Measuring patients' medical treatment preferences in advance care planning: development and validation of the Treat-Me-ACP instrument - a secondary analysis of a cluster-randomized controlled trial.

BACKGROUND: Advance Care Planning interventions should be evaluated as broadly as possible to gain a holistic understanding of the Advance Care Planning process. However, validated early stage outcome instruments are lacking. Therefore, the Treatment-Preference-Measure-Advance Care Planning (Treat-Me-ACP) instrument was developed and validated as part of the cluster-randomized controlled trial STADPLAN (Study on Advance Care Planning in care-dependent community-dwelling older persons) to assess the effects of Advance Care Planning interventions on patients' medical treatment preferences. METHODS: The design of Treat-Me-ACP is based on the Emanuel Medical Directive and the Life Support Preferences Questionnaires. Using a multi-stage team approach a preliminary version of the Treat-Me-ACP was developed and pre-tested. The pre-tested instrument consists of one global medical care goal-item, five hypothetical scenarios with five hypothetical treatments, and one how would you feel-item within each scenario. A total of five scenario preference scores and five treatment preference scores can be formed. This version was subsequently applied to a subsample of the STADPLAN project (n = 80) to assess patient's preferences at baseline (T0) and at 12-month follow-up (T2). The further validation steps were based on this subsample and included: (1) acceptance by using completion rate and frequencies of missing data, (2) internal consistency by using Cronbach's α to test whether it was possible to create preference scores by scenario and treatment, (3) concurrent validation examining the association between the global medical care goal-item and the preference scores and the association between the how would you feel-items and the scenario preference scores, and (4) responsiveness of the instrument to changes in preferences for life-sustaining treatments by comparing preference scores from T0 to T2 between study groups. RESULTS: Acceptance of the instrument was high. Results of concurrent validation indicate that the five scenarios represent the global medical care goal well. The preference scores showed an average tendency for decreasing preferences for life-sustaining treatments across all scales for the intervention group during study follow-up. CONCLUSIONS: The Treat-Me-ACP can be used to evaluate the dynamics of patients' medical treatment preferences in Advance Care Planning. It has been validated for care-dependent community-dwelling older persons and can be used as an additional outcome measure in evaluating the effectiveness of ACP interventions. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00016886 on 04/06/2019.

Effects of advance care planning in care dependent community-dwelling older persons (STADPLAN): A cluster-randomised controlled trial.

BACKGROUND: Most randomised controlled trials on advance care planning were conducted in people with advanced, life-limiting illnesses or in institutional settings. There are few studies on its effect in older people living in the community. AIM: To determine the effects of advance care planning in older community dwelling people. DESIGN: The STADPLAN study was a cluster-randomised trial with 12 months follow-up. The complex intervention comprised a 2-days training for nurse facilitators that delivered a formal advance care planning counselling and a written information brochure. Patients in the control group received optimised usual care, that is, provision of a short information brochure. SETTING/PARTICIPANTS: Home care services in three regions of Germany were randomised using concealed allocation. Care dependent clients of participating home care services, aged 60 years or older, and rated to have a life-expectancy of at least 4 weeks were included. Primary outcome was active participation in care at 12 months, assessed by blinded investigators using the Patient Activation Measure (PAM-13). RESULTS: Twenty-seven home care services and 380 patients took part. Three hundred seventy-three patients were included in the primary analysis (n = 206 in the intervention and n = 167 in the control group). There was no statistically significant difference between the intervention and control group with regard to the PAM-13 after 12 months (75.7 vs 78.4; p = 0.13). No differences in quality of life, anxiety and depression, advance care planning engagement, and in proportion of participants with advance directives were found between groups. CONCLUSIONS: The intervention showed no relevant effects on patient activation or quality of life in community dwelling older persons, possibly indicating the need for more tailored interventions. However, results are limited by a lack of statistical power. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00016886.

Factors facilitating the implementation of a clinical decision support system in primary care practices: a fuzzy set qualitative comparative analysis.

BACKGROUND: Understanding how to implement innovations in primary care practices is key to improve primary health care. Aiming to contribute to this understanding, we investigate the implementation of a clinical decision support system (CDSS) as part of the innovation fund project AdAM (01NVF16006). Originating from complexity theory, the practice change and development model (PCD) proposes several interdependent factors that enable organizational-level change and thus accounts for the complex settings of primary care practices. Leveraging the PCD, we seek to answer the following research questions: Which combinations of internal and external factors based on the PCD contribute to successful implementation in primary care practices? Given these results, how can implementation in the primary care setting be improved? METHODS: We analyzed the joint contributions of internal and external factors on implementation success using qualitative comparative analysis (QCA). QCA is a set-theoretic approach that allows to identify configurations of multiple factors that lead to one outcome (here: successful implementation of a CDSS in primary care practices). Using survey data, we conducted our analysis based on a sample of 224 primary care practices. RESULTS: We identified two configurations of internal and external factors that likewise enable successful implementation. The first configuration enables implementation based on a combination of Strong Inside Motivation, High Capability for Development, and Strong Outside Motivation; the second configuration based on a combination of Strong Inside Motivators, Many Options for Development and the absence of High Capability for Development. CONCLUSION: In line with the PCD, our results demonstrate the importance of the combination of internal and external factors for implementation outcomes. Moreover, the two identified configurations show that different ways exist to achieve successful implementation in primary care practices. TRIAL REGISTRATION: AdAM was registered on ClinicalTrials.gov ( NCT03430336 ) on February 6, 2018.

Factors Influencing the Acceptability, Acceptance, and Adoption of Conversational Agents in Health Care: Integrative Review.

BACKGROUND: Conversational agents (CAs), also known as chatbots, are digital dialog systems that enable people to have a text-based, speech-based, or nonverbal conversation with a computer or another machine based on natural language via an interface. The use of CAs offers new opportunities and various benefits for health care. However, they are not yet ubiquitous in daily practice. Nevertheless, research regarding the implementation of CAs in health care has grown tremendously in recent years. OBJECTIVE: This review aims to present a synthesis of the factors that facilitate or hinder the implementation of CAs from the perspectives of patients and health care professionals. Specifically, it focuses on the early implementation outcomes of acceptability, acceptance, and adoption as cornerstones of later implementation success. METHODS: We performed an integrative review. To identify relevant literature, a broad literature search was conducted in June 2021 with no date limits and using all fields in PubMed, Cochrane Library, Web of Science, LIVIVO, and PsycINFO. To keep the review current, another search was conducted in March 2022. To identify as many eligible primary sources as possible, we used a snowballing approach by searching reference lists and conducted a hand search. Factors influencing the acceptability, acceptance, and adoption of CAs in health care were coded through parallel deductive and inductive approaches, which were informed by current technology acceptance and adoption models. Finally, the factors were synthesized in a thematic map. RESULTS: Overall, 76 studies were included in this review. We identified influencing factors related to 4 core Unified Theory of Acceptance and Use of Technology (UTAUT) and Unified Theory of Acceptance and Use of Technology 2 (UTAUT2) factors (performance expectancy, effort expectancy, facilitating conditions, and hedonic motivation), with most studies underlining the relevance of performance and effort expectancy. To meet the particularities of the health care context, we redefined the UTAUT2 factors social influence, habit, and price value. We identified 6 other influencing factors: perceived risk, trust, anthropomorphism, health issue, working alliance, and user characteristics. Overall, we identified 10 factors influencing acceptability, acceptance, and adoption among health care professionals (performance expectancy, effort expectancy, facilitating conditions, social influence, price value, perceived risk, trust, anthropomorphism, working alliance, and user characteristics) and 13 factors influencing acceptability, acceptance, and adoption among patients (additionally hedonic motivation, habit, and health issue). CONCLUSIONS: This review shows manifold factors influencing the acceptability, acceptance, and adoption of CAs in health care. Knowledge of these factors is fundamental for implementation planning. Therefore, the findings of this review can serve as a basis for future studies to develop appropriate implementation strategies. Furthermore, this review provides an empirical test of current technology acceptance and adoption models and identifies areas where additional research is necessary. TRIAL REGISTRATION: PROSPERO CRD42022343690; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=343690.

Contextual factors influencing advance care planning in home care: process evaluation of the cluster-randomised controlled trial STADPLAN.

BACKGROUND: The STADPLAN study is a cluster-randomised controlled trial including 27 home care services in Germany. It assesses the effect of an advance care planning (ACP) intervention delivered by trained nurses to older care-dependent patients. Patients received two ACP conversations and an information brochure. Nurses were educated through a two-day programme and topic guides structuring the conversations. Objectives of the process evaluation were to determine: [1] whether the intervention was implemented as planned, [2] which change mechanisms were observed, [3] whether targeted process outcomes were achieved and [4] in which way contextual factors influenced the implementation process. METHODS: The process evaluation is based on a mixed methods approach following the recommendations of the UK-MRC framework for the development and evaluation of complex interventions. Qualitative and quantitative assessments were developed and analysed guided by a logic model comprising intervention, participants, mechanisms of change and context factors. The results of the main trial will be published elsewhere. RESULTS: Educational programme and topic guides were mostly implemented as planned and resulted in motivation, knowledge, and perceived competencies to facilitate ACP conversations in nurses. Deviances in the performance of ACP conversations indicated patients' varied individual needs, but also obstacles like reluctance of patients and caregivers to participate actively and time constraints of nurse facilitators. Patients and caregivers reported increased awareness of ACP, planning and other activities indicating that targeted process outcomes could be achieved. The relevance of multifaceted contextual factors acting as barriers or facilitators for the engagement in ACP interventions on the individual, organisational and macro level was evident. CONCLUSIONS: The process evaluation elicits obstacles and achievements of the ACP intervention. The logic model organised a plethora of mixed methods data into a holistic picture of multifaceted results. Nurses as ACP facilitators in home care can fulfil a crucial initiating role based on a trusting relationship with their patients. To support older care-dependent people's ACP engagement, access should be simplified. Furthermore, education for nurse facilitators and sufficient resources for service provision are needed. Independent of monetary reimbursement, healthcare providers must respect patients' choice for or against any ACP intervention. ETHICS AND TRIAL REGISTRATION: Approved by the Ethics Committees of Martin Luther University Halle-Wittenberg (Ref.-No. 2019-045), Carl von Ossietzky University Oldenburg (Ref.-No. 2019-024), and University of Lübeck (Ref.-No. 19-080). GERMAN CLINICAL TRIALS REGISTER: DRKS00016886. Registered retrospectively 04/06/2019, first participant included 29/05/2019.

How is leadership behavior associated with organization-related variables? Translation and psychometric evaluation of the implementation leadership scale in German primary healthcare.

BACKGROUND: The Implementation Leadership Scale (ILS) was developed to assess leadership behavior with regard to being proactive, knowledgeable, supportive, or perseverant in implementing evidence-based practices (EBPs). As part of a study on the implementation of a digitally supported polypharmacy management application in primary care, the original ILS was translated and validated for use in the German language. RATIONALE: This study aimed to translate the original ILS into German and evaluate its psychometric properties. METHODS: The validation sample consisted of 198 primary care physicians in a cluster-randomized controlled trial in which the intervention group implemented a digitally supported clinical decision support system for polypharmacy management. The ILS was assessed using a 12-item scale. The study included a process evaluation with two evaluation waves between 2019 and 2021. The ILS was used within this process evaluation study to assess the leadership support with regard to the implementation of the polypharmacy management. The ILS was translated in a multi-step process, including pre-testing of the instrument and triple, back-and-forth translation of the instrument. We tested the reliability (Cronbach's alpha) and validity (construct and criterion-related validity) of the scale. RESULTS: The four-dimensional structure of the instrument was confirmed (comparative fit index = .97; root mean square error of approximation = .06). Convergent validity was demonstrated by correlations with organizational innovation climate, social capital, and workload, which was consistent with the proposed hypothesis. Criterion-related validity of the ILS was demonstrated by predicting the organizational readiness for change scores using structural equation modeling. The reliability of the scale was good (α = .875). CONCLUSION: The German version of the ILS created in this study is a reliable and valid measure. The original four-dimensional structure of the ILS was confirmed in a primary care setting. Further psychometric testing is needed to establish the validity and reliability of the ILS and to transfer it to other health care settings. It is a useful tool for identifying the areas for implementation leadership development. Further research is needed on how, why, and when distinct types of leadership behaviors have different effects on healthcare organizations in implementation processes.

Nurse-led decision coaching by specialized nurses for healthy BRCA1/2 gene mutation carriers - adaptation and pilot testing of a curriculum for nurses: a qualitative study.

BACKGROUND: Women with BRCA1/2 mutations are at high risk to develop breast and ovarian cancer. To support these women to participate in shared decision-making, structured nurse-led decision coaching combined with an evidence-based decision aid may be employed. In preparation of the interprofessional randomized controlled trial to evaluate a decision coaching program to support preventive decisions of healthy female BRCA 1/2 gene mutation carriers (EDCP-BRCA), we adapted and piloted an existing training program for specialized nurses and included elements from an existing physician communication training. METHODS: The training was adapted according to the six-step-approach for medical curriculum development. The educational design is based on experience- and problem-based learning. Subsequently, we conducted a qualitative pilot study. Nurses were recruited from six German centers for familial breast and ovarian cancer. The acceptability and feasibility were assessed by structured class observations, field notes and participants' feedback. Data were analyzed using qualitative content analysis. The training was revised according to the results. Due to the COVID-19 pandemic, the patient intervention was adapted as a virtual coaching and a brief additional training for nurses was added. RESULTS: The training consists of two modules (2 + 1 day) that teach competences in evidence-based medicine and patient information, (risk) communication and decision coaching. One pilot test was conducted with six nurses of which three were specialized and experienced in patient counselling. A final set of eight main categories was derived from the data: framework conditions; interaction; schedule, transparency of goals, content, methods, materials and practical relevance and feasibility. Overall, the training was feasible and comprehensible. Decision coaching materials were awkward to handle and decision coaching role plays were set too short. Therefore, materials will be sent out in advance and the training was extended. CONCLUSIONS: Specialized nurses are rarely available and nurse-led counselling is not routinely implemented in the centers of familial breast and ovarian cancer. However, training of less qualified nurses seems feasible. Decision coaching in a virtual format seems to be a promising approach. Further research is needed to evaluate its feasibility, acceptability and effectiveness. TRIAL REGISTRATION: The main trial is registered under DRKS-ID: DRKS00015527 .

The Analyzation of Change in Documentation due to the Introduction of Electronic Patient Records in Hospitals-A Systematic Review.

The major impact on healthcare through the ongoing digital transformation and new technologies results in opportunities for improving quality of care. Electronic patient records (EPR) are a substantial part in this transformation, even though their influence on documentation remains often unclear. This review aims to answer the question of which effect the introduction of the EPR has on the documentation proper in hospitals. To do this, studies are reviewed that analyze the documentation itself, rather than merely conducting interviews or surveys about it. Several databases were searched in this systematic review (PubMed including PubMed, PubMed Central and Medline; PDQ Evidence; Web of Science Core Collection; CINHAL). To be included, studies needed to analyze written documentation and empirical data, be in either German or English language, published between 2010 and 2020, conducted in a hospital setting, focused on transition from paper-based to electronic patient records, and peer reviewed. Quantitative, qualitative and mixed methods studies were included. Studies were independently screened for inclusion by two researchers in three stages (title, abstract, full text) and, in case of disagreement, discussed with a third person from the research team until consensus was reached. The main outcome assessed was whether the studies indicated a negative or positive effect on documentation (e.g. changing the completeness of documentation) by introducing an EPR. Mixed Methods Appraisal Tool was used to assess the individual risk of bias in the included studies. Overall, 264 studies were found. Of these, 17 met the inclusion criteria and were included in this review. Of all included studies, 11 of 17 proved a positive effect of the introduction of the EPR on documentation such as an improved completeness or guideline adherence of the documentation. Six of 17 showed a mixed effect with positive and negative or no changes. No study showed an exclusively negative effect. Most studies found a positive effect of EPR introduction on documentation. However, it is difficult to draw specific conclusions about how the EPR affects or does not affect documentation since the included studies examined a variety of outcomes. As a result, various scenarios are conceivable with higher or reduced burden for practitioners. Additionally, the impact on treatment remains unclear.

[Nurses' perspectives on their potential role in advance care planning in home care: A qualitative study]. / Die Sichtweise von Pflegefachpersonen auf ihre mögliche Rolle bei Advance Care Planning in der ambulanten Pflege.

Nurses' perspectives on their potential role in advance care planning in home care: A qualitative study Abstract. Background: Advance Care Planning (ACP) in long-term care in Germany has been identified as a potential area of nurses' responsibility. In the StAdPlan study (DRKS0016886), an ACP intervention in outpatient care was implemented and evaluated: Trained nurses conducted ACP conversations with patients. A comprehensive process evaluation was part of the study. Aim: A partial result of the process evaluation was analysing the perspective of nurses on their potential role as ACP facilitators for outpatients. Methods: Semi-structured interviews with nursing professionals and nursing service managers (n = 42) were carried out prior to the implementation of the ACP intervention. A qualitative content analysis of the recorded interviews was performed. Results: Participants described the importance of ACP in outpatient care, their personal motivation and competence as well as necessary contextual conditions. Nursing professionals are motivated to offer ACP to patients to be able to care for them according to their wishes. For effective ACP conversations, nurse professionals considered in-depth knowledge of ACP, conversational skills and sufficient time resources as necessary. ACP consultations can be a suitable field of action for nurses as they have access and an established relationship of trust with patients. Conclusions: Under certain conditions, nurses' role in offering guidance on ACP in outpatient care was seen as feasible and beneficial. Prerequisites for implementation are financial resources and training for nurses for this service.

[Advance care planning conversations in home care: Intervention development with the Behaviour Change Wheel]. / Beratung zu Advance Care Planning in der ambulanten Pflege.

Advance care planning conversations in home care: Intervention development with the Behaviour Change Wheel Abstract. Background: StAdPlan is a multicenter, cluster-randomized controlled trial aimed to develop and evaluate an advance care planning (ACP) intervention for the German home care setting. Aim: This paper reports the intervention development. Available ACP concepts were reviewed and adapted to the German home care context in terms of staffing and available time resources. Skilled nurses are assigned to raise the awareness on ACP among older care-dependent people and their informal caregivers/relatives through structured conversation and facilitating the use of existing counselling services. Methods: The Behavior Change Wheel (BCW) was applied to the development of the intervention components. Results: The complex intervention addresses care-dependent people aged 65 years and above and their informal caregivers. A two-day training session qualifies nursing professionals to offer guideline-based conversations which take place at least twice at the care-dependent person's home, if possible with the involvement of relatives. An additional information brochure is provided. Conclusions: The application of the BCW model proved to be appropriate for the analysis, description and definition of the specific functions of the intervention. The intervention is prepared for the effectiveness study.

Electronic patient record and its effects on social aspects of interprofessional collaboration and clinical workflows in hospitals (eCoCo): a mixed methods study protocol.

BACKGROUND: The need for and usage of electronic patient records within hospitals has steadily increased over the last decade for economic reasons as well as the proceeding digitalization. While there are numerous benefits from this system, the potential risks of using electronic patient records for hospitals, patients and healthcare professionals must also be discussed. There is a lack in research, particularly regarding effects on healthcare professionals and their daily work in health services. The study eCoCo aims to gain insight into changes in interprofessional collaboration and clinical workflows resulting from introducing electronic patient records. METHODS: eCoCo is a multi-center case study integrating mixed methods from qualitative and quantitative social research. The case studies include three hospitals that undergo the process of introducing electronic patient records. Data are collected before and after the introduction of electronic patient records using participant observation, interviews, focus groups, time measurement, patient and employee questionnaires and a questionnaire to measure the level of digitalization. Furthermore, documents (patient records) as well as structural and administrative data are gathered. To analyze the interprofessional collaboration qualitative network analyses, reconstructive-hermeneutic analyses and document analyses are conducted. The workflow analyses, patient and employee assessment analyses and classification within the clinical adoption meta-model are conducted to provide insights into clinical workflows. DISCUSSION: This study will be the first to investigate the effects of introducing electronic patient records on interprofessional collaboration and clinical workflows from the perspective of healthcare professionals. Thereby, it will consider patients' safety, legal and ethical concerns and quality of care. The results will help to understand the organization and thereby improve the performance of health services working with electronic patient records. TRIAL REGISTRATION: The study was registered at the German clinical trials register (DRKS00023343, Pre-Results) on November 17, 2020.

Study on advance care planning in care dependent community-dwelling older persons in Germany (STADPLAN): protocol of a cluster-randomised controlled trial.

BACKGROUND: In Germany, advance care planning (ACP) was first introduced by law in 2015. However, ACP is still uncommon in Germany and only few people have advance directive forms. This study aims to evaluate an ACP program in care dependent community-dwelling persons, compared to optimised usual care. METHODS: A cluster-randomised controlled trial of 12 months duration will be conducted in 3 German study sites comparing the pretested ACP-counselling offered by trained nurses with a control group receiving optimised usual care. Using external concealed randomisation, 16 home care services each will be included in the intervention and the control group (30 participants per cluster; n = 960). Eligibility criteria for patients are: ≥60 years, somehow care dependent, adequate German language skills, assumed life-expectancy of ≥4 weeks, and cognitive ability for participation. ACP will be delivered by trained nurse facilitators of the respective home care services and communication will include proxy decision-makers. The primary endpoint will be patient activation, assessed by the Patient Activation Measure (PAM-13). Secondary endpoints include ACP-engagement, proportion of prepared advance directives, number and duration of hospitalisations, quality of life as well as depression and anxiety. Further, comprehensive economic and process evaluations will be conducted. DISCUSSION: STADPLAN is the first study in Germany that assesses an adapted ACP intervention with trained nurses in home care services and the first international study focusing on cost effectiveness of ACP in community-dwelling older persons. The results will help to improve the understanding and communicating of patients' preferences regarding medical treatment and care and thereby contribute to patients' autonomy. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00016886 (Date of registration: 04.06.2019).

[Interface Problems Between Inpatient, GP and Outpatient Specialist Care: Viewpoint of General Practitioners in Dresden]. / "Da kann man sich ja totklingeln, geht ja keiner ran" ­ Schnittstellenprobleme zwischen stationärer, hausärztlicher und ambulant-fachspezialisierter Patientenversorgung aus Sicht Dresdner Hausärzte.

OBJECTIVES: The aim of the study was to identify interface problems between inpatient, GP and outpatient specialist care from the perspective of general practitioners in Dresden, especially in older multimorbid patients. METHODS: The data were collected in the context of the pilot study "Multimedication and its Consequences for the Primary Care of Patients in Saxony" and included guided interviews with 7 general practitioners. The interviews were transcribed and analyzed according to the inductive content analysis of Mayring. RESULTS: At the interface of inpatient to outpatient care, several problems regarding discharge management, intersectoral communication and cooperation as well as in the management of medication were found. Concerning the interface between general practitioners and outpatient specialist care, problems were particularly marked with regard to free choice of doctors, appointment management, medical decision-making process, medication management as well as the use of the electronic health card. Regardless of the interfaces, the lack of communication could be worked out as a central challenge. CONCLUSION: There are several problems with all adjacent interfaces. What is striking here is the lack of communication and cooperation between all parties involved. Possible causes were the often very different working methods and framework conditions, human and material resources and therapeutic intentions and approaches between the different interfaces. One possible approach to improve the situation may be the law regarding secure digital communications and healthcare applications, which exists since 2016. Among other things, it promises a secure and rapid inter- and intrasectoral exchange of patient data. The overall goal of healthcare in Germany should be an optimized and process-oriented interface management in order to ensure a secure and seamless sectoral transition to patients.

[Checklist for the Development and Assessment of Cost-of-Illness Studies]. / Checkliste zur Erstellung und Bewertung von Krankheitskostenstudien.

BACKGROUND: Cost-of-illness (CoI) studies are important instruments for estimating the socioeconomic burden of specified diseases. CoI studies provide important information about the cost structure of a disease, the resulting research need, approaches to improve aspects of care and, monetary consequences from different perspectives. This information can be useful for healthcare research and health policy. Due to heterogeneity of available Cost-of-Illness studies, the working group 'Health Economics' of the German Network for Healthcare Research (DNVF) in accordance with the German Society for Health Economics (DGGÖ) developed an instrument for the planning, conduct and assessment of CoI studies. METHODS: The checklist was developed based on a systematic literature search of published national and international checklists as well as guidelines and recommendations for development and assessment of CoI studies and health economic evaluations. Structure and subject matter of the generic checklist was designed, approved and, finally, examined in a pretest by the working group. RESULTS: Based on the results of the literature search (n=2 454), 58 articles were used for the identification of relevant criteria for the checklist. With respect to the results of the pretest, 6 dimensions were included in the checklist: (i) general aspects, (ii) identification of resources, (iii) description and quantification of resource consumption, (iv) valuation of resources (v) analysis and presentation of results and (vi) discussion and conclusion. In total, the 6 dimensions were operationalized through 37 items. CONCLUSION: This checklist is an initial approach to improve transparency and understanding of CoI studies in terms of the extent, structure and development of the socioeconomic burden of diseases. The checklist supports the comparability of different studies and facilitates study conception.

Why do family doctors prescribe potentially inappropriate medication to elderly patients?

BACKGROUND: Based on changes in pharmacokinetics and -dynamics in elderly patients, there are potentially inappropriate medications (PIM) that should be avoided in patients aged ≥ 65 years. Current studies showed prescription rates of PIM between 22.5 and 28.4 % in the primary care setting. The evidence concerning reasons for PIM prescription by FPs is limited. METHODS: This mixed method study consisted of three research parts: 1) semi-standardized content analysis of patients' records, 2) qualitative interviews with FPs using a) open questions and b) selected patient-specific case vignettes and 3) qualitative interviews with FPs' medical assistants. The integration of qualitative interviews was used to explain the quantitative results (triangulation design). PIM were identified according to the German PRISCUS list. Descriptive and multivariate statistical analysis was done using SPSS 22.0. Qualitative content analysis of interviews was used to classify the content of the interviews for indicating pertinent categories. All data were pseudonymously recorded and analyzed. RESULTS: Content analysis of 1846 patients' records and interviews with 7 related FPs were conducted. Elderly patients [n = 1241, mean age: 76, females: 56.6 %] were characterized in average by 8.3 documented chronic diagnosis. 23.9 % of elderly patients received at least one PIM prescription. Sedatives/hypnotics were the most frequent prescribed PIM-drugs (13.7 %). Mental disorders, gender and number of long-term medication were detected as predictors for the probability of a PIM prescription. Common reported reasons for PIM prescription by FPs concerned limited knowledge regarding PIM, limited applicability of PIM lists in daily practice, lack of time, having no alternatives in medication, stronger patient-related factors than age that influence prescription, own bad experiences regarding changes of medication or refusal of following prescriptions of sedative/hypnotics. CONCLUSIONS: It is essential to see FPs in a complex decision making situation with several influencing factors on their prescribing, including: patient-oriented prioritization, FPs' experiences in daily practice, FPs' knowledge regarding existing recommendations and their trust in it and organizational characteristics of FPs' daily medical practice. These pros and cons of PIM prescription in elderly patients should be considered in FPs' advanced training.

[Implementing systematically: To what extent can implementation science make an educational contribution to health care practice?] / Systematisch implementieren. Inwiefern kann die Implementierungswissenschaft einen Bildungsbeitrag für die Akteure im Gesundheitswesen leisten?

BACKGROUND: Implementation science is currently struggling with the challenge to translate its findings into implementation practice in health care. Therefore, it is of interest to explore to what extent advanced trainings are relevant for health care practice to support knowledge circulation, and what needs to be considered in their design. DESIGN OF EDUCATIONAL INITIATIVES AND TRAINING: Internationally, numerous initiatives have emerged in recent years to make implementation science more accessible to health care implementers. They focus, in particular, on the development of curricula for actors in health care practice and the widespread implementation of these qualification programs. In German-speaking countries, the interest in health services research is particularly evident at the level of Master's degree programs to make implementation science accessible to health care. However, these efforts need to be complemented by a participatory, needs-oriented and theory-based approach to advanced training for implementers in health care practice. This will enable the required competencies to be addressed on different levels of training and the further development of training formats. DISCUSSION: Recent literature shows that implementers in German-speaking countries can benefit from a training program tailored to their needs. International experience in the field of advanced training in implementation science for health care practice allows us to derive essential components for the development of advanced training for the German-speaking region.

[The situation of early career researchers in health services research: A survey study]. / Situation des wissenschaftlichen Nachwuchses in der Versorgungsforschung ­ eine Survey-Studie.

BACKGROUND: Early career researchers in health services research work in an interdisciplinary field of research. So far, information on early career researchers in health services research has only been available from surveys of individual disciplines, which do not adequately reflect the concerns in the field of health services research. Therefore, a working group of the German Network for Health Services Research (DNVF) conducted a first survey. The following research questions can be answered on the basis of the data obtained: (1) Which socio-demographic aspects characterize early career researchers in health services research? (2) What is the professional biographical background of early career researchers in health services research? (3) What are the research fields of early career researchers? (4) What are the career perspectives of early career researchers? METHOD: The survey among early career researchers was conducted as an online survey in January/February 2019. The study was addressed to individuals currently working as early career researchers in health services research in Germany. The online survey was conducted using a standardized questionnaire. Participants were recruited through the DNVF access points and by snowball sampling. RESULTS: 336 early career researcher aged between 23 and 57 participated in the online survey study, 102 of whom held a doctorate. The majority were employed as scientific staff (58%) and were in temporary employment (75%); 69% of them were emplyed at a university, followed by health care institutions (17%) and non-university research institutions (16%). About one-third of the respondents (36%) completed a vocational training prior to their studies. Of the participants, 50% said they were strongly or very strongly aspiring to a professional career in academia, 43% at a non-university research institution, and 30% at a university of applied sciences. DISCUSSION: The results of the online survey show the heterogeneity in terms of age and professional biography of early career researchers in health services research. Few researchers have permanent positions. However, the majority of respondents would like to have a professional future at a university, a research institute or a university of applied sciences. Further studies should be conducted to determine (possible) career paths taken by young scientists in health services research. CONCLUSION: There is still scope for improvement in the promotion of early career researchers.

The Implementation of an Electronic Medical Record in a German Hospital and the Change in Completeness of Documentation: Longitudinal Document Analysis.

BACKGROUND: Electronic medical records (EMR) are considered a key component of the health care system's digital transformation. The implementation of an EMR promises various improvements, for example, in the availability of information, coordination of care, or patient safety, and is required for big data analytics. To ensure those possibilities, the included documentation must be of high quality. In this matter, the most frequently described dimension of data quality is the completeness of documentation. In this regard, little is known about how and why the completeness of documentation might change after the implementation of an EMR. OBJECTIVE: This study aims to compare the completeness of documentation in paper-based medical records and EMRs and to discuss the possible impact of an EMR on the completeness of documentation. METHODS: A retrospective document analysis was conducted, comparing the completeness of paper-based medical records and EMRs. Data were collected before and after the implementation of an EMR on an orthopaedical ward in a German academic teaching hospital. The anonymized records represent all treated patients for a 3-week period each. Unpaired, 2-tailed t tests, chi-square tests, and relative risks were calculated to analyze and compare the mean completeness of the 2 record types in general and of 10 specific items in detail (blood pressure, body temperature, diagnosis, diet, excretions, height, pain, pulse, reanimation status, and weight). For this purpose, each of the 10 items received a dichotomous score of 1 if it was documented on the first day of patient care on the ward; otherwise, it was scored as 0. RESULTS: The analysis consisted of 180 medical records. The average completeness was 6.25 (SD 2.15) out of 10 in the paper-based medical record, significantly rising to an average of 7.13 (SD 2.01) in the EMR (t178=-2.469; P=.01; d=-0.428). When looking at the significant changes of the 10 items in detail, the documentation of diet (P<.001), height (P<.001), and weight (P<.001) was more complete in the EMR, while the documentation of diagnosis (P<.001), excretions (P=.02), and pain (P=.008) was less complete in the EMR. The completeness remained unchanged for the documentation of pulse (P=.28), blood pressure (P=.47), body temperature (P=.497), and reanimation status (P=.73). CONCLUSIONS: Implementing EMRs can influence the completeness of documentation, with a possible change in both increased and decreased completeness. However, the mechanisms that determine those changes are often neglected. There are mechanisms that might facilitate an improved completeness of documentation and could decrease or increase the staff's burden caused by documentation tasks. Research is needed to take advantage of these mechanisms and use them for mutual profit in the interests of all stakeholders. TRIAL REGISTRATION: German Clinical Trials Register DRKS00023343; https://drks.de/search/de/trial/DRKS00023343.

Decision Coaching for Healthy Women With BRCA1/2 Pathogenic Variants­Findings of the Randomized Controlled EDCP-BRCA Trial.

BACKGROUND: Women with BRCA1/2 pathogenic variants (PVs) have a choice of preventive options. To help these women decide for themselves, we developed and implemented a decision coaching (DC) program and evaluated it for congruence between the participants' desired and actual roles in decision-making. METHODS: Healthy BRCA1/2 PV carriers (from 25 to 60 years of age) were recruited at six centers in Germany. Those returning baseline T1-questionnaires were randomly assigned to the intervention group (IG) or the control group (CG). The IG attended a nurse-led DC program. The primary outcome was congruence between the participants' desired and actual roles in decision-making. The secondary outcomes included an active role, satisfaction, decisional conflict, and knowledge. Follow-up data were obtained by questionnaire at 12 weeks (T2) and 6 months (T3). RESULTS: Of the 413 women who were recruited, 389 returned baseline T1 questionnaires. At T2, the IG and CG groups did not differ significantly in congruence between their desired and actual roles in decision-making (0.12 [95% confidence interval -0.03; 0.28], p=0.128), with a slightly higher congruence in the CG. Women in both groups were more active at T2 than their stated preference at T1, with a notably higher percentage in the IG (IG: 40%, CG: 24.4%; [-25.1; -6.1]). IG participants were more satisfied with the role that they had assumed and had less decisional conflict and greater knowledge. CONCLUSION: These findings imply that this DC program can help women with BRCA1/2 PVs participate actively in decision-making with regard to preventive measures.

Digital Medication Management in Polypharmacy.

BACKGROUND: Inappropriate drug prescriptions for patients with polypharmacy can have avoidable adverse consequences. We studied the effects of a clinical decision-support system (CDSS) for medication management on hospitalizations and mortality. METHODS: This stepped-wedge, cluster-randomized, controlled trial involved an open cohort of adult patients with polypharmacy in primary care practices (=clusters) in Westphalia-Lippe, Germany. During the period of the intervention, their medication lists were checked annually using the CDSS. The CDSS warns against inappropriate prescriptions on the basis of patient-related health insurance data. The combined primary endpoint consisted of overall mortality and hospitalization for any reason. The secondary endpoints were mortality, hospitalizations, and high-risk prescription. We analyzed the quarterly health insurance data of the intention- to-treat population with a mixed logistic model taking account of clustering and repeated measurements. Sensitivity analyses addressed effects of the COVID-19 pandemic and other effects. RESULTS: 688 primary care practices were randomized, and data were obtained on 42 700 patients over 391 994 quarter years. No significant reduction was found in either the primary endpoint (odds ratio [OR] 1.00; 95% confidence interval [0.95; 1.04]; p = 0.8716) or the secondary endpoints (hospitalizations: OR 1.00 [0.95; 1.05]; mortality: OR 1.04 [0.92; 1.17]; high-risk prescription: OR 0.98 [0.92; 1.04]). CONCLUSION: The planned analyses did not reveal any significant effect of the intervention. Pandemicadjusted analyses yielded evidence that the mortality of adult patients with polypharmacy might potentially be lowered by the CDSS. Controlled trials with appropriate follow-up are needed to prove that a CDSS has significant effects on mortality in patients with polypharmacy.