Community-based Personalized Care and QOL

Study Overview
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Brief Summary
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A pragmatic randomized trial to evaluate the impact of an integrated patient experience and outcome measurement system supported by citizens, caregivers and community through eHealth technology. The primary research question is: What is the effectiveness of the WECCC approach on quality of life in people aged 65 and older or who self-identify as disabled compared to people not receiving the Health TAPESTRY program?

Detailed Description
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Secondary research questions include: what is the feasibility of obtaining study measures through routinely collected program participant data and what design adjustments are needed to balance pragmatism and high quality data collection? What are the analytic approaches to be developed to aggregate data from individual participants into meaningful units (e.g. care-team level, organizational level, social network, and geographic area) to inform ongoing adaptation of the components of the intervention? what are the perceptions of knowledge users on the usefulness of comparative effectiveness pragmatic trial evidence? The project involves using administrative data from the ICES to create outcome measures and feedback systems for communities, and the INSPIRE PHC Unit for expertise in health system integration, care in the community, and knowledge translation. Inclusion criteria: Seniors (65+) and people who self-identify as having a functional disability. Pilot study sites: 7 municipalities and the city of Windsor in Windsor-Essex County in Ontario. The combined total eligible population in all 8 sites is about 60,000 people, from which a minimum sample of 3000 registered patients and 1000 registered caregivers will be drawn In Year 1, planned enrolment includes a minimum of 1100 intervention clients from all recruitment methods in the care model intervention, with similar numbers of control and intention to treat clients. The primary outcomes are quality of life (QOL); perceived health; experience of care, and perceived social connection. The primary outcomes for caregivers will be quality of life; perceived burden; caregiver perceptions of care; and perceived social connection. Secondary outcomes for both will include goal attainment, distress management, symptom management, places of care, and health care utilization and costs. In terms of health equity, the investigators will measure the difference between the average/median population quality of life and cost outcomes compared to patients at the bottom income quartiles stratified by risk level. At a systems level, algorithms will be developed and applied to the data collected from participants to provide aggregate organization and system-level reports, co-designed with end users to support them as learning organizations.

Official Title
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A Pragmatic Trial to Evaluate the Impact of Community-based Personalized Care on Quality of Life in Older and Disabled Adults

Conditions
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Aging, Disability or Chronic Disease Leading to Disablement

Intervention / Treatment
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* Behavioral: Community-based personalized care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals who: are 65 years of age and over have a long-term disability or one or more chronic diseases able to communicate in English OR can provide a formal or informal translator willing to facilitate the participant's involvement Exclusion Criteria: Individuals not meeting above criteria

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| WE Health Tapestry<br>Completion of baseline measures then enrolled in a community-based personalized care intervention that consists of four core elements: volunteer support, interprofessional care, technology, social network linkage | Behavioral: Community-based personalized care<br>* volunteer support, health technology, interprofessional care, social network linkage<br>|
| Usual Care<br>Completion of baseline measures with six-month delayed community-based personalized care intervention: volunteer support, interprofessional care, technology, social network linkage | Behavioral: Community-based personalized care<br>* volunteer support, health technology, interprofessional care, social network linkage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | McGill QoL - patient and family | Baseline and then monthly for 24 months | 
| Perceived health | EQ-5D-5L - patient | Baseline and then monthly for 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caregiver Burden 1 | InterRAI-home care | Baseline and then monthly for 24 months | 
| Caregiver Burden 2 | Zarit burden interview | Baseline and then monthly for 24 months | 
| Patient experience | CANHelp Patient | Baseline and then monthly for 24 months | 
| Family experience | CANHelp Family | Baseline and then monthly for 24 months | 
| Symptom management 1 | Edmonton Symptom Assessment Scale | Baseline and then monthly for 24 months | 
| Symptom management 2 | Palliative Performance Scale | Baseline and then monthly for 24 months | 
| Symptom management 3 | InterRAI-home care | Baseline and then monthly for 24 months | 
| Health services utilization 1 | hospitalization | Baseline and then monthly for 24 months | 
| Health services utilization 2 | Emergency care | Baseline and then monthly for 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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e-health, community networks, pragmatic RCT