Community-based Personalized Care and QOL

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

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?

Study Overview

• Status: Unknown
• Conditions: Aging; Disability or Chronic Disease Leading to Disablement
• Intervention / Treatment: Behavioral: Community-based personalized care

Detailed Description

Secondary research questions include:

1. 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?
2. 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?
3. 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.

• Study Type: Observational
• Enrollment (Anticipated): 1100

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Windsor, Ontario, Canada, N8T 1B5
      • Recruiting
      • Windsor-Essex Compassionate Care Community Program Management Office
      • Sub-Investigator: Merrick Zwarenstein, PhD
      • Contact: Deborah Sattler; Phone Number: 2420 519-974-2581; Email: deborah@deborahsattler.ca
      • Contact: Diane Halbgewachs; Phone Number: 2420 519-974-2581; Email: DHalbgewachs2@thehospice.ca
      • Principal Investigator: Michelle Howard, PhD
      • Sub-Investigator: Lisa Dolovich, PhD
      • Sub-Investigator: Kathryn Pfaff, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Seniors who identify with having a functional disability or serious chronic disease; and informal caregivers. Many patients within this broad target population will be at risk of worsening quality of life or escalating health care utilization now or in the future due to aging, disease progression, or unmet health, social or economic needs.

Description

Inclusion Criteria:

Individuals who:

1. are 65 years of age and over
2. have a long-term disability or one or more chronic diseases
3. 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
WE Health Tapestry; 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; volunteer support, health technology, interprofessional care, social network linkage
Usual Care; 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; volunteer support, health technology, interprofessional care, social network linkage

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Windsor-Essex Compassionate Care Community
• Collaborators: McMaster University; University of Western Ontario, Canada; University of Windsor; Erie St. Clair Local Health Integration Network (LHIN); Green Shield Canada Inc.
• Investigators: Principal Investigator: Michelle Howard, PhD, McMaster University; Principal Investigator: Kathryn Pfaff, PhD, University of Windsor; Principal Investigator: Lisa Dolovich, PhD, McMaster University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Anticipated): September 30, 2018
• Study Completion (Anticipated): September 30, 2018

Study Registration Dates

• First Submitted: August 21, 2017
• First Submitted That Met QC Criteria: August 23, 2017
• First Posted (Actual): August 28, 2017

Study Record Updates

• Last Update Posted (Actual): August 28, 2017
• Last Update Submitted That Met QC Criteria: August 23, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: e-health, community networks, pragmatic RCT
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: HealthTap-WEPilot

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No