Clinical trial NCT03397836: Health TAPESTRY Ontario
Official title: Health TAPESTRY Ontario: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: Older adults
Optimal aging
Primary health care
Randomized control trial
Integrated care
Health care volunteers
interdisciplinary health care teams
Implementation
Health services research
Patient centered care
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Red Cross
name: Ontario Ministry of Health and Long Term Care
name: David Braley
First posted: 2018-01-12
Enrollment: 599
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The Health Teams Advancing Patient Experience: Strengthening Quality (Health TAPESTRY) is a community-based program led by primary care teams, that creates connections between trained community volunteers, interprofessional health care teams, novel technology and community engagement through improved system navigation. The overall vision is to help people stay healthier for longer in the places where they live.

Detailed description: The Health Teams Advancing Patient Experience: Strengthening Quality (Health TAPESTRY) involves recording a person's life and health goals, screening for health risks and needs, and then initiating a plan that supports achievement of those goals and address risks and needs. It includes four parts:

1. Trained volunteers connect with clients (patients) in their home to gather health and social information and discuss and record life and health goals
2. Interprofessional health care teams provide health care services to the client and focuses on a plan to support them on meeting their health goals
3. Technology is used to collect and share information
4. Community engagement connects clients with resources and supports in the community

Initial findings from Implementation Phase I: 6-month unblinded delayed intervention pragmatic randomized controlled trial that took place in Hamilton, ON (HiREB File #14-726, Clinical Trials.gov NCT02283723) showed significant differences between the intervention and control group. Specifically, at 6-months the it was found:

* a reduction in the intervention group versus control group in self-reported time sitting
* an increase in minutes walking in the intervention group versus the control group
* an increase in number of primary care visits in the intervention group versus the control group
* a reduction in odds of people experiencing 1 or more hospitalizations in the intervention group versus the control group

Understanding the feasibility of implementing Health TAPESTRY in other primary care sites is important to evaluate its potential as an approach. Replication of these initial findings are critical in terms of empirical support for the approach as well as spread and scalability in the wider primary health care system.

Six sites have been identified as Health TAPESTRY-Ontario implementation sites. It should be noted that all appropriate site approvals will be obtained prior to implementation.

1. Niagara North Family Health Team (Niagara-on-the-Lake) (Mary Keith, executive Lead; Dr. Karen Berti, family health team lead)
2. McMaster Family Health Team (Hamilton) (Doug Oliver, family health team lead)
3. Superior Family Health Team (Sault Ste Marie) (Michelle Brisbois, executive lead, Dr. Sarah White, family health team lead)
4. Dufferin and Area Family Health Team (Dufferin County) (Lianne Barbour, executive Lead, Dr. Mercedes Rodriguez, family health team lead)
5. Windsor Family Health Team (Windsor and surrounding area) (Sara Dalo, executive lead)
6. Harrow Family Health Team (Harrow and surrounding communities) (Margo Reilly, executive lead, Dr. Alexandra Lindberg, family health team lead)

A broad alliance between Canadian Red Cross and the Department of Family Medicine has been made, with Health TAPESTRY being a part of that alliance. As part of this partnership, the Canadian Red Cross partner will recruit, train, schedule, and retain community volunteers to operate in the 6 sites.

Eligibility criteria: Participant Inclusion Criteria:

* Be 70 years of age or older
* Rostered to a participating family physician

Participant Exclusion Criteria:

* They are expected to die within 12 months
* They live in a long-term care facility
* They (or their caregiver) are unable to speak and understand English
* They have other conditions or circumstances that means the patient is unable to engage with the volunteers or complete the TAP-App (e.g., severe dementia)
* They are out of the country for more than 6 months or otherwise unavailable for the intervention and assessments
* Participated in Health TAPESTRY phase I implementation (for Hamilton site)

Site Inclusion Criteria:

A Health TAPESTRY site must have the commitment and capacity to implement and sustain the full Health TAPESTRY Program (all four parts). As such, the following success factors are essential:

* A strong Lead Organization with a clearly identified Health TAPESTRY Practice Model Champion from primary care;
* Visible and influential primary care partner in governance and implementation;
* Team-based use of an electronic system for documentation;
* Primary care team available to provide core of implementation;
* Available Information Technology capacity and commitment to integrate with TAP-App (minimum HL7 document transfer capability) and kindred PHR within 6-9 months of program start date;
* Volunteer infrastructure that can recruit, train, sustain, and coordinate/schedule volunteers, and ensure volunteers have access to the digital health tools needed to fulfill role;
* Existing partnerships with local community services;
* Capacity for local program management either through existing staff or with the addition of new staff;
* Available in-kind resources that can support participation in the Health TAPESTRY Program (e.g., clinician and staff engagement, community engagement, patient engagement, etc.); and
* Commitment to evaluation including, but not limited to, collecting and sharing data from electronic documentation system (based on consent).

Site Exclusion Criteria:

* No functional primary care team linkage to support individual patient or client assessments
* Focused assessment on a single condition or disease

Primary outcomes:
measure: Change in Hospitalizations
timeFrame: Change of number of hospitalizations from baseline to 6 months
measure: Change in Physical activity
timeFrame: Change in physical activity from baseline measurement to 6 months
Secondary outcomes:
measure: Emergency department and urgent care visits
timeFrame: Baseline, 6 months
measure: Falls
timeFrame: Baseline, 6 months
measure: Hours sitting
timeFrame: Baseline, 6 months
measure: Patient enablement
timeFrame: Baseline, 6 months
measure: Quality of life
timeFrame: Baseline, 6 months
measure: Treatment burden
timeFrame: Baseline, 6 months
measure: Disease burden
timeFrame: Baseline, 6 months
measure: Medications
timeFrame: Baseline, 6 months
measure: Negative effects (unmet expectations)
timeFrame: Baseline, 6 months
measure: Negative effects (effects of labeling)
timeFrame: 6 months
measure: Negative effects (serious adverse events)
timeFrame: 6 months
measure: Primary care visits
timeFrame: Baseline, 6 months
measure: Reason for hospitalization
timeFrame: Baseline, 6 months
Other outcomes:
measure: Best and worst parts of intervention
timeFrame: 12 months
measure: Recommend to others
timeFrame: 6-months post intervention (patients), 12-months (healthcare providers)
measure: Satisfaction with volunteer
timeFrame: 6 months
measure: Type of primary care visit
timeFrame: 6 months
measure: Length of hospital stay
timeFrame: 6 months
measure: Critical incidents
timeFrame: 12 months
measure: Implementation processes
timeFrame: 1 months, 2 months, 3 months, 6 months, 9 months, 12 months
Locations:
city: Hamilton
country: Canada
facility: Department of Family Medicine
state: Ontario
Study officials:
affiliation: McMaster University
name: Dee Mangin, MBChB,DPH,FR
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lamarche L, Clark RE, Parascandalo F, Mangin D. The implementation and validation of the NoMAD during a complex primary care intervention. BMC Med Res Methodol. 2022 Jun 19;22(1):175. doi: 10.1186/s12874-022-01655-0.
citation: Gaber J, Datta J, Clark R, Lamarche L, Parascandalo F, Di Pelino S, Forsyth P, Oliver D, Mangin D, Price D. Understanding how context and culture in six communities can shape implementation of a complex intervention: a comparative case study. BMC Health Serv Res. 2022 Feb 17;22(1):221. doi: 10.1186/s12913-022-07615-0.
citation: Mangin D, Lamarche L, Oliver D, Bomze S, Borhan S, Browne T, Carr T, Datta J, Dolovich L, Howard M, Marentette-Brown S, Risdon C, Talat S, Tarride JE, Thabane L, Valaitis R, Price D. Health TAPESTRY Ontario: protocol for a randomized controlled trial to test reproducibility and implementation. Trials. 2020 Aug 14;21(1):714. doi: 10.1186/s13063-020-04600-y.