NCT04180722

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 444 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Long-term Ventilation at Home

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-03-01
• Primary completion: 2026-01-30
• Completion: 2026-01-30
• First posted: 2019-11-27
• Last updated: 2026-02-03

Locations

8 sites across 1 country: Canada