BETTER HEALTH: Durham -- protocol for a cluster randomized trial of BETTER in community and public health settings

Lawrence Paszat, Rinku Sutradhar, Mary Ann O’Brien, Aisha Lofters, Andrew Pinto, Peter Selby, Nancy Baxter, Peter D. Donnelly, Regina Elliott, Richard H. Glazier, Robert Kyle, Donna Manca, Mary-Anne Pietrusiak, Linda Rabeneck, Nicolette Sopcak, Jill Tinmouth, Becky Wall, Eva Grunfeld

The Building on Existing Tools to Improve Chronic Disease Prevention and Screening (BETTER) cluster randomized trial in primary care settings demonstrated a 30% improvement in adherence to evidence-based Chronic Disease Prevention and Screening (CDPS) activities. CDPS activities included healthy activities, lifestyle modifications, and screening tests. We present a protocol for the adaptation of BETTER to a public health setting, and testing the adaptation in a cluster randomized trial (BETTER HEALTH: Durham) among low income neighbourhoods in Durham Region, Ontario (Canada). The BETTER intervention consists of a personalized prevention visit between a participant and a prevention practitioner, which is focused on the participant's eligible CDPS activities, and uses Brief Action Planning, to empower the participant to set achievable short-term goals. Durham aims to establish that the BETTER intervention can be adapted and proven effective among 40-64 year old residents of low income areas when provided in the community by public health nurses trained as prevention practitioners. Focus groups and key informant interviews among stakeholders and eligible residents of low income areas will inform the adaptation, along with feedback from the trial's Community Advisory Committee. We have created a sampling frame of 16 clusters composed of census dissemination areas in the lowest urban quintile of median household income, and will sample 10 clusters to be randomly allocated to immediate intervention or six month wait list control. Accounting for the clustered design effect, the trial will have 80% power to detect an absolute 30% difference in the primary outcome, a composite score of completed eligible CDPS actions six months after enrollment. The prevention practitioner will attempt to link participants without a primary care provider (PCP) to a local PCP. The implementation of BETTER HEALTH: Durham will be evaluated by focus groups and key informant interviews. The effectiveness of BETTER HEALTH: Durham will be tested for delivery in low income neighbourhoods by a public health department. NCT03052959, registered February 10, 2017.