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Transition to LIVE (Long-term In Home Ventilation Engagement) Study (TTLive)

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ClinicalTrials.gov Identifier: NCT04180722
Recruitment Status : Not yet recruiting
First Posted : November 27, 2019
Last Update Posted : February 11, 2021
Sponsor:
Collaborators:
West Park Healthcare Centre
The Ottawa Hospital
Sunnybrook Health Sciences Centre
London Health Sciences Centre
Children's Hospital of Eastern Ontario
McMaster Children's Hospital
Kingston Health Sciences Centre
Aetonix Systems
Information provided by (Responsible Party):
Reshma Amin, The Hospital for Sick Children

Brief Summary:
The rising prevalence of ventilator assisted individuals (VAIs) who depend on Home Mechanical Ventilation (HMV) is an escalating public health challenge with important social and economic implications. VAIs are high cost users of the healthcare system, requiring competent healthcare and family caregivers for successful transition to HMV. The TTLive Study will evaluate the effect of a virtual transition intervention delivered through a virtual care platform, compared to usual care on emergent healthcare utilization, caregiver burden, health cost-effectiveness including cost of family caregiver time, and efficiency of clinical encounters for individuals newly transitioning to HMV.

Condition or disease Intervention/treatment Phase
Long-term Ventilation at Home Device: aTouchAway™ platform Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter, prospective 12 months, 7-centre, pragmatic, parallel group, randomized controlled trial with 1:1 allocation of individuals (children and adults) newly transitioning to Home Mechanical Ventilation (HMV) in Ontario that compares a virtual transition intervention to usual care provided by specialist HMV programs.
Masking: Single (Outcomes Assessor)
Masking Description: The research coordinator that is consenting the patient and doing the intervention allocation will be different than the research coordinator assessing the outcomes. The outcomes assessor will remain blinded as to whether the participant has received the intervention or not
Primary Purpose: Health Services Research
Official Title: A Virtual Transition Intervention for Children and Adults Transitioning to Home Ventilation in Ontario: A Pragmatic Randomized Controlled Trial
Estimated Study Start Date : March 1, 2021
Estimated Primary Completion Date : January 30, 2023
Estimated Study Completion Date : July 30, 2023

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.
Device: aTouchAway™ platform
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.

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.



Primary Outcome Measures :
  1. 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

  2. To measure patient reported sense of 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. Time to first ED visit and first hospital admission. [ Time Frame: 12 months ]
    Using health administrative databases and the Ambulatory Health Care Record-modified

  6. Overall survival at 6 months. [ Time Frame: 6 months ]
    Using health administrative databases and the Ambulatory Health Care Record-modified

  7. Overall survival at 12 months. [ Time Frame: 12 months ]
    Using health administrative databases and the Ambulatory Health Care Record-modified

  8. 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

  9. 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

  10. 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

  11. 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. Number of family physician visits at 6 months. [ Time Frame: 6 months ]
    Using health administrative databases and the Ambulatory Health Care Record-modified

  13. Number of family physician visits at 12 months. [ Time Frame: 12 months ]
    Using health administrative databases and the Ambulatory Health Care Record-modified

  14. Homecare service use at 6 months. [ Time Frame: 6 months ]
    Using health administrative databases and the Ambulatory Health Care Record-modified

  15. Homecare service use at 12 months. [ Time Frame: 12 months ]
    Using health administrative databases and the Ambulatory Health Care Record-modified

  16. 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

  17. 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

  18. 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 ]
    Health Related Quality of Life Outcome

  19. 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

  20. Quality of care coordination using Family Experiences with Care Coordination (FECC) for qualitative interview participants only [ Time Frame: 6 months ]
    Care Coordination Outcome

  21. Quality of care coordination using Family Experiences with Care Coordination (FECC) for qualitative interview participants only [ Time Frame: 12 months ]
    Care Coordination Outcome

  22. 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 ]
    Economic Outcome

  23. 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

  24. 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

  25. Encounter time spent by clinicians over 12 months measured using the Care Coordination Measurement Tool [ Time Frame: 12 months ]
    HealthCare Provider Outcome

  26. Process Measure Outcomes [ Time Frame: 12 months ]
    n(%) of 5 clinic visits conducted virtually as opposed to face to face

  27. Process Measure Outcomes [ Time Frame: 12 months ]
    n (%) of virtual data downloads available for the virtual clinic visits

  28. Process Measure Outcomes [ Time Frame: 12 months ]
    n(%) participants that completed the virtual care plan within 6 weeks after intervention initiation

  29. Process Measure Outcomes [ Time Frame: 12 months ]
    n (%) of the 52 weekly check-ins completed

  30. Process Measure Outcomes [ Time Frame: 12 months ]
    n(%) of the 12 monthly S3-NIV check-ins completed

  31. Process Measure Outcomes [ Time Frame: 12 months ]
    number of ad hoc questions/concerns in which healthcare team contacted via the platform

  32. 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

  33. 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

  34. 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



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:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


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): NCT04180722


Contacts
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Contact: Munazzah Ambreen (416) 813-7654 ext 328361 munazzah.ambreen@sickkids.ca

Locations
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Canada, Ontario
McMaster Children's Hospital
Hamilton, Ontario, Canada
Contact: Audrey Lim, MD    905-521-2100 ext 76340    limau@mcmaster.ca   
London Health Sciences Center
London, Ontario, Canada
Contact: David J Leasa, MD    519-663-3921    linda.wunnink@lhsc.on.ca   
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada
Contact: Sherri Katz, MD    (613) 737-7600 ext 2956    skatz@cheo.on.ca   
The Ottawa Hospital
Ottawa, Ontario, Canada
Contact: Doug Kim, MD    613-737-8899 ext 75318    dmckim@toh.on.ca   
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Contact: Jackie Chiang, MD    416-813-6346 ext 206346    jackie.chiang@sickkids.ca   
Contact    416-813-7654 ext 328361      
Principal Investigator: Reshma Amin, MD         
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada
Contact: Anu Tandon, MD    416.480.4758    anu.tandon@sunnybrook.ca   
West Park Healthcare Centre
York, Ontario, Canada, M6M 2J5
Contact: Roger Goldstein, MBChB, MRCP (UK), FRCP    (416) 243-3631    rgoldstein@westpark.org   
Sponsors and Collaborators
The Hospital for Sick Children
West Park Healthcare Centre
The Ottawa Hospital
Sunnybrook Health Sciences Centre
London Health Sciences Centre
Children's Hospital of Eastern Ontario
McMaster Children's Hospital
Kingston Health Sciences Centre
Aetonix Systems
Investigators
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Principal Investigator: Reshma Amin, MD, MSc The Hospital for Sick Children
Principal Investigator: Louise Rose, PhD King's College London
Principal Investigator: Andrea Gershon, MD, MSc Sunnybrook Health Sciences Centre
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Responsible Party: Reshma Amin, Staff Physician, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT04180722    
Other Study ID Numbers: 1000000000
First Posted: November 27, 2019    Key Record Dates
Last Update Posted: February 11, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Reshma Amin, The Hospital for Sick Children:
Home mechanical ventilation
Ventilator assisted individuals
Virtual Intervention