Evaluation of the Effectiveness and Implementation of the BETTER Women Peer Health Coaching Program

NCT ID: NCT04746859

Last Updated: 2024-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

268 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-14

Study Completion Date

2025-04-30

Brief Summary

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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

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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.

Conditions

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Chronic Disease Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention

Patients will have a prevention visit with a Prevention Practitioner (a healthcare provider who has received additional training), complete the baseline survey then be invited to receive ongoing support from a trained, volunteer peer health coach, for up to six months. The coach will support the patient as she works towards achieving personalized health goals to reduce her risk of chronic diseases, including cancer. Patients will be administered additional surveys at 3 and 6 months and a final survey at 12 months.

Group Type EXPERIMENTAL

Prevention Visit

Intervention Type OTHER

Patients will have a one-on-one, approximately one-hour long visit with a specially trained Prevention Practitioner. During this visit, they will discuss the patient's health history, their risks for developing chronic diseases, including cancer, and possible steps they can take to reduce those risks. The Prevention Practitioner will also assist the patient to develop and articulate specific goals the patient would like to work on to reduce their risk of chronic diseases.

Peer health coaching

Intervention Type BEHAVIORAL

Patients will be invited to register with the software platform used to facilitate peer health coaching. Once they have registered, they will be matched to a peer health coach who will connect with the patient to initiate the process. The coach will work collaboratively with the patient to help her follow through on a step-wise, personalized plan to achieve health goals that were developed with their prevention practitioner. The coach's approach will be informed by principles of brief action planning and motivational interviewing. Coaches will also provide social support, help to navigate to relevant information and community resources, and advise about options for self-monitoring. Coaching will occur over 12-16 sessions via phone calls, text messages, video calls and/or in-person meetings as desired/convenient and in accordance with local public health guidelines.

Wait-list Control

Patients will have a prevention visit with a Prevention Practitioner (a healthcare provider who has received additional training) and complete a baseline survey, after which they will receive usual care from their healthcare providers. Patients will be administered another survey at 3 months and a final survey at 6 months. After study completion (about 6-months after the initial prevention visit), patients will be invited to receive ongoing support from a trained, volunteer peer health coach, for up to six months. The coach will support the patient as she works towards achieving personalized health goals to reduce her risk of chronic diseases, including cancer.

Group Type OTHER

Prevention Visit

Intervention Type OTHER

Patients will have a one-on-one, approximately one-hour long visit with a specially trained Prevention Practitioner. During this visit, they will discuss the patient's health history, their risks for developing chronic diseases, including cancer, and possible steps they can take to reduce those risks. The Prevention Practitioner will also assist the patient to develop and articulate specific goals the patient would like to work on to reduce their risk of chronic diseases.

Interventions

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Prevention Visit

Patients will have a one-on-one, approximately one-hour long visit with a specially trained Prevention Practitioner. During this visit, they will discuss the patient's health history, their risks for developing chronic diseases, including cancer, and possible steps they can take to reduce those risks. The Prevention Practitioner will also assist the patient to develop and articulate specific goals the patient would like to work on to reduce their risk of chronic diseases.

Intervention Type OTHER

Peer health coaching

Patients will be invited to register with the software platform used to facilitate peer health coaching. Once they have registered, they will be matched to a peer health coach who will connect with the patient to initiate the process. The coach will work collaboratively with the patient to help her follow through on a step-wise, personalized plan to achieve health goals that were developed with their prevention practitioner. The coach's approach will be informed by principles of brief action planning and motivational interviewing. Coaches will also provide social support, help to navigate to relevant information and community resources, and advise about options for self-monitoring. Coaching will occur over 12-16 sessions via phone calls, text messages, video calls and/or in-person meetings as desired/convenient and in accordance with local public health guidelines.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

68 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Canadian Cancer Society (CCS)

OTHER

Sponsor Role collaborator

Public Health Agency of Canada (PHAC)

OTHER_GOV

Sponsor Role collaborator

Women's College Hospital Foundation

UNKNOWN

Sponsor Role collaborator

Women's College Hospital Family Practice Health Centre

UNKNOWN

Sponsor Role collaborator

Barrie and Community Family Health Team

UNKNOWN

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role collaborator

Applied Health Research Centre

OTHER

Sponsor Role collaborator

Summerville Family Health Team

UNKNOWN

Sponsor Role collaborator

Women's College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Noah Ivers

Clinician-Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Noah M Ivers, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Women's College Hospital

Aisha Lofters, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Women's College Hospital

Locations

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Barrie and Community Family Health Team

Barrie, Ontario, Canada

Site Status

Summerville Family Health Team

Mississauga, Ontario, Canada

Site Status

Women's College Hospital Family Practice Health Centre

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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; 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.

Reference Type BACKGROUND
PMID: 24252125 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24191075 (View on PubMed)

Kithulegoda N, Williams C, Senthilmurugan A, Aimola S, Atkinson J, Banerjee AT, Bazeghi F, Bender JL, Flynn S, Ghatage L, Goulbourne E, Grunfeld E, Heisey R, Rao A, Sutcliffe K, Lofters A, Ivers NM. Assessing the effectiveness of "BETTER Women", a community-based, primary care-linked peer health coaching programme for chronic disease prevention: protocol for a pragmatic, wait-list controlled, type 1 hybrid effectiveness-implementation trial. BMJ Open. 2024 Jul 24;14(7):e085933. doi: 10.1136/bmjopen-2024-085933.

Reference Type DERIVED
PMID: 39053957 (View on PubMed)

Related Links

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https://auditscreen.org/

Information about the Alcohol Use Disorders Identification Test (AUDIT)

https://www.dietitians.ca/Advocacy/Toolkits-and-Resources

Mediterranean Diet Toolkit (Nov 2018) by Dietitians of Canada

https://www.gov.uk/government/publications/general-practice-physical-activity-questionnaire-gppaq

The screening tool used to provide the physical activity index (PAI)

Other Identifiers

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2020-0079-E

Identifier Type: -

Identifier Source: org_study_id

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