Transition to LIVE (Long-term In Home Ventilation Engagement) Study
- Conditions
- Long-term Ventilation at Home
- Registration Number
- NCT04180722
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 440
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.
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method ED Visits: ED visit rates at 12 months determined using health administrative databases 12 months± 4 weeks 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) 12 months± 4 weeks 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
Name Time Method 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'. 12 months ± 4 weeks 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 6 months ± 4 weeks Health Related Quality of Life Outcome
Time to first ED visit and first hospital admission. 12 months ± 4 weeks Using health administrative databases and the Ambulatory Health Care Record-modified
Overall survival at 6 months. 6 months ± 4 weeks Using health administrative databases and the Ambulatory Health Care Record-modified
Overall survival at 12 months. 12 months ± 4 weeks Using health administrative databases and the Ambulatory Health Care Record-modified
Mean monthly healthcare costs (public, private and caregiver lost time) over 12 months 12 months ± 4 weeks Economic Outcome: Using health administrative databases and the Ambulatory Health Care Record-modified
Process Measure Outcomes 12 months ± 4 weeks 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
Encounter time spent by clinicians over 12 months measured using the Care Coordination Measurement Tool 12 months ± 4 weeks HealthCare Provider Outcome
Hospital free survival using health administrative data at 12 months. 12 Months ± 4 weeks Using health administrative databases and the Ambulatory Health Care Record-modified
Number of hospital admissions and days in hospital over 6 months using health administrative databases. 6 months± 4 weeks 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. 12 months ± 4 weeks Using health administrative databases and the Ambulatory Health Care Record-modified
Hospital free survival using health administrative data at 6 months. 6 months ± 4 weeks Using health administrative databases and the Ambulatory Health Care Record-modified
Respiratory and non-respiratory causes of death at 6 months. 6 months ± 4 weeks Using health administrative databases and the Ambulatory Health Care Record-modified
Respiratory and non-respiratory causes of death at 12 months. 12 months ± 4 weeks Using health administrative databases and the Ambulatory Health Care Record-modified
Number and type of outpatient specialist visits at 6 months. 6 months ± 4 weeks Using health administrative databases and the Ambulatory Health Care Record-modified
Number and type of outpatient specialist visits at 12 months. 12 months ± 4 weeks Using health administrative databases and the Ambulatory Health Care Record-modified
Number of family physician visits at 6 months. 6 months ± 4 weeks Using health administrative databases and the Ambulatory Health Care Record-modified
Number of family physician visits at 12 months. 12 months ± 4 weeks Using health administrative databases and the Ambulatory Health Care Record-modified
Homecare service use at 6 months. 6 months ± 4 weeks Using health administrative databases and the Ambulatory Health Care Record-modified
Homecare service use at 12 months. 12 months ± 4 weeks 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'. 6 months ± 4 weeks Caregiver 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 12 months ± 4 weeks Health Related Quality of Life 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 12 months ± 4 weeks Economic Outcome
Quality of care coordination using Family Experiences with Care Coordination (FECC) for qualitative interview participants only 6 months ± 4 weeks Care Coordination Outcome
Mean monthly healthcare costs (public, private and caregiver lost time) over 6 months 6 months ± 4 weeks Economic Outcome: Using health administrative databases and the Ambulatory Health Care Record-modified
Process Measure Outcome- Qualitative Interviews 6 months ± 4 weeks Qualitative interviews to explore the experience with the aTouchAway intervention by study participants, caregivers and healthcare providers
Process Measure Outcome- Site focus Groups 24 months ± 4 weeks Our LIVE study data has shown reduction in ED visits due to the pandemic and since ED Visits are the primary outcome for TtLIVE, as a process measure, we will conduct a one-time focus group to generate a hierarchy of important study primary and secondary outcomes with participating sites.
Site focus groups: Every participating site will get an opportunity to participate in a 30-60-minute focus group to discuss and rank outcomes relevant to their practice over zoom
Trial Locations
- Locations (8)
McMaster Children's Hospital
🇨🇦Hamilton, Ontario, Canada
Children's Hospital, London Health Sciences
🇨🇦London, Ontario, Canada
London Health Sciences Center
🇨🇦London, Ontario, Canada
Children's Hospital of Eastern Ontario
🇨🇦Ottawa, Ontario, Canada
The Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Sunnybrook Health Sciences Center
🇨🇦Toronto, Ontario, Canada
West Park Healthcare Centre
🇨🇦York, Ontario, Canada
McMaster Children's Hospital🇨🇦Hamilton, Ontario, Canada