Evaluation of a program for routine implementation of shared decision-making in cancer care: results of a stepped wedge cluster randomized trial

Abstract

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.

Effects of a shared decision‐making implementation programme on patient‐centred communication in oncology—Secondary analysis of a randomised controlled trial

“…32,34,44 In a recent study by Amsalem et al 34 healthcare delivery, payment models) and ( 5) the implementation process (e.g., participation during working hours, integration into existing structures). 21,29 One important reason for the lack of effect found in this study might be the limited reach of the training. Across all departments, only 52% of the eligible physicians participated in the training.…”

“…This quantitative study is a secondary analysis of data gathered between March 2018 and October 2020 as part of the outcome evaluation of the cluster-randomised SDM implementation trial PREPARED. 21 The data used here included audio recordings before and after the roll-out of the SDM implementation programme within the PREPARED trial. 21,23…”

“…21 The data used here included audio recordings before and after the roll-out of the SDM implementation programme within the PREPARED trial. 21,23…”

“…6 All other physicians and nurses participated in 1-h interdisciplinary trainings, which were conducted by trained multipliers together with a study team member (A. L., Further details on the design, methodology, outcome and process evaluation of the PREPARED trial are reported elsewhere. 21,23,29…”

“…Effects of the SDM implementation programme on PC communication of physicians can be expected since PC communication training and coaching (with a focus on SDM) were conducted within the trial and specifically addressed HCPs' PC behaviour. 21 Thus, the aim of the present secondary analysis of data from the PREPARED trial was to assess whether the SDM implementation programme had effects on PC communication in clinical encounters in routine cancer care.…”