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Randomized Controlled Trial
. 2017 Sep 29;17(1):754.
doi: 10.1186/s12889-017-4797-3.

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

Affiliations
Randomized Controlled Trial

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

Lawrence Paszat et al. BMC Public Health. .

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.

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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.

Figures

Fig. 1
Fig. 1
Consolidated Framework for Implementation Research adapted to BETTER HEALTH: Durham. Adapted from: Damschroder [25]
Fig. 2
Fig. 2
Adapted Knowledge to Action Process for BETTER HEALTH: Durham. Adapted from Canadian Institues for Health Research [35]

References

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