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

NCT04746859 | Active Not Recruiting

• 1 other identifier: 2020-0079-E
• Study Type: interventional
• Target: 268
• Locations: 1 country
• Sites: 3

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.

Conditions

Chronic Disease; Cancer

Keywords

chronic disease prevention; cancer screening; community health worker; family practice; randomized control trial; hybrid design; process evaluation

Outcome Measures

Primary Outcomes (1)

• Increased targeted behaviours from baseline

  The primary outcome is binary and defined as whether a patient increased the number of completed targeted behaviours from baseline to end of follow-up at 6 months. The targeted behaviours include the status (up to date or out of date) of three cancer screening tests (cervical, breast, colorectal) and the status (meeting evidence-based target or not) of four behavioural determinants for risk of cancer and chronic disease (diet, smoking, alcohol use, physical activity). If a patient meets at least one more target at 6 months than they met at baseline, their outcome will be considered positive.

  0, 6 months

Secondary Outcomes (32)

• Goal achievement

  0, 6 months; 12 months for intervention group only

• Breast cancer screening status

  0, 6 months

• Cervical cancer screening status

  0, 6 months

• Colorectal cancer screening status

  0, 6 months

• Diet status

  0, 3, 6 months; 12 months for intervention group only

Other Outcomes (8)

• Cardiovascular risk

  0, 6 months; 12 months for intervention group only

• Health-related quality of life

  0, 3, 6 months; 12 months for intervention group only

• Quality-adjusted life year (QALY)

  0, 3, 6 months; 12 months for intervention group only

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Other: Prevention Visit; Behavioral: Peer health coaching

Wait-list Control

OTHER

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.

Other: Prevention Visit

Interventions

Prevention Visit 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.

Intervention; Wait-list Control

Peer health coaching 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.

Intervention

Eligibility Criteria

• Age: 40 Years - 68 Years
• Gender Eligibility Details: Any person who self-identifies as a woman, regardless of sex assigned at birth, and meets all other eligibility criteria will be invited to participate.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Women's College Hospital: lead
• Canadian Cancer Society (CCS): collaborator
• Public Health Agency of Canada (PHAC): collaborator
• Women's College Hospital Foundation: collaborator
• Women's College Hospital Family Practice Health Centre: collaborator
• Barrie and Community Family Health Team: collaborator
• University Health Network, Toronto: collaborator
• Applied Health Research Centre: collaborator
• Summerville Family Health Team: collaborator

Study Sites (3)

Barrie and Community Family Health Team

Barrie, Ontario, L4N 7L3, Canada

Location

Summerville Family Health Team

Mississauga, Ontario, L5B 2P7, Canada

Location

Women's College Hospital Family Practice Health Centre

Toronto, Ontario, M5S 1B3, Canada

Location

Related Publications (3)

• 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.

  PMID: 24252125 BACKGROUND

• 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.

  PMID: 24191075 BACKGROUND

• 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.

  PMID: 39053957 DERIVED

Related Links

• Information about the Alcohol Use Disorders Identification Test (AUDIT)
• Mediterranean Diet Toolkit (Nov 2018) by Dietitians of Canada
• The screening tool used to provide the physical activity index (PAI)

MeSH Terms

Conditions

Chronic Disease; Neoplasms

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Noah M Ivers, MD, PhD

  Women's College Hospital

  PRINCIPAL INVESTIGATOR

• Aisha Lofters, MD, PhD

  Women's College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician-Scientist

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 10, 2021
• Study Start: June 14, 2021
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available starting from the completion of the primary outcome analysis and will remain available for at least 10 years as mandated by WCH data storage policies.
• Access Criteria: External researchers who have a legitimate interest in the data, subject to approval, must submit a detailed data access request, including their research proposal, analysis plan, and plan for research ethics board approval.

Locations

CA (3)