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Clinical Trials/NCT03212001
NCT03212001
Unknown
Not Applicable

TeleHomecaRe InterVention Evaluation (THRIVE) Study

University of Toronto1 site in 1 country5,400 target enrollmentJuly 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
University of Toronto
Enrollment
5400
Locations
1
Primary Endpoint
Disease specific hospitalization and ED visits
Last Updated
7 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
July 2016
End Date
October 2019
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Valeria Rac

Associate Program Director

University of Toronto

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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)

Secondary Outcomes

  • Number of admissions to long-term care facilities(18 months)
  • Number of all-cause hospitalization/ED visits(18 months)
  • Number of visits to in-home health professionals(18 months)
  • Length of stay in hospital(18 months)
  • Medication use(18 months)
  • Number of visits to primary care physicians(18 months)
  • Number of visits to specialists(18 months)

Study Sites (1)

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