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.
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
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
444
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.
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
ED Visits: ED visit rates at 12 months determined using health administrative databases
Using health administrative databases and the Ambulatory Health Care Record-modified
Time frame: 12 months± 4 weeks
To measure caregiver reported sense of mastery (Pearlin Mastery Scale; scores range up to 28, higher scores = higher mastery), if no caregiver available then patient reported sense of mastery will be utilized
To measure caregiver reported sense of mastery, an outcome that is often linked to patient empowerment using the Pearlin Self-Mastery Scale, if no caregiver available then patient reported sense of mastery will be utilized
Time frame: 12 months± 4 weeks
Number of hospital admissions and days in hospital over 6 months using health administrative databases.
Using health administrative databases and the Ambulatory Health Care Record-modified
Time frame: 6 months± 4 weeks
Number of hospital admissions and days in hospital over 12 months using health administrative databases.
Using health administrative databases and the Ambulatory Health Care Record-modified
Time frame: 12 months ± 4 weeks
Hospital free survival using health administrative data at 6 months.
Using health administrative databases and the Ambulatory Health Care Record-modified
Time frame: 6 months ± 4 weeks
Hospital free survival using health administrative data at 12 months.
Using health administrative databases and the Ambulatory Health Care Record-modified
Time frame: 12 Months ± 4 weeks
Time to first ED visit and first hospital admission.
Using health administrative databases and the Ambulatory Health Care Record-modified
Time frame: 12 months ± 4 weeks
Overall survival at 6 months.
Using health administrative databases and the Ambulatory Health Care Record-modified
Time frame: 6 months ± 4 weeks
Overall survival at 12 months.
Using health administrative databases and the Ambulatory Health Care Record-modified
Time frame: 12 months ± 4 weeks
Respiratory and non-respiratory causes of death at 6 months.
Using health administrative databases and the Ambulatory Health Care Record-modified
Time frame: 6 months ± 4 weeks
Respiratory and non-respiratory causes of death at 12 months.
Using health administrative databases and the Ambulatory Health Care Record-modified
Time frame: 12 months ± 4 weeks
Number and type of outpatient specialist visits at 6 months.
Using health administrative databases and the Ambulatory Health Care Record-modified
Time frame: 6 months ± 4 weeks
Number and type of outpatient specialist visits at 12 months.
Using health administrative databases and the Ambulatory Health Care Record-modified
Time frame: 12 months ± 4 weeks
Number of family physician visits at 6 months.
Using health administrative databases and the Ambulatory Health Care Record-modified
Time frame: 6 months ± 4 weeks
Number of family physician visits at 12 months.
Using health administrative databases and the Ambulatory Health Care Record-modified
Time frame: 12 months ± 4 weeks
Homecare service use at 6 months.
Using health administrative databases and the Ambulatory Health Care Record-modified
Time frame: 6 months ± 4 weeks
Homecare service use at 12 months.
Using health administrative databases and the Ambulatory Health Care Record-modified
Time frame: 12 months ± 4 weeks
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'.
Caregiver Outcome
Time frame: 6 months ± 4 weeks
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'.
Caregiver Outcome
Time frame: 12 months ± 4 weeks
Change in study participant health related quality of life using the EQ-5D (adults) and ED-5DY (children) change from baseline and 6 months
Health Related Quality of Life Outcome
Time frame: 6 months ± 4 weeks
Change in study participant health related quality of life using the EQ-5D (adults) and ED-5DY (children) change from baseline and 12 months
Health Related Quality of Life Outcome
Time frame: 12 months ± 4 weeks
Quality of care coordination using Family Experiences with Care Coordination (FECC) for qualitative interview participants only
Care Coordination Outcome
Time frame: 6 months ± 4 weeks
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
Economic Outcome
Time frame: 12 months ± 4 weeks
Mean monthly healthcare costs (public, private and caregiver lost time) over 6 months
Economic Outcome: Using health administrative databases and the Ambulatory Health Care Record-modified
Time frame: 6 months ± 4 weeks
Mean monthly healthcare costs (public, private and caregiver lost time) over 12 months
Economic Outcome: Using health administrative databases and the Ambulatory Health Care Record-modified
Time frame: 12 months ± 4 weeks
Encounter time spent by clinicians over 12 months measured using the Care Coordination Measurement Tool
HealthCare Provider Outcome
Time frame: 12 months ± 4 weeks
Process Measure Outcomes
n(%) of 5 clinic visits conducted virtually as opposed to face to face
Time frame: 12 months ± 4 weeks
Process Measure Outcomes
n (%) of virtual data downloads available for the virtual clinic visits
Time frame: 12 months ± 4 weeks
Process Measure Outcomes
n(%) participants that completed the virtual care plan within 6 weeks after intervention initiation
Time frame: 12 months ± 4 weeks
Process Measure Outcomes
n (%) of the 52 weekly check-ins completed
Time frame: 12 months ± 4 weeks
Process Measure Outcomes
n(%) of the 12 monthly S3-NIV check-ins completed
Time frame: 12 months ± 4 weeks
Process Measure Outcomes
number of ad hoc questions/concerns in which healthcare team contacted via the platform
Time frame: 12 months ± 4 weeks
Process Measure Outcomes
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
Time frame: 12 months ± 4 weeks
Process Measure Outcome- Qualitative Interviews
Qualitative interviews to explore the experience with the aTouchAway intervention by study participants, caregivers and healthcare providers
Time frame: 6 months ± 4 weeks
Process Measure Outcome- Site focus Groups
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
Time frame: 24 months ± 4 weeks
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