Transition to LIVE (Long-term In Home Ventilation Engagement) Study (TTLive)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04180722 |
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Recruitment Status :
Recruiting
First Posted : November 27, 2019
Last Update Posted : August 5, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Long-term Ventilation at Home | Device: aTouchAway™ platform | Not Applicable |
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 : | 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 |
| Actual Study Start Date : | March 1, 2021 |
| Estimated Primary Completion Date : | March 30, 2023 |
| Estimated Study Completion Date : | March 30, 2023 |
| Arm | Intervention/treatment |
|---|---|
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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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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. |
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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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- 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
- 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
- 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
- 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
- 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
- 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
- Time to first ED visit and first hospital admission. [ Time Frame: 12 months ]Using health administrative databases and the Ambulatory Health Care Record-modified
- Overall survival at 6 months. [ Time Frame: 6 months ]Using health administrative databases and the Ambulatory Health Care Record-modified
- Overall survival at 12 months. [ Time Frame: 12 months ]Using health administrative databases and the Ambulatory Health Care Record-modified
- 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
- 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
- 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
- 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
- Number of family physician visits at 6 months. [ Time Frame: 6 months ]Using health administrative databases and the Ambulatory Health Care Record-modified
- Number of family physician visits at 12 months. [ Time Frame: 12 months ]Using health administrative databases and the Ambulatory Health Care Record-modified
- Homecare service use at 6 months. [ Time Frame: 6 months ]Using health administrative databases and the Ambulatory Health Care Record-modified
- Homecare service use at 12 months. [ Time Frame: 12 months ]Using health administrative databases and the Ambulatory Health Care Record-modified
- 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
- 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
- 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
- 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
- Quality of care coordination using Family Experiences with Care Coordination (FECC) for qualitative interview participants only [ Time Frame: 6 months ]Care Coordination Outcome
- Quality of care coordination using Family Experiences with Care Coordination (FECC) for qualitative interview participants only [ Time Frame: 12 months ]Care Coordination Outcome
- 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
- 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
- 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
- Encounter time spent by clinicians over 12 months measured using the Care Coordination Measurement Tool [ Time Frame: 12 months ]HealthCare Provider Outcome
- Process Measure Outcomes [ Time Frame: 12 months ]n(%) of 5 clinic visits conducted virtually as opposed to face to face
- Process Measure Outcomes [ Time Frame: 12 months ]n (%) of virtual data downloads available for the virtual clinic visits
- Process Measure Outcomes [ Time Frame: 12 months ]n(%) participants that completed the virtual care plan within 6 weeks after intervention initiation
- Process Measure Outcomes [ Time Frame: 12 months ]n (%) of the 52 weekly check-ins completed
- Process Measure Outcomes [ Time Frame: 12 months ]n(%) of the 12 monthly S3-NIV check-ins completed
- Process Measure Outcomes [ Time Frame: 12 months ]number of ad hoc questions/concerns in which healthcare team contacted via the platform
- 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
- 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
- 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
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.
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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
| Contact: Munazzah Ambreen | (416) 813-7654 ext 328361 | munazzah.ambreen@sickkids.ca |
| Canada, Ontario | |
| McMaster Children's Hospital | Recruiting |
| Hamilton, Ontario, Canada | |
| Contact: Audrey Lim, MD 905-521-2100 ext 76340 limau@mcmaster.ca | |
| Children's Hospital, London Health Sciences | Not yet recruiting |
| London, Ontario, Canada, N6A 5W9 | |
| Contact: Aaron St-Laurent, MD 5196858500 aaron.st-laurent@lhsc.on.ca | |
| London Health Sciences Center | Recruiting |
| London, Ontario, Canada | |
| Contact: David J Leasa, MD 519-663-3921 linda.wunnink@lhsc.on.ca | |
| Children's Hospital of Eastern Ontario | Recruiting |
| Ottawa, Ontario, Canada | |
| Contact: Sherri Katz, MD (613) 737-7600 ext 2956 skatz@cheo.on.ca | |
| The Ottawa Hospital | Recruiting |
| Ottawa, Ontario, Canada | |
| Contact: Doug Kim, MD 613-737-8899 ext 75318 dmckim@toh.on.ca | |
| The Hospital for Sick Children | Recruiting |
| 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 | Recruiting |
| Toronto, Ontario, Canada | |
| Contact: Anu Tandon, MD 416.480.4758 anu.tandon@sunnybrook.ca | |
| West Park Healthcare Centre | Recruiting |
| York, Ontario, Canada, M6M 2J5 | |
| Contact: Roger Goldstein, MBChB, MRCP (UK), FRCP (416) 243-3631 rgoldstein@westpark.org | |
| 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 |
| 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: | August 5, 2022 |
| Last Verified: | August 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Home mechanical ventilation Ventilator assisted individuals Virtual Intervention |