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Health TAPESTRY Ontario

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ClinicalTrials.gov Identifier: NCT03397836
Recruitment Status : Recruiting
First Posted : January 12, 2018
Last Update Posted : July 11, 2018
Sponsor:
Collaborators:
Canadian Red Cross
Ontario Ministry of Health and Long Term Care
David Braley
Information provided by (Responsible Party):
McMaster University

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.

Condition or disease Intervention/treatment Phase
Aging Other: Health TAPESTRY Intervention Other: Usual Care Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Health TAPESTRY Ontario: A Randomized Controlled Trial
Actual Study Start Date : March 15, 2018
Estimated Primary Completion Date : August 1, 2020
Estimated Study Completion Date : November 1, 2020

Arm Intervention/treatment
Experimental: Health TAPESTRY Intervention
This patient group will begin receiving the TAPESTRY interventions from time zero
Other: 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.

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




Primary Outcome Measures :
  1. Change in Hospitalizations [ Time Frame: Change of number of hospitalizations from baseline to 6 months ]
    Number of hospitalizations in the past 6 months.

  2. Change in Physical activity [ Time Frame: Change in physical activity from baseline measurement to 6 months ]
    Physical activity will be measured by the Short version of the International Physical Activity Questionnaire. Respondents indicate how many days in the past seven days and for how many minutes they have engaged in vigorous and moderate intensity activity and walking activity. Scores are calculated by multiplying the days by the number of minutes on one day, by the metabolic equivalent of task (8.0,4.0 and 3.3 for vigorous, moderate, walking activity respectively). Minimum score is of the scale is zero, with higher scores representing higher levels of physical activity.


Secondary Outcome Measures :
  1. Emergency department and urgent care visits [ Time Frame: Baseline, 6 months ]
    Number of emergency department and urgent care visits in the past 6 months. Reasons for each visit will also be extracted in order to describe the nature of visits.

  2. Falls [ Time Frame: Baseline, 6 months ]
    Number of falls in the past 6 months (those resulting in medical treatment).

  3. Hours sitting [ Time Frame: Baseline, 6 months ]
    Hours sitting will be measured by the sitting item on the Short version of the International Physical Activity Questionnaire. Respondents indicate for how many hours they sit in a typical day. Scale ranges from 0 hours to 24 hours, higher scores indicate higher hours sitting.

  4. Patient enablement [ Time Frame: Baseline, 6 months ]
    A modified version of the Patient Enablement Instrument will be used as a measure of patient empowerment in their own care. Specifically, the stem "as a result of your visit to the doctor today…" was deleted and instead, "after a usual visit with your family health care team, do you feel that you are…" was used.

  5. Quality of life [ Time Frame: Baseline, 6 months ]
    The EuroQol five dimension (EQ-5D-5L) will be used to measure quality of life. This survey asks respondents to rate their ability in five different domains: mobility, self-care, usual activities, pain, and anxiety/depression. In addition, respondents are asked to rate their current health state on a scale from 0 ('worst health you can imagine') to 100 ('best health you can imagine'). A score from the five domains is calculated using a macro program and ranges from 0 to 1.

  6. Treatment burden [ Time Frame: Baseline, 6 months ]
    Treatment burden will be measured by the Brief Treatment Burden Scale. Respondents are asked to rate their level of difficulty they have with ten different treatment-related tasks on a scale from "not difficult" to "extremely difficult".

  7. Disease burden [ Time Frame: Baseline, 6 months ]
    Disease burden will be measured using the Disease Burden survey. Respondents are asked to indicate which conditions they have, and for those conditions present, the degree to which the condition hurts their daily activity from "not at all" to "a lot". The list contains common chronic conditions.

  8. Medications [ Time Frame: Baseline, 6 months ]
    Number of long-term prescription medications (defined as use of a medication for 3 or more months).

  9. Negative effects (unmet expectations) [ Time Frame: Baseline, 6 months ]
    A measure of unmet expectations specifically developed for this trial. Participants will be asked to rate the level of their expectation with the question: 'In thinking about the kind and amount of care you received as a result of Health TAPESTRY, to what extent did it meet your expectations?' Answer option include: exceeded expectations, met expectations, no real difference in kind or amount of care received, or kind and amount of care received was worse than before Health TAPESTRY.

  10. Negative effects (effects of labeling) [ Time Frame: 6 months ]
    The negative effects of labeling will be measured using a survey developed for this trial. For those identifying that Health TAPESTRY made them aware of health conditions or risks they were unaware of before, an open-ended question to describe the impact of this awareness will be asked.

  11. Negative effects (serious adverse events) [ Time Frame: 6 months ]
    Serious adverse events will be recorded using retrospective chart audit.

  12. Primary care visits [ Time Frame: Baseline, 6 months ]
    Number of primary care visits.

  13. Reason for hospitalization [ Time Frame: Baseline, 6 months ]
    Reason for each hospitalization will be categorized into ambulatory care sensitive conditions or acute care conditions.


Other Outcome Measures:
  1. Best and worst parts of intervention [ Time Frame: 12 months ]
    Open-ended list of the five best and five worst parts of Health TAPESTRY for patients and health care providers.

  2. Recommend to others [ Time Frame: 6-months post intervention (patients), 12-months (healthcare providers) ]
    Patients and health care providers asked whether or not they would recommend Health TAPESTRY to others.

  3. Satisfaction with volunteer [ Time Frame: 6 months ]
    Satisfaction with interpersonal relationships with volunteer survey completed by patients.

  4. Type of primary care visit [ Time Frame: 6 months ]
    Recorded profession of the clinician holding the visit with the patient.

  5. Length of hospital stay [ Time Frame: 6 months ]
    Number of days spent in the hospital. Same-day hospitalizations will reflect zero days spent in the hospital for that particular hospitalization.

  6. Critical incidents [ Time Frame: 12 months ]
    Number and type of critical incidents will be tracked electronically.

  7. Implementation processes [ Time Frame: 1 months, 2 months, 3 months, 6 months, 9 months, 12 months ]
    NoMAD survey



Information from the National Library of Medicine

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03397836


Contacts
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Contact: Larkin Lamarche, PhD 905-525-9140 ext 20305 lamarche@mcmaster.ca
Contact: Fiona Parascandalo, MA 905-525-9140 ext 21578 parascf@mcmaster.ca

Locations
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Canada, Ontario
Department of Family Medicine Recruiting
Hamilton, Ontario, Canada, L8P 1H6
Contact: Dee Mangin    905-525-9140 ext 21219    mangind@mcmaster.ca   
Contact: Larkin Lamarche    905-525-9140 ext 21224    lamarche@mcmaster.ca   
Sponsors and Collaborators
McMaster University
Canadian Red Cross
Ontario Ministry of Health and Long Term Care
David Braley
Investigators
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Principal Investigator: Dee Mangin, MBChB,DPH,FR McMaster University

Additional Information:
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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT03397836     History of Changes
Other Study ID Numbers: 3967
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by McMaster University:
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