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

Long-term Ventilation at Home Clinical Trial

— TTLive  

Official title:

A Virtual Transition Intervention for Children and Adults Transitioning to Home Ventilation in Ontario: A Pragmatic Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04180722
• Other study ID #: 1000000000
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: March 30, 2025

Study information

• Verified date: November 2023
• Source: The Hospital for Sick Children
• Contact: Munazzah Ambreen
• Phone: (416) 813-7654
• Email: munazzah.ambreen[@]sickkids.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 440
• Est. completion date: March 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Long-term Ventilation at Home

Intervention

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.

Locations

Country	Name	City	State
Canada	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	Sunnybrook Health Sciences Center	Toronto	Ontario
Canada	The Hospital for Sick Children	Toronto	Ontario
Canada	West Park Healthcare Centre	York	Ontario

Sponsors (9)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Aetonix Systems, Children's Hospital of Eastern Ontario, London Health Sciences Centre, McMaster Children's Hospital, Queen's University, Sunnybrook Health Sciences Centre, The Ottawa Hospital, West Park Healthcare Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ED Visits: ED visit rates at 12 months determined using health administrative databases	Using health administrative databases and the Ambulatory Health Care Record-modified	12 months
Primary	To measure patient reported sense of mastery (Pearlin Mastery Scale; scores range up to 28, higher scores = higher mastery)	To measure patient reported sense of mastery, an outcome that is often linked to patient empowerment using the Pearlin Self-Mastery Scale	12 months
Secondary	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	6 months
Secondary	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	12 months
Secondary	Hospital free survival using health administrative data at 6 months.	Using health administrative databases and the Ambulatory Health Care Record-modified	6 months
Secondary	Hospital free survival using health administrative data at 12 months.	Using health administrative databases and the Ambulatory Health Care Record-modified	12 Months
Secondary	Time to first ED visit and first hospital admission.	Using health administrative databases and the Ambulatory Health Care Record-modified	12 months
Secondary	Overall survival at 6 months.	Using health administrative databases and the Ambulatory Health Care Record-modified	6 months
Secondary	Overall survival at 12 months.	Using health administrative databases and the Ambulatory Health Care Record-modified	12 months
Secondary	Respiratory and non-respiratory causes of death at 6 months.	Using health administrative databases and the Ambulatory Health Care Record-modified	6 months
Secondary	Respiratory and non-respiratory causes of death at 12 months.	Using health administrative databases and the Ambulatory Health Care Record-modified	12 months
Secondary	Number and type of outpatient specialist visits at 6 months.	Using health administrative databases and the Ambulatory Health Care Record-modified	6 months
Secondary	Number and type of outpatient specialist visits at 12 months.	Using health administrative databases and the Ambulatory Health Care Record-modified	12 months
Secondary	Number of family physician visits at 6 months.	Using health administrative databases and the Ambulatory Health Care Record-modified	6 months
Secondary	Number of family physician visits at 12 months.	Using health administrative databases and the Ambulatory Health Care Record-modified	12 months
Secondary	Homecare service use at 6 months.	Using health administrative databases and the Ambulatory Health Care Record-modified	6 months
Secondary	Homecare service use at 12 months.	Using health administrative databases and the Ambulatory Health Care Record-modified	12 months
Secondary	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	6 months
Secondary	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	12 months
Secondary	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	6 months
Secondary	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	12 months
Secondary	Quality of care coordination using Family Experiences with Care Coordination (FECC) for qualitative interview participants only	Care Coordination Outcome	6 months
Secondary	Quality of care coordination using Family Experiences with Care Coordination (FECC) for qualitative interview participants only	Care Coordination Outcome	12 months
Secondary	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	12 months
Secondary	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	6 months
Secondary	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	12 months
Secondary	Encounter time spent by clinicians over 12 months measured using the Care Coordination Measurement Tool	HealthCare Provider Outcome	12 months
Secondary	Process Measure Outcomes	n(%) of 5 clinic visits conducted virtually as opposed to face to face	12 months
Secondary	Process Measure Outcomes	n (%) of virtual data downloads available for the virtual clinic visits	12 months
Secondary	Process Measure Outcomes	n(%) participants that completed the virtual care plan within 6 weeks after intervention initiation	12 months
Secondary	Process Measure Outcomes	n (%) of the 52 weekly check-ins completed	12 months
Secondary	Process Measure Outcomes	n(%) of the 12 monthly S3-NIV check-ins completed	12 months
Secondary	Process Measure Outcomes	number of ad hoc questions/concerns in which healthcare team contacted via the platform	12 months
Secondary	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	12 months
Secondary	Process Measure Outcome- Qualitative Interviews	Qualitative interviews to explore the experience with the aTouchAway intervention by study participants, caregivers and healthcare providers	6 months
Secondary	Process Measure Outcome- Qualitative Interviews	Qualitative interviews to explore the experience with the aTouchAway intervention by study participants, caregivers and healthcare providers	12 months