Digital learning about patients: An online survey of German medical students investigating learning strategies for family medical video consultations.

Objective: Training in video consultations is seldom included in the curriculum for future physicians. Exploration of preferred teaching methods and learning objectives in this context among medical students remains limited. This study addresses this research gap by conducting a survey among medical students in Germany to assess their educational requirements concerning video consultations and patient-centred distance learning. Methods: This quantitative study employed an online questionnaire designed for German medical students, following the guidelines of the International Association for Health Professions Education. The study primarily focused on discerning the didactic preferences related to patient-centred digital teaching regarding family medical video consultations. We provided a detailed explanation of a concrete learning concept, a family medical synchronous distance learning seminar. Subsequently, we surveyed students to gauge their needs, expectations, and evaluations of this concept. The collected data were subjected to descriptive analysis. Results: The analysis revealed that students aspire to offer video consulting services to their patients in the future (sample size (n) = 369, median (med) = 68 of 101 Likert scale points, interquartile range (IQR) = 53.75), despite having limited knowledge in this area (n = 353, med = 21, IQR = 33.25). To acquire expertise in telehealth, students favor blended learning models (n = 331, med = 76, IQR = 50). They also recognize the benefits of distance learning, particularly for students with family responsibilities or those who must travel long distances to their learning institutions,. The presented distance seminar concept resonated with them (n = 278, med = 72.5, IQR = 50.5), surpassing five other digital learning models in preference. Furthermore, they expressed a desire for its continued implementation beyond the Coronavirus SARS-CoV-2 pandemic (n = 188, med = 77.5, IQR = 44.75). Conclusions: The deficiency in medical school education regarding video consultations requires attention. This issue could be resolved by integrating one of the five distance learning concepts outlined in this article.

Understanding inherent influencing factors to digital health adoption in general practices through a mixed-methods analysis.

Extensive research has shown the potential value of digital health solutions and highlighted the importance of clinicians' adoption. As general practitioners (GPs) are patients' first point of contact, understanding influencing factors to their digital health adoption is especially important to derive personalized practical recommendations. Using a mixed-methods approach, this study broadly identifies adoption barriers and potential improvement strategies in general practices, including the impact of GPs' inherent characteristics - especially their personality - on digital health adoption. Results of our online survey with 216 GPs reveal moderate overall barriers on a 5-point Likert-type scale, with required workflow adjustments (M = 4.13, SD = 0.93), inadequate reimbursement (M = 4.02, SD = 1.02), and high training effort (M = 3.87, SD = 1.01) as substantial barriers. Improvement strategies are considered important overall, with respondents especially wishing for improved interoperability (M = 4.38, SD = 0.81), continued technical support (M = 4.33, SD = 0.91), and improved usability (M = 4.20, SD = 0.88). In our regression model, practice-related characteristics, the expected future digital health usage, GPs' digital affinity, several personality traits, and digital maturity are significant predictors of the perceived strength of barriers. For the perceived importance of improvement strategies, only demographics and usage-related variables are significant predictors. This study provides strong evidence for the impact of GPs' inherent characteristics on barriers and improvement strategies. Our findings highlight the need for comprehensive approaches integrating personal and emotional elements to make digitization in practices more engaging, tangible, and applicable.

Big 5 Personality Traits and Individual- and Practice-Related Characteristics as Influencing Factors of Digital Maturity in General Practices: Quantitative Web-Based Survey Study.

BACKGROUND: Various studies propose the significance of digital maturity in ensuring effective patient care and enabling improved health outcomes, a successful digital transformation, and optimized service delivery. Although previous research has centered around inpatient health care settings, research on digital maturity in general practices is still in its infancy. OBJECTIVE: As general practitioners (GPs) are the first point of contact for most patients, we aimed to shed light on the pivotal role of GPs' inherent characteristics, especially their personality, in the digital maturity of general practices. METHODS: In the first step, we applied a sequential mixed methods approach involving a literature review and expert interviews with GPs to construct the digital maturity scale used in this study. Next, we designed a web-based survey to assess digital maturity on a 5-point Likert-type scale and analyze the relationship with relevant inherent characteristics using ANOVAs and regression analysis. RESULTS: Our web-based survey with 219 GPs revealed that digital maturity was overall moderate (mean 3.31, SD 0.64) and substantially associated with several characteristics inherent to the GP. We found differences in overall digital maturity based on GPs' gender, the expected future use of digital health solutions, the perceived digital affinity of medical assistants, GPs' level of digital affinity, and GPs' level of extraversion and neuroticism. In a regression model, a higher expected future use, a higher perceived digital affinity of medical assistants, a higher digital affinity of GPs, and lower neuroticism were substantial predictors of overall digital maturity. CONCLUSIONS: Our study highlights the impact of GPs' inherent characteristics, especially their personality, on the digital maturity of general practices. By identifying these inherent influencing factors, our findings support targeted approaches to drive digital maturity in general practice settings.

[Interface Communication and Information Transfer in Medical Care for People with Intellectual Disabilities: Qualitative Expert Interviews]. / Schnittstellenkommunikation und Informationstransfer in der medizinischen Versorgung von Menschen mit intellektueller Entwicklungsstörung: Qualitative Expert*innen-Interviews.

BACKGROUND: The aim of this study was to investigate the experiences, barriers, and solutions in communication during the provision of care for people with intellectual developmental disabilities in Germany. As there are approximately 350,000 people living with intellectual or developmental disabilities in Germany, who rely on assistance when communicating with healthcare providers, this study was conducted to examine the communication challenges and potential solutions in this population. The analysis especially focused on the potentials of digital applications facilitating information transfer. METHODS: Thirteen expert interviews were conducted using a structured interview guide with caregivers and medical providers to people with intellectual developmental disabilities. The interviews were analyzed using an inductive and deductive content analysis approach, according to Meuser and Nagel. RESULTS: The results revealed that the provision of care for people with intellectual developmental disabilities was characterized by time constraints and uncertainty when caregivers lack experience in caring for this population. Additionally, information transfer increased in complexity due to an overload of individual information provided by caregivers verbally or paper-based as well due to the passive role of patients who were usually not actively involved in the communication process. With regard to the potential for integrating digital applications for information transfer, a controversy between opportunity and risk emerged. CONCLUSION: The findings demonstrate that there is a need to implement training programs for professionals to enable them to offer improved health care for people with intellectual developmental disabilities. It is essential that caregivers are given sufficient time to communicate with patients, and that digital applications are utilized to support information transfer. Moreover, other research shows that digital applications offer new possibilities to communicate with people with intellectual developmental disabilities, such as the use of simplified or pictorial language. By addressing these communication challenges, healthcare professionals may be able to provide more effective and efficient care to this population. However, this requires further research, which addresses the controversial results regarding digital applications outlined in this paper.

[Physician assistants as a future model in primary care: Experiences, needs, potentials and barriers]. / Physician Assistants als Zukunftsmodell in der hausärztlichen Versorgung ­ Erfahrungen, Bedarfe, Potenziale und Hürden.

INTRODUCTION: In the coming decades, demographic change will dramatically increase health care needs, especially for general practitioners (GPs). However, there is a shortage of young primary care physicians, with signs of (impending) underuse already becoming apparent in rural and structurally weak areas. Innovative care concepts are needed to counteract this development and ensure the future of primary care. In addition to medical assistants (MFA), academically trained physician assistants (PAs) could be considered for more demanding delegation tasks and be involved in direct patient care under the responsibility of a physician in the practice team. In England, the Netherlands and the USA, PAs have been a part of the health care systems for many years. RESEARCH QUESTIONS: 1) What are the potentials for delegation/possibilities for PAs working in primary care practices in contrast to medical assistants? 2) What structural requirements are necessary to regularly integrate PAs in primary care practices? METHODS: After preliminary interviews with PA experts and primary care researchers and practitioners (n=29), four expert interviews (n=4) with GPs and PAs were performed in a case analysis in order to elicit experiences with PAs in family practice. Based on this, three focus groups were conducted with GPs and practice staff (n=15) to discuss the extent, the need and the willingness to delegate physician services to PAs, as well as existing barriers. After transcription, analyses were performed using qualitative content analysis according to Mayring. RESULTS: The participants acknowledged the potential to reduce physician workloads and showed a high willingness to delegate tasks. Practical examples suggest that a clearly defined delegation of medical tasks to PAs, e.g. participation in infection consultations, is possible after only a few weeks working in family practices. Thus, the cooperation between GPs, PAs and medical assistants can be successful. Uncertainties exist regarding the legal possibilities and limits of delegation as well as the current and future financial reimbursement of PAs. DISCUSSION: The legal and financial framework for the utilization of PAs in ambulatory care should be reliably clarified as well as transparently communicated so that the considerable potentials of delegating tasks to academically trained staff, e.g. PAs, especially in the GP sector, can be exploited in the future. CONCLUSION: Participation of PAs in the GP team could be key to overcoming the often threatening or already existing under-provision of medical care in structurally weak regions.

Family Conferences to Facilitate Deprescribing in Older Outpatients With Frailty and With Polypharmacy: The COFRAIL Cluster Randomized Trial.

Importance: For older adults with frailty syndrome, reducing polypharmacy may have utility as a safety-promoting treatment option. Objective: To investigate the effects of family conferences on medication and clinical outcomes in community-dwelling older adults with frailty receiving polypharmacy. Design, Setting, and Participants: This cluster randomized clinical trial was conducted from April 30, 2019, to June 30, 221, at 110 primary care practices in Germany. The study included community-dwelling adults aged 70 years or older with frailty syndrome, daily use of at least 5 different medications, a life expectancy of at least 6 months, and no moderate or severe dementia. Interventions: General practitioners (GPs) in the intervention group received 3 training sessions on family conferences, a deprescribing guideline, and a toolkit with relevant nonpharmacologic interventions. Three GP-led family conferences for shared decision-making involving the participants and family caregivers and/or nursing services were subsequently held per patient at home over a period of 9 months. Patients in the control group received care as usual. Main Outcomes and Measures: The primary outcome was the number of hospitalizations within 12 months, as assessed by nurses during home visits or telephone interviews. Secondary outcomes included the number of medications, the number of European Union list of the number of potentially inappropriate medication (EU[7]-PIM) for older people, and geriatric assessment parameters. Both per-protocol and intention-to-treat analyses were conducted. Results: The baseline assessment included 521 individuals (356 women [68.3%]; mean [SD] age, 83.5 [6.17] years). The intention-to-treat analysis with 510 patients showed no significant difference in the adjusted mean (SD) number of hospitalizations between the intervention group (0.98 [1.72]) and the control group (0.99 [1.53]). In the per-protocol analysis including 385 individuals, the mean (SD) number of medications decreased from 8.98 (3.56) to 8.11 (3.21) at 6 months and to 8.49 (3.63) at 12 months in the intervention group and from 9.24 (3.44) to 9.32 (3.59) at 6 months and to 9.16 (3.42) at 12 months in the control group, with a statistically significant difference at 6 months in the mixed-effect Poisson regression model (P = .001). After 6 months, the mean (SD) number of EU(7)-PIMs was significantly lower in the intervention group (1.30 [1.05]) than in the control group (1.71 [1.25]; P = .04). There was no significant difference in the mean number of EU(7)-PIMs after 12 months. Conclusions and Relevance: In this cluster randomized clinical trial with older adults taking 5 or more medications, the intervention consisting of GP-led family conferences did not achieve sustainable effects in reducing the number of hospitalizations or the number of medications and EU(7)-PIMs after 12 months. Trial Registration: German Clinical Trials Register: DRKS00015055.

Development of a deprescribing manual for frail older people for use in the COFRAIL study and in primary care.

Introduction: Many older adults are affected by multimorbidity and subsequent polypharmacy which is associated with adverse outcomes. This is especially relevant for frail older patients. Polypharmacy may be reduced via deprescribing. As part of the complex intervention in the COFRAIL study, we developed a deprescribing manual to be used by general practitioners (GPs) in family conferences, in which GPs, patients and caregivers jointly discuss treatments. Methods: We selected indications with a high prevalence in older adults in primary care (e.g. diabetes mellitus, hypertension) and conducted a literature search to identify deprescribing criteria for these indications. We additionally reviewed clinical practice guidelines. Based on the extracted information, we created a deprescribing manual which was then piloted in an expert workshop and in family conferences with volunteer patients according to the inclusion and exclusion criteria of the study protocol. Results: Initially, 13 indications/topics were selected. The literature search identified deprescribing guides, reviews and clinical trials as well as lists of potentially inappropriate medication and systematic reviews on the risk and benefits of specific drugs and drug classes in older patients. After piloting and revisions, the deprescribing manual now covers 11 indications/topics. In each chapter, patient- and medication-related deprescribing criteria, monitoring and communication strategies, and information about concerns related to the use of specific drugs in older patients are provided. Discussion: We found varying deprescribing strategies in the literature, which we consolidated in our deprescribing manual. Whether this approach leads to successful deprescribing in family conferences is being investigated in the cluster-randomised controlled COFRAIL study. Plain Language Summary: Development of a manual to help doctors to identify which medications can be withdrawn Many older adults suffer from chronic diseases and take multiple medications concurrently. This can lead to side effects and other undesired events. We developed a manual to help doctors identify which medications can be withdrawn, so that they can discuss this with their patients. This manual was used in the COFRAIL study where doctors, patients and caregivers met in family conferences to discuss their preferences and decide together how future treatments should be handled. The manual contains information on common medications, symptoms and diseases in older patients such as diabetes and high blood pressure. Before the manual was used in the study, it was tested by volunteer patients and their doctors and caregivers to make sure that it is user-friendly.

Patient Care via Video Consultations: Piloting and S.W.O.T. Analysis of a Family Medicine Digitally Synchronous Seminar for Medical Students.

BACKGROUND: There is a need to familiarize medical students with the specifics of video consultations. This paper presents the concept and tests of a digitally synchronous distance seminar in which medical students practice video consultations as an aid to a family physician's activity in a patient-oriented manner. The aim of the evaluation was to analyze the strengths, weaknesses, opportunities, and threats (S.W.O.T.) of the teaching concept. METHODS: A total of 12 students carried out video consultations independently and under medical supervision. The seminar included two elements: (A) All students and teachers were video consulted in a family practice; (B) A small group performed a video consultation in a patient´s home environment. The students' evaluation was conducted with two questionnaires (pre/post), which were analyzed with descriptive statistics and qualitative content analysis. The S.W.O.T. analysis was elaborated by the author team based on the results of the questionnaires and the interviews with the teachers. RESULTS: Students learned the limits and possibilities of teleconsultations and deepened their family medical knowledge. Strengths: Among others; increase interest in video consultations, patient contact, focused work. Weaknesses: Among others; technical difficulties and the time it requires. OPPORTUNITIES: Among others; involve students with multiple workloads in patient teaching. RISKS: Among others; no integration into the curriculum yet, few personnel resources. CONCLUSIONS: The learning model familiarizes medical students with competences in family medical patient care using video communication. The results of S.W.O.T. analyses can be weighted differently. Project groups can decide individually if they want to integrate the learning concept into their curriculum and which further improvements are necessary.

HIOPP-6 - a pilot study on the evaluation of an electronic tool to assess and reduce the complexity of drug treatment considering patients' views.

BACKGROUND: A complex drug treatment might pose a barrier to safe and reliable drug administration for patients. Therefore, a novel tool automatically analyzes structured medication data for factors possibly contributing to complexity and subsequently personalizes the results by evaluating the relevance of each identified factor for the patient by means of key questions. Hence, tailor-made optimization measures can be proposed. METHODS: In this controlled, prospective, exploratory trial the tool was evaluated with nine general practitioners (GP) in three study groups: In the two intervention groups the tool was applied in a version with (GI_with) and a version without (GI_without) integrated key questions for the personalization of the analysis, while the control group (GC) did not use any tools (routine care). Four to eight weeks after application of the tool, the benefits of the optimization measures to reduce or mitigate complexity of drug treatment were evaluated from the patient perspective. RESULTS: A total of 126 patients regularly using more than five drugs could be included for analysis. GP suggested 117 optimization measures in GI_with, 83 in GI_without, and 2 in GC. Patients in GI_with were more likely to rate an optimization measure as helpful than patients in GI_without (IRR: 3.5; 95% CI: 1.2-10.3). Thereby, the number of optimization measures recommended by the GP had no significant influence (P = 0.167). CONCLUSIONS: The study suggests that an automated analysis considering patient perspectives results in more helpful optimization measures than an automated analysis alone - a result which should be further assessed in confirmatory studies. TRIAL REGISTRATION: The trial was registered retrospectively at the German Clinical Trials register under DRKS-ID DRKS00025257 (17/05/2021).

Prevalence and patient-rated relevance of complexity factors in medication regimens of community-dwelling patients with polypharmacy.

PURPOSE: To describe the prevalence of complexity factors in the medication regimens of community-dwelling patients with more than five drugs and to evaluate the relevance of these factors for individual patients. METHODS: Data were derived from the HIOPP-6 trial, a controlled study conducted in 9 general practices which evaluated an electronic tool to detect and reduce complexity of drug treatment. The prevalence of complexity factors was based on the results of the automated analysis of 139 patients' medication data. The relevance assessment was based on the patients' rating of each factor in an interview (48 patients included for analysis). RESULTS: A median of 5 (range 0-21) complexity factors per medication regimen were detected and at least one factor was observed in 131 of 139 patients. Almost half of these patients found no complexity factor in their medication regimen relevant. CONCLUSION: In most medication regimens, complexity factors could be identified automatically, yet less than 15% of factors were indeed relevant for patients as judged by themselves. When assessing complexity of medication regimens, one should especially consider factors that are both particularly frequent and often challenging for patients, such as use of inhalers or tablet splitting. TRIAL REGISTRATION: The HIOPP-6 trial was registered retrospectively on May 17, 2021, in the German Clinical Trials register under DRKS-ID DRKS00025257.

General practitioners treating their own family members: a cross-sectional survey in Germany.

BACKGROUND: In Germany, there are neither guidelines provided by the medical associations nor a public discussion about general practitioners (GPs) treating their family members. Only few studies on this topic from the primary care setting exist. The aim of this study is to describe GPs' treatment of family members and to generate empirical data on the most common reasons for this. METHODS: In June 2018 we conducted a postal survey among GPs in the North Rhine region of Germany. The questionnaire was developed in a stepwise process including initial expert panels, interviews with GPs, item construction workshops, cognitive pre-tests and pilot testing with 40 questionnaires. The final questionnaire addressed: type and frequency of treatment, documentation and place of treatment, engagement as the official GP as well as reasons for and against the treatment. For data evaluation, descriptive and explorative statistical analyses were conducted. RESULTS: Overall, 393 questionnaires were returned (response rate 39.8%). 96.7% of the GPs had treated at least one family member during the last 12 months. Services that were provided frequently (more than three times in the last 12 months) included the prescription or dispensing of medication (partner 45%, children 37%, parents 43%, partner's parents 26%), physical examinations (partner 18%, children 24%, parents 25%, partner's parents 15%), and the arrangement or provision of laboratory tests (partner 14%, children 7%, parents 16%, partner's parents 9%). Less than one third of the study participants always treated their relatives in their office. Male GPs more often provided care to family members (except children) registered in their practice. Senior male GPs treated their relatives more often than junior female GPs. Family members were most commonly treated for practical reasons. CONCLUSION: The subject of GPs treating their relatives is of high everyday relevance, since nearly all GPs are involved in the treatment of their family members. Frequent at-home treatments and low documentation rates may indicate risks due to deviating from the professional routine.

Patients' perspective on supposedly patient-relevant process and outcome parameters: a cross-sectional survey within the 'PRO patients study'.

BACKGROUND: To be able to make informed choices based on their individual preferences, patients need to be adequately informed about treatment options and their potential outcomes. This implies that studies measure the effects of care based on parameters that are relevant to patients. In a previous scoping review, we found a wide variety of supposedly patient-relevant parameters that equally addressed processes and outcomes of care. We were unable to identify a consistent understanding of patient relevance and therefore aimed to develop an empirically based concept including a generic set of patient-relevant parameters. As a first step we evaluated the process and outcome parameters identified in the scoping review from the patients' perspective. METHODS: We conducted a cross-sectional survey among German general practice patients. Ten research practices of Witten/Herdecke University supported the study. During a two-week period in the fall of 2020, patients willing to participate self-administered a short questionnaire. It evaluated the relevance of the 32 parameters identified in the scoping review on a 5-point Likert scale and offered a free-text field for additional parameters. These free-text answers were inductively categorized by two researchers. Quantitative data were analyzed using descriptive statistics. Bivariate analyses were performed to determine whether there are any correlations between rating a parameter as highly relevant and patients' characteristics. RESULTS: Data from 299 patients were eligible for analysis. All outcomes except 'sexuality' and 'frequency of healthcare service utilization' were rated important. 'Confidence in therapy' was rated most important, followed by 'prevention of comorbidity' and 'mobility'. Relevance ratings of five parameters were associated with patients' age and gender, but not with their chronic status. The free-text analysis revealed 15 additional parameters, 12 of which addressed processes of care, i.e., 'enough time in physician consultation'. CONCLUSION: Patients attach great value to parameters addressing processes of care. It appears as though the way in which patients experience the care process is not less relevant than what comes of it. Relevance ratings were not associated with chronic status, but few parameters were gender- and age-related. TRIAL REGISTRATION: Core Outcome Measures in Effectiveness Trials Initiative, registration number: 1685.

[Recommendations for the Use of Family Conferences in Family Medicine - a Scoping Review]. / Handlungsempfehlungen für den Einsatz von Familienkonferenzen im hausärztlichen Bereich - ein Scoping Review.

Background: Family conferences are pre-planned meetings between the treatment team, patient, family members and representatives of other involved disciplines on an agreed topic. There is no review of family conferences in family medicine. The aim of the scoping review is to compile the available recommendations on the use, implementation and documentation of family conferences in family medicine and other medical fields that can be transferred to the family practice setting. Methods: Systematic literature search in the databases PubMed, Scopus, Google Scholar and Cochrane Library. Articles published in German or English up to 31.12.2021 were included. The fields of family therapy, paediatrics and neonatology were excluded. Results: The search yielded 1,557 hits; after deducting duplicates and reviewing the abstracts, 108 hits were used for the full-text review. Of these, 53 hits were included in the review. Many recommendations on the use, preparation and implementation of family conferences can be transferred to the FM setting. For successful family conferences, a structured procedure is recommended, which includes good preparation of all participants, a multi-stage procedure during the family conference itself, as well as good documentation and follow-up of the agreements. The use of proven patient-centred communication models is recommended. Conclusions: Although there are no validated concepts for the procedure of family conferences in the FM setting, practice recommendations can be derived that should be empirically tested in practice and in studies.

Burden Associated with Telephone Calls on COVID-19: Results of a Flash Mob Study in Family Practices.

Background: Family practices are the primary contact for inquiries relating to COVID-19. This study reveals the reasons why German family practices are called during the pandemic and which burden is associated with patients' inquiries related to COVID-19 among practice assistants (PAs). Methods: On April 28, 2021 a cross-sectional flash mob study was conducted in family practices across Germany. The study material and invitation were disseminated via social media and postal or electronic mails. During half a day, participating practices counted every incoming call. For calls addressing COVID-19, the reason, duration, and perceived stress level were documented. Descriptive statistics and regression analyses were performed using SPSS. Results: 5,646 calls, 1,826 of which were related to COVID-19 (32.3%), were documented by 73 practices (practice average: 25.0 ± 17.7) within a single Wednesday morning. Most calls addressed vaccination (n = 1,050, 59.0%). During 22.0% (n = 388) of COVID-19-related calls, PAs felt stressed, which was mainly influenced by the call duration (calls of 5 minutes and longer were perceived significantly more stressful [OR 8.94, 95% CI 6.47-12.37]). Feeling well-prepared to meet patients' inquiries relating to COVID-19 was a protective factor for the average stress perceived per PA. Overall, less than 10% of calls on COVID-19 were transferred to a physician. Conclusions: Family practice teams experience a high volume of partly stressful phone calls about COVID-19 but are often able to handle the pandemic challenges. PAs play a central role in advising the practice population on issues related to COVID-19. This deserves greater recognition.

Mixed-methods approach to develop an agreed concept on patient relevance: study protocol for the 'PRO patients study'.

INTRODUCTION: With respect to patient-centred care and shared decision-making, measuring care effects based on outcomes relevant to patients is becoming increasingly important. Recently, a scoping review of the international literature revealed a wide range of supposedly patient-relevant outcomes and found that there is neither a sound definition of patient relevance nor a consistent set of outcomes relevant to patients. To close this gap, this study aims to develop an agreed concept on patient relevance including a set of outcomes relevant to patients irrespective of diseases, which grades outcomes according to their importance. METHODS AND ANALYSIS: This prospective mixed-methods study will integrate the perspectives of patients across diseases, healthcare professionals and researchers. The consensus process will consist of four phases. Based on the results of the recent scoping review, a patient survey will be conducted first, followed by a multiprofessional group discussion. Finally, a two-round online Delphi approach based on data from the previous phases will be applied to agree on a concept. ETHICS AND DISSEMINATION: Ethics approval for the study was granted on 26 August 2020 by the Ethics Commission of Witten/Herdecke University (reference number: 156/2020). In the long run, the implementation of an agreed concept on patient relevance will help improve the comparability of study results regarding the patient benefit and thereby strengthen the role of patients in the decision-making process. Also, the experiences regarding grading outcomes according to importance will help to develop a method on how to individualise clinical trial outcomes according to each patient's individual specifics and priorities in order to more adequately represent the patient perspective in clinical research. TRIAL REGISTRATION NUMBER: Core Outcome Measures in Effectiveness Trials Initiative (registration number: 1685).

Typology of drug discontinuation trials - Methodological recommendations.

OBJECTIVE: Due to the increasing concerns about polypharmacy, there is a growing need for clinical recommendations for drug discontinuation. This requires studies investigating the process on several levels. This paper addresses the methodological problems of drug discontinuation trials (DDTs). To that end, we offer a new typology of research aims and corresponding methodological recommendations for trials evaluating drug discontinuation. STUDY DESIGN AND SETTING: Multi-stage development process, including literature search and expert panels. RESULTS: Clinical trials are only required in cases of scientific uncertainty. We identified three situations of uncertainty associated with drug discontinuation from which we derived three study types: 1) Uncertainty regarding the effectiveness and/or safety of a drug; 2) Uncertainty regarding the procedure of discontinuing a previously taken drug; 3) Uncertainty regarding the effectiveness of complex strategies used to discontinue one or more drugs. We developed specific methodological recommendations for each study type. CONCLUSION: We offer a comprehensive definition of research aims, study designs, and methodological recommendations regarding DDTs. The typology we propose can help investigators clarify their research aims and study design. The type-specific methodological recommendation should improve the quality of future drug discontinuation trials.

Development of an algorithm to detect and reduce complexity of drug treatment and its technical realisation.

BACKGROUND: The increasing complexity of current drug therapies jeopardizes patient adherence. While individual needs to simplify a medication regimen vary from patient to patient, a straightforward approach to integrate the patients' perspective into decision making for complexity reduction is still lacking. We therefore aimed to develop an electronic, algorithm-based tool that analyses complexity of drug treatment and supports the assessment and consideration of patient preferences and needs regarding the reduction of complexity of drug treatment. METHODS: Complexity factors were selected based on literature and expert rating and specified for integration in the automated assessment. Subsequently, distinct key questions were phrased and allocated to each complexity factor to guide conversation with the patient and personalize the results of the automated assessment. Furthermore, each complexity factor was complemented with a potential optimisation measure to facilitate drug treatment (e.g. a patient leaflet). Complexity factors, key questions, and optimisation strategies were technically realized as tablet computer-based application, tested, and adapted iteratively until no further technical or content-related errors occurred. RESULTS: In total, 61 complexity factors referring to the dosage form, the dosage scheme, additional instructions, the patient, the product, and the process were considered relevant for inclusion in the tool; 38 of them allowed for automated detection. In total, 52 complexity factors were complemented with at least one key question for preference assessment and at least one optimisation measure. These measures included 29 recommendations for action for the health care provider (e.g. to suggest a dosage aid), 27 training videos, 44 patient leaflets, and 5 algorithms to select and suggest alternative drugs. CONCLUSIONS: Both the set-up of an algorithm and its technical realisation as computer-based app was successful. The electronic tool covers a wide range of different factors that potentially increase the complexity of drug treatment. For the majority of factors, simple key questions could be phrased to include the patients' perspective, and, even more important, for each complexity factor, specific measures to mitigate or reduce complexity could be defined.

Family conferences and shared prioritisation to improve patient safety in the frail elderly (COFRAIL): study protocol of a cluster randomised intervention trial in primary care.

BACKGROUND: Frailty in elderly patients is associated with an increased risk of poor health outcomes, including falls, delirium, malnutrition, hospitalisation, and mortality. Because polypharmacy is recognised as a possible major contributor to the pathogenesis of geriatric frailty, reducing inappropriate medication exposure is supposed to be a promising approach to improve health-related quality of life and prevent adverse outcomes. A major challenge for the process of deprescribing of inappropriate polypharmacy is to improve the communication between general practitioner (GPs), patient and family carer. This study investigates the effects of a complex intervention in frail elderly patients with polypharmacy living at home. METHODS: This is a cluster randomised controlled trial including 136 GPs and 676 patients. Patients with a positive clinical screening for frailty are eligible if they are aged 70 years or older, receiving family or professional nursing care at home, and taking in five or more drugs per day. Exclusion criteria are higher grade of dementia and life expectancy of 6 months or less. The GPs of the intervention group receive an educational training promoting a deprescribing guideline and providing information on how to conduct a family conference focussing on prioritisation of treatment goals concerning drug therapy. During the 1-year intervention, GPs are expected to perform a total of three family conferences, each including a structured medication review with patients and their family carers. GPs of the control group will receive no training and will deliver care as usual. Geriatric assessment of all patients will be performed by study nurses during home visits at baseline and after 6 and 12 months. The primary outcome is the hospitalisation rate during the observation period of 12 months. Secondary outcomes are number and appropriateness of medications, mobility, weakness, cognition, depressive disorder, health-related quality of life, activities of daily living, weight, and costs of health care use. DISCUSSION: This study will provide evidence for a pragmatic co-operative and patient-centred educational intervention using family conferences to improve patient safety in frail elderly patients with polypharmacy. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00015055 (WHO International Clinical Trials Registry Platform [ICTRP]). Registered on 6 February 2019.

Narrative medicine-based intervention in primary care to reduce polypharmacy: results from the cluster-randomised controlled trial MultiCare AGENDA.

OBJECTIVES: To determine if patient-centred communication leads to a reduction of the number of medications taken without reducing health-related quality of life. DESIGN: Two-arm cluster-randomised controlled trial. SETTING: 55 primary care practices in Hamburg, Düsseldorf and Rostock, Germany. PARTICIPANTS: 604 patients 65 to 84 years of age with at least three chronic conditions. INTERVENTIONS: Within the 12-month intervention, general practitioners (GPs) had three 30 min talks with each of their patients in addition to routine consultations. The first talk aimed at identifying treatment targets and priorities of the patient. During the second talk, the medication taken by the patient was discussed based on a 'brown bag' review of all the medications the patient had at home. The third talk served to discuss goal attainment and future treatment targets. GPs in the control group performed care as usual. PRIMARY OUTCOME MEASURES: We assumed that the number of medications taken by the patient would be reduced by 1.5 substances in the intervention group and that the change in the intervention group's health-related quality of life would not be statistically significantly inferior to the control group. RESULTS: The patients took a mean of 7.0±3.5 medications at baseline and 6.8±3.5 medications at follow-up. There was no difference between treatment and control group in the change of the number of medications taken (0.43; 95% CI -0.07 to 0.93; P=0.094) and no difference in health-related quality of life (0.03; -0.02 to 0.08; P=0.207). The likelihood of receiving a new prescription for analgesics was twice as high in the intervention group compared with the control group (risk ratio, 2.043; P=0.019), but the days spent in hospital were reduced by the intervention (-3.07; -5.25 to -0.89; P=0.006). CONCLUSIONS: Intensifying the doctor-patient dialogue and discussing the patient's agenda and personal needs did not lead to a reduction of medication intake and did not alter health-related quality of life. TRIAL REGISTRATION NUMBER: ISRCTN46272088; Pre-results.