BackgroundShared decision-making (SDM) has become increasingly important in health care. However, despite scientific evidence, effective implementation strategies, and a prominent position on the health policy agenda, SDM is not widely implemented in routine practice so far. Therefore, we developed a program for routine implementation of SDM in oncology by conducting an analysis of the current state and a needs assessment in a pilot study based on the Consolidated Framework for Implementation Research (CFIR). Based on these results, the main aim of our current study is to evaluate the process and outcome of this theoretically and empirically grounded multicomponent implementation program designed to foster SDM in routine cancer care.MethodsWe use a stepped wedge design, a variant of the cluster randomized controlled trial. The intervention to be implemented is SDM. Three participating clinics of one comprehensive cancer center will be randomized and receive the multicomponent SDM implementation program in a time-delayed sequence. The program consists of the following strategies: (a) SDM training for health care professionals, (b) individual coaching for physicians, (c) patient activation strategy, (d) provision of patient information material and decision aids, (e) revision of the clinics’ quality management documents, and (f) critical reflection of current organization of multidisciplinary team meetings. We will conduct a mixed methods outcome and process evaluation. The outcome evaluation will consist of four measurement points. The primary outcome is adoption of SDM, measured by the 9-item Shared Decision Making Questionnaire. A range of other implementation outcomes will be assessed (i.e., acceptability, readiness for implementing change, appropriateness, penetration). The implementation process will be evaluated using stakeholder interviews and field notes. This will allow adapting interventions if necessary.DiscussionThis study is the first large study on routine implementation of SDM conducted in German cancer care. We expect to foster implementation of SDM at the enrolled clinics. Insights gained from this study, using a theoretically and empirically grounded approach, can inform other SDM implementation studies and health policy developments, both nationally and internationally.Trial registrationclinicaltrials.gov, NCT03393351. Registered 8 January 2018.Electronic supplementary materialThe online version of this article (10.1186/s13012-018-0740-y) contains supplementary material, which is available to authorized users.

Background Shared decision-making (SDM) is preferred by many patients in cancer care. However, despite scientific evidence and promotion by health policy makers, SDM implementation in routine health care lags behind. This study aimed to evaluate an empirically and theoretically grounded implementation program for SDM in cancer care. Methods In a stepped wedge design, three departments of a comprehensive cancer center sequentially received the implementation program in a randomized order. It included six components: training for health care professionals (HCPs), individual coaching for physicians, patient activation intervention, patient information material/decision aids, revision of quality management documents, and reflection on multidisciplinary team meetings (MDTMs). Outcome evaluation comprised four measurement waves. The primary endpoint was patient-reported SDM uptake using the 9-item Shared Decision Making Questionnaire. Several secondary implementation outcomes were assessed. A mixed-methods process evaluation was conducted to evaluate reach and fidelity. Data were analyzed using mixed linear models, qualitative content analysis, and descriptive statistics. Results A total of 2,128 patient questionnaires, 559 questionnaires from 408 HCPs, 132 audio recordings of clinical encounters, and 842 case discussions from 66 MDTMs were evaluated. There was no statistically significant improvement in the primary endpoint SDM uptake. Patients in the intervention condition were more likely to experience shared or patient-lead decision-making than in the control condition (d=0.24). HCPs in the intervention condition reported more knowledge about SDM than in the control condition (d = 0.50). In MDTMs the quality of psycho-social information was lower in the intervention than in the control condition (d = − 0.48). Further secondary outcomes did not differ statistically significantly between conditions. All components were implemented in all departments, but reach was limited (e.g., training of 44% of eligible HCPs) and several adaptations occurred (e.g., reduced dose of coaching). Conclusions The process evaluation provides possible explanations for the lack of statistically significant effects in the primary and most of the secondary outcomes. Low reach and adaptations, particularly in dose, may explain the results. Other or more intensive approaches are needed for successful department-wide implementation of SDM in routine cancer care. Further research is needed to understand factors influencing implementation of SDM in cancer care. Trial registration clinicaltrials.gov, NCT03393351, registered 8 January 2018.

ObjectivesTo translate the Organisational Readiness for Implementing Change measure into German and assess its psychometric properties.DesignCross-sectional psychometric study based on secondary analysis of baseline data from a shared decision-making implementation study.SettingThree departments within one academic cancer centre in Hamburg, Germany.ParticipantsFor comprehensibility assessment of the translated ORIC version, we conducted cognitive interviews with healthcare professionals (HCPs, n=11). Afterwards, HCPs (n=230) filled out the measure.Primary and secondary outcome measuresThe original English version of the ORIC was translated into German using a team translation protocol. Based on comprehensibility assessment via cognitive interviews with HCPs, the translated version was revised. We analysed acceptance (completion rate), factorial structure (exploratory factor analysis (EFA), confirmatory factor analysis (CFA), model fit), item characteristics (item difficulties, corrected item-total correlations, inter-item correlations) and internal consistency (Cronbach’s α).ResultsTranslation and cognitive testing of the German ORIC was successful except for item 10, which showed low comprehensibility as part of content validity in cognitive interviews. Completion rate was >97%. EFA and CFA provided a one-factorial structure. Item difficulties ranged between 55.98 and 65.32, corrected item-total-correlation ranged between 0.665 and 0.774, inter-item correlations ranged between 0.434 and 0.723 and Cronbach’s α was 0.93.ConclusionsThe German ORIC is a reliable measure with high completion rates and satisfying psychometric properties. A one-factorial structure of the German ORIC was confirmed. Item 10 showed limited comprehensibility and therefore reduces content validity of the measure. The German ORIC can be used to analyse organisational readiness for change as a precursor for implementation success of various interventions.