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

T

The Hospital for Sick Children

Status

Completed

Conditions

Long-term Ventilation at Home

Treatments

Device: aTouchAway™ platform

Study type

Interventional

Funder types

Other

Identifiers

NCT04180722
1000000000

Details and patient eligibility

About

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.

Full 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.

Enrollment

444 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

444 participants in 2 patient groups

Intervention
Experimental group
Description:
Participants will receive multi-component Virtual Transition Intervention facilitated through the aTouchAway™ platform including the usual care provided by specialist HMV programs.
Treatment:
Device: aTouchAway™ platform
Control
No Intervention group
Description:
Usual care will be delivered in accordance with the Canadian Thoracic Society (CTS) clinical practice guidelines and includes scheduled face-to-face clinic visits with the ventilator team with the ventilator team within the first month of starting HMV and then every 3, 6, or 12 months depending on medical stability with additional telephone calls/email contact for equipment trouble shooting and management of intercurrent illnesses as needed.

Trial contacts and locations

8

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Central trial contact

Munazzah Ambreen

Data sourced from clinicaltrials.gov

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