- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04180722
Transition to LIVE (Long-term In Home Ventilation Engagement) Study (TTLive)
A Virtual Transition Intervention for Children and Adults Transitioning to Home Ventilation in Ontario: A Pragmatic Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Ventilator Assisted Individuals (VAIs) on HMVs are an ideal population for a virtual care platform that offers a comprehensive bundle of virtual care solutions, sophisticated enough for the complex care demands of this population. A first complex care demand is the challenging clinical follow ups that impose significant financial and medical costs associated with travel to healthcare appointments, and which can predispose these patients to adverse events during travel periods due to an inability to maintain access to some vital technology such as suctioning.
A second complex care demand is the multiple transitions in care as some VAIs on HMVs move between and within healthcare sectors due to changing health status or care needs, and multi-morbidity. Formalized handovers between providers are lacking. This results in information gaps and additional and sometimes unnecessary time spent by healthcare providers searching for care plan documentation.
A third demand is the lack of timely access to respiratory health professionals experienced in HMV and availability of home follow-up, particularly in the early stages of transition which impedes the transition process.
Virtual Care can be defined as any interaction between patients and/or members of their circle of care, occurring remotely, using any form of communication or information technology, with the aim of facilitating or maximizing the effectiveness and quality of patient care. It includes electronic messaging, tele-consultations and tele-monitoring. The advantages of virtual care include the following: 1) enabling the preconditions for truly empowered patients and patient/family-centered care; 2) overcoming the silos of care, and 3) reducing redundancy within the healthcare system by greater knowledge sharing across healthcare sectors. Virtual care provides an opportunity to make healthcare better by overcoming constraints of distance, cost, and time.
In TTLive Study, a multi-component platform delivered on an electronic tablet developed for complex care management at home is used in partnership with the patient, family and healthcare team to enable the following: 1) virtual home visits; 2) customizable care plans; 3) basic clinical workflows that incorporate reminders, completion of symptom profiles and tele-monitoring, and 4) secure communication via messaging, audio, and video calls. Investigators hypothesize that this virtual transition intervention will reduce emergent healthcare utilization, improve the experience of care, reduce caregiver burden, become more cost-effective than usual care, and enable more efficient use of healthcare provider time.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Munazzah Ambreen
- Phone Number: 328361 (416) 813-7654
- Email: munazzah.ambreen@sickkids.ca
Study Locations
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Ontario
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Hamilton, Ontario, Canada
- Recruiting
- McMaster Children's Hospital
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Contact:
- Audrey Lim, MD
- Phone Number: 76340 905-521-2100
- Email: limau@mcmaster.ca
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London, Ontario, Canada
- Recruiting
- London Health Sciences Center
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Contact:
- David J Leasa, MD
- Phone Number: 519-663-3921
- Email: linda.wunnink@lhsc.on.ca
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London, Ontario, Canada, N6A 5W9
- Not yet recruiting
- Children's Hospital, London Health Sciences
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Contact:
- Aaron St-Laurent, MD
- Phone Number: 5196858500
- Email: aaron.st-laurent@lhsc.on.ca
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Ottawa, Ontario, Canada
- Recruiting
- The Ottawa Hospital
-
Contact:
- Doug Kim, MD
- Phone Number: 75318 613-737-8899
- Email: dmckim@toh.on.ca
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Ottawa, Ontario, Canada
- Recruiting
- Children's Hospital of Eastern Ontario
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Contact:
- Sherri Katz, MD
- Phone Number: 2956 (613) 737-7600
- Email: skatz@cheo.on.ca
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Toronto, Ontario, Canada, M5G 1X8
- Recruiting
- The Hospital for Sick Children
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Contact:
- Jackie Chiang, MD
- Phone Number: 206346 416-813-6346
- Email: jackie.chiang@sickkids.ca
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Contact:
- Phone Number: 328361 416-813-7654
-
Principal Investigator:
- Reshma Amin, MD
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Toronto, Ontario, Canada
- Recruiting
- Sunnybrook Health Sciences Center
-
Contact:
- Anu Tandon, MD
- Phone Number: 416.480.4758
- Email: anu.tandon@sunnybrook.ca
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York, Ontario, Canada, M6M 2J5
- Recruiting
- West Park Healthcare Centre
-
Contact:
- Roger Goldstein, MBChB, MRCP (UK), FRCP
- Phone Number: (416) 243-3631
- Email: rgoldstein@westpark.org
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Participant Eligibility Criteria
Inclusion Criteria:
i. Individuals newly initiated (in-hospital or as an outpatient) on a ventilator for HMV prescribed by a participating ventilation program in the previous two months.
ii. Reads, writes and understands English if does not have a caregiver than can do so.
iii. Provides informed consent.
Exclusion criteria:
i. Projected life expectancy of ≤ 2 months. ii. Significant cognitive impairment and absence/inability of a family caregiver to use aTouchAway™ or complete questionnaires.
iii. Uncontrolled psychiatric illness. iv. No internet access (SIM cards and data costs will be covered by the project budget).
v. Currently enrolled in a research study to evaluate another eHealth platform or care coordination.
vi. Plans to move outside of Ontario within the next 12 months.
Caregivers Eligibility Criteria
Caregiver Inclusion Criteria:
i. Primary caregiver of an individual newly initiated (in-hospital or outpatient) on a ventilator for HMV prescribed by a participating clinic in the previous two months; ii. Reads, writes and understands English; and iii. Provides informed consent.
Eligibility Criteria for the Qualitative Interviews
Investigators will exclude those participants:
i. Unable to communicate verbally for the duration of an interview
Inclusion Criteria for Healthcare Providers in the Circle of Care for the Intervention Group
Healthcare provider of an individual from a participating centre i. Use of the aTouchAway for at least five participant encounters ii. Provides informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Participants will receive multi-component Virtual Transition Intervention facilitated through the aTouchAway™ platform including the usual care provided by specialist HMV programs.
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Participants will receive multi-component Virtual Transition Intervention.
The four components of the intervention comprise: (1) routine virtual clinic visits scheduled at the same frequency as usual care; (2) virtual care plan and action plan for respiratory infection/deterioration and management of ventilator issues; (3) remote, weekly and monthly monitoring of ventilator and cough assist metrics, VAI symptoms, and oxygen saturations; and (4) as needed clinical consultations triggered by identification of abnormal parameters or requested by the VAI or family caregiver.
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No Intervention: Control
Usual care will be delivered in accordance with the Canadian Thoracic Society (CTS) clinical practice guidelines and includes scheduled face-to-face clinic visits with the ventilator team with the ventilator team within the first month of starting HMV and then every 3, 6, or 12 months depending on medical stability with additional telephone calls/email contact for equipment trouble shooting and management of intercurrent illnesses as needed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ED Visits: ED visit rates at 12 months determined using health administrative databases
Time Frame: 12 months
|
Using health administrative databases and the Ambulatory Health Care Record-modified
|
12 months
|
To measure patient reported sense of mastery (Pearlin Mastery Scale; scores range up to 28, higher scores = higher mastery)
Time Frame: 12 months
|
To measure patient reported sense of mastery, an outcome that is often linked to patient empowerment using the Pearlin Self-Mastery Scale
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of hospital admissions and days in hospital over 6 months using health administrative databases.
Time Frame: 6 months
|
Using health administrative databases and the Ambulatory Health Care Record-modified
|
6 months
|
Number of hospital admissions and days in hospital over 12 months using health administrative databases.
Time Frame: 12 months
|
Using health administrative databases and the Ambulatory Health Care Record-modified
|
12 months
|
Hospital free survival using health administrative data at 6 months.
Time Frame: 6 months
|
Using health administrative databases and the Ambulatory Health Care Record-modified
|
6 months
|
Hospital free survival using health administrative data at 12 months.
Time Frame: 12 Months
|
Using health administrative databases and the Ambulatory Health Care Record-modified
|
12 Months
|
Time to first ED visit and first hospital admission.
Time Frame: 12 months
|
Using health administrative databases and the Ambulatory Health Care Record-modified
|
12 months
|
Overall survival at 6 months.
Time Frame: 6 months
|
Using health administrative databases and the Ambulatory Health Care Record-modified
|
6 months
|
Overall survival at 12 months.
Time Frame: 12 months
|
Using health administrative databases and the Ambulatory Health Care Record-modified
|
12 months
|
Respiratory and non-respiratory causes of death at 6 months.
Time Frame: 6 months
|
Using health administrative databases and the Ambulatory Health Care Record-modified
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6 months
|
Respiratory and non-respiratory causes of death at 12 months.
Time Frame: 12 months
|
Using health administrative databases and the Ambulatory Health Care Record-modified
|
12 months
|
Number and type of outpatient specialist visits at 6 months.
Time Frame: 6 months
|
Using health administrative databases and the Ambulatory Health Care Record-modified
|
6 months
|
Number and type of outpatient specialist visits at 12 months.
Time Frame: 12 months
|
Using health administrative databases and the Ambulatory Health Care Record-modified
|
12 months
|
Number of family physician visits at 6 months.
Time Frame: 6 months
|
Using health administrative databases and the Ambulatory Health Care Record-modified
|
6 months
|
Number of family physician visits at 12 months.
Time Frame: 12 months
|
Using health administrative databases and the Ambulatory Health Care Record-modified
|
12 months
|
Homecare service use at 6 months.
Time Frame: 6 months
|
Using health administrative databases and the Ambulatory Health Care Record-modified
|
6 months
|
Homecare service use at 12 months.
Time Frame: 12 months
|
Using health administrative databases and the Ambulatory Health Care Record-modified
|
12 months
|
Change in Zarit Burden Interview Score from baseline to 6 months.The 22 items are assessed on a 5-point Likert scale, ranging from 0 = 'never' to 4 = 'nearly always'.
Time Frame: 6 months
|
Caregiver Outcome
|
6 months
|
Change in Zarit Burden Interview Score from baseline to 12 months.The 22 items are assessed on a 5-point Likert scale, ranging from 0 = 'never' to 4 = 'nearly always'.
Time Frame: 12 months
|
Caregiver Outcome
|
12 months
|
Change in study participant health related quality of life using the EQ-5D (adults) and ED-5DY (children) change from baseline and 6 months
Time Frame: 6 months
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Health Related Quality of Life Outcome
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6 months
|
Change in study participant health related quality of life using the EQ-5D (adults) and ED-5DY (children) change from baseline and 12 months
Time Frame: 12 months
|
Health Related Quality of Life Outcome
|
12 months
|
Quality of care coordination using Family Experiences with Care Coordination (FECC) for qualitative interview participants only
Time Frame: 6 months
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Care Coordination Outcome
|
6 months
|
Quality of care coordination using Family Experiences with Care Coordination (FECC) for qualitative interview participants only
Time Frame: 12 months
|
Care Coordination Outcome
|
12 months
|
Incremental Cost Effectiveness Ratios (ICER) of Virtual Transition intervention compared to usual care in improving patient utility from a societal perspective and using a one-year time horizon
Time Frame: 12 months
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Economic Outcome
|
12 months
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Mean monthly healthcare costs (public, private and caregiver lost time) over 6 months
Time Frame: 6 months
|
Economic Outcome: Using health administrative databases and the Ambulatory Health Care Record-modified
|
6 months
|
Mean monthly healthcare costs (public, private and caregiver lost time) over 12 months
Time Frame: 12 months
|
Economic Outcome: Using health administrative databases and the Ambulatory Health Care Record-modified
|
12 months
|
Encounter time spent by clinicians over 12 months measured using the Care Coordination Measurement Tool
Time Frame: 12 months
|
HealthCare Provider Outcome
|
12 months
|
Process Measure Outcomes
Time Frame: 12 months
|
n(%) of 5 clinic visits conducted virtually as opposed to face to face
|
12 months
|
Process Measure Outcomes
Time Frame: 12 months
|
n (%) of virtual data downloads available for the virtual clinic visits
|
12 months
|
Process Measure Outcomes
Time Frame: 12 months
|
n(%) participants that completed the virtual care plan within 6 weeks after intervention initiation
|
12 months
|
Process Measure Outcomes
Time Frame: 12 months
|
n (%) of the 52 weekly check-ins completed
|
12 months
|
Process Measure Outcomes
Time Frame: 12 months
|
n(%) of the 12 monthly S3-NIV check-ins completed
|
12 months
|
Process Measure Outcomes
Time Frame: 12 months
|
number of ad hoc questions/concerns in which healthcare team contacted via the platform
|
12 months
|
Process Measure Outcomes
Time Frame: 12 months
|
number of status yellow monitoring alerts initiated based on the weekly and monthly symptom monitoring and time to alert being addressed by a member of the circle of care
|
12 months
|
Process Measure Outcome- Qualitative Interviews
Time Frame: 6 months
|
Qualitative interviews to explore the experience with the aTouchAway intervention by study participants, caregivers and healthcare providers
|
6 months
|
Process Measure Outcome- Qualitative Interviews
Time Frame: 12 months
|
Qualitative interviews to explore the experience with the aTouchAway intervention by study participants, caregivers and healthcare providers
|
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Louise Rose, PhD, King's College London
- Principal Investigator: Reshma Amin, MD, MSc, The Hospital for Sick Children
- Principal Investigator: Andrea Gershon, MD, MSc, Sunnybrook Health Sciences Centre
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1000000000
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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