An interventional study of Immediate Intervention and Wait List Intervention in Cancer and Chronic Disease Prevention, sponsored by Unity Health Toronto. Completed at 1 site in Canada. Open to participants aged 40 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-11-01.
Sponsored by Unity Health Toronto · Not applicable, Interventional, and Prevention
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:
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.
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:
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.
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Exclusion Criteria:
Behavioral: Immediate Intervention
Other: Wait List Intervention
The 'BETTER' prevention practitioner intervention involves assessment of a person's current participation, or lack of participation, among domains of evidence-based chronic disease prevention and surveillance (CDPS) actions. The assessment is followed several days later by a supportive meeting with a prevention practitioner nurse, using principles of shared decision making and health coaching, to establish goals for accomplishing CDPS activities of the individual's choice during the subsequent six months to develop personal goals and targets for participating in CDPS actions during the following six months. In BETTER HEALTH: DURHAM, the prevention practitioner nurse will be a public health nurse from the Durham Region Health Department.
The control arm will receive the prevention practitioner intervention 6 months after the intervention arm. Their outcomes will not be assessed in the study.
Composite Outcome Measure: Mean Percentage of CDPS Actions at Baseline That Are Subsequently Met at Follow-up
The primary outcome measure is the mean percentage of the number of eligible CDPS actions at baseline that are subsequently met (by self-report) at follow-up, measured at the patient level. As a function of baseline characteristics, certain individuals are eligible for certain CDPS actions. At follow-up, each patient will be re-evaluated and the number of eligible actions met will be enumerated. Six months after the baseline survey interview, the research assistant will administer the outcome survey on health and CDPS actions to participants in intervention and control clusters alike. All outcomes are self-reports of the completion of CDPS actions.
Time frame: Six months
Completion of Individual Actions
The investigators will report the frequency with which individual CDPS actions were completed, for those actions for which the individual was eligible at baseline
Time frame: Six months
Number of Self-referrals
The investigators will report the frequency with which self-referrals were reported to the prevention practitioner.
Time frame: Six months
| Milestone | Immediate Intervention | Wait List Intervention |
|---|---|---|
| Started | 59 | 66 |
| Completed | 55 | 61 |
| Not completed | 4 | 5 |
| Withdrew: Lost to follow-up | 4 | 5 |
The primary outcome measure is the mean percentage of the number of eligible CDPS actions at baseline that are subsequently met (by self-report) at follow-up, measured at the patient level. As a function of baseline characteristics, certain individuals are eligible for certain CDPS actions. At follow-up, each patient will be re-evaluated and the number of eligible actions met will be enumerated. Six months after the baseline survey interview, the research assistant will administer the outcome survey on health and CDPS actions to participants in intervention and control clusters alike. All outcomes are self-reports of the completion of CDPS actions.
| percent of actions | Immediate Intervention | Wait List Intervention |
|---|---|---|
| Composite Outcome Measure: Mean Percentage of CDPS Actions at Baseline That Are Subsequently Met at Follow-up | 64.5 ± 27.5 | 42.1 ± 23.8 |
The investigators will report the frequency with which individual CDPS actions were completed, for those actions for which the individual was eligible at baseline
| percentage of eligible actions | Immediate Intervention | Wait List Intervention |
|---|---|---|
| Fasting blood sugar/A1C screen | 29.0 | 25.0 |
| Blood pressure screen | 81.8 | 41.7 |
| Blood pressure monitor | 66.7 | 66.7 |
| LDL measured | 31.6 | 26.3 |
| Breast screening | 50 | 0 |
| Colorectal screening | 14.3 | 0 |
| Cervical screening | 25 | 11.1 |
| Body mass index screening | 72.7 | 0 |
| Waist circumference | 73.6 | 1.6 |
| Weight control | 53.8 | 57.1 |
| Referral for body mass index greater than 25 | 76.9 | 46.9 |
| Smoking cessation | 11.1 | 3.6 |
| Smoking cessation referral | 59.3 | 32.1 |
| Alcohol control | 66.7 | 52.4 |
| Alcohol cessation referral | 40 | 9.5 |
| Physical activity improved | 62.2 | 64.3 |
| Physical activity referral | 71.1 | 41.1 |
| Healthy diet score improved | 90.4 | 91.8 |
| Nutrition referral | 67.3 | 29.5 |
The investigators will report the frequency with which self-referrals were reported to the prevention practitioner.
| percentage of eligible actions | Immediate Intervention | Wait List Intervention |
|---|---|---|
| Fasting blood sugar/A1C screen | 29.0 | 25.0 |
| Blood pressure screen | 81.8 | 41.7 |
| Blood pressure monitored | 66.7 | 66.7 |
| LDL measured | 31.6 | 26.3 |
| Breast cancer screening | 50 | 0 |
| Colorectal cancer screening | 14.3 | 0 |
| Cervical screening | 25.0 | 11.1 |
| Weight control | 53.8 | 57.1 |
| Referral for body mass index greater than 25 | 76.9 | 46.9 |
| Smoking cessation referral | 59.3 | 32.1 |
| Alcohol cessation referral | 40 | 9.5 |
| Physical activity referral | 71.1 | 41.1 |
| Nutrition referral | 67.3 | 29.5 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Immediate Intervention | 0/59 (0%) | 0/59 (0%) | 0/59 (0%) |
| Wait List Intervention | 0/66 (0%) | 0/66 (0%) | 0/66 (0%) |
| Age, Continuous(years) | Immediate Intervention | Wait List Intervention | Total |
|---|---|---|---|
| Mean | 54.5 ± 6.4 | 53.2 ± 6.6 | 53.8 ± 6.5 |
| Sex: Female, Male(Participants) | Immediate Intervention | Wait List Intervention | Total |
|---|---|---|---|
| Female | 21 | 32 | 53 |
| Male | 38 | 34 | 72 |
| Race/Ethnicity, Customized(Participants) | Immediate Intervention | Wait List Intervention | Total |
|---|---|---|---|
| Race/ethnicity — White | 50 | 52 | 102 |
| Race/ethnicity — Other | 9 | 14 | 23 |
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