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AgingHealthTAPESTRYNCT02283723

A Randomized Controlled Trial Using the Health TAPESTRY Approach to Care for Older Adults

A study testing Health TAPESTRY Intervention in people with Aging, run by McMaster University at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Health TAPESTRY is a delayed intervention pragmatic randomized control trial promoting interprofessional team collaboration, facilitating connection to the community through system navigation and trained community volunteers, enhancing communication and improving care through the use of technology to better understand… Read more about this study

Who is it for?
Ages 70 years and olderHealthy volunteers can take part
Conditions the study is for
Aging
What is being tested?
Health TAPESTRY Intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
316 participants
Where
2 sitesCanada
Study dates
Dec 2014to Nov 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 70 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Any community-dwelling patient of McMaster Family Health Team over the age of 70

Who cannot join

  • Patient is palliative or receiving end-of-life care
  • Patient is deceased
  • Has explicitly stated that they do not want to be part of a research project
  • Patient resides in long-term care
  • Patient has indicated that they do not want to receive a home visit from trained community volunteers.
  • Patient or family member does not speak English
  • Patient will be out of the country for more than 50% of trial duration

Trial locations and contacts

2 sites in 1 country.

Canada2 sites

  • McMaster Family Practice

    Hamilton, Ontario

  • Stonechurch Family Health Centre

    Hamilton, Ontario

Other trials in Canada

About this study

Official title: Health Teams Advancing Patient Experience: Strengthening Quality (TAPESTRY): A Randomized Controlled Trial Using the Health TAPESTRY Approach to Care for Older Adults

Health TAPESTRY is a delayed intervention pragmatic randomized control trial promoting interprofessional team collaboration, facilitating connection to the community through system navigation and trained community volunteers, enhancing communication and improving care through the use of technology to better understand and assist older adult patients in achieving their health goals and to enable them to have optimal aging.

Read the detailed description

The overarching aim of the integrated multicomponent Health TAPESTRY approach is to promote optimal aging. Optimal aging within the Health TAPESTRY program means supporting people to move through life with good health in the best possible way: Being Alive Well. Health TAPESTRY is a health and social care approach that centres on meeting a person's health goals with the support of technology, trained community volunteers, an interprofessional team, system navigation, and better links between primary care and community organizations. The Health TAPESTRY intervention takes a complex, multilevel approach to integration, from both system level and individual level perspectives. The Health TAPESTRY program will provide processes and tools to activate and support individuals to access and use the broad range of available primary health care, social and community services to achieve their personal health goals and strategies to better integrate care at the system level. More specifically Health TAPESTRY will promote optimal aging:

  • through intentional, proactive conversations about a person's life, health and care goals within the primary healthcare setting;
  • through improved connections between inter-professional primary care teams, community service providers and informal caregivers;
  • by training volunteers to serve as a link between the primary care team and a person in their home;
  • by using technology from the home to link directly with the primary health care team which includes
  • the tablet-based Health TAPESTRY app for volunteers to use;
  • the Personal Health Record (PHR) and
  • innovative resources (i.e. Optimal Aging Portal).

It is anticipated that together these will enable transformation of how primary healthcare and interprofessional teams provide care to older adults in a manner that provides value for resources used and meets needs and goals of older adults.

Conditions
Aging
Being tested
Health TAPESTRY Intervention, Usual care
Keywords
older adults, goal attainment, optimal aging

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Health TAPESTRY InterventionOther

    The patient will receive in-home visits from trained volunteers to assess overall health and wellness and discover any health goals patient might have. This information will be electronically communicated back to interprofessional healthcare team and used to create informed care plan, link to relevant community services and allow the patient to age optimally.

  • Usual careOther

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

Study groups in NCT02283723
Study groupRoleWhat they receive
Patient Group 1ExperimentalThis patient group will begin receiving the Health TAPESTRY intervention from time zero.
Receives: Other: Health TAPESTRY Intervention
Patient Group 2Active comparatorUsing a step-wedge approach, this patient group will receive the intervention after a six month waiting period where they will be used as a comparable group. In the first six months, they will receive usual care.
Receives: Other: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progress attaining health goals

    The participant will identify up to 5 areas of health that will serve as the basis for Goal Attainment Scale(GAS) measurement and will assign subjective weights using a scale of 1 to 9 (higher scores indicating greater importance). An indicator for each goal is selected and used to indicate progress in meeting the goal. The expected outcomes for each problem area will be identified. These outcomes will be standardized and as descriptive, objective and observable as possible. The indicators will be applied to the intervention group and control group in the same manner. Participants will be followed up at the end of 6 months by an independent and blinded assessor for the purpose of study comparison to evaluate the patient's level of goal attainment for each priority problem area that has a goal attainment scale constructed for it although participants in the intervention group may have follow occur more frequently as the information about goals is transmitted to the health care team

    Measured: 12 months

Secondary outcomes (12)

  1. Quality of life measures (2 tools)

    1)The EuroQol-5 Demensop-5 Level (EQ-5D-5L) is comprised of six questions investigating patients' present health status. The last question requires patients to rate one's own current health status on a scale from 0-100, 0 being worst and 100 being the best; and 2)Veterans Rand-12 (VR-12) It's a 9 item survey that focuses mainly on physical and emotional health. The survey was developed at RAND Corporation with the support of US Department of Veterans Affairs. Both of these tools are under consideration by the Canadian Institute of Health Research (CIHR) led community based primary healthcare indicators group and the proposed TAPESTRY study offers the opportunity to compare the two tools.

    Measured: 12 months

  2. Self-efficacy Scale

    The scale measures the ability and confidence of patient to self-manage their own health. The scale comprises of 6 items and each item is responded on a 10-point Likert scale with 0 indicates not at all confident and 10 denotes totally confident.

    Measured: 12 months

  3. Optimal aging

    Single question, "In terms of your own healthy aging, would you say it is excellent, very good, good, fair, or poor?" Ratings become a 5-point scale ranging from 1 to 5. A similar question has been used in the Canadian Longitudinal Study on Aging.

    Measured: 12 months

  4. Duke Social Support Index

    This validated scale is comprised of 11 questions. The first seven questions measure satisfaction with social support and the latter five questions assess social networking. Satisfaction score range from 6-18 whereas networking scores ranges from 4-12. The scale facilitates understanding patients' relationships with friends/family and whoever supports them. Those individuals who score less than 10 on the satisfaction scale are considered at risk.

    Measured: 12 months

  5. Comprehensiveness

    Perceived clinic comprehensives regarding patient healthcare needs will be assessed via CIHR common indicator (comprehensiveness domain). Participants respond to 4 questions using a 4-point scale ("not at all" to "definitely"), with an additional option of "I haven't needed such support.

    Measured: 12 months

  6. Patient Empowerment

    The extent to which participants feel in control with regard to healthcare is measure via CIHR common indicator (patient empowerment domain). Participants respond to 5 questions using a 4-point scale ("not at all" to "definitely").

    Measured: 12 months

  7. Patient Centredness

    The extent to which participants feel their healthcare team addresses what matters to them will be assessed via CIHR common indicator (Patient-Centredness domain). Participants respond to 6 questions using a 4-point scale ("not at all" to "completely").

    Measured: 12 months

  8. Access

    Patient access to services will be assessed via CIHR common indicators project: Access subdomain.

    Measured: 12 months

  9. Satisfaction with Care

    This is a one item scale that about satisfaction with primary care received. Participants are asked to rate their level of satisfaction from 1 ("not at all satisfied") to 10 ("completely satisfied").

    Measured: 12 months

  10. Hospitalizations for Ambulatory Care Sensitive Conditions (ACSC) for Chronic Disease

    An indirect measure of access to primary care is seen for example, in increased for diagnoses that can be effectively managed outside hospital (ambulatory care sensitive conditions; ACSCs). ACSCs such as chronic obstructive pulmonary diseases, asthma, diabetes, hypertension, angina and others), have rates of 387 per 100,000 for those aged 75 to 84 years compared to 2240 per 100,000 for those 85 years or older. Hospitalizations for Adverse Events will also be calculated.

    Measured: 12 months

  11. Caregiver Strain Index

    For those participant who answer "yes" to being a caregiver, the 4-item Zarit screen will be administered in addition to a description of the context of their caregiving will be given. For this screen, participants answer 4 questions using a 5-point scale from "never" to "always".

    Measured: 12 months

  12. Cost-effectiveness

    Program costs: Will be measured using micro costing techniques where a healthcare cost and Resource utilization form has been pilot tested to record resources used during the implementation of the TAPESTRY program. This resource use information will be combined with unit prices for each resource and summed across all resources to estimate the total cost of the program. Maintaining and updating infrastructure costs will be included. Healthcare resource use and cost: Will be obtained from the patient questionnaire that will assess cost and resources involved in providing healthcare for older adults.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2014 (estimated)
  2. Study startDec 2014
  3. Primary completionNov 2016
  4. Study completionNov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
316 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02283723
Sponsor's protocol ID
14-726
Acronym
HealthTAPESTRY
Status last verified
Jan 2018
First submitted
3 Nov 2014
Last updated
3 Jan 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Gaber J, Oliver D, Valaitis R, Cleghorn L, Lamarche L, Avilla E, Parascandalo F, Price D, Dolovich L. Experiences of integrating community volunteers as extensions of the primary care team to help support older adults at home: a qualitative study. BMC Fam Pract. 2020 May 16;21(1):92. doi: 10.1186/s12875-020-01165-2.

    PubMed 32416718

  • Valaitis R, Cleghorn L, Dolovich L, Agarwal G, Gaber J, Mangin D, Oliver D, Parascandalo F, Ploeg J, Risdon C. Examining Interprofessional teams structures and processes in the implementation of a primary care intervention (Health TAPESTRY) for older adults using normalization process theory. BMC Fam Pract. 2020 Apr 15;21(1):63. doi: 10.1186/s12875-020-01131-y.

    PubMed 32295524

  • Dolovich L, Oliver D, Lamarche L, Thabane L, Valaitis R, Agarwal G, Carr T, Foster G, Griffith L, Javadi D, Kastner M, Mangin D, Papaioannou A, Ploeg J, Raina P, Richardson J, Risdon C, Santaguida P, Straus S, Price D. Combining volunteers and primary care teamwork to support health goals and needs of older adults: a pragmatic randomized controlled trial. CMAJ. 2019 May 6;191(18):E491-E500. doi: 10.1503/cmaj.181173.

    PubMed 31061074

  • Dolovich L, Oliver D, Lamarche L, Agarwal G, Carr T, Chan D, Cleghorn L, Griffith L, Javadi D, Kastner M, Longaphy J, Mangin D, Papaioannou A, Ploeg J, Raina P, Richardson J, Risdon C, Santaguida PL, Straus S, Thabane L, Valaitis R, Price D. A protocol for a pragmatic randomized controlled trial using the Health Teams Advancing Patient Experience: Strengthening Quality (Health TAPESTRY) platform approach to promote person-focused primary healthcare for older adults. Implement Sci. 2016 Apr 5;11:49. doi: 10.1186/s13012-016-0407-5.

    PubMed 27044360

Questions about this trial

What is this clinical trial studying?

A study testing Health TAPESTRY Intervention in people with Aging, run by McMaster University at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progress attaining health goals (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02283723, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2018.

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