Health TAPESTRY Ontario

NCT ID: NCT03397836

Last Updated: 2021-06-10

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

COMPLETED

Clinical Phase

NA

Total Enrollment

599 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-15

Study Completion Date

2020-10-29

Brief Summary

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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

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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.

Conditions

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Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Health TAPESTRY Intervention

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Group Type EXPERIMENTAL

Health TAPESTRY Intervention

Intervention Type OTHER

The patient will receive in-home visits from trained volunteers who will collect information electronically using a tablet computer. The volunteers will collect information about the client's health goals, health risks, and needs using a specifically designed application (TAP-App). Once the data is gathered, it is summarized into a report (TAP-report) which is securely and electronically sent to the health care clinic (TAP huddle). The team can leverage clinic supports and/or community supports as they deem appropriate to help clients reach their health goals and address any needs and risks which were reported during the volunteer visits.

Usual Care

This patient group will receive the intervention after a 6 month waiting period. In the first 6 months they will receive usual care and they will be used as a comparison group.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

Usual care while waiting for the Health TAPESTRY intervention, the control group will receive usual care from their healthcare providers.

Interventions

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Health TAPESTRY Intervention

The patient will receive in-home visits from trained volunteers who will collect information electronically using a tablet computer. The volunteers will collect information about the client's health goals, health risks, and needs using a specifically designed application (TAP-App). Once the data is gathered, it is summarized into a report (TAP-report) which is securely and electronically sent to the health care clinic (TAP huddle). The team can leverage clinic supports and/or community supports as they deem appropriate to help clients reach their health goals and address any needs and risks which were reported during the volunteer visits.

Intervention Type OTHER

Usual Care

Usual care while waiting for the Health TAPESTRY intervention, the control group will receive usual care from their healthcare providers.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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


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).

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)


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

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Canadian Red Cross

OTHER

Sponsor Role collaborator

Ontario Ministry of Health and Long Term Care

OTHER_GOV

Sponsor Role collaborator

David Braley

UNKNOWN

Sponsor Role collaborator

McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dee Mangin, MBChB,DPH,FR

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

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Department of Family Medicine

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

References

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Mangin D, Lamarche L, Oliver D, Blackhouse G, Bomze S, Borhan S, Carr T, Clark R, Datta J, Dolovich L, Gaber J, Forsyth P, Howard M, Marentette-Brown S, Risdon C, Talat S, Tarride JE, Thabane L, Valaitis R, Price D. Health TAPESTRY Ontario: A Multi-Site Randomized Controlled Trial Testing Implementation and Reproducibility. Ann Fam Med. 2023 Mar-Apr;21(2):132-142. doi: 10.1370/afm.2944.

Reference Type DERIVED
PMID: 36973055 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35718763 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35177040 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32795381 (View on PubMed)

Related Links

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http://healthtapestry.ca/

Health TAPESTRY website

Other Identifiers

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3967

Identifier Type: -

Identifier Source: org_study_id

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