Clinical trial NCT04746859: Evaluation of the Effectiveness and Implementation of the BETTER Women Peer Health Coaching Program
Official title: BETTER Women: Community-Based, Primary Care-Linked Peer Health Coaching to Achieve Evidence-Based Preventive Care Goals - A Pragmatic, Wait-List Controlled Effectiveness-Implementation Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Disease
Cancer
Keywords: chronic disease prevention
cancer screening
community health worker
family practice
randomized control trial
hybrid design
process evaluation
Lead sponsor: Women's College Hospital
Sponsor class: OTHER
Collaborators: name: Canadian Cancer Society (CCS)
name: Public Health Agency of Canada (PHAC)
name: Women's College Hospital Foundation
name: Women's College Hospital Family Practice Health Centre
name: Barrie and Community Family Health Team
name: University Health Network, Toronto
name: Applied Health Research Centre
name: Summerville Family Health Team
First posted: 2021-02-10
Enrollment: 268
Sex: ALL
Minimum age (years): 40
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The Building on Existing Tools To improvE cancer and chronic disease pRevention and screening in primary care (BETTER) Program allows patients in primary care to have a dedicated visit with a prevention practitioner to discuss chronic disease prevention and cancer screening. A prevention practitioner is a health professional, working in primary care, who has received additional training to discuss chronic disease prevention and screening and develop health goals with patients through shared decision-making. Previous studies have shown that this approach increases the number of prevention and screening actions completed by program participants. However, maintenance of health behaviour changes is difficult without on-going support. There is also some evidence that peer-delivered coaching can improve health outcomes in community settings. As such, the BETTER Women program extends the BETTER program by focusing on 40 to 68-year-old women and providing time-limited support for health behaviour change through peer health coaches. Coaches are volunteers - trained in techniques to support health behaviour change - who support women to achieve their health goals over a 6-month period. In this study, the investigators will explore: (i) whether patients who participate in health coaching after a prevention visit are more likely to increase the number of prevention and screening actions that they complete after six months, compared to women who participate in a prevention visit but do not get health coaching; (ii) whether the intervention effects endure six months after the intervention ends; and (iii) the implementation of the program to learn about factors that affect various aspects of the success and sustainability of the program.

Detailed description: While the BETTER program has been shown to successfully increase the number of preventive care and screening actions completed by patient participants after six months, it is known that it is difficult to maintain new health behaviours in the long-term. Unfortunately, it is not feasible to fund health professionals to offer repeated follow-up visits over the time needed to turn initial behaviour changes into long-term habits. Therefore, the investigators are building upon the existing BETTER program by adding a peer health coaching extension that will provide time-limited coaching for patients who want support as they work towards achieving preventive health goals. This approach takes advantage of growing awareness of the role of lay health coaches in improving and extending the quality and value of primary care.

This is a three-site, pragmatic, wait-list-controlled, randomized, Type 1 hybrid effectiveness-implementation trial with blinded outcome collection after 6 months. One site will be an urban, academic, hospital-based clinic; the second will be a clinic serving a greater proportion of patients from rural areas; and the third site will be a suburban clinic with a large South Asian population. Investigators will invite women who are 40-68 years old to have a single visit with a prevention practitioner and receive behaviour change support for up to six months from a health coach. Coaches will do a 24-hr training course, which includes special techniques to support health behaviour change, before they are matched to a patient. At the suburban site, only South Asian peer health coaches will be recruited and this work is being guided by a South Asian Community Advisory Council made up of members of various community organizations in that region. Patients who enroll in BETTER Women will be randomized to receive health coaching either immediately (intervention group) or after a 6-month delay (wait-list control group).

Effectiveness of the program will be assessed by evaluating for each patient, how many of a set of target chronic disease prevention and screening actions were completed at six months, in comparison to baseline. Investigators will also assess whether patients achieved the health goals that they set with their prevention practitioners, physiological markers of health, as well as habits and behaviours related to diet, physical activity, smoking and alcohol use. These outcomes will be collected via electronic surveys administered at baseline, 3- and 6-months\* post enrollment as well as through extraction of data from the patients' electronic medical records and BETTER program documents. These outcomes will be compared between the two groups of patients in the study. Additionally, investigators will survey intervention group participants and extract relevant data from their electronic medical records at 12-months\* post enrollment.

An embedded process evaluation will be conducted during the trial to examine the implementation of the program. The process evaluation will include collection of program data, electronic surveys administered to patients as well as qualitative interviews with intervention group patients, peer health coaches and prevention practitioners. Investigators will examine how acceptable the program was to patients; whether and why any adaptations were made; how well the program was utilized; how well the coaches delivered the intervention (e.g., what behaviour change techniques were used); how engaged patients and coaches were with the program; and mechanism(s) of action. Ultimately, investigators expect to gain an understanding of the program's sustainability, acceptability, cost-effectiveness, and factors that might impact future attempts at spread and scale.

Investigators expect to see that women in the intervention group (i.e., those who had a health coach) will complete more preventive and screening actions after six months. Investigators also expect to see that women in the intervention group will make more progress on achieving health goals and making lifestyle changes which reduce the risk of chronic diseases and cancers, that the intervention will increase women's access to resources in their primary care clinics and community, as well as improve the women's ability to maintain healthy behaviours.

Note\*: The investigators initially planned to collect surveys and data for the primary outcome (for both groups) at 12 months post enrollment. However, due to pandemic-related recruitment challenges, the data collection timeline was amended as described above to allow more time for recruitment within the project timeline.

Eligibility criteria: Inclusion Criteria:

* Patient identifies as a woman;
* Patient is 40-68yo;
* Patient has an email address;
* Patient has at least one behavioural risk factor not at target or at least one cancer screening overdue as defined below:

  * Score of less than 9 on the Mediterranean Diet Tool
  * Less than 150 minutes of moderate to vigorous physical activity per week
  * Smoked a cigarette within the last 30 days
  * Average number of drinks per day is ≥1 and/or has \>1 drink on any single occasion
  * Due or overdue for one or more of breast, cervical or colorectal cancer screenings;
* Patient has a valid number for the provincial health insurance program (Ontario Health Insurance Program \[OHIP\]); and
* Patient's medical records for, at least the previous 3 years are accessible through their family physician.

Exclusion Criteria:

* Patient is unable to give informed consent in English due to language, literacy, or competence;
* Patient is unable or unwilling to communicate with the study team to collect outcomes in English via both email and phone; or
* Patient's primary care provider has identified medical comorbidities or other conditions at baseline that might interfere with the patient's ability to follow through on the intervention.

Primary outcomes:
measure: Increased targeted behaviours from baseline
timeFrame: 0, 6 months
Secondary outcomes:
measure: Goal achievement
timeFrame: 0, 6 months; 12 months for intervention group only
measure: Breast cancer screening status
timeFrame: 0, 6 months
measure: Cervical cancer screening status
timeFrame: 0, 6 months
measure: Colorectal cancer screening status
timeFrame: 0, 6 months
measure: Diet status
timeFrame: 0, 3, 6 months; 12 months for intervention group only
measure: Improvement in diet
timeFrame: 0, 3, 6 months; 12 months for intervention group only
measure: Diet management
timeFrame: 0, 3, 6 months; 12 months for intervention group only
measure: Physical activity status
timeFrame: 0, 3, 6 months; 12 months for intervention group only
measure: Improvement in physical activity
timeFrame: 0, 3, 6 months; 12 months for intervention group only
measure: Physical activity management
timeFrame: 0, 3, 6 months; 12 months for intervention group only
measure: Smoking status
timeFrame: 0, 3, 6 months; 12 months for intervention group only
measure: Improvement in smoking
timeFrame: 0, 3, 6 months; 12 months for intervention group only
measure: Smoking management
timeFrame: 0, 3, 6 months; 12 months for intervention group only
measure: Alcohol use status
timeFrame: 0, 3, 6 months; 12 months for intervention group only
measure: Improvement in alcohol use
timeFrame: 0, 3, 6 months; 12 months for intervention group only
measure: Alcohol use management
timeFrame: 0, 3, 6 months; 12 months for intervention group only
measure: Up-to-date measurement of glycated haemoglobin (HbA1c)
timeFrame: 0, 6 months; 12 months for intervention group only
measure: HbA1c control
timeFrame: 0, 6 months; 12 months for intervention group only
measure: HbA1c
timeFrame: 0, 6 months; 12 months for intervention group only
measure: Glycemic management
timeFrame: 0, 3, 6 months; 12 months for intervention group only
measure: Up-to-date measurement of blood pressure (BP)
timeFrame: 0, 6 months; 12 months for intervention group only
measure: BP control
timeFrame: 0, 6 months; 12 months for intervention group only
measure: Systolic BP
timeFrame: 0, 6 months; 12 months for intervention group only
measure: Diastolic BP
timeFrame: 0, 6 months; 12 months for intervention group only
measure: Hypertension management
timeFrame: 0, 3, 6 months; 12 months for intervention group only
measure: Up-to-date assessment of low-density lipoprotein (LDL) cholesterol
timeFrame: 0, 6 months; 12 months for intervention group only
measure: LDL control
timeFrame: 0, 6 months; 12 months for intervention group only
measure: LDL
timeFrame: 0, 6 months; 12 months for intervention group only
measure: LDL cholesterol management
timeFrame: 0, 3, 6 months; 12 months for intervention group only
measure: Up-to-date assessment for obesity
timeFrame: 0, 6 months; 12 months for intervention group only
measure: BMI control
timeFrame: 0, 6 months; 12 months for intervention group only
measure: Management of obesity
timeFrame: 0, 3, 6 months; 12 months for intervention group only
Other outcomes:
measure: Cardiovascular risk
timeFrame: 0, 6 months; 12 months for intervention group only
measure: Health-related quality of life
timeFrame: 0, 3, 6 months; 12 months for intervention group only
measure: Quality-adjusted life year (QALY)
timeFrame: 0, 3, 6 months; 12 months for intervention group only
measure: Outpatient visits
timeFrame: 6 months
measure: Emergency room (ER) visits
timeFrame: 6 months
measure: Total healthcare costs
timeFrame: 6 months
measure: Intervention cost/patient
timeFrame: 4 years
measure: Duration of intervention effect
timeFrame: 6, 12 months
Locations:
city: Barrie
country: Canada
facility: Barrie and Community Family Health Team
state: Ontario
city: Mississauga
country: Canada
facility: Summerville Family Health Team
state: Ontario
city: Toronto
country: Canada
facility: Women's College Hospital Family Practice Health Centre
state: Ontario
Study officials:
affiliation: Women's College Hospital
name: Noah M Ivers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Women's College Hospital
name: Aisha Lofters, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grunfeld E, Manca D, Moineddin R, Thorpe KE, Hoch JS, Campbell-Scherer D, Meaney C, Rogers J, Beca J, Krueger P, Mamdani M; 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 Nov 20;14:175. doi: 10.1186/1471-2296-14-175.
citation: Bodenheimer TS, Smith MD. Primary care: proposed solutions to the physician shortage without training more physicians. Health Aff (Millwood). 2013 Nov;32(11):1881-6. doi: 10.1377/hlthaff.2013.0234.