Clinical trial NCT03052959: BETTER HEALTH: Durham
Official title: Building on Existing Tools To Improve Chronic Disease Prevention and Screening in Public Health: Durham
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer and Chronic Disease Prevention
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
Collaborators: name: Sunnybrook Health Sciences Centre
name: Durham Region Health Department
name: University of Toronto
First posted: 2017-02-14
Enrollment: 126
Sex: ALL
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The BETTER intervention consists of supportive meetings between a specially trained prevention practitioner nurse and individuals aged 40-64 years to review recommended chronic disease prevention and screening activities (CDPS). The prevention practitioner nurse will assist participants to identify goals for accomplishing CDPS activities in the next 6 months. Promotion, recruitment of participants and delivery of the BETTER intervention will be adapted to meet the needs of the residents through the use of participatory research methods and community engagement strategies. The study population consists of individuals aged 40-64 years living in 10 designated areas or "clusters" within Durham Region in Oshawa and Whitby.

Objectives:

1. Help people in the designated areas identify personal goals related to chronic disease prevention and screening activities.
2. Evaluate whether the prevention practitioner was effective in helping people achieve their goals and explore whether this type of intervention could work in other settings.
3. Share what the investigators learn with government and other public health units in Ontario and across Canada.

Some clusters will receive the BETTER intervention right away and other clusters will be in a wait-list control group to receive the intervention 6 months later. Our main outcome is the change in a score that considers the number of preventive health items a person has achieved during the 6 months. The investigators will also be doing in-depth interviews and focus groups with health care providers, community organizations and people who live in the designated areas to understand whether the primary practitioner was effective.

Detailed description: Research has shown that many Ontarians do not participate in all the chronic disease prevention and screening activities that could keep them healthy. Previous studies have found that a prevention practitioner, a nurse who works with health care providers and their practices, can be effective at improving the uptake of chronic disease prevention and screening activities.

The goal of this study is to adapt the BETTER intervention from a health care setting with family practice teams to a community-based strategy in designated areas in Durham Region. The BETTER intervention consists of supportive meetings between a specially trained prevention practitioner nurse and individuals aged 40-64 years to review recommended chronic disease prevention and screening activities (CDPS). The prevention practitioner nurse will assist participants to identify goals for accomplishing CDPS activities in the next 6 months. Promotion, recruitment of participants and delivery of the BETTER intervention will be adapted to meet the needs of the residents through the use of participatory research methods and community engagement strategies.

Previous work by the researchers identified census dissemination areas in Ontario with: (1) the lowest quintile of median household income, (2) low cancer screening rates, and 3) poor access to primary care services. The study population consists of individuals aged 40-64 years living in 10 designated areas or "clusters" within Durham Region in Oshawa and Whitby. The investigators will be working closely with local community agencies and primary care providers to identify people who may benefit from this study.

Objectives:

1. Help people in the designated areas identify personal goals related to chronic disease prevention and screening activities.
2. Evaluate whether the prevention practitioner was effective in helping people achieve their goals and explore whether this type of intervention could work in other settings.
3. Share what the investigators learn with government and other public health units in Ontario and across Canada.

Some clusters will receive the BETTER intervention right away and other clusters will be in a wait-list control group to receive the intervention 6 months later. The investigators will compare the two groups. The study will involve about 120 residents in 10 designated areas. Our main outcome is the change in a score that considers the number of preventive health items a person has achieved during the 6 months. The investigators will also be doing in-depth interviews and focus groups with health care providers, community organizations and people who live in the designated areas to understand whether the primary practitioner was effective.

Eligibility criteria: Inclusion Criteria:

* Males and females aged 40 - 64 years living in sampled low income clusters in Durham region who are English speakers (including illiterate persons). Only one participant per residential household may participate.

Exclusion Criteria:

* Unable to provide informed consent

Primary outcomes:
measure: Composite Outcome Measure: Mean Percentage of CDPS Actions at Baseline That Are Subsequently Met at Follow-up
timeFrame: Six months
Secondary outcomes:
measure: Completion of Individual Actions
timeFrame: Six months
measure: Number of Self-referrals
timeFrame: Six months
Other outcomes:
Locations:
city: Whitby
country: Canada
facility: Durham Region Health Department
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Lawrence Paszat
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lofters AK, O'Brien MA, Sutradhar R, Pinto AD, Baxter NN, Donnelly P, Elliott R, Glazier RH, Huizinga J, Kyle R, Manca D, Pietrusiak MA, Rabeneck L, Riordan B, Selby P, Sivayoganathan K, Snider C, Sopcak N, Thorpe K, Tinmouth J, Wall B, Zuo F, Grunfeld E, Paszat L. Building on existing tools to improve chronic disease prevention and screening in public health: a cluster randomized trial. BMC Public Health. 2021 Aug 3;21(1):1496. doi: 10.1186/s12889-021-11452-x.
citation: Paszat L, Sutradhar R, O'Brien MA, Lofters A, Pinto A, Selby P, Baxter N, Donnelly PD, Elliott R, Glazier RH, Kyle R, Manca D, Pietrusiak MA, Rabeneck L, Sopcak N, Tinmouth J, Wall B, Grunfeld E. BETTER HEALTH: Durham -- protocol for a cluster randomized trial of BETTER in community and public health settings. BMC Public Health. 2017 Sep 29;17(1):754. doi: 10.1186/s12889-017-4797-3.