TeleHomecaRe InterVention Evaluation Study

Heart Failure Clinical Trial

— THRIVE  

Official title:

TeleHomecaRe InterVention Evaluation (THRIVE) Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03212001
• Other study ID #: 16-5136
• Status: Recruiting
• Start date: July 2016
• Est. completion date: October 2019

Study information

• Verified date: April 2019
• Source: University of Toronto
• Contact: Valeria Rac, MD, PhD
• Phone: 416-634-8799
• Email: valeria.rac[@]theta.utoronto.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5400
• Est. completion date: October 2019
• Est. primary completion date: October 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Heart Failure
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Toronto	University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Costs associated with Telehomecare equipment and services	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
Other	Comparison of health services costs for Telehomecare and 'usual care'	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
Other	Incremental cost-effectiveness ratio (ICER) of Telehomecare compared with 'usual care'	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
Other	Patterns of use of the program	Patterns of use of the program; patient quality of life, disease self-management skills and satisfaction with Telehomecare; Informal caregivers strain	12 months
Other	Patient quality of life, disease self-management skills and satisfaction with Telehomecare	Patterns of use of the program; patient quality of life, disease self-management skills and satisfaction with Telehomecare; Informal caregivers strain	12 months
Other	Informal caregivers strain	Patterns of use of the program; patient quality of life, disease self-management skills and satisfaction with Telehomecare; Informal caregivers strain	12 months
Other	Perceptions and experiences of patients	Perceptions and experiences of patients, informal caregivers, providers, administrators/decision-makers; overall adoption, integration and sustainability of the program	12 months
Other	Overall adoption, integration and sustainability of the program	Perceptions and experiences of patients, informal caregivers, providers, administrators/decision-makers; overall adoption, integration and sustainability of the program	12 months
Primary	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	Number of all-cause hospitalization/ED visits	Comparison of the number of all-cause hospitalization/ED visits between patients receiving Telehomecare vs. 'usual care' (followed up to 18 months)	18 months
Secondary	Number of visits to primary care physicians	Comparison of the number of visits to primary care physicians between patients receiving Telehomecare vs. 'usual care' (followed up to 18 months)	18 months
Secondary	Number of visits to specialists	Comparison of the number of visits to specialists between patients receiving Telehomecare vs. 'usual care' (followed up to 18 months)	18 months
Secondary	Number of visits to in-home health professionals	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
Secondary	Number of admissions to long-term care facilities	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
Secondary	Length of stay in hospital	Comparison of length-of-stay in hospital between patients receiving Telehomecare vs. 'usual care' (followed up to 18 months)	18 months
Secondary	Medication use	Comparison of medication use between patients receiving Telehomecare vs. 'usual care' (followed up to 18 months)	18 months