Comparing traditional and participatory dissemination of a shared decision making intervention (ADAPT-NC): a cluster randomized trial.

Background: Asthma is a common disease that affects people of all ages and has significant morbidity and mortality. Poor outcomes and health disparities related to asthma result in part from the difficulty of disseminating new evidence and care delivery methods such as shared decision making (SDM) into clinical practice.

Methods/design: This non-blinded study will randomize 30 primary care clinics in NC stratified by four PBRNs. We will test dissemination across these practices using a facilitator-led participatory approach to dissemination (FLOW), a novel method of participatory dissemination involving key principles of community-based participatory research, and a more typical "lunch and learn" dissemination method. Specifically, we will use cluster randomization to assign each of the 30 practices to one of three arms: (1) control, no dissemination; (2) traditional dissemination, one didactic session a year and distribution of educational material; and (3) FLOW dissemination. We hypothesize that at the unit of randomization, the clinic, patients in the FLOW dissemination arm will be more likely to share in their treatment decisions compared to patients in the traditional dissemination or control arms. All outcomes will be measured at the level of the clinic. Adoption of the SDM approach will be evaluated by 1) asthma exacerbations, 2) level of patient involvement in the decision making process, and 3) qualitative assessments from patients and providers.

Trial Registration: The trial was registered on January 27, 2014 through the United States National Institutes of Health's ClinicalTrials.gov NCT02047929 and funded by the Patient-Centered Outcomes Research Institute (PCORI).