate this work to nursing services by means of … a home nursing prescription, thereby passing the majority of the work. (E10).

One person reported that private service providers had exploited this gap and viewed this critically due to suspected opaque incentives and a conflict of interest.

The doctor or the patient wants the wound to be closed, these home carers want to earn money, so to speak, and they earn it through the dressing materials they supply. And how companies … or individuals … deal with this conflict, whether there are perhaps incentive systems for employees, is all completely intransparent. (E10).

However, several respondents had the opinion that GP practices were in fact capable of providing cost‐effective primary care for VLU patients (‘It can be done in the practice in a relatively straightforward and very practical way.’ (E08)).

3.2.3. Environmental Context and Resources

Most interviewees described the care of VLU patients as very resource‐consuming and considered the remuneration to be insufficient in view of the high demand of time and human resources:

Of course, GPs aren't really interested in patients with wounds, that has to be said. They're just crazy expensive and the reimbursement is poor. So, nobody makes any money from wounds. (E09).

An improvement in remuneration was seen as necessary to enable GP practices to cover the costs of the complex VLU care and to increase their motivation to keep VLU patients for treatment instead of referring them to other providers like outpatient wound centres or outpatient care services:

You know that a lot of medical treatment depends on health insurance, on remuneration, and let's be honest, that's a big problem. And in principle, these [chronic wounds; author's note] areas are neglected… the focus becomes, okay, this is a treatment that takes time, (.) time for explanation and also time for treatment, so we try to pass them away, to put it bluntly. (E08).

With a constant increase in workload in many GP practices, a lack of time and staff were seen as constrains to ensuring adequate care for VLU patients and to continuously keep knowledge up‐to‐date.

3.3. Requirements for Interventions

3.3.1. Training of GP Practice Teams

To promote knowledge and skills and ensure adequate qualification in VLU care, particularly in compression therapy, trainings for GP practice teams were seen as imperative:

Here we simply have a training deficit, which can certainly be remedied… and doctors should also be trained to apply the right therapy, but also to know when referrals to other professionals might be appropriate. (E03)/We must constantly remind ourselves of tried and tested methods [compression therapy; author's note] so that we do not forget them. (E08).

Modular training courses adapted to prior knowledge were advocated, for example by designing a compulsory basic module that could be supplemented by optional modules for further study to account for heterogenous levels of knowledge among care providers. Few participants expressed a preference for face‐to‐face training, as this was viewed as essential for learning success in practical aspects such as the application of compression bandages. Advantages of the digital eLearning approach were primarily seen in the repeatability and low threshold of the offering, which, if integrated into standard care, would ensure high scalability, thereby greatly facilitating widespread dissemination:

In order to really be able to offer something on a broad scale, which is ultimately what we want to do… online formats are great. (E10).

On the written survey, participants indicated that they considered the time required to complete the UCC eLearning course to be manageable (2.4 ± 1.3, with 1 = very little effort and 5 = very high effort).

In terms of content, the interviewees considered the pathophysiology, effectiveness and mode of action of compression therapy, as well as limitations of local wound treatment to be particularly relevant. One person with special expertise in compression therapy also advocated to focus more on modern and less error‐prone compression variants that would offer greater practicality and efficiency and could be applied safely and effectively by patients or relatives themselves. This person highlighted MAC for the decongestion phase and ulcer stocking systems for the maintenance phase, which were stated to be superior to classic compression devices and therefore more contemporary. It was also advised to emphasise circumstances under which patients should be referred to specialist providers or outpatient nursing services should be involved in care. For instance, this was mentioned to be the case with particularly complicated and therapy‐resistant wounds or when there are no relatives that can support the application of compression on a regular basis.

According to the interviewees, training modules for MAs should be structured similarly but with explicit emphasis on communication skills and patient concerns about compression therapy, as well as everyday assistance such as the correct use of compression materials. From the interviewees' point of view, training should generally take place on a regular basis to ensure that the knowledge imparted is up to date and sustainable. Some participants considered in‐person workshops more effective than a digital learning format, especially for practicing skills in compression therapy:

It is essential to have it demonstrated properly at least once. Therefore, this workshop concept in conjunction with the webinar is very effective. One can receive preliminary training through the films, but there should be at least one practical application and observation to ensure that the person learning it is doing it correctly. (E08)/In compression therapy, I consider it essential that practical application is taught and that these materials are also seen, touched etc.… because we have so many errors and uncertainties in application. (E09).

Based on the survey data, the experts assumed that GP practices would benefit from the use of guideline‐compliant and evidence‐based eLearning modules, particularly on compression therapy (4.8 ± 0.4).

3.3.2. Patient Education

From the participants' perspective, patient and relative education was considered equally important as healthcare provider training, since a high degree of adherence was considered vital in light of the protracted nature of VLU treatment:

I strongly believe that educating patients and their relatives, not just patients but also relatives and loved ones, is extremely important in order to ensure a high level of compliance in wound care or, in particular, in the case of ulcers, because treatment can take a long time. (E1).

A focus on disease pathogenesis and particular emphasis on the importance of compression therapy and accompanying measures to support wound healing (such as physical exercise) were recommended to promote patient adherence and wound healing. Empathetic and patient‐friendly knowledge transfer was emphasised as crucial to enable patients for taking an active role in their treatment:

Communication first! How do you communicate with chronic patients? From experience, regardless of the chronic illness, many hide behind technical terms and jargon in order to maintain a bit of distance. This makes it significantly more difficult for them to follow. … Empathetic knowledge transfer is required… to impart knowledge to the patient and, on the other hand, to show the patient how to take action themselves. (E1).

Concerning the eLearning, several participants doubted it would be accepted by older patients. For older patients and their family members, written information materials in conjunction with verbal education were considered more useful instead, especially when focusing on essential key messages and practical implications and using visual media to illustrate the concepts. However, one expert stated that online formats will become more accepted in the future, ‘at least as we get older… because access will be much greater and more accepted.’ (E01) According to the interviewees, care should be taken not to overload patients with information and overwhelm them, be it in verbal or written education:

What you say is only worth as much as the other person understands… You can try to convey the greatest knowledge, but if the other person cannot absorb it, then it was all for nothing… Less is more, the most important information must be included. Otherwise, it will be overloaded and people will be overwhelmed. (E08)

An explicit training of GP practice teams in patient counselling was endorsed by all respondents, and the quantitative data suggest an expected improvement in patient education as a result (4.1 ± 1.0).

3.3.3. Software for Wound Documentation and Monitoring

In the written survey, participants indicated that electronic data processing systems were important components for a practice in the context of patient care (4.3 ± 0.7). A software‐supported wound documentation was considered helpful to present the therapy course in a clear and standardised manner and a prerequisite for monitoring, which was described as essential for responsive VLU care.

A documentation is extremely important to be able to make a monitoring over time… so that I can record decompensations or wound courses in a timely manner. (E03).

Several participants admonished that a documentation should not be designed ‘too elaborate’ (E06) to ensure an actual ‘time‐saving’ (E02), but rather to establish interfaces between different documentation systems to avoid unnecessary ‘double documentation’ (E06). Particularly in cases of changing responsibilities, a uniform documentation could bring all involved parties to a common level of knowledge so that a high standard of care would be maintained even with personnel changes. The quantitative data showed that a software‐supported wound documentation in GP practices was expected to provide an added value (4.2 ± 0.8) and an improved standardisation (4.7 ± 0.5).

3.3.4. Standard Operating Procedures (SOPs)

From the perspective of the interviewees, SOPs could support therapeutic decision‐making by providing action recommendations for various wound situations:

That is indeed the red thread, along which one can hang on or at least start with. (E07).

The expectation was expressed that SOPs could contribute to a structured treatment along uniform criteria and thus simplify and streamline the treatment process. SOPs were considered useful to update one's own knowledge and to review one's own approach, which would reduce the ‘burden of failure or the wrong therapeutic path.’ (E05). In case of changing responsibilities within a practice, SOPs were considered to contribute to maintaining standards. This was also reflected in the survey data which indicated that SOPs could contribute to standardisation of VLU care (4.7 ± 0.5) and that GP practices would benefit from their use (4.6 ± 0.7).

3.3.5. Strong Involvement of MAs as Case Managers

A strong integration of qualified MAs into VLU care was endorsed by all respondents. In their opinion, MAs could play a central role as case managers in VLU care.

I see the doctor more as someone who comes in to consult when something doesn't go according to the normal course. But the care, the intensive care, the counselling of patients, I see that actually with the MA. (E07)/I think case management encompasses a lot, and I would trust them with all of that. (E10).

In particular, respondents felt that verbal education by MAs was an effective supplementation to patient education via written information materials:

‘Sometimes the tip from the MA that takes care of it [the wound; author's note] is worth more than any glossy brochure. (E07).

In order to allow for proper patient education, it was seen as necessary ‘that certain windows are made available in the practices, where the MFAs then specifically care for patients with leg ulcers.’ (E08). In the interviews, participants described several benefits of a strengthened role of MAs in VLU care for all parties involved (‘win‐win‐win‐win’ (E10)), such as an upgrading of the MA profession, a work relief for GPs, and a release of resources for patients. The survey data indicated that programs such as the UCC intervention could contribute to a shortening of wound healing durations (4.7 ± 0.5), an improvement in the quality of VLU care (4.7 ± 0.5) and cost savings (4.5 ± 0.8).

4. Discussion

All participants saw potential for optimization in VLU care and the need for targeted interventions to effectively address existing deficits. This study aligns with the results of a previous survey study, in which GPs, MAs, and patients identified similar care deficits in Germany and a need for educational interventions to tackle, in particular, knowledge and knowledge deficits in compression therapy [39]. The experts considered the UCC intervention as suitable to effectively close competence gaps and promote the use of guideline‐based compression therapy. In addition to healthcare provider training, educating patients and facilitating their active participation in treatment should be another priority to improve adherence in compression therapy [40]. Training interventions for patients can improve knowledge and adherence as well as wound‐related and patient‐reported outcomes [41, 42] and should hence be an integral part of outpatient VLU care. Research findings suggest that multimodal approaches to improving patient adherence, as pursued in the UCC project, may have a greater potential for improving care and quality of life of affected patients and reducing healthcare costs than advances in local wound care [26, 43, 44].

In light of increasingly scarce resources in GP practices and the expected increase in chronic wounds, it appears necessary to promote the wound care competence of MAs and to involve them more intensively in treatment. The interviewed experts strongly supported a strengthening and expansion of the MA role in VLU care and suspected that the software‐supported case management approach and SOPs could effectively support this transfer of responsibilities. As suggested by one expert, an expansion of MAs’ competencies could be backed by formalising them into a new professional code for MAs, for example, by offering a specialisation in VLU care (‘the VLU nurse’; E04) following designated training. Participants anticipated significant cost savings through the deployment of MAs as case managers and the assumption of a larger scope of tasks in VLU care.

In other countries such as the United Kingdom, Australia or the Netherlands, VLU care is regularly taken over by community nurses or district nurses in the neighbourhood, with research indicating positive effects on treatment quality, patient outcomes, costs and patient satisfaction with care [40, 45, 46, 47, 48, 49], even though more research evaluating nurse‐led care models is needed [50]. A routine data analysis from Germany has also shown that the integration of further trained MAs (‘care assistance in general practitioner practices’) into primary care is associated with positive outcomes. Consequently, the expansion of responsibilities of MAs can be a successful strategy to compensate for the high workload in GP practices and at the same time improve the quality and efficiency of primary care [51].

Another care deficit was seen in the fact that GP practices often referred VLU patients to other healthcare providers or involved outpatient care services rather than treating them themselves as primary caregivers. While this is particularly indicated in cases of complicated and therapy‐refractory wounds, it often does not occur in a timely manner [23], for non‐complicated VLUs, guidelines recommend that GP practice teams assume a leading role, comprising for example, basic diagnostics, initiation of compression therapy and coordination of care [52]. However, an inadequate remuneration of VLU treatment considering the resource‐intensive care was assumed to seemingly amplify this problem, as inexperienced practices without an efficient approach to VLU care might be disincentivized to care for VLU patients as primary care providers. From the experts' perspectives, it was considered challenging but entirely possible for GP practices to treat VLUs cost‐effectively. They expressed the expectation that the UCC interventions could facilitate the establishment of a standardised and structured approach to VLU care in GP practices, fostering the rationalisation and efficiency of care processes in the long term. The results of the UCC pilot study indicated that care supported by the UCC intervention could be associated with lower treatment costs (1.380 ± 1.347 EUR) compared with standard care (2.049 ± 2.748 EUR) [28]. Considering the incidence of VLU, this could extrapolate to an estimated annual cost saving of ~230 million EUR in Germany, which appears to make a widespread dissemination of the UCC intervention desirable from both a patient and a health economics perspective.

Due to the high error‐proneness and resource‐intensive nature of compression bandages, alternative compression methods were considered to gain importance. MACs and multi‐component compression systems effectively address the contextual factor of disproportionate remuneration, as they can be associated with significant time savings, which also enables inexperienced GP practices to provide efficient and cost‐effective care as primary caregivers. They facilitate the setting and maintenance of necessary target pressures for decongestion [53], are considered more comfortable by patients [54] and can be applied independently by patients or relatives after proper instruction, thereby promoting active participation and potentially reducing the need for additional care by outpatient care services [55]. Furthermore, they have the billing advantage of being reimbursed through the assistive device budget in Germany [54]. However, the majority of care providers are not familiar with modern compression variants [13]. The multimodal approach of UCC has the potential to effectively disseminate knowledge about the various compression systems and their benefits to the broad care landscape through eLearning modules in an efficient and low‐threshold way.

4.1. Strengths and Limitations

To our knowledge, this is the first study that explored expert assessments regarding the state of VLU care and requirements for interventions to address barriers for evidence‐based treatment in light of a possible transfer to routine care in Germany. With the purposive sampling strategy, participants who were considered information‐rich for the phenomenon under study were intentionally selected and recruited for the study. This sampling approach emphasises the depth and relevance of insights rather than a high sample size and a claim of statistical representativeness [34]. The synergistic use of qualitative and quantitative data allowed for an in‐depth analysis and contributed to supporting or contrasting statements from the interviews. Experts from all relevant interest groups in the context of VLU care were interviewed and a broad range of perspectives was taken into account, which enabled a sufficient degree of thematic saturation [56, 57] and information power [58] to be achieved. Under consideration of the methodological limitations, the results of this study could be transferable to and serve as a basis for planning and designing targeted interventions for regional contexts in which similar care deficits regarding compression therapy and patient adherence exist.

Nevertheless, this study is subject to some limitations. First, there is a potential selection bias, since participants were identified via web search and approached via mail or phone. Hence, potentially eligible participants whose contact details could not be found on the web could not be recruited. Second, data were collected from a divided sample during two different phases of the UCC project with the intention to refine the intervention first for the trial and second for a potential dissemination into routine care. The Covid‐19 pandemic was an important contextual factor during the 2021 expert survey that seemingly influenced interviewees’ perceptions. The most evident example was the eLearning and online webinar format which was used for the practice training: While participants of the first survey in 2021 were very positive about the eLearning format since that was the only feasible approach considering the curfews during the peak of the pandemic, participants of the 2024 expert survey were more sceptical, particularly regarding its effectiveness for conveying (practical) skills in compression therapy. Also, resource constraints appeared to be more relevant during 2021, when practice teams were additionally burdened by the vaccination campaign. Third, due to the total sample size of n = 10, it cannot be ruled out that additional participants might have mentioned further aspects at both measuring points. However, a sample size of 10 within a qualitative study is not unusual. Research suggests that thematic or theme saturation can be achieved with nine [56] or 9–17 interviews [59]. The newer concept of ‘information power’ links saturation closely to the respective methodology and indicates that the more information relevant for an actual study a sample holds, the lower the number of participants necessary to achieve saturation [58], which is the case with the sample of this study.

Also, non‐validated study‐specific questionnaires with unclear psychometric properties were used and not analysed for internal consistency. Lastly, the majority of participants were active in the federal state of Baden‐Wuerttemberg, which limits the external validity of our study. Due to the contextual relevance of findings, conclusions are regionally specific and possibly not transferable to other regional contexts. Future studies should include broader geographic sampling to increase external validity.

Author Contributions

TF: writing – first draft. RPD, GL, MW, JS, AA and JDS: conceptualization and supervision. TF, NSa, GL, MW, AA, JS and JDS: project administration. TF, NSa, RPD, JDS: resources. TF, NSa, RPD: validation. TF, RPD, GL, MW and JDS: methodology. TF and NSa: data collection and formal analysis. RPD, GL, JDS and MW: data curation. GL, MW, JS, AA and JDS: funding acquisition. NSa, GL, RPD, MW, AA, JS and JDS: writing – review and editing.

Funding

The ‘Ulcus Cruris Care’ project is funded by the Innovation Fund of the Joint Federal Committee Gemeinsame Bundesausschuss (G‐BA), Berlin, under the reference number 01VSF19043. The funder had no role in the design of the study or the writing of the manuscript, nor do they have a role in the collection, analysis, or interpretation of the data.

Ethics Statement

This study was approved by the Ethics Committee of the Medical Faculty of the University of Heidelberg (Reference Number S‐423/2020 and Reference Number S‐608/2021) and the Ethics Committee of the State Medical Association of Baden‐Württemberg (Reference Number B‐F‐2020‐082 and Reference Number B‐F‐2021‐101). The study followed all relevant guidelines and regulations and was conducted in accordance with the Declaration of Helsinki.

Consent

All participants provided their written consent to participate in the study prior to data collection. With signing the written consent form, participants also agreed to the scientific evaluation of the collected data and the subsequent publication of the results.

Conflicts of Interest

The authors declare no conflicts of interest.

Supporting information

Data S1: COREQ Checklist.

Fleischhauer T., Poß‐Doering R., Sander N., et al., “Developing an Evidence‐Based and Patient‐Centred Care Concept to Address Deficits in German Primary Care of Venous Leg Ulcers: Results of an Expert Survey Within the ULCUS CRURIS CARE Project,” International Wound Journal 23, no. 1 (2026): e70829, 10.1111/iwj.70829.

Data Availability Statement

The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.