[Interprofessional weaning boards and weaning consults for long-term ventilated patients: A qualitative study of perceived potential for patient care]. / Interprofessionelle Weaning-Boards und Weaning-Konsile für Langzeitbeatmungspatient*innen: Eine qualitative Studie zum wahrgenommenen Potenzial für die Patientenversorgung.

BACKGROUND: The PRiVENT project aims to improve the care of invasively ventilated patients and to reduce the number of out-of-hospital long-term ventilated patients. PRiVENT offers intensive care units the opportunity to exchange information with experts from specialized weaning centers in interprofessional weaning boards and weaning consults and to exploit the full weaning potential of the patients. In the context of the accompanying process evaluation, the PRiVENT intervention components will be examined for sustainability, scalability and effectiveness, and the interprofessional collaboration between intensive care units and the responsible weaning centers will be investigated in order to identify potentials for the care of invasively managed patients. METHODS: In a qualitative cross-sectional study, semistructured, problem-oriented interviews were conducted with care providers of participating ICUs. The data were digitally recorded, pseudonymized and verbatim transcribed. Data analysis was based on Brown and Clarke's Thematic Analysis and the Consolidated Framework for Implementation Research. MAXQDA 2020 software was used to organize the data. RESULTS: Fourteen interviews were conducted with ICU care providers. The early transfer of patients to a weaning center and the integration of pulmonary expertise into routine care were identified as positively perceived potentials of the weaning boards and weaning consults. Especially in critically ill, multimorbid patients suffering from COVID-19, the expertise of the weaning centers was considered helpful. Due to heavy workloads, nurses were unable to participate in weaning boards and weaning consults. CONCLUSION: Interprofessional collaboration between weaning centers and ICUs in weaning boards and weaning consults can improve the care of invasively ventilated patients. Strategies to promote the involvement of nurses should be discussed and developed.

[Between New Responsibility and Daily Routines - The Role of the VERAH in GP Care: A Qualitative Secondary Data Case Study of the Introduction of Software-Based Case Management]. / Zwischen neuer Verantwortung und Routinetätigkeit: Die Rolle der VERAH in der hausärztlichen Versorgung ­ Eine qualitative Sekundärdatenanalyse am Beispiel des softwaregestützten Case Management.

BACKGROUND: The concept of Care Assistant in General Practice (VERAH) was developed in order to integrate non-medical staff more strongly into primary care and thus to meet the increasing demand for care and the simultaneous shortage of medical staff. VERAHs are increasingly responsible for software-supported case management and are thus confronted with new tasks. The aim of this study was therefore to explore the role of the VERAH in primary care practices. METHODS: The present study is a qualitative secondary data analysis; the data collection took place within the projects VESPEERA and TelePraCMan. Twenty individual interviews and two focus group meetings were conducted with a total of 30 physicians, VERAHs and medical assistants from primary care. The data were analysed qualitatively according to Emerson. Contextual and socio-demographic data were collected with an accompanying questionnaire. RESULTS: The VERAHs of all primary care practices from which interview partners participated performed tasks within software-supported case management. Concerning the role of the VERAH, three themes were identified in the interviews: a) concrete tasks of the VERAH in software-supported case management within the practice team, b) relevance of software-supported case management within the activities of the VERAHS and c) relationship between VERAHs and patients. CONCLUSION: Taking over tasks in software-supported case management can contribute to strengthening and expanding the role of the VERAH. In the future, more attention should be paid to a clear description of the new role, and the conditions of the VERAHs' task fulfilment should be considered.

Climate change mitigation: Qualitative analysis of environmental impact-reducing strategies in German primary care.

BACKGROUND: The German healthcare system is responsible for 5,2% of the national emissions of greenhouse gases. Therefore, mitigation actions to reduce the carbon footprint are crucial. However, there have been few approaches to achieve this in German primary care. OBJECTIVES: This study aimed to identify environmental impact-reducing strategies of German primary care practices. METHODS: During the summer of 2021, a qualitative study was conducted using interviews and focus groups with experts in primary care across Germany, such as physicians, medical assistants, health scientists and experts on the health system level. Verbatim transcribed data were analyzed using Thematic Analysis. RESULTS: The sample comprised 26 individual interviews and two focus groups with a total of N = 40 participants. Findings provide a first overview of pursued mitigation strategies and contextual factors influencing their implementation. Strategies referred to the use of water and energy, recycling and waste management, supply chains and procurement, digitisation, mobility, patient care, behavioural changes and system level. Implementing sustainable actions in daily care was considered expensive and often unfeasible due to lack of staff, time and restrictive hygiene regulations. Participants called for more instruction on implementing mitigating actions, for example, through websites, podcasts, guidelines or quality indicators. CONCLUSION: This study's findings can support the development of future environmental impact-reducing strategies in primary care. Potential options for guidance and support should be considered to facilitate sustainability.

Prevention of invasive ventilation (PRiVENT)-a prospective, mixed-methods interventional, multicentre study with a parallel comparison group: study protocol.

BACKGROUND: Invasive mechanical ventilation (IMV) is a standard therapy for intensive care patients with respiratory failure. With increasing population age and multimorbidity, the number of patients who cannot be weaned from IMV increases, resulting in impaired quality of life and high costs. In addition, human resources are tied up in the care of these patients. METHODS: The PRiVENT intervention is a prospective, mixed-methods interventional, multicentre study with a parallel comparison group selected from insurance claims data of the health insurer Allgemeine Ortskrankenkasse Baden-Württemberg (AOK-BW) conducted in Baden-Württemberg, Germany, over 24 months. Four weaning centres supervise 40 intensive care units (ICUs), that are responsible for patient recruitment. The primary outcome, successful weaning from IMV, will be evaluated using a mixed logistic regression model. Secondary outcomes will be evaluated using mixed regression models. DISCUSSION: The overall objective of the PRiVENT project is the evaluation of strategies to prevent long-term IMV. Additional objectives aim to improve weaning expertise in and cooperation with the adjacent Intensive Care Units. TRIAL REGISTRATION: This study is registered at ClinicalTrials.gov (NCT05260853).

Hospital Admission and Discharge: Lessons Learned from a Large Programme in Southwest Germany.

Introduction: In the context of a GP-based care programme, we implemented an admission, discharge and follow-up programme. Description: The VESPEERA programme consists of three sets of components: pre-admission interventions, in-hospital interventions and post-discharge interventions. It was aimed at all patients with a hospital stay participating in the GP-based care programme and was implemented in 7 hospitals and 72 general practices in southwest Germany using a range of strategies. Its' effectiveness was evaluated using readmissions within 90 days after discharge as primary outcome. Questionnaires with staff were used to explore the implementation process. Discussion: A statistically significant effect was not found, but the effect size was similar to other interventions. Intervention fidelity was low and contextual factors affecting the implementation, amongst others, were available resources, external requirements such as legal regulations and networking between care providers. Lessons learned were derived that can aid to inform future political or scientific initiatives. Conclusion: Structured information transfer at hospital admission and discharge makes sense but the added value in the context of a GP-based programme seems modest. Primary care teams should be involved in pre- and post-hospital care.

Interprofessional weaning boards for invasively ventilated patients in intensive care units: Qualitative interview study with healthcare professionals in Germany.

Numbers of mechanically ventilated patients are increasing worldwide. Weaning Boards could support weaning from the ventilator by facilitating interprofessional consultations between Weaning Centers and nonpneumological intensive care units. This study, which is linked to the project Prevention of invasive Ventilation, aimed to explore the design and implementation of future Weaning Boards. Semistructured interviews were conducted with physicians, nurses, respiratory therapists, and physiotherapists of intensive care units and Weaning Centers in Baden-Wuerttemberg, Germany. Participants were asked to share their views on (a) required characteristics of Weaning Boards and (b) the current care of weaning patients in their wards. Qualitative data analysis included inductive and deductive steps referring to the Template for Intervention Description and Replication checklist and the Consolidated Framework for Implementation Research. The 14 interviewed healthcare professionals addressed characteristics of future Weaning Boards including (a) preconditions, (b) procedure, (c) interprofessional participants, (d) type of performance, and (d) time frame. Identified determinants for successful implementation were related to (a) individual characteristics of healthcare professionals, (b) ward characteristics, and (c) healthcare system characteristics. Weaning Boards could be a useful tool to advance knowledge sharing between professionals, improve education about weaning protocols, and support patient-oriented care. The implementation of Weaning Boards can be influenced by individual characteristics of participating professionals, difficulties in the interaction between professional groups, the present workplace culture, and the current coronavirus disease 2019 (COVID-19) pandemic.

How to fall into a new routine: factors influencing the implementation of an admission and discharge programme in hospitals and general practices.

INTRODUCTION: The VESPEERA programme is a multifaceted programme to enhance information transfer between general practice and hospital across the process of hospital admission, stay and discharge. It was implemented in 7 hospitals and 72 general practices in Southern Germany. Uptake was heterogeneous and overall low. A process evaluation aimed at identifying factors associated with the implementation of the VESPEERA programme. METHODS: This was a qualitative study using semi-structured interviews in a purposeful sample of health workers in hospitals and general practices in the VESPEERA programme. Qualitative framework analysis using the Consolidated Framework for Implementation Research was performed and revealed the topic of previous and new routines to be protruding. Inductive content analysis was used for in-depth examination of stages in the process of staying in a previous or falling into a new routines. RESULTS: Thirty-six interviews were conducted with 17 participants from general practices and 19 participants from hospitals. The interviewees were in different stages of the implementation process at the time of the interviews. Four stages were identified: Stage 1,'Previous routine and tension for change', describes the situation in which VESPEERA was to be implemented and the factors leading to the decision to participate. In stage 2,'Adoption of the VESPEERA programme', factors that influenced whether individuals decided to employ the innovation are relevant. Stage 3 comprises 'Determinants for falling into and staying in the new VESPEERA-routine' relates to actual implementation and finally, in stage 4, the participants reflect on the success of the implementation. CONCLUSIONS: The individuals and organisations participating in the VESPEERA programme were in different stages of a process from the previous to the new routine, which were characterised by different determinants of implementation. In all stages, organisational factors were main determinants of implementation, but different factors emerged in different implementation stages. A low distinction between decision-making power and executive, as well as available resources, were beneficial for the implementation of the innovation. TRIAL REGISTRATION: DRKS00015183 on DRKS / Universal Trial Number (UTN): U1111-1218-0992.

Building resilience in German primary care practices: a qualitative study.

BACKGROUND: In recent years, healthcare has faced many different crises around the world such as HIV-, Ebola- or H1N1-outbrakes, opioid addiction, natural disasters and terrorism attacks). In particular, the current pandemic of Covid-19 has challenged the resilience of health systems. In many healthcare systems, primary care practices play a crucial role in the management of crises as they are often the first point of contact and main health care provider for patients. Therefore, this study explored which situations are perceived as crises by primary care practice teams and potential strategies for crisis management. METHODS: A qualitative observational study was conducted. Data were collected in interviews and focus groups with experts from primary care practices and stakeholders focusing on primary care practices in Germany such as physicians, medical assistants, practice managers, quality managers, hygiene managers and institutions on health system level (politics, research and health insurance). All interviews and focus groups were audio-recorded and transcribed verbatim. A qualitative content analysis was performed using a rapid qualitative analysis approach first, followed by a thematic analysis. RESULTS: Two focus groups and 26 interviews including 40 participating experts were conducted. Many different situations were perceived as crises, varying from issues in the practice organization to problems on health system level and international disasters. Distinct aspects associated with the perception of a crisis situation by interviewees were the presence of emotional reactions, a need for organizational changes and a lack of necessary resources. A broad spectrum of possible strategies was discussed that could help to cope with or even prevent the emergence of an actual crisis. In particular, strengthening communication within practice teams and resilience among employees was perceived to be fundamental for improving responses to crises or preventing them. CONCLUSIONS: The study provides perspectives of primary health care workers on crises in health, that could inform health policy regarding prevention and management of future crises in primary care facilities.

Effects and Processes of an mHealth Intervention for the Management of Chronic Diseases: Prospective Observational Study.

BACKGROUND: Mobile health (mHealth) interventions for self-management are a promising way to meet the needs of patients with chronic diseases in primary care practices. Therefore, an mHealth intervention, TelePraCMan, was developed and evaluated for patients with type 2 diabetes mellitus, chronic obstructive pulmonary disease, high blood pressure, or heart failure in a German primary care setting. TelePraCMan entails a symptom diary, an appointment manager, a manager to document goals, and a warning system. The app should foster the self-management of participating patients. OBJECTIVE: We aimed to examine the effects of TelePraCMan on patient activation and quality of life and explored the underlying contextual factors, impacts, and degree of implementation. METHODS: In a prospective observational study design, we collected data by using interviews and written questionnaires from participating patients (intervention and control groups) and primary care workers (physicians and practice assistants). The primary outcomes of interest were patient-reported quality of life (12-Item Short Form Survey) and patient activation (patient activation measure). The quantitative analysis focused on differences between patients in the intervention and control groups, as well as before (T0) and after (T1) the intervention. Interviews were analyzed by using qualitative content analysis via MAXQDA (VERBI GmbH). RESULTS: At baseline, 25 patients and 24 primary care workers completed the questionnaire, and 18 patients and 21 primary care workers completed the follow-up survey. The patients were predominantly male and, on average, aged 64 (SD 11) years (T0). The primary care workers were mostly female (62%) and, on average, aged 47 (SD 10) years (T0). No differences were observed in the outcomes before and after the intervention or between the intervention and control groups. In the additional interviews, 4 patients and 11 primary care workers were included. The interviewees perceived that the intervention was useful for some patients. However, contextual factors and problems with implementation activities negatively affected the use of the app with patients. The main reasons for the low participation were the COVID-19 pandemic and the target group, which seemed to have less interest in mHealth; the interviewees attributed this to the older age of patients. However, the respondents felt that the app would be better accepted in 5 or 10 years. CONCLUSIONS: Although the TelePraCMan app was rated as very good and important by the participants, few patients used it. The digital intervention was hardly implemented and had limited impact in the current setting of German primary care. TRIAL REGISTRATION: German Clinical Trials Register DRKS00017320; https://tinyurl.com/4uwrzu85.

Risk Factors for Prolonged Mechanical Ventilation and Weaning Failure: A Systematic Review.

INTRODUCTION: Prolonged mechanical ventilation (PMV) and weaning failure are factors associated with prolonged hospital length of stay and increased morbidity and mortality. In addition to the burden these places on patients and their families, it also imposes high costs on the public health system. The aim of this systematic review was to identify risk factors for PMV and weaning failure. METHODS: The study was conducted according to PRISMA guidelines. After a comprehensive search of the COCHRANE Library, CINHAL, Web of Science, MEDLINE, and the LILACS Database a PubMed request was made on June 8, 2020. Studies that examined risk factors for PMV, defined as mechanical ventilation ≥96 h, weaning failure, and prolonged weaning in German and English were considered eligible; reviews, meta-analyses, and studies in very specific patient populations whose results are not necessarily applicable to the majority of ICU patients as well as pediatric studies were excluded from the analysis. This systematic review was registered in the PROSPERO register under the number CRD42021271038. RESULTS: Of 532 articles identified, 23 studies with a total of 23,418 patients met the inclusion criteria. Fourteen studies investigated risk factors of PMV including prolonged weaning, 9 studies analyzed risk factors of weaning failure. The concrete definitions of these outcomes varied considerably between studies. For PMV, a variety of risk factors were identified, including comorbidities, site of intubation, various laboratory or blood gas parameters, ventilator settings, functional parameters, and critical care scoring systems. The risk of weaning failure was mainly related to age, previous home mechanical ventilation (HMV), cause of ventilation, and preexisting underlying diseases. Elevated PaCO2 values during spontaneous breathing trials were indicative of prolonged weaning and weaning failure. CONCLUSION: A direct comparison of risk factors was not possible because of the heterogeneity of the studies. The large number of different definitions and relevant parameters reflects the heterogeneity of patients undergoing PMV and those discharged to HMV after unsuccessful weaning. Multidimensional scores are more likely to reflect the full spectrum of patients ventilated in different ICUs than single risk factors.

[An exploratory cross-sectional study on technical affinity and smartphone use among practice staff and patients: development of an app for multimorbid patients in general practice]. / Eine explorative Querschnittsstudie zur Technikaffinität und Smartphone-Nutzung von Praxispersonal und PatientInnen ­ Entwicklung einer App für multimorbide PatientInnen in der allgemeinmedizinischen Versorgung.

INTRODUCTION: Due to individual care needs, the provision of care to patients with two or more chronic diseases (multimorbidity) is described as complex. In addition, the number of chronically ill people is increasing, due in part to demographic changes which pose a challenge, especially for outpatient primary care. In order to fulfil patients' needs and to promote self-management as a central care element of chronically ill patients, the use of eHealth applications increases. TelePraCMan will be developed as one of these applications and includes a symptom-based electronic diary, which will be implemented in the established German disease management programme 'PraCMan'. This study is conducted as a part of the TelePraCMan project and aims to detect the needs of potential end users (physicians, medical assistants, patients). METHODS: In the TelePraCMan development phase, an explorative cross-sectional study was conducted with potential end users of the TelePraCMan app (patients, physicians and medical assistants). For this purpose, a written survey was conducted in Baden-Wurttemberg between April 2019 and March 2020. The survey covered smartphone usage behaviour, technology affinity using the standardised questionnaire TA-EG, support network for technical questions and sociodemographic data. RESULTS: A total of n=202 patients (n=98), physicians (n=58) and medical assistants (n=43) participated in the survey. Concerning smartphone use, 78.2 % of the participants stated that the function used most frequently was writing short messages. Health apps were the least used function (9.6 %). Furthermore, patients (12.6 %) use health apps more often than medical assistants (10.3%) and doctors (4.4 %). Participants aged 50 and younger were found to have a higher affinity for technology (mean=3.20, SD=0.51) than participants over 50 years of age (mean=2.98, SD=0.67). Older, multimorbid respondents had a particularly low affinity for technology (mean=2.52, SD=0.69). 10.9 % of the over-fifties and 12.5 % of the multimorbid persons felt able to fix any technical problems on their own without help. Multimorbid participants over the age of 50 were observed to prefer personal support over internet-based support. DISCUSSION: On average, multimorbid respondents in the age group over 50 have a lower affinity for technology than respondents aged under 50 without multimorbidity. The most frequent negative attitude towards electronic devices is also found among patients over 50 years of age, who are expected to be the main target group of the TelePraCMan app. These findings can be used to derive requirements for the design and development of functions of the app, as well as accompanying measures, such as intuitive and simple user interface, a telephone hotline to support users, close consultation with users on the planned functions, and more. CONCLUSION: Based on this survey, we were able to determine the needs of the future target group of the TelePraCMan app. This is seen as a starting point for the development of an implementation strategy and the pilot testing of the app in primary care.

The role of personalised professional relations across care sectors in achieving high continuity of care.

BACKGROUND: High continuity of care has a positive impact on health outcomes, but insight into the mechanisms underlying this impact is limited. Information continuity, on which our study focuses, is especially important when relational continuity is not given, which is often the case at hospital admission or hospital discharge. The aim of this study is to provide insight into the information flows between general practices and hospitals in Germany, and to identify factors associated with these flows of information. METHODS: This is a qualitative interview study in a purposeful sample of staff from hospitals and general practices (general practitioners, care assistants in general practice, hospital management, hospital physicians, and nursing staff). Interviews were conducted via telephone or face-to-face using a self-developed semi-structured interview guide. Stepwise systematic content analysis was used to structure collected material into themes and sub-themes that related to the study aim. Data was analysed by two researchers in several cycles, alternating between inductive and deductive approaches. RESULTS: A total of 49 interviews were conducted. Duration of the interviews varies between 21 and 78 min (mean duration 43 min). Across all groups, more than two thirds of participants were female (n = 34, 69%). The analysis highlighted six interdependent main themes regarding factors that affect information flows between hospitals and general practices: organisational, legal, financial, patient factors, individual characteristics, and emotional & social factors. The latter theme emerged as particularly rich and was therefore divided into four subthemes: appreciation and understanding of the respective other, (intrinsic) motivation, socialisation, and relationships. Organised meetings and events were mentioned as strategies to address emotional and social factors. CONCLUSIONS: Digitalisation can facilitate information flows between care providers. However, knowing each other and good personal relations remain important for effective collaboration. Cooperation between all stakeholders is needed to aim to achieve continuity of care. TRIAL REGISTRATION: DRKS00015183 on DRKS/ Universal Trial Number (UTN): U1111-1218-0992. Date of registration 23/08/2018.

A New Method for Structured Integration of User Needs in Two Health Technology Development Projects: Action Sheets.

An early integration of users and stakeholders is needed for a successful innovation process. Nonetheless, the integration of users is often hard to realize - especially when dealing with persons with chronic diseases. In addition, patients or users in general often are not able to formulate the requirements in a technical manner. Therefore, even if user requirements are collected, it is not certain that the developers know or understand 'what is really wanted'. To overcome these 'gaps', we have developed so-called Action Sheets (AS). This article presents the use of AS in two projects: the development of health technologies for people with cancer (INFOPAT) and dementia (QuartrBack). Depending on the project context, group sessions were conducted with different stakeholders to identify the needs of (potential) users. Within the INFOPAT project, ten focus groups were conducted with patients, physicians and other healthcare professionals. In QuartrBack stakeholders like e.g. care professionals, technical assistance organizations and citizens participated in two focus groups and three world cafés. Their requirements were then 'fed' into the technology development by the use of AS. AS appear to be a promising tool to make user needs based on social values more tangible and implementable into technology development processes. In addition, it shows up that four phases seem to be necessary for transferring identified user and stakeholder needs into AS, which can therefore be seen as essential to translate non-technically formulated requirements into technically feasible ones. The case study shows as lessons learned that despite the successful integration of user needs, context-sensitive adjustments are still necessary.

Caregivers' role in using a personal electronic health record: a qualitative study of cancer patients and caregivers in Germany.

BACKGROUND: Particularly in the context of severe diseases like cancer, many patients wish to include caregivers in the planning of treatment and care. Many caregivers like to be involved but feel insufficiently enabled. This study aimed at providing insight into patients' and caregivers' perspectives on caregivers' roles in managing the patient portal of an electronic personal health record (PHR). METHODS: A descriptive qualitative study was conducted comprising two study phases: (1) Usability tests and interviews with patients with cancer and caregivers (2) additional patient interviews after a 3-month-pilot-testing of the PHR. For both study parts, a convenience sample was selected, focusing on current state of health and therapy process and basic willingness to participate and ending up with a mixed sample as well as saturation of data. All interviews were audio-recorded, pseudonymized, transcribed verbatim and qualitatively analyzed. RESULTS: Two main categories emerged from qualitative data: 'Caregivers' role' and 'Graduation of access rights' - consisting of four subcategories each. The interviewed patients (n = 22) and caregivers (n = 9) felt that the involvement of caregivers is central to foster the acceptance of a PHR for cancer patients. However, their role varied from providing technical support to representing patients, e.g. if the patient's state of health made this necessary. Heterogeneous opinions emerged regarding the question whether caregivers should receive full or graduated access on a patient's PHR. CONCLUSIONS: In order to support the patient and to participate in the care process, caregivers need up-to-date information on the patient's health and treatment. Nevertheless, some patients do not want to share all medical data with caregivers, which might strain the patient-caregiver relationship. This needs to be considered in development and implementation of personal health records. Generally, in the debate on patient portals of a personal health record, paying attention to the role of caregivers is essential. By appreciating the important relationship between patients and caregivers right from the beginning, implementation, of a PHR would be enhanced. TRIAL REGISTRATION: ISRCTN85224823 . Date of registration: 23/12/2015 (retrospectively registered).

An Electronic Medication Module to Improve Health Literacy in Patients With Type 2 Diabetes Mellitus: Pilot Randomized Controlled Trial.

BACKGROUND: In primary care, patients play a crucial role in managing care processes and handling drug treatment. A decisive factor for success is their health literacy, and several interventions have been introduced to support patients in fulfilling their responsibility. OBJECTIVE: The aim of this study is to assess the influence of such an intervention (ie, a medication module) within a patient-led electronic health record on patients' health literacy. METHODS: We conducted a randomized controlled study among community-dwelling patients with type 2 diabetes mellitus. Patients were recruited from primary care practices. After randomization, patients either had access to an internet-based medication module allowing them to store their medication information, look up drug information, and print a medication schedule (intervention group), or they received an information brochure on the importance of medication schedules (control group). After 4-8 weeks, all patients were invited to attend a structured medication review (ie, follow-up visit). Data were collected via questionnaires before the start of the intervention and during the follow-up visit. The main outcome measure was the mean difference in health literacy between baseline and follow-up assessments of patients in the control and intervention groups. RESULTS: Of 116 recruited patients, 107 (92.2%) completed the follow-up assessment and were eligible for intention-to-treat analyses. Only 73 patients, of which 29 were in the intervention group, followed the study protocol and were eligible for per-protocol analysis. No differences in overall health literacy were observed in either the intention-to-treat or in the per-protocol cohorts. Reasons for a null effect might be that the cohort was not particularly enriched with participants with low health literacy, thus precluding measurable improvement (ie, ceiling effect). Moreover, the success of implementation was considered poor because both the correct application of the study procedure (ie, randomization according to the protocol and dropout of 29 patients) and the actual interaction with the medication module was modest (ie, dropout of 9 patients). CONCLUSIONS: The conduct of this randomized controlled study was challenging, leaving it open whether inadequate implementation, too short of a duration, or insufficient efficacy of the intervention, as such, contributed to the null effect of this study. This clearly outlines the value of piloting complex interventions and the accompanying process evaluations.