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

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

Non Recruiting
All
Phase N/A

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Overview

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.

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.

Study details
    Long-term Ventilation at Home

NCT04180722

The Hospital for Sick Children

20 August 2025

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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