TeleHomecaRe InterVention Evaluation Study

NCT03212001 | Unknown

• 1 other identifier: 16-5136
• Study Type: observational
• Target: 5,400
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Disease specific hospitalization and ED visits

  Comparison of disease specific hospitalization and ED visits between patients receiving Telehomecare vs. 'usual care' (followed up to 18 months)

  18 months

Secondary Outcomes (7)

• Number of all-cause hospitalization/ED visits

  18 months

• Number of visits to primary care physicians

  18 months

• Number of visits to specialists

  18 months

• Number of visits to in-home health professionals

  18 months

• Number of admissions to long-term care facilities

  18 months

Other Outcomes (8)

• Costs associated with Telehomecare equipment and services

  18 months

• Comparison of health services costs for Telehomecare and 'usual care'

  18 months

• Incremental cost-effectiveness ratio (ICER) of Telehomecare compared with 'usual care'

  18 months

Study Arms (7)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Toronto: lead
• University Health Network, Toronto: collaborator

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

MeSH Terms

Conditions

Heart Failure; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Valeria Rac, MD, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valeria Rac, MD, PhD

CONTACT

416-634-8799; valeria.rac@theta.utoronto.ca

Nida Shahid

CONTACT

416-634-8804; nida.shahid@theta.utoronto.ca

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Program Director

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: July 11, 2017
• Study Start: July 1, 2016
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: April 25, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)