Embedding shared decision-making in the care of patients with severe and enduring mental health problems: The EQUIP pragmatic cluster randomised trial

Background Severe mental illness is a major driver of worldwide disease burden. Shared decision-making is critical for high quality care, and can enhance patient satisfaction and outcomes. However, it has not been translated into routine practice. This reflects a lack of evidence on the best way to implement shared decision-making, and the challenges of implementation in routine settings with limited resources. Our aim was to test whether we could deliver a practical and feasible intervention in routine community mental health services to embed shared decision-making for patients with severe mental illness, by improving patient and carer involvement in care planning. Methods We cluster randomised community mental health teams to the training intervention or usual care, to avoid contamination. Training was co-delivered to a total of 350 staff in 18 teams by clinical academics, working alongside patients and carers. The primary outcome was the Health Care Climate Questionnaire, a self-report measure of ‘autonomy support’. Primary and secondary outcomes were collected by self-report, six months after allocation. Findings In total, 604 patients and 90 carers were recruited to main trial cohort. Retention at six months was 82% (n = 497). In the main analysis, results showed no statistically significant difference in the primary outcome between the intervention and usual care at 6 months (adjusted mean difference -0.064, 95% CI -0.343 to 0.215, p = 0.654). We found significant effects on only 1 secondary outcome. Conclusions An intervention to embed shared decision-making in routine practice by improving involvement in care planning was well attended and acceptable to staff, but had no significant effects on patient outcomes. Enhancing shared decision-making may require considerably greater investment of resources and effects may only be apparent over the longer term