- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02311114
Program Evaluation of Telehomecare: TeLeCare Study (TLC)
Program Evaluation of Telehomecare for Patients With Heart Failure or Chronic Obstructive Pulmonary Disease: TeLeCare (TLC) Study
Study Overview
Status
Intervention / Treatment
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.
Study Type
Contacts and Locations
Study Locations
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-
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Toronto, Canada
- University of Toronto
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Telehomecare patients
Observational fieldwork, in depth interviews and surveys up to 4 times will be conducted.
|
In Depth interview will be conducted for 30-60 min using semi-structured questionnaire to assess participants experience with telehomecare program.
Observational fieldwork will conducted to observe everyday routine activities related to telehomecare.
May last up to 1h per observation.
Surveys with participants will be conducted using validated survey tools.
|
Health care providers
In-Depth interviews, observational fieldwork and one time survey will be conducted.
|
In Depth interview will be conducted for 30-60 min using semi-structured questionnaire to assess participants experience with telehomecare program.
Observational fieldwork will conducted to observe everyday routine activities related to telehomecare.
May last up to 1h per observation.
Surveys with participants will be conducted using validated survey tools.
|
Telehomecare administrators
In depth interviews will be conducted
|
In Depth interview will be conducted for 30-60 min using semi-structured questionnaire to assess participants experience with telehomecare program.
Observational fieldwork will conducted to observe everyday routine activities related to telehomecare.
May last up to 1h per observation.
|
Telehomecare technicians
In-depth interviews, observational fieldwork will be conducted.
|
In Depth interview will be conducted for 30-60 min using semi-structured questionnaire to assess participants experience with telehomecare program.
Observational fieldwork will conducted to observe everyday routine activities related to telehomecare.
May last up to 1h per observation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Organizational Factors (Semi-structured interviews and general observation)
Time Frame: The data collection period will be approximately 3 months
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Those factors will be identified via qualitative research methods, hence no measurable units are applicable for them. Semi-structured interviews and general observation of all types of participants will be done at different times/stages of program. |
The data collection period will be approximately 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall patterns of use (length of stay, drop out rates, nurse workload, etc.)
Time Frame: 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
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Participants' demographics, average length of stay within the program, drop out rates, nurses workload (number of patients per nurses), number of alerts per patients and per nurse.
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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
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Telemedicine perception (Telemedicine perception questionnaire (TMPQ))
Time Frame: Prospectively at baseline, and at month 1, 2, 3 follow-up
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Measured via Telemedicine perception questionnaire (TMPQ)
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Prospectively at baseline, and at month 1, 2, 3 follow-up
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Health services utilization (hospitalization, LOS, ED visits, etc.)
Time Frame: 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.
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Number of hospitalizations, length of stay, ED visits, primary care visits, cost related to health services utilization.
Will be done through linkage with ICES database
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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.
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Quality of life
Time Frame: Prospectively at baseline, and at month 1, 2, 3 follow-up
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Measured via EQ-5D and SF-12 questionnaires
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Prospectively at baseline, and at month 1, 2, 3 follow-up
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Client satisfaction (satisfaction questionnaire (CSQ-8)
Time Frame: Prospectively at baseline, and at month 1, 2, 3 follow-up
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Measured via client satisfaction questionnaire (CSQ-8)
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Prospectively at baseline, and at month 1, 2, 3 follow-up
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Chronic disease management (Stanford Chronic Disease Self-Management 33-item scale)
Time Frame: Prospectively at baseline, and at month 1, 2, 3 follow-up
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Measured via Stanford Chronic Disease Self-Management 33-item scale
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Prospectively at baseline, and at month 1, 2, 3 follow-up
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Murray Krahn, MD,MSc, THETA Collaborative
- Principal Investigator: Valeria Rac, MD, PhD, THETA Collaborative
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 30158
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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