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.

Determinants of practice for providing decision coaching to facilitate informed values-based decision-making: protocol for a mixed-methods systematic review.

INTRODUCTION: Decision coaching is a non-directive approach to support patients to prepare for making health decisions. It is used to facilitate patients' involvement in informed values-based decision-making and use of evidence-based health information. A recent systematic review revealed low certainty evidence for its effectiveness with and without evidence-based information. However, there may be opportunities to improve the study and use of decision coaching in clinical practice by systematically investigating its determinants of practice. We aim to conduct a systematic review to identify and synthesise the determinants of practice for providing decision coaching to facilitate patient involvement in decision-making from multiple perspectives that influence its use. METHODS AND ANALYSIS: We will conduct a mixed-methods systematic review guided by the Cochrane' Handbook of Systematic Reviews. We will include studies reporting determinants of practice influencing decision coaching with or without evidence-based patient information with adults making a health decision for themselves or a family member. Systematic literature searches will be conducted in Medline, EMBASE, Cochrane CENTRAL and PsycINFO via Ovid and CINAHL via EBSCO including quantitative, qualitative and mixed-methods study designs. Additionally, experts in the field will be contacted.Two reviewers will independently screen and extract data. We will synthesise determinants using deductive and inductive qualitative content analysis and a coding frame developed specifically for this review based on a taxonomy of barriers and enablers of shared decision-making mapped onto the major domains of the Consolidated Framework for Implementation Research. We will assess the quality of included studies using the Mixed Methods Appraisal Tool. ETHICS AND DISSEMINATION: Ethical approval is not required as this systematic review involves only previously published literature. The results will be published in a peer-reviewed journal, presented at scientific conferences and disseminated to relevant consumer groups. PROSPERO REGISTRATION NUMBER: CRD42022338299.

MAPPinfo - mapping quality of health information: Validation study of an assessment instrument.

BACKGROUND: Health information is a prerequisite for informed choices-decisions, made by individuals about their own health based on knowledge and in congruence with own preferences. Criteria for development, content and design have been defined in a corresponding guideline. However, no instruments exist that provide reasonably operationalised measurement items. Therefore, we drafted the checklist, MAPPinfo, addressing the existing criteria with 19 items. OBJECTIVES: The current study aimed to validate MAPPinfo. METHODS: Five substudies were conducted subsequently at the Martin Luther University Halle-Wittenberg, Germany and the Medical University of Graz, Austria: (1) to determine content validity through expert reviews of the first draft, (2) to determine feasibility using 'think aloud' in piloting with untrained users, (3) to determine inter-rater reliability and criterion validity through a pretest on 50 health information materials, (4) to determine construct validity using 50 developers' self-declarations about development methods as a reference standard, (5) to determine divergent validity in comparison with the Ensuring Quality Information for Patients (EQIP) (expanded) Scale. The analyses used were qualitative methods and correlation-based methods for determining both inter-rater reliability and validity. RESULTS: The instrument was considered by experts to operationalise the existing guidelines convincingly. Health and nursing science students found it easy to understand and use. It also had good interrater reliability (mean of T coefficients = .79) and provided a very good estimate of the reference standard (Spearman's rho = .89), implying sound construct validity. Finally, comparison with the EQIP instrument revealed important and distinct areas of similarities and differences. CONCLUSIONS: The new instrument is ready for use as a screening instrument without the need for training. According to its underpinning concept the instrument exclusively comprises items which are justified by either ethics or research evidence, implying negligence of not yet evidence based, however, potentially important criteria. Further research is needed to complete the body of evidence-based criteria, aiming at an extension of the guideline and MAPPinfo. TRIAL REGISTRATION NUMBER: AsPredicted22546; date of registration: 24 July 2019.

Enhancing Transsectoral Interdisciplinary Patient-Centered Care for Patients With Rare Cancers: Protocol for a Mixed Methods Process Evaluation.

BACKGROUND: Rare cancers account for approximately 24% of all new cancers. The category of rare tumor diseases includes almost 200 different entities. In particular, the treatment of patients with extensive care needs requires cooperation between service providers, both between sectors (outpatient and inpatient) and within sectors (eg, between different medical disciplines). The treatment pathway is associated with a high need for coordination and information sharing between providers. When crossing sectoral boundaries in the German health care system, interface problems between the outpatient and inpatient sectors can lead to gaps in care delivery. The multicomponent program Trans-sectoral Personalised Care Concept for Patients with Rare Cancers aims to optimize transsectoral cooperation and coordination of care to enhance patient involvement and the medical care coordination of patients with rare cancers. OBJECTIVE: This process evaluation will contribute to answering questions about intervention fidelity and the implementation of transsectoral communication, identifying and describing the intended and nonintended effects of the intervention, and exploring the barriers to and facilitators of the implementation. METHODS: We will include patients who participate in the intervention phase; all persons and staff involved in the development and implementation of the intervention (Onco Coach, psychologists, physicians on the contact platform, IT staff, and staff of the Bavarian Association of Statutory Health Insurance Physicians); physicians from the Ludwig-Maximilians-University Hospital Munich and the hospital of the Technical University Munich who are involved in the treatment of patients during the course of the project; and participating office-based hematologists and oncologists. Data collection will be conducted at the beginning, during, and at the end of the intervention using mixed methods. Data will be collected from questionnaires, document analyses, semistructured interviews, and structured observations and will cover different aspects of process evaluation. These include examining the context to explore existing patterns, changes in patterns, attitudes, and interactions; analyzing the implementation of intervention elements; and exploring the complex causal pathways and mediators of the intervention. Qualitative data will be analyzed using thematic analysis. The data will then be combined using between-methods triangulation. RESULTS: This project received funding on March 1, 2022. The intervention phase and recruitment for the process evaluation began on March 1, 2023, and the recruitment is expected to end on September 30, 2025. At the time of protocol submission in June 2023, a total of 8 doctors from hematology and oncology practices were enrolled. Data collection began on March 14, 2023. CONCLUSIONS: The Trans-sectoral Personalised Care Concept for Patients with Rare Cancers project is a complex intervention that is to be implemented in an equally complex health care context. The process evaluation will help understand the influence of contextual factors and assess the mechanisms of change. TRIAL REGISTRATION: ISRCTN registry ISRCTN16441179; https://doi.org/10.1186/ISRCTN16441179. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/49731.

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.

Specialised nursing tasks in cancer care and their effects.

Background: Several reviews are available on the effects of specific nursing tasks in oncology care. However, a synthesis across cancer entities and stages is lacking. Aim: To synthesise the results of reviews assessing the scope and effectiveness of tasks of nurses specifically qualified in cancer care. Methods: We conducted an Umbrella Review based on systematic searches in six databases and a search for grey literature following a priori-defined inclusion criteria. Further steps: standardised data extraction and quality assessment, determination of the degree of overlap, and structured narrative summary on outcome measures of health-related quality of life, symptom burden, utilisation of care services/resources, and patient satisfaction. All reviews were categorised according to the EONS Cancer Nursing Education Framework and the Omaha System Intervention Scheme. Results: After screening 2,657 references, 11 reviews (10 high quality) for a total of 148 studies were included. Specially qualified nurses and advanced practice nurses take on a variety of tasks in the disease process, especially related to education, counselling, and case management. Effects on outcome measures are mixed, with increased indications of reduced symptom burden. Conclusion: Specially qualified nurses with expanded roles have the potential to contribute to improved oncology care. This emphasises the importance of appropriate task profiles and qualification programs. More well-reported studies based on theoretical framework models are needed.

Development and Piloting of a Web-Based Tool to Teach Relative and Absolute Risk Reductions.

Interpreting study results is an essential component of decision-making. Both laypeople and healthcare professionals often misinterpret treatment effects that are presented as relative risk reduction. Therefore, we developed and piloted a web-based tool to teach the difference between relative and absolute risk reductions. This project follows the UKMRC-guidance for complex interventions. The tool was developed based on adult learning and design theories. This was followed by a qualitative feasibility study focusing on acceptance, applicability, and comprehensibility with healthcare professionals and laypersons. We conducted think-aloud and semi-structured interviews and analysed them using qualitative content analysis. In addition, we explored calculation skills. Between January 2020 and April 2021, we conducted 22 interviews with 8 laypeople and 14 healthcare professionals from different settings. Overall, the tool proved to be feasible and relevant. With regard to comprehension, we observed an awareness of the interpretation of risk reduction, presented therapy effects were questioned more critically, and the influence of relative effects was recognized. Nevertheless, there were comprehension problems in some of the participants, especially with calculations in connection with low mathematical skills. The tool can be used to improve the interpretation of risk reductions in various target groups and to supplement existing educational programs.

Evidence-based decision-making in nursing - development and piloting of a train-the-trainer concept for teachers at schools for health care professionals: A pilot study.

BACKGROUND: Train-the-trainer concepts (TTT concepts) to impart evidence-based practice competences aim at promoting the implementation of evidence-based practice. The aim of this study was to develop and pilot-test a TTT training program for teachers at schools for health care professionals. The program is based on the core curriculum "Evidence-based Decision-making" set up by the German Network for Evidence-based Medicine e.V. (DNEbM). METHOD: The study was conducted according to the UKMRC framework for complex interventions and consisted of Phase 1 (Development) and Phase 2 (Piloting). In Phase 1, the intervention was modelled on the basis of a systematic literature search. In Phase 2, the TTT concept was piloted with teachers at two schools for health care professionals. For the evaluation, short interviews with the participants were carried out after each module; classroom observations took place during the training and were followed by a focus group interview. In addition, baseline characteristics were collected prior to the training and descriptively evaluated. Critical health competence was surveyed using the Critical Health Competence Test (CHC test) before and after the course. The questionnaires, interviews and classroom observation protocols were processed according to Mayring's qualitative content analysis. Person parameters ±SD were calculated to determine the level of competence. RESULTS: Piloting took place in September 2018 and from September to November 2019. Eight teachers from two training institutions participated. The evaluation of the focus group interviews and the classroom observation protocols resulted in a category system comprising 6 main and 17 subcategories. The feasibility of the materials and methods could be demonstrated in both pilot tests. Reactivation and extension of prior knowledge were confirmed by the participants. The small group size was appreciated; the participants took an active part during the lessons and were stimulated to plan their own lessons. The evaluation of the CHC test revealed average person parameters of 432 ± 45 (pretest, n=8) and 512 ± 65 (posttest, n=8). DISCUSSION: Using mixed methods, the results show the feasibility of the curriculum. CONCLUSION: Further evaluation in a randomized controlled trial (RCT) is needed to prove the efficacy of the curriculum.

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 .

Process evaluation of a multicomponent intervention to prevent physical restraints in nursing homes (IMPRINT): A mixed methods study.

AIMS: To describe the implementation process and fidelity of two versions of a guideline-based, multicomponent intervention to reduce physical restraints in nursing homes and to identify factors that might explain the heterogeneity of effects between different clusters. DESIGN: Mixed methods evaluation of the implementation process (dose delivered, dose received, response, and adaption) alongside a pragmatic three-arm cluster randomized controlled trial. METHODS: Quantitative and qualitative process data were collected during the study period (February 2015-February 2017). Quantitative data from questionnaires and short surveys were analysed by descriptive statistics. Qualitative data from focus groups and semi-structured interviews were analysed using content analysis. An in-depth analysis was conducted by contrasting responding and non-responding clusters regarding the intervention goal and primary outcome. RESULTS: Both interventions were implemented as planned in all clusters: we found no deviations from the protocol regarding the dose delivered to and received by the clusters. Satisfaction of staff targeted by the interventions was high. The in-depth analysis did not reveal any pronounced variation in the degree of implementation or adoption in clusters with a good or nearly no response to the interventions or factors explaining different study effects. CONCLUSION: Although both versions of a guideline-based multicomponent intervention to prevent physical restraints in nursing homes were implemented as planned and the response was generally acceptable, the interventions' goal to change nursing practice towards a least-restraint policy was not achieved by the entire nursing staff in all of the clusters. No factors could be identified that might explain the different effects of the interventions. IMPACT: For some nursing homes, different approaches than addressing nurses' attitudes and institutional policies might be needed to sustainably reduce the use of physical restraints; however, the process evaluation did not reveal characteristics that might have hampered or facilitated the effectiveness of the intervention.

MAPPinfo, mapping quality of health information: study protocol for a validation study of an assessment instrument.

INTRODUCTION: Health information is a prerequisite of informed decision-making. Criteria for development, content and presentation have recently been published in a corresponding guideline. Within a systematic search, 27 relevant checklists were identified, none of them, however, complying with the guideline or providing reasonably operationalised measurement items. Therefore, a draft of a checklist with 19 criteria was drafted. The current study aims at developing and validating this measure of quality. METHODS AND ANALYSIS: The validation design consists of five single studies to be conducted at the University of Halle-Wittenberg/Germany and Graz/Austria. (1) Achieving content validity through expert reviews of the first draft, (2) achieving feasibility using 'think aloud' in piloting with untrained users, (3) pretesting the instrument applied to health information materials without use of secondary sources: determining inter-rater reliability and criterion validity, (4) determining construct validity using information on proceedings and methods in the development process provided by the developers and (5) determining divergent validity in comparison with the Ensuring Quality Information for Patients (EQUIP) (expanded) Scale. The substudies will use varying samples of experts, students and developers and will apply the instrument to materials of various domains. Sample sizes will be adjusted to the particular research designs and questions. Analyses will employ qualitative methods, such as content analyses and discourse within the expert panel, and correlation-based methods both for determining inter-rater reliability and validity. ETHICS AND DISSEMINATION: The project is approved by the ethics committee of the Martin Luther University Halle-Wittenberg (approval number: 2019 115). Results will be published, and the instrument made accessible on public health platforms. It is meant to become a certification standard. MAPPinfo can be used as a screening instrument without training or secondary sources. Although developed in the German language, the instrument will be applicable also in other languages. TRIAL REGISTRATION NUMBER: AsPredected22546; date of registration: 24 July 2019. PROTOCOL VERSION: July 2020.

Development and piloting of a blended learning training programme for physicians and medical students to enhance their competences in evidence-based decision-making.

INTRODUCTION: In 2016, the German Network for Evidence-based Medicine revised its basic curriculum for competences in evidence-based medicine. A curriculum-based training programme for physicians and medical students to enhance their competences in evidence-based decision-making was developed. The training programme was planned on the basis of problem-based learning. The aim of this qualitative pilot study was to explore the feasibility and acceptability of the training programme. Hypotheses concerning its influence on critical health literacy and the attitude toward evidence-based decision-making were to be generated. METHODS: Participating healthcare professionals received a structured training in a blended learning format. Data collection was conducted during the training sessions. The lessons were observed and protocolled and the working results were documented. Two focus group interviews were conducted after the training blocks with focus on acceptability and feasibility of the training programme. Interview transcripts and protocols were analysed using qualitative content analysis according to Mayring. Data saturation was intended by an iterative process of testing, analysing and revising the training programme. In addition, critical health literacy was assessed using the validated Critical Health Competence test. Levels of competence were calculated to measure the effect of the training on critical health competences. RESULTS: Two pilot courses with 29 physicians and other healthcare professionals were conducted between January and March 2019. Overall, the training programme proved to be feasible. The participants rated the comprehensibility of the learning modules as high. However, the practical exercises (e.g. role plays in shared decision-making) revealed that relevant subjects were insufficiently understood (e.g. the difference between the benefits and harms of a diagnostic test and its test accuracy). The interactive instructional design was appreciated. The participants appraised the work tasks as comprehensible but also challenging and requested a theoretical introduction to statistical terms in preparation for work tasks. The programme was revised iteratively according to the results. Critical health competences increased significantly after the training. Mean values (±SD) of levels of competence were 571.21 (±82.87) before training and 671.90 (±51.38) after training (p<0.0001) (levels of competence with a range from 0 to 1,000). CONCLUSION: The training programme is feasible and was well accepted by the participants. It should be established as a continuing medical education opportunity for practitioners. Evaluation in a randomised controlled trial is recommended. Furthermore, the training can easily be adapted for interprofessional training. A concept for long-term implementation is needed.

Efficacy of a training programme to support the application of the guideline evidence-based health information: study protocol of a randomised controlled trial.

BACKGROUND: The evidence-based guideline entitled guideline evidence-based health information emerged from the German Network for Evidence-based Medicine (DNEbM) and was published in February 2017. The guideline addresses providers of health information and its goal is to improve the quality of health information. In addition, we explored the competences of providers of health information and developed a training programme. The aim of this study is to evaluate the efficacy of a training programme addressing providers of health information to support the application of the guideline evidence-based health information. We expected the intervention to improve the quality of health information in comparison to the provision of the guideline on its own. METHODS/DESIGN: The trial uses a superiority randomised control group design with 10 months' follow-up. Twenty-six providers of health information (groups with up to ten members) will be enrolled to compare the intervention (guideline and training programme) with usual care (a publicly available guideline). The 5-day training programme comprises an evidence-based medicine training module and a module to prepare the application of the guideline. The primary outcome parameter is the quality of the health information. Quality is operationalised as the extent of adherence to the guideline's recommendations. Each provider will prepare a single health information item informing a health-related decision on a topic freely chosen before randomisation. The quality of this information will be rated using the Mapping Health Information Quality (MAPPinfo) Checklist. An accompanying process evaluation will then be conducted. DISCUSSION: The study results should show whether the efficacy of the intervention justifies implementation of the training programme to enhance health information developers' competences in evidence-based medicine and to ensure high-quality evidence-based health information (EBHI) in the long term. TRIAL REGISTRATION: ISRCTN registry, ID: ISRCTN96941060. Registered on 7 March 2019.

A blended learning training programme for health information providers to enhance implementation of the Guideline Evidence-based Health Information: development and qualitative pilot study.

BACKGROUND: The Guideline Evidence-based Health Information was published in 2017 and addresses health information providers. The long-term goal of the guideline is to improve the quality of health information. Evidence-based health information represents a prerequisite for informed decision-making. Health information providers lack competences in evidence-based medicine. Therefore, our aim was to develop and pilot-test a blended learning training programme for health information providers to enhance application of the guideline. METHODS: 1. DEVELOPMENT: We developed the training programme according to the Medical Research Council guidance for developing and evaluating complex interventions. The training programme was planned on the basis of problem-based learning. It aims to impart competences in evidence-based medicine. Furthermore, it comprises the application of criteria for evidence-based health information. 2.Pilot testing: We conducted a qualitative pilot study focusing on the acceptability and feasibility of the training programme. Health information providers were recruited and in-house training sessions were offered. Feasibility and acceptability were explored by structured class observations and in semi-structured focus group interviews with the participants after the training sessions. The transcripts and documentations were analysed using qualitative content analysis according to Mayring. The training was revised iteratively according to the results. RESULTS: We conducted two training courses with 17 participants between November 2018 and March 2019. The adequacy of the training for the target group was identified as a major issue. There was significant heterogeneity concerning previous knowledge. Some wished to delve deeper while others seemed to be overwhelmed. In general, the work tasks were understandable. However, the participants asked for a more detailed theoretical introduction in advance. The practical relevance of the evidence-based medicine contents was rated rather low compared to the content about evidence-based health information. Based on these results, we revised the programme. CONCLUSIONS: Overall, the training proved to be feasible for implementation. Meeting the needs of all the participants was a challenge, since they were heterogeneous. Not all of them will be able or intend to implement the training contents into their working routine to the full extent. The implementation will be evaluated in a randomised controlled trial.

Implementation of a multicomponent intervention to prevent physical restraints in nursing homes (IMPRINT): A pragmatic cluster randomized controlled trial.

BACKGROUND: Despite clear evidence for the lack of effectiveness and safety, physical restraints are frequently applied in nursing homes. Multicomponent interventions addressing nurses' attitudes and organizational culture have been effective in reducing physical restraints. OBJECTIVE: To evaluate the effectiveness of two versions of a guideline and theory-based multicomponent intervention to reduce physical restraints in nursing homes. DESIGN: Pragmatic cluster randomized controlled trial. SETTING: The study was conducted in 120 nursing homes in four regions in Germany. PARTICIPANTS: All residents living in the participating nursing home during follow-up, newly admitted residents were also included. A total of 12,245 residents included in the primary analysis (4126 and 3547 residents in intervention group 1 and 2 and 4572 residents in the control group). METHODS: Intervention group 1 received an updated version of a successfully tested guideline-based multicomponent intervention (comprising brief education for the nursing staff, intensive training of nominated key nurses in each cluster, introduction of a least-restraint policy and supportive material), intervention group 2 received a concise version of the original program and the control group received optimized usual care (i.e. supportive materials only). Primary outcome was physical restraint prevalence at twelve months, assessed through direct observation by blinded investigators. Intervention and control groups were compared using baseline-adjusted linear regression on cluster level, Bonferroni-adjusted for double testing. Secondary outcomes included falls, fall-related fractures, and quality of life. We also described intervention costs and performed a comprehensive process analysis. RESULTS: At baseline, mean physical restraint prevalence was 17.4% and 19.6% in intervention groups 1 and 2, and 18.8% in the control group. After twelve months, mean prevalence was 14.6%, 15.7%, and 17.6%. Baseline-adjusted differences between mean prevalences were 2.0% (97.5% CI, -5.8 to 1.9) lower in intervention group 1 and 2.5% (97.5% CI, -6.4 to 1.4) lower in intervention group 2 compared to controls. Physical restraint prevalence showed a pronounced variation between the different clusters in all study groups. We found no significant differences in the secondary outcomes. According to the process evaluation, the intervention was mainly implemented as planned, but the expected change towards a least restraint culture of care was not achieved in all clusters. CONCLUSIONS: Neither intervention showed a clear advantage compared to control. The pronounced center variation in physical restraint prevalence indicates that other approaches like governmental policies are needed to sustainably change physical restraint practice and reduce center variations in nursing homes. TRIAL REGISTRATION: ClinicalTrials.gov : NCT02341898.

Nurse-led coaching of shared decision-making for women with ductal carcinoma in situ in breast care centers: A cluster randomized controlled trial.

BACKGROUND: Women with breast cancer demand informed shared decision-making. Guidelines support these claims. OBJECTIVES: To investigate whether an informed shared decision-making intervention for women with 'ductal carcinoma in situ' comprising an evidence-based decision aid with nurse-led decision coaching enhances the extent of the mutual shared decision-making behavior of patients and professionals regarding treatment options, and to analyze implementation barriers. DESIGN: Cluster randomized controlled trial with accompanying process evaluation. SETTING: Certified breast care centers in Germany. PARTICIPANTS: Women with ductal carcinoma in situ and no previous history of breast cancer facing a primary treatment decision. METHODS: Sixteen breast centers were randomized to intervention or standard care to recruit 192 patients (partially-blinded). All coaching sessions and physician consultations were videotaped to assess the primary outcome 'extent of patient involvement in shared decision-making' using the MAPPIN-Odyad observer instrument (scores 0 to 4). Secondary endpoints included the sub-measures of the MAPPIN-inventory (MAPPIN-Onurse, MAPPIN-Ophysician, MAPPIN-Opatient, MAPPIN-Qnurse, MAPPIN-Qpatient and MAPPIN-Qphysician), 'informed choice', 'decisional conflict' and 'duration of consultations'. Primary intention-to-treat analyses were on cluster level comparing means of cluster values using t-tests. An accompanying process evaluation was conducted comprising 1) analysis of all video recordings with focus on procedures and intervention fidelity and 2) field notes of researchers and feedback from professionals and patients assessed by questionnaires and interviews with focus on barriers and facilitators for implementation at different time points. RESULTS: Due to protracted recruitment, the study was terminated after 14 centers had included 64 patients (intervention group 36, control group 28). Patient participation in informed shared decision-making was significantly higher in the intervention group (mean (SD) score 2.29 (0.56) vs. 0.42 (0.51) in the control group; difference 1.88 (95% CI 1.26-2.50, p < 0.0001). 47.7% women in the intervention group made informed choices, but none in the control group, difference 47.7% (95% CI 12.6-82.7%, p = 0.016). In the intervention group physician consultations lasted 12.8 (6.6) min. vs. 24.3 (6.3) min. in the control group. Physicians' attitudes, false incentives and structural barriers hindered implementation of informed shared decision-making. Nurses appreciated their new roles. CONCLUSIONS: Informed shared decision-making is not yet implemented in German breast care centers. Nurse-led decision coaching grounded on evidence-based patient information enhances informed shared decision-making. Trial registration No. ISRCTN46305518.

Communicating prognosis to women with early breast cancer - overview of prediction tools and the development and pilot testing of a decision aid.

BACKGROUND: Shared decision-making in oncology requires information on individual prognosis. This comprises cancer prognosis as well as competing risks of dying due to age and comorbidities. Decision aids usually do not provide such information on competing risks. We conducted an overview on clinical prediction tools for early breast cancer and developed and pilot-tested a decision aid (DA) addressing individual prognosis using additional chemotherapy in early, hormone receptor-positive breast cancer as an example. METHODS: Systematic literature search on clinical prediction tools for the effects of drug treatment on survival of breast cancer. The DA was developed following criteria for evidence-based patient information and International Patient Decision Aids Standards. We included data on the influence of age and comorbidities on overall prognosis. The DA was pilot-tested in focus groups. Comprehension was additionally evaluated through an online survey with women in breast cancer self-help groups. RESULTS: We identified three prediction tools: Adjuvant!Online, PREDICT and CancerMath. All tools consider age and tumor characteristics. Adjuvant!Online considers comorbidities, CancerMath displays age-dependent non-cancer mortality. Harm due to therapy is not reported. Twenty women participated in focus groups piloting the DA until data saturation was achieved. A total of 102 women consented to participate in the online survey, of which 86 completed the survey. The rate of correct responses was 90.5% and ranged between 84 and 95% for individual questions. CONCLUSIONS: None of the clinical prediction tools fulfilled the requirements to provide women with all the necessary information for informed decision-making. Information on individual prognosis was well understood and can be included in patient decision aids.

Implementation of shared decision-making in oncology: development and pilot study of a nurse-led decision-coaching programme for women with ductal carcinoma in situ.

BACKGROUND: To implement informed shared decision-making (ISDM) in breast care centres, we developed and piloted an inter-professional complex intervention. METHODS: We developed an intervention consisting of three components: an evidence-based patient decision aid (DA) for women with ductal carcinoma in situ, a decision-coaching led by specialised nurses (breast care nurses and oncology nurses) and structured physician encounters. In order to enable professionals to gain ISDM competencies, we developed and tested a curriculum-based training programme for specialised nurses and a workshop for physicians. After successful testing of the components, we conducted a pilot study to test the feasibility of the entire revised intervention in two breast care centres. Here the acceptance of the intervention by women and professionals, the applicability to the breast care centres' procedures, women's knowledge, patient involvement in treatment decision-making assessed with the MAPPIN'SDM-observer instrument MAPPIN'Odyad, and barriers to and facilitators of the implementation were taken into consideration. We used questionnaires, structured verbal and written feedback and video recordings. Qualitative data were analysed descriptively, and mean values and ranges of quantitative data were calculated. RESULTS: To test the DA, focus groups and individual interviews were conducted with 27 women. Six expert reviews were obtained. The components of the nurse training were tested with 18 specialised nurses and 19 health science students. The development and piloting of the components were successful. The pilot test of the entire intervention included seven patients. In general, the intervention is applicable. Patients attained adequate knowledge (range of correct answers: 9-11 of 11). On average, a basic level of patient involvement in treatment decision-making was observed for nurses and patient-nurse dyads (M(MAPPIN-Odyad): 2.15 and M(MAPPIN-Onurse): 1.90). Relevant barriers were identified; physicians barely tolerated women's preferences that were not in line with the medical recommendation. Classifying women as inappropriate for ISDM due to age or education led physicians to neglect eligible women during the recruitment phase. CONCLUSION: Decision-coaching is feasible. Nevertheless, there are some indications that structural changes are needed for long-term implementation. We are currently evaluating the intervention in a cluster randomised controlled trial in 16 breast care centres.

Informed shared decision-making supported by decision coaches for women with ductal carcinoma in situ: study protocol for a cluster randomized controlled trial.

BACKGROUND: Women with breast cancer want to participate in treatment decision-making. Guidelines have confirmed the right of informed shared decision-making. However, previous research has shown that the implementation of informed shared decision-making is suboptimal for reasons of limited resources of physicians, power imbalances between patients and physicians and missing evidence-based patient information. We developed an informed shared decision-making program for women with primary ductal carcinoma in situ (DCIS). The program provides decision coaching for women by specialized nurses and aims at supporting involvement in decision-making and informed choices. In this trial, the informed shared decision-making program will be evaluated in breast care centers. METHODS/DESIGN: A cluster randomized controlled trial will be conducted to compare the informed shared decision-making program with standard care. The program comprises an evidence-based patient decision aid and training of physicians (2 hours) and specialized breast care and oncology nurses (4 days) in informed shared decision-making. Sixteen certified breast care centers will be included, with 192 women with primary DCIS being recruited. Primary outcome is the extent of patients' involvement in shared decision-making as assessed by the MAPPIN-Odyad (Multifocal approach to the 'sharing' in shared decision-making: observer instrument dyad). Secondary endpoints include the sub-measures of the MAPPIN-inventory (MAPPIN-Onurse, MAPPIN-Ophysician, MAPPIN-Opatient, MAPPIN-Qnurse, MAPPIN-Qpatient and MAPPIN-Qphysician), informed choice, decisional conflict and the duration of encounters. It is expected that decision coaching and the provision of evidence-based patient decision aids will increase patients' involvement in decision-making with informed choices and reduce decisional conflicts and duration of physician encounters. Furthermore, an accompanying process evaluation will be conducted. DISCUSSION: To our knowledge, this is the first study investigating the implementation of decision coaches in German breast care centers. TRIAL REGISTRATION: Current Controlled Trials ISRCTN46305518 , date of registration: 5 June 2015.