Lessons learned in administering the "decide" efficacy-effectiveness trial in community mental health settings

Multi-site mental health services trials are needed to test the efficacy and effectiveness of interventions among culturally diverse populations. However, the administration of such studies in community mental health clinics may encounter barriers that are specific to these settings. We discuss how specific scientific and operational concerns were addressed in the DECIDE study, a hybrid efficacy-effectiveness trial of a patient activation intervention for predominantly low-income adults in mental health treatment. Using the PRECIS framework for describing clinical trials, we describe lessons learned to improve effectiveness research in community mental health settings. Observations are drawn from the experience of the authors in conducting the study, supplemented by observations from weekly conference calls with study care managers and local site investigators. Domains that will be addressed include determination of eligibility criteria (including cultural considerations), expectations for practitioner expertise when delivering the intervention, selection of comparison interventions by appreciating the local context, determining follow-up intensity and primary trial outcomes in the context of low clinic resources, measuring practitioner adherence to the study protocol, planning analysis of primary outcomes, and maintaining effective teamwork. We summarize practical approaches to administration of a project that aimed to balance the rigor of an efficacy study with the real-world accommodations of an effectiveness study. Inevitable scientific and operational challenges were addressed to enable collaborative research relationships with community sites and to improve the evidence base for mental health treatment among racial/ethnic minorities.