BETTER HEALTH: Durham -- protocol for a cluster randomized trial of BETTER in community and public health settings
- PMID: 28962558
- PMCID: PMC5622533
- DOI: 10.1186/s12889-017-4797-3
BETTER HEALTH: Durham -- protocol for a cluster randomized trial of BETTER in community and public health settings
Abstract
Background: 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).
Methods: 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.
Better health: 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.
Discussion: The effectiveness of BETTER HEALTH: Durham will be tested for delivery in low income neighbourhoods by a public health department.
Trial registration: NCT03052959, registered February 10, 2017.
Keywords: Chronic disease; Cluster randomized trial; Deprivation; Prevention; Screening.
Conflict of interest statement
Authors’ information
There is no other authors’ information.
Ethics approval and consent to participate
This work has been approved by the Research Ethics Board of Sunnybrook Health Sciences Centre, Toronto, Ontario Canada (approval number 222–2016). . Recruitment has not commenced. When recruitment commences, written informed consent will be sought from individual participants.
Consent for publication
This manuscript does not contain any material or data for which consent for publication is required.
Competing interests
All authors have received research funding for this trial from the Canadian Institutes for Health Research and the Canadian Cancer Society Research Institute. There are no other competing interests.
Publisher’s Note
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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References
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- Borkhoff CM, Saskin R, Rabeneck L, Baxter NN, Liu Y, Tinmouth J, Paszat LF. Disparities in receipt of screening tests for cancer, diabetes and high cholesterol in Ontario, Canada: a population-based study using area-based methods. Can J Public Health. 2013;104(4):e284–e290. doi: 10.17269/cjph.104.3699. - DOI - PMC - PubMed
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- Grunfeld E, Manca D, Moineddin R, Thorpe KE, Hoch JS, Campbell-Scherer D, Meaney C, Rogers J, Beca J, Krueger P, Mamdani M for the BETTER Trial Investigators Improving chronic disease prevention and screening in primary care: results of the BETTER pragmatic cluster randomized controlled trial. BMC Fam Pract. 2013;14:175. doi: 10.1186/1471-2296-14-175. - DOI - PMC - PubMed
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