Clinical trial NCT04180722: Transition to LIVE (Long-term In Home Ventilation Engagement) Study
Official title: A Virtual Transition Intervention for Children and Adults Transitioning to Home Ventilation in Ontario: A Pragmatic Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Long-term Ventilation at Home
Keywords: Home mechanical ventilation
Ventilator assisted individuals
Virtual Intervention
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: West Park Healthcare Centre
name: The Ottawa Hospital
name: Sunnybrook Health Sciences Centre
name: London Health Sciences Centre
name: Children's Hospital of Eastern Ontario
name: McMaster Children's Hospital
name: Kingston Health Sciences Centre
name: Aetonix Systems
First posted: 2019-11-27
Enrollment: 440
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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.

Primary outcomes:
measure: ED Visits: ED visit rates at 12 months determined using health administrative databases
timeFrame: 12 months± 4 weeks
measure: To measure patient reported sense of mastery (Pearlin Mastery Scale; scores range up to 28, higher scores = higher mastery)
timeFrame: 12 months± 4 weeks
Secondary outcomes:
measure: Number of hospital admissions and days in hospital over 6 months using health administrative databases.
timeFrame: 6 months± 4 weeks
measure: Number of hospital admissions and days in hospital over 12 months using health administrative databases.
timeFrame: 12 months ± 4 weeks
measure: Hospital free survival using health administrative data at 6 months.
timeFrame: 6 months ± 4 weeks
measure: Hospital free survival using health administrative data at 12 months.
timeFrame: 12 Months ± 4 weeks
measure: Time to first ED visit and first hospital admission.
timeFrame: 12 months ± 4 weeks
measure: Overall survival at 6 months.
timeFrame: 6 months ± 4 weeks
measure: Overall survival at 12 months.
timeFrame: 12 months ± 4 weeks
measure: Respiratory and non-respiratory causes of death at 6 months.
timeFrame: 6 months ± 4 weeks
measure: Respiratory and non-respiratory causes of death at 12 months.
timeFrame: 12 months ± 4 weeks
measure: Number and type of outpatient specialist visits at 6 months.
timeFrame: 6 months ± 4 weeks
measure: Number and type of outpatient specialist visits at 12 months.
timeFrame: 12 months ± 4 weeks
measure: Number of family physician visits at 6 months.
timeFrame: 6 months ± 4 weeks
measure: Number of family physician visits at 12 months.
timeFrame: 12 months ± 4 weeks
measure: Homecare service use at 6 months.
timeFrame: 6 months ± 4 weeks
measure: Homecare service use at 12 months.
timeFrame: 12 months ± 4 weeks
measure: 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'.
timeFrame: 6 months ± 4 weeks
measure: 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'.
timeFrame: 12 months ± 4 weeks
measure: Change in study participant health related quality of life using the EQ-5D (adults) and ED-5DY (children) change from baseline and 6 months
timeFrame: 6 months ± 4 weeks
measure: Change in study participant health related quality of life using the EQ-5D (adults) and ED-5DY (children) change from baseline and 12 months
timeFrame: 12 months ± 4 weeks
measure: Quality of care coordination using Family Experiences with Care Coordination (FECC) for qualitative interview participants only
timeFrame: 6 months ± 4 weeks
measure: 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
timeFrame: 12 months ± 4 weeks
measure: Mean monthly healthcare costs (public, private and caregiver lost time) over 6 months
timeFrame: 6 months ± 4 weeks
measure: Mean monthly healthcare costs (public, private and caregiver lost time) over 12 months
timeFrame: 12 months ± 4 weeks
measure: Encounter time spent by clinicians over 12 months measured using the Care Coordination Measurement Tool
timeFrame: 12 months ± 4 weeks
measure: Process Measure Outcomes
timeFrame: 12 months ± 4 weeks
measure: Process Measure Outcomes
timeFrame: 12 months ± 4 weeks
measure: Process Measure Outcomes
timeFrame: 12 months ± 4 weeks
measure: Process Measure Outcomes
timeFrame: 12 months ± 4 weeks
measure: Process Measure Outcomes
timeFrame: 12 months ± 4 weeks
measure: Process Measure Outcomes
timeFrame: 12 months ± 4 weeks
measure: Process Measure Outcomes
timeFrame: 12 months ± 4 weeks
measure: Process Measure Outcome- Qualitative Interviews
timeFrame: 6 months ± 4 weeks
measure: Process Measure Outcome- Site focus Groups
timeFrame: 24 months ± 4 weeks
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster Children's Hospital
state: Ontario
city: London
country: Canada
facility: Children's Hospital, London Health Sciences
state: Ontario
city: London
country: Canada
facility: London Health Sciences Center
state: Ontario
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Center
state: Ontario
city: York
country: Canada
facility: West Park Healthcare Centre
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Reshma Amin, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: King's College London
name: Louise Rose, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sunnybrook Health Sciences Centre
name: Andrea Gershon, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amin R, Gershon A, Buchanan F, Pizzuti R, Qazi A, Patel N, Pinto R, Moretti ME, Ambreen M; TtLIVE Group; Rose L. The Transitions to Long-term In Home Ventilator Engagement Study (Transitions to LIVE): study protocol for a pragmatic randomized controlled trial. Trials. 2022 Feb 7;23(1):125. doi: 10.1186/s13063-022-06035-z.