Study Results
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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COMPLETED
NA
599 participants
INTERVENTIONAL
2018-03-15
2020-10-29
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Health TAPESTRY Intervention
This patient group will begin receiving the TAPESTRY interventions from time zero
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.
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.
Usual Care
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.
Usual Care
Usual care while waiting for the Health TAPESTRY intervention, the control group will receive usual care from their healthcare providers.
Eligibility Criteria
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Inclusion Criteria
* 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 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
70 Years
ALL
Yes
Sponsors
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Canadian Red Cross
OTHER
Ontario Ministry of Health and Long Term Care
OTHER_GOV
David Braley
UNKNOWN
McMaster University
OTHER
Responsible Party
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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
Countries
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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.
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.
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.
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.
Related Links
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Health TAPESTRY website
Other Identifiers
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3967
Identifier Type: -
Identifier Source: org_study_id
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