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Program Evaluation of Telehomecare: TeLeCare Study (TLC)

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ClinicalTrials.gov Identifier: NCT02311114
Recruitment Status : Unknown
Verified March 2018 by Murray Krahn, University of Toronto.
Recruitment status was:  Active, not recruiting
First Posted : December 8, 2014
Last Update Posted : March 22, 2018
Sponsor:
Collaborator:
Ontario Ministry of Health and Long Term Care
Information provided by (Responsible Party):
Murray Krahn, University of Toronto

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.

Condition or disease Intervention/treatment
Heart Failure Chronic Obstructive Pulmonary Disease Other: In Depth interview Other: Observational fieldwork Other: Survey

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.

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Study Type : Observational
Observational Model: Other
Time Perspective: Other
Official Title: Program Evaluation of Telehomecare for Patients With Heart Failure or Chronic Obstructive Pulmonary Disease: TeLeCare (TLC) Study
Study Start Date : June 2014
Actual Primary Completion Date : December 2014
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Telehomecare patients
Observational fieldwork, in depth interviews and surveys up to 4 times will be conducted.
Other: In Depth interview
In Depth interview will be conducted for 30-60 min using semi-structured questionnaire to assess participants experience with telehomecare program.

Other: Observational fieldwork
Observational fieldwork will conducted to observe everyday routine activities related to telehomecare. May last up to 1h per observation.

Other: Survey
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.
Other: In Depth interview
In Depth interview will be conducted for 30-60 min using semi-structured questionnaire to assess participants experience with telehomecare program.

Other: Observational fieldwork
Observational fieldwork will conducted to observe everyday routine activities related to telehomecare. May last up to 1h per observation.

Other: Survey
Surveys with participants will be conducted using validated survey tools.

Telehomecare administrators
In depth interviews will be conducted
Other: In Depth interview
In Depth interview will be conducted for 30-60 min using semi-structured questionnaire to assess participants experience with telehomecare program.

Other: Observational fieldwork
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.
Other: In Depth interview
In Depth interview will be conducted for 30-60 min using semi-structured questionnaire to assess participants experience with telehomecare program.

Other: Observational fieldwork
Observational fieldwork will conducted to observe everyday routine activities related to telehomecare. May last up to 1h per observation.




Primary Outcome Measures :
  1. Organizational Factors (Semi-structured interviews and general observation) [ Time Frame: The data collection period will be approximately 3 months ]

    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.



Secondary Outcome Measures :
  1. 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 ]
    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.

  2. Telemedicine perception (Telemedicine perception questionnaire (TMPQ)) [ Time Frame: Prospectively at baseline, and at month 1, 2, 3 follow-up ]
    Measured via Telemedicine perception questionnaire (TMPQ)

  3. 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. ]
    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

  4. Quality of life [ Time Frame: Prospectively at baseline, and at month 1, 2, 3 follow-up ]
    Measured via EQ-5D and SF-12 questionnaires

  5. Client satisfaction (satisfaction questionnaire (CSQ-8) [ Time Frame: Prospectively at baseline, and at month 1, 2, 3 follow-up ]
    Measured via client satisfaction questionnaire (CSQ-8)

  6. Chronic disease management (Stanford Chronic Disease Self-Management 33-item scale) [ Time Frame: Prospectively at baseline, and at month 1, 2, 3 follow-up ]
    Measured via Stanford Chronic Disease Self-Management 33-item scale



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Health care providers, technicians, administrators/decision makers and patients enrolled in the Telehomecare Program.
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02311114


Locations
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Canada
University of Toronto
Toronto, Canada
Sponsors and Collaborators
University of Toronto
Ontario Ministry of Health and Long Term Care
Investigators
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Principal Investigator: Murray Krahn, MD,MSc THETA Collaborative
Principal Investigator: Valeria Rac, MD, PhD THETA Collaborative
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Responsible Party: Murray Krahn, MD MSc, University of Toronto
ClinicalTrials.gov Identifier: NCT02311114    
Other Study ID Numbers: 30158
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: March 22, 2018
Last Verified: March 2018
Keywords provided by Murray Krahn, University of Toronto:
Program Evaluation
Telehomecare
Chronic Obstructive Pulmonary Disease
Heart Failure
LHINs
Local Health Integrative Network
OTN
Ontario Telemedicine Network
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Heart Failure
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases