Clinical trial NCT02311114: Program Evaluation of Telehomecare: TeLeCare Study
Official title: Program Evaluation of Telehomecare for Patients With Heart Failure or Chronic Obstructive Pulmonary Disease: TeLeCare (TLC) Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Chronic Obstructive Pulmonary Disease
Keywords: Program Evaluation
Telehomecare
Chronic Obstructive Pulmonary Disease
Heart Failure
LHINs
Local Health Integrative Network
OTN
Ontario Telemedicine Network
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Ontario Ministry of Health and Long Term Care
First posted: 2014-12-08
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Health care providers, technicians, administrators/decision makers and patients enrolled in the Telehomecare Program.

Brief summary: This study will evaluate the Telehomecare (THC) Program offered to patients with heart failure or chronic obstructive pulmonary disease across the Central West, Toronto Central and North East Local Health Integration Networks in Ontario. It will explore the opinions and experiences of patients, providers, technicians and administrators involved with THC Program in order to provide stakeholders with information about the processes and organizational factors impacting the program's adoption, the experiences of its participants, impact on patient outcomes, costs to the health-care system and who is benefiting the most from participating. These factors will be determined using semi-structured interviews, surveys, and observation of practices of everyone involved with THC. The study will also evaluate patient data to determine changes in patients' utilization of healthcare services.

Detailed description: The program evaluation will consist of three components that will employ two research methods, qualitative and quantitative.

Comparative Practice Study (Qualitative) This study will explore how factors related to the technology, patients, providers and organizational structures and processes influence the adoption and implementation of THC across selected sites (including micro-, meso- and macro-systems) in Ontario. Ethnographic study, in-depth semi-structured interviews and documentation collection and review will be employed to explore, among other factors, the behaviours, communication patterns, workflows and tasks of health care providers and their interaction with patients. Interviewees will be selected using purposive sampling.

Descriptive Study (Quantitative) The patterns of THC use will be evaluated by conducting a descriptive study based on the data routinely collected by the Ontario Telemedicine Newtrok that tracks all encounters (i.e. telephone calls, remote patient monitoring data transmission, face to face visits) between patients and THC providers. A randomly selected subset of THC participants/caregivers will also complete validated structured questionnaires at up to four time points during program, baseline, one, two, and three months after enrollment. These are the Quality of Life Profile Measure (SF12), Quality of Life Preference Measure (EQ5D), Telemedicine Perception Questionnaire (TMPQ), Stanford self-efficacy scale and Client Satisfaction Questionnaire (CSQ-8). The providers of THC will also be asked to complete questionnaires; physicians will be asked to complete Penn State Physician Telehomecare Survey, whereas the nurses will be asked to complete a Nurse Satisfaction Survey.

ICES Linkage Study (Quantitative) Primary collected research data will be linked to the Institute for Clinical Evaluative Sciences (ICES) administrative databases. Outcomes (i.e. hospitalizations, primary care visits) of patients receiving or have received Telehomecare, will be assessed for a period of 6 months prior to enrolment, during the program and for up to 6 months after discharge.

Eligibility criteria: Inclusion Criteria:

Patient

* The patient has a documented diagnosis of HF or COPD (with or without co-morbid conditions)
* The patient is 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
* Is receiving nursing services via CCAC
* Frequent visits to primary care provider in the past year
* The patient or informal caregiver (if applicable) is an adult (over 18 yrs) able and willing to provide informed consent.
* The patient or informal caregiver (if applicable) is fluent in English
* The patient or informal caregiver is able and willing to operate the THC equipment
* The patient lives in a residential (private home or retirement home) setting with an active landline
* The patient or informal caregiver have agreed to be contacted for evaluation of this program when consenting to participate in the Telehomecare program.

Health Care Provider

* Any health care provider who referred a patient to the telehomecare program
* Primary care providers of patients who are enrolled in the study
* Telehomecare nurses/physicians involved in the provision of care to patients enrolled in the telehomecare program
* For interviews and surveys telehomecare nurses/physicians must have 3 months experience with telehomecare

Technician, Administrators and/or Decision Makers

* Technicians involved in the set-up of telehomecare equipment at patients' homes.
* Administrators and/or Decision Makers of the THC program as a larger network of care such as Healthcare Program Managers, key members of the LHIN, OTN etc.

Exclusion Criteria:

Patient

* Less than 18 years of age
* Individuals without an established diagnosis of COPD or chronic HF
* Unable or unwilling to provide verbal informed consent
* Demonstrated non-adherence to the THC program
* The THC Clinician 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 THC equipment
* Do not have a regular caregiver to assist in the use of the equipment

Health Care Provider, Technician, Administrators and/or Decision Makers

- Unable or unwilling to provide verbal informed consent

Primary outcomes:
measure: Organizational Factors (Semi-structured interviews and general observation)
timeFrame: The data collection period will be approximately 3 months
Secondary outcomes:
measure: Overall patterns of use (length of stay, drop out rates, nurse workload, etc.)
timeFrame: Retrospectively using Ontario Telemedicine Network database, for all participants who were enrolled in the Telehomecare program. The data collection period will be approximately 3 months
measure: Telemedicine perception (Telemedicine perception questionnaire (TMPQ))
timeFrame: Prospectively at baseline, and at month 1, 2, 3 follow-up
measure: Health services utilization (hospitalization, LOS, ED visits, etc.)
timeFrame: Retrospectively, six months before, during and after the Telehomecare program. Will be collected for the patients who completed the Telehomecare by the 28 Feb 2014.
measure: Quality of life
timeFrame: Prospectively at baseline, and at month 1, 2, 3 follow-up
measure: Client satisfaction (satisfaction questionnaire (CSQ-8)
timeFrame: Prospectively at baseline, and at month 1, 2, 3 follow-up
measure: Chronic disease management (Stanford Chronic Disease Self-Management 33-item scale)
timeFrame: Prospectively at baseline, and at month 1, 2, 3 follow-up
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University of Toronto
Study officials:
affiliation: THETA Collaborative
name: Murray Krahn, MD,MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: THETA Collaborative
name: Valeria Rac, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: