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.

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.

Digital Medication Management in Polypharmacy­Findings of a Cluster-Randomized, Controlled Trial With a Stepped-Wedge Design in Primary Care Practices (AdAM).

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. Pandemic-adjusted 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.

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.

[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.

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.

Validation of the German Normalisation Process Theory Measure G-NoMAD: translation, adaptation, and pilot testing.

BACKGROUND: Implementing evidence-based healthcare practices (EBPs) is a complex endeavour and often lags behind research-informed decision processes. Understanding and systematically improving implementation using implementation theory can help bridge the gap between research findings and practice. This study aims to translate, pilot, and validate a German version of the English NoMAD questionnaire (G-NoMAD), an instrument derived from the Normalisation Process Theory, to explore the implementation of EBPs. METHODS: Survey data has been collected in four German research projects and subsequently combined into a validation data set. Two versions of the G-NoMAD existed, independently translated from the original English version by two research groups. A measurement invariance analysis was conducted, comparing latent scale structures between groups of respondents to both versions. After determining the baseline model, the questionnaire was tested for different degrees of invariance (configural, metric, scalar, and uniqueness) across samples. A confirmatory factor analysis for three models (a four-factor, a unidimensional, and a hierarchical model) was used to examine the theoretical structure of the G-NoMAD. Finally, psychometric results were discussed in a consensus meeting, and the final instructions, items, and scale format were consented to. RESULTS: A total of 539 health care professionals completed the questionnaire. The results of the measurement invariance analysis showed configural, partial metric, and partial scalar invariance indicating that the questionnaire versions are comparable. Internal consistency ranged from acceptable to good (0.79 ≤ α ≤ 0.85) per subscale. Both the four factor and the hierarchical model achieved a better fit than the unidimensional model, with indices from acceptable (SRMR = 0.08) to good (CFI = 0.97; TLI = 0.96). However, the RMSEA values were only close to acceptable (four-factor model: χ2164 = 1029.84, RMSEA = 0.10; hierarchical model: χ2166 = 1073.43, RMSEA = 0.10). CONCLUSIONS: The G-NoMAD provides a reliable and promising tool to measure the degree of normalisation among individuals involved in implementation activities. Since the fit was similar in the four-factor and the hierarchical model, priority should be given to the practical relevance of the hierarchical model, including a total score and four subscale scores. The findings of this study support the further usage of the G-NoMAD in German implementation settings. TRIAL REGISTRATION: Both the AdAM project (No. NCT03430336, 06/02/2018) and the EU-project ImpleMentAll (No. NCT03652883, 29/08/2018) were registered on ClinicalTrials.gov. The ImplementIT study was registered at the German Clinical Trial Registration (No. DRKS00017078, 18/04/2019). The G-NoMAD validation study was registered at the Open Science Framework (No7u9ab, 17/04/2023).

A mHealth intervention to reduce perceived stress in patients with ischemic heart disease: study protocol of the randomized, controlled confirmatory intervention "mStress-IHD" trial.

BACKGROUND: Stress is highly prevalent in patients with ischemic heart disease (IHD) and is associated with lower health-related quality of life and impaired cardiovascular outcome. The importance of stress management is now recognized in recent guidelines for the management of cardiovascular disease. However, effective stress management interventions are not implemented in clinical routine yet. The development of easily disseminated eHealth interventions, particularly mHealth, may offer a cost-effective and scalable solution to this problem. The aim of the proposed trial is to assess the efficiency and cost-effectiveness of the mHealth intervention "mindfulHeart" in terms of reducing stress in patients with IHD. METHODS AND ANALYSIS: This randomized controlled confirmatory interventional trial with two parallel arms has assessments at six measurement time points: baseline (T0, prior randomization), post-treatment (T1), and four follow-ups at months 1, 3, 6, and 12 after intervention (T2, T3, T4, and T5). We will include patients with confirmed diagnosis of IHD, high-perceived stress, and use of an internet-enabled smartphone. Patients will be randomized into two groups (intervention vs. control). The proposed sample size calculation allocates 128 participants in total. The primary analysis will be performed in the intention-to-treat population, with missing data imputed. An ANCOVA with the outcome at T1, a between-subject factor (intervention vs. control), and the participants' pre-intervention baseline values as a covariate will be used. Different ANOVAs, regression, and descriptive approaches will be performed for secondary analyses. ETHICS: The Ethics Committee of the Medical Faculty of the University of Duisburg-Essen approved the study (22-11,015-BO). TRIAL REGISTRATION: ClinicalTrials NCT05846334. Release 26.04.2023.

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.

Complex implementation mechanisms in primary care: do physicians' beliefs about the effectiveness of innovation play a mediating role? Applying a realist inquiry and structural equation modeling approach in a formative evaluation study.

BACKGROUND: The adoption of digital health technologies can improve the quality of care for polypharmacy patients, if the underlying complex implementation mechanisms are better understood. Context effects play a critical role in relation to implementation mechanisms. In primary care research, evidence on the effects of context in the adoption of digital innovation for polypharmacy management is lacking. STUDY AIM: This study aims to identify contextual factors relevant to physician behavior and how they might mediate the adoption process. METHODS: The physicians who participated in this formative evaluation study (n = 218) were part of the intervention group in a cluster-randomized controlled trial (AdAM). The intervention group implemented a digital innovation for clinical decision making in polypharmacy. A three-step methodological approach was used: (1) a realist inquiry approach, which involves the description of a context-mechanism-outcome configuration for the primary care setting; (2) a belief elicitation approach, which involves qualitative content analysis and the development of a quantitative latent contextualized scale; and (3) a mediation analysis using structural equation modeling (SEM) based on quantitative survey data from physicians to assess the mediating role of the contextualized scale (n = 179). RESULTS: The key dimensions of a (1) context-mechanism-outcome model were mapped and refined. A (2) latent construct of the physicians' innovation beliefs related to the effectiveness of polypharmacy management practices was identified. Innovation beliefs play a (3) mediating role between the organizational readiness to implement change (p < 0.01) and the desired behavioral intent of physicians to adopt digital innovation (p < 0.01; R2 = 0.645). Our contextualized model estimated significant mediation, with a relative size of 38% for the mediation effect. Overall, the model demonstrated good fit indices (CFI = 0.985, RMSEA = 0.034). CONCLUSION: Physician adoption is directly affected by the readiness of primary care organizations for the implementation of change. In addition, the mediation analysis revealed that this relationship is indirectly influenced by primary care physicians' beliefs regarding the effectiveness of digital innovation. Both individual physician beliefs and practice organizational capacity could be equally prioritized in developing implementation strategies. The methodological approach used is suitable for the evaluation of complex implementation mechanisms. It has been proven to be an advantageous approach for formative evaluation. TRIAL REGISTRATION: NCT03430336 . First registration: 12/02/2018. CLINICALTRIALS: gov.

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.

Effectiveness of an evidence-based care pathway to improve mobility and participation in older patients with vertigo and balance disorders in primary care (MobilE-PHY2): study protocol for a multicentre cluster-randomised controlled trial.

BACKGROUND: Vertigo, dizziness or balance disorders (VDB) are common leading symptoms in older people, which can have a negative impact on their mobility and participation in daily live, yet, diagnosis is challenging and specific treatment is often insufficient. An evidence-based, multidisciplinary care pathway (CPW) in primary care was developed and pilot tested in a previous study. The aim of the present study is to evaluate the effectiveness and safety of the CPW in terms of improving mobility and participation in community-dwelling older people with VDB in primary care. METHODS: For this multicentre cluster randomised controlled clinic trial, general practitioners (GP) will be recruited in two regions of Germany. A total of 120 patients over 60 years old with VDB will be included. The intervention is an algorithmized CPW. GPs receive a checklist for standardise clinical decision making regarding diagnostic screening and treatment of VDB. Physiotherapists (PT) receive a decision tree for evidence-based physiotherapeutic clinical reasoning and treatment of VDB. Implementation strategies comprises educational trainings as well as a workshop to give a platform for exchange for the GPs and PTs, an information meeting and a pocket card for home care nurses and informal caregivers and telephone peer counselling to give all participants the capability, opportunity and the motivation to apply the intervention. In order to ensure an optimised usual care in the control group, GPs get an information meeting addressing the national guideline. The primary outcome is the impact of VDB on participation and mobility of patients after 6 month follow-up, assessed using the Dizziness Handicap Inventory (DHI) questionnaire. Secondary outcomes are physical activity, static and dynamic balance, falls and fear of falling as well as quality of life. We will also evaluate safety and health economic aspects of the intervention. Behavioural changes of the participants as well as barriers, facilitating factors and mechanisms of impact of the implementation will be investigated with a comprehensive process evaluation in a mixed-methods design. DISCUSSION: With our results, we aim to improve evidence-based health care of community-dwelling older people with VDB in primary care. TRIAL REGISTRATION: DRKS, DRKS00028524 retrospectively registered on March 24, 2022.

Coping Self-Efficacy and Its Relationship with Psychological Morbidity after Genetic Test Result Disclosure: Results from Cancer-Unaffected BRCA1/2 Mutation Carriers.

Women who are found to carry a BRCA1/2 pathogenic variant experience psychological distress due to an increased risk of breast and ovarian cancer. They may decide between different preventive options. In this secondary analysis of data collected alongside a larger randomized controlled trial, we are looking at 130 newly found BRCA1/2 pathogenic variant carriers and how their coping self-efficacy immediately after genetic test result disclosure is related to their psychological burden and status of preventive decision making. Participants received the Coping Self-Efficacy Scale, the Hospital Anxiety and Depression Scale, the Impact of Event Scale, the Decisional Conflict Scale, and the Stage of Decision-Making Scale after positive genetic test result disclosure. We found that women with higher coping self-efficacy showed fewer symptoms of anxiety or depression and were less affected by receiving the genetic test result in terms of post-traumatic stress. However, coping self-efficacy had no relationship with any decision-related criteria, such as decisional conflict or stage of decision making. This shows that despite its buffering capacity on psychological burden, possessing coping self-efficacy does not lead to more decisiveness in preference-sensitive decisions.

Correlation of internet search enquiries, incidence of ophthalmological diseases and corneal, cataract and refractive surgical procedures.

Analysis of internet search queries (ISQ) could be useful to study public interest and medical need for corneal, cataract, and refractive surgery. To date, there are preliminary data on seasonal trends in ophthalmic conditions, but only few studies correlate these data with real data from healthcare systems. The aim of this study is to analyze ISQ and correlate it with real healthcare system data. Data were retrieved from the KBV registry of patients who underwent outpatient ophthalmic surgery in Germany from 2017 to 2019 and from Statista GmbH from 2010 to 2020 for corneal refractive surgery. Time Series analysis of ISQ was analyzed from 2004 to 2020 and correlated with healthcare system data using bivariate correlation analysis. ISQ correlated significantly with the incidence of ophthalmic procedures such as corneal transplantations (r = 0.69, p < 0.05), cataract- (r = 0.59, p < 0.05) and refractive laser surgery (r = 0.83, p < 0.05) in Germany. In addition, specific trends were observed with respect to individual surgical procedures. The correlation between search intensities and surgical procedures varied significantly. Thus, interests in surgical procedures can be tracked by observing changes in ISQ over time. These data correlate with real healthcare data and could be used in the future for now-casting or even forecasting.

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.

[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.

COVID-19 vaccinations in German pharmacies: A survey on patient and provider satisfaction.

BACKGROUND: COVID-19 vaccinations applied in pharmacies can facilitate accessibility and potentially increase the vaccination rate but remain controversial in many countries. This study aimed to explore the patients' motivation to receive their COVID-19 vaccination in a pharmacy and examine patient and provider satisfaction with this novel service. METHODS: The study was designed as an explorative cross-sectional multicenter in-house quantitative survey and was conducted during the first weeks of COVID-19 vaccinations in German pharmacies from February to April 2022. The survey consisted of a paper-based questionnaire with scaling questions, multiple choice questions and open questions. Patients were recruited consecutively before their vaccination and completed the survey directly after the service. Vaccinating pharmacists were also invited to answer a questionnaire on their experiences, motivation and expectations. RESULTS: A total of 427 questionnaires out of 11 pharmacies were be included. The overall patient satisfaction with vaccinations in pharmacies was rated with the highest remarks by 91.5% of the participants, another 7.8% were fairly satisfied. Patient satisfaction with scheduling, waiting time, information, hygiene, vaccination technique and a feeling of safety was very high (96.5-97.9%). Patients' motivation on COVID-19 vaccination was to prevent severe COVID-19 symptoms (88.9%) and to protect others (72.3%). Easy accessibility, low barriers and proximity were other reasons for utilizing this service, mentioned by 61.8% of the patients. Pharmacists were highly motivated and found the task meaningful but experienced considerable personnel shortage. General practitioners rather expressed relief on their workload. CONCLUSIONS: Data of this study strongly supports to include pharmacies as additional providers of COVID-19 vaccinations. Patients stated marked satisfaction with this setting and expressed a feeling of safety and trust. Whereas most patients may have utilized the service for convenience, easy accessibility and low barriers were appreciated and can potentially contribute to higher vaccination rates.

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.

[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.

Use of an Electronic Medication Management Support System in Patients with Polypharmacy in General Practice: A Quantitative Process Evaluation of the AdAM Trial.

Polypharmacy is associated with a risk of negative health outcomes. Potentially inappropriate medications, interactions resulting from contradicting medical guidelines, and inappropriate monitoring, all increase the risk. This process evaluation (PE) of the AdAM study investigates implementation and use of a computerized decision-support system (CDSS). The CDSS analyzes medication appropriateness by including claims data, and hence provides general practitioners (GPs) with full access to patients' medical treatments. We based our PE on pseudonymized logbook entries into the CDSS and used the four dimensions of the Medical Research Council PE framework. Reach, which examines the extent to which the intended study population was included, and Dose, Fidelity, and Tailoring, which examine how the software was actually used by GPs. The PE was explorative and descriptive. Study participants were representative of the target population, except for patients receiving a high level of nursing care, as they were treated less frequently. GPs identified and corrected inappropriate prescriptions flagged by the CDSS. The frequency and intensity of interventions documented in the form of logbook entries lagged behind expectations, raising questions about implementation barriers to the intervention and the limitations of the PE. Impossibility to connect the CDSS to GPs' electronic medical records (EMR) of GPs due to technical conditions in the German healthcare system may have hindered the implementation of the intervention. Data logged in the CDSS may underestimate medication changes in patients, as documentation was voluntary and already included in EMR.