TeleHomecaRe InterVention Evaluation Study (THRIVE)

April 24, 2019 updated by: Dr. Valeria Rac, University of Toronto

TeleHomecaRe InterVention Evaluation (THRIVE) Study

The goal of this study is to evaluate the overall impact of Telehomecare on COPD and HF patients and system level outcomes using a comparison group of patients that did not participate in the program (for up to 18 months). This evaluation study will explore costs, participants' experiences, perceptions, and patterns of use related to Telehomecare. The study will include eight Local Health Integration Networks (LHINs) across Ontario, Canada.

Study Overview

Status

Unknown

Conditions

Detailed Description

The key question to answer is how different models of Telehomecare enabled self-management impacts patient outcomes, experiences and system costs across Ontario. The evaluation study will also attempt to answer questions on who is benefitting the most from the program and the quantifiable benefits a patient would experience from participating.

The intervention evaluation study will use a mixed-methods design comprising of four components (sub-studies), using both qualitative and quantitative research methods: (1) Comparative Effectiveness Study that evaluates patient-level clinical outcomes (e.g. hospitalization, ED visits) using administrative data in comparison with usual care; (2) Economic Evaluation Study that will evaluate costs associated with the program and patient level outcomes as well as cost-effectiveness of the program in comparison with 'usual care'; (3) Evaluation study of Telehomecare use that will evaluate the patterns of program use and perceived quality of life, disease management, satisfaction and caregiver strain; and (4) Adoption study that will use ethnographic fieldwork, semi-structured interviews (during and after program participation) and review of documentary sources to gain understanding of program adoption.

Study Type

Observational

Enrollment (Anticipated)

5400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

This community based study will be conducted across 8 Local Health Integration Networks (LHINs) in Ontario: Toronto Central, North East, Central West, Erie St Claire, Central, North Simcoe Muskoka, North West and South West LHINs.

The study population will include COPD and HF patients that currently or previously participated in Telehomecare program. The study population will also include informal caregivers and healthcare providers involved in and/or caring for a patient enrolled in the program as well as administrators /decision makers involved with the Telehomecare program.

Description

Inclusion Criteria:

Patient:

  • The patient has a documented diagnosis of HF or COPD (with or without co-morbid conditions);
  • The patient has been classified as a 'heavy user' of the health care system, characterized by any of the following:

    • A minimum of one hospitalization for a respiratory or cardiac complaint in the past six months;
    • A minimum of two emergency department/urgent care center visits for a respiratory or cardiac complaint in the past six months;
    • Currently receiving nursing services via CCAC;
    • Frequent visits to primary care provider in the past year;
  • Patient/informal caregiver (if applicable) is an adult (over 18 years), able and willing to provide informed consent;
  • Patient/informal caregiver (if applicable) is fluent in English;
  • Patient/informal caregiver is able and willing to operate the Telehomecare equipment; and
  • Patient lives in a residential (private home or retirement home) setting with an active landline.

In addition to the program eligibility criteria, the following criteria for the intervention evaluation study apply to recruitment of patients:

  • Patient must have a documented consent for participating in Telehomecare
  • Patients enrolled in the Telehomecare program must have agreed to share their contact and health information for evaluative purposes
  • Patients must provide informed consent before participating in observations, interviews, and surveys as part of the program evaluation study

Healthcare Provider

A healthcare provider that has:

  • Referred a patient that has been previously enrolled in the Telehomecare program, and/or;
  • Provided primary care to a patient enrolled in the evaluation study
  • Previously or currently participated in delivering Telehomecare as a provider or care administrator; o For observations, interviews, and surveys: nurses/physicians must have at least 2 months experience in providing care using Telehomecare

Technicians, Administrators, and/or Decision Makers

The following are eligible for inclusion in the study:

  • Technicians involved in the set-up of Telehomecare equipment in the patient home.
  • Administrators and/or decision makers of the Telehomecare program as a larger network of care such as Healthcare Program Managers, key members of the LHINs, OTN etc.

Exclusion Criteria:

Patient

  • Less than 18 years of age;
  • Individuals without an established diagnosis of COPD or HF
  • Unable or unwilling to provide verbal informed consent
  • Demonstrated non-adherence to the THC program:

    o The Telehomecare Nurse works with each patient on a case-by-case review to assess willingness to partner in their own care, and if the number of missed consultation appointments and reasons for demonstrate overall non-adherence with the program;

  • Inability or unwillingness to use Telehomecare equipment, and/or;
  • Do not have a regular caregiver to assist in the use of the equipment (if assistance is required)

Healthcare Provider

  • Is not a practicing healthcare provider in any of the said LHINs

Technicians, Administrators and/or Decision Makers

  • Unable or unwilling to provide verbal informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Telehomecare patients (matched cohort study)
COPD and HF patients in Telehomecare program (followed up to 18 months)
Usual-care patients (matched cohort study)
COPD and HF patients in 'usual care' (followed up to 18 months)
Telehomecare patients (observations, interviews and surveys)
  1. Observational fieldwork conducted to observe everyday routine activities related to Telehomecare.
  2. In-depth interview conducted for 30-60 min using semi-structured interview guide to assess patient experience with Telehomecare program.
  3. Surveys conducted up to four times using validated survey tools.
Informal caregiver (observations, interviews and surveys)
  1. Observational fieldwork conducted to observe everyday routine activities related to Telehomecare.
  2. In-depth interview conducted for 30-60 min using semi-structured interview guide to assess caregiver experience with Telehomecare program.
  3. Surveys conducted up to four times using validated survey tools.
Healthcare providers (observations, interviews and surveys)
  1. Observational fieldwork conducted to observe everyday routine activities related to Telehomecare.
  2. In-depth interview conducted for 30-60 min using semi-structured interview guide to assess provider experience with Telehomecare program.
Administrators and Decision Makers (observations, interviews)
  1. Observational fieldwork conducted to observe everyday routine activities related to Telehomecare.
  2. In-depth interview conducted for 30-60 min using semi-structured interview guide to assess administrator/decision-maker experience with Telehomecare program.
Technician (observation, interviews)
  1. Observational fieldwork conducted to observe everyday routine activities related to Telehomecare.
  2. In-depth interview conducted for 30-60 min using semi-structured interview guide to assess technician experience with Telehomecare program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease specific hospitalization and ED visits
Time Frame: 18 months
Comparison of disease specific hospitalization and ED visits between patients receiving Telehomecare vs. 'usual care' (followed up to 18 months)
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of all-cause hospitalization/ED visits
Time Frame: 18 months
Comparison of the number of all-cause hospitalization/ED visits between patients receiving Telehomecare vs. 'usual care' (followed up to 18 months)
18 months
Number of visits to primary care physicians
Time Frame: 18 months
Comparison of the number of visits to primary care physicians between patients receiving Telehomecare vs. 'usual care' (followed up to 18 months)
18 months
Number of visits to specialists
Time Frame: 18 months
Comparison of the number of visits to specialists between patients receiving Telehomecare vs. 'usual care' (followed up to 18 months)
18 months
Number of visits to in-home health professionals
Time Frame: 18 months
Comparison of the number of visits to in-home health professionals between patients receiving Telehomecare vs. 'usual care' (followed up to 18 months)
18 months
Number of admissions to long-term care facilities
Time Frame: 18 months
Comparison of the number of admissions to long-term care facilities between patients receiving Telehomecare vs. 'usual care' (followed up to 18 months)
18 months
Length of stay in hospital
Time Frame: 18 months
Comparison of length-of-stay in hospital between patients receiving Telehomecare vs. 'usual care' (followed up to 18 months)
18 months
Medication use
Time Frame: 18 months
Comparison of medication use between patients receiving Telehomecare vs. 'usual care' (followed up to 18 months)
18 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Costs associated with Telehomecare equipment and services
Time Frame: 18 months
Costs associated with Telehomecare equipment and services; comparison of health services costs for Telehomecare and 'usual care'; incremental cost-effectiveness ratio (ICER) of Telehomecare compared with 'usual care'
18 months
Comparison of health services costs for Telehomecare and 'usual care'
Time Frame: 18 months
Costs associated with Telehomecare equipment and services; comparison of health services costs for Telehomecare and 'usual care'; incremental cost-effectiveness ratio (ICER) of Telehomecare compared with 'usual care'
18 months
Incremental cost-effectiveness ratio (ICER) of Telehomecare compared with 'usual care'
Time Frame: 18 months
Costs associated with Telehomecare equipment and services; comparison of health services costs for Telehomecare and 'usual care'; incremental cost-effectiveness ratio (ICER) of Telehomecare compared with 'usual care'
18 months
Patterns of use of the program
Time Frame: 12 months
Patterns of use of the program; patient quality of life, disease self-management skills and satisfaction with Telehomecare; Informal caregivers strain
12 months
Patient quality of life, disease self-management skills and satisfaction with Telehomecare
Time Frame: 12 months
Patterns of use of the program; patient quality of life, disease self-management skills and satisfaction with Telehomecare; Informal caregivers strain
12 months
Informal caregivers strain
Time Frame: 12 months
Patterns of use of the program; patient quality of life, disease self-management skills and satisfaction with Telehomecare; Informal caregivers strain
12 months
Perceptions and experiences of patients
Time Frame: 12 months
Perceptions and experiences of patients, informal caregivers, providers, administrators/decision-makers; overall adoption, integration and sustainability of the program
12 months
Overall adoption, integration and sustainability of the program
Time Frame: 12 months
Perceptions and experiences of patients, informal caregivers, providers, administrators/decision-makers; overall adoption, integration and sustainability of the program
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Investigators

  • Principal Investigator: Valeria Rac, MD, PhD, University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

October 1, 2019

Study Registration Dates

First Submitted

March 27, 2017

First Submitted That Met QC Criteria

July 5, 2017

First Posted (Actual)

July 11, 2017

Study Record Updates

Last Update Posted (Actual)

April 25, 2019

Last Update Submitted That Met QC Criteria

April 24, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • 16-5136

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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