Clinical trial NCT03212001: TeleHomecaRe InterVention Evaluation Study
Official title: TeleHomecaRe InterVention Evaluation (THRIVE) Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Chronic Obstructive Pulmonary Disease
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: University Health Network, Toronto
First posted: 2017-07-11
Enrollment: 5400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Disease specific hospitalization and ED visits
timeFrame: 18 months
Secondary outcomes:
measure: Number of all-cause hospitalization/ED visits
timeFrame: 18 months
measure: Number of visits to primary care physicians
timeFrame: 18 months
measure: Number of visits to specialists
timeFrame: 18 months
measure: Number of visits to in-home health professionals
timeFrame: 18 months
measure: Number of admissions to long-term care facilities
timeFrame: 18 months
measure: Length of stay in hospital
timeFrame: 18 months
measure: Medication use
timeFrame: 18 months
Other outcomes:
measure: Costs associated with Telehomecare equipment and services
timeFrame: 18 months
measure: Comparison of health services costs for Telehomecare and 'usual care'
timeFrame: 18 months
measure: Incremental cost-effectiveness ratio (ICER) of Telehomecare compared with 'usual care'
timeFrame: 18 months
measure: Patterns of use of the program
timeFrame: 12 months
measure: Patient quality of life, disease self-management skills and satisfaction with Telehomecare
timeFrame: 12 months
measure: Informal caregivers strain
timeFrame: 12 months
measure: Perceptions and experiences of patients
timeFrame: 12 months
measure: Overall adoption, integration and sustainability of the program
timeFrame: 12 months
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Valeria Rac, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: