The Transitions to Long-term In Home Ventilator Engagement Study (Transitions to LIVE): study protocol for a pragmatic randomized controlled trial
Authors: Amin Reshma , Gershon Andrea , Buchanan Francine , Pizzuti Regina , Qazi Adam , Patel Nishali , Pinto Ruxandra , Moretti Myla E. , Ambreen Munazzah ,   TtLIVE Group, Abelha Paula , Baker Adele , Bhatia Sacha , Brennan Cindy , Bokhaut Julia , Chiang Jackie , Cithiravel Nisha , Collins Jana , Cornejo Palma Daniel , Costa Leah , Dainty Katie N , Ersu Refika , Fisher Tom , Fleischer Erin , Fodey Sandy , Fraser Ian , Goldstein Roger , Hyatt Janet , Inman Ashley , Irven Mary , Janevsk Joanna , Kohli Raj , Katz Sherri Lynne , Koopman Wilma , Kuyntjes Sarah , Leasa David , Lim Audrey , Lopez Paty Sala , Martins Denise , Mawdsley Cathy , McKay Sandra , McKim Doug , McMillan Kristin , McNay Ramsay , Mehta Kevan , Moss Riley , Naylor Jodee , Nonoyama Mika , Overholt Michelle , Price April , Roy Josee , Shoesmith Madan Roy Christen , Sidhu Aman , Smith Joanne , Spooner Lisa , St-Laurent Aaron , Syed Faiza , Tandon Anu , Thompson Mark , Toonders Brenda , Tran Tuyen , Trinh Melissa , Varadi Robert , Venance Shannon , Workentin Kevin , Zweerink Allison , Rose Louise 
Published: February 2022

Abstract
Background overview and rationale
We co-developed a multi-component virtual care solution (TtLIVE) for the home mechanical ventilation (HMV) population using the aTouchAway™ platform (Aetonix). The TtLIVE intervention includes (1) virtual home visits; (2) customizable care plans; (3) clinical workflows that incorporate reminders, completion of symptom profiles, and tele-monitoring; and (4) digitally secure communication via messaging, audio, and video calls; (5) Resource library including print and audiovisual material.

Objectives and brief methods
Our primary objective is to evaluate the TtLIVE intervention compared to a usual care control group using an eight-center, pragmatic, parallel-group single-blind (outcome assessors) randomized controlled trial. Eligible patients are children and adults newly transitioning to HMV in Ontario, Canada. Our target sample size is 440 participants (220 each arm). Our co-primary outcomes are a number of emergency department (ED) visits in the 12 months after randomization and change in family caregiver (FC) reported Pearlin Mastery Scale score from baseline to 12 months. Secondary outcomes also measured in the 12 months post randomization include healthcare utilization measured using a hybrid Ambulatory Home Care Record (AHCR-hybrid), FC burden using the Zarit Burden Interview, and health-related quality of life using the EQ-5D. In addition, we will conduct a cost-utility analysis over a 1-year time horizon and measure process outcomes including healthcare provider time using the Care Coordination Measurement Tool. We will use qualitative interviews in a subset of study participants to understand acceptability, barriers, and facilitators to the TtLIVE intervention. We will administer the Family Experiences with Care Coordination (FECC) to interview participants. We will use Poisson regression for a number of ED visits at 12 months. We will use linear regression for the Pearlin Mastery scale score at 12 months. We will adjust for the baseline score to estimate the effect of the intervention on the primary outcomes. Analysis of secondary outcomes will employ regression, causal, and linear mixed modeling. Primary analysis will follow intention-to-treat principles. We have Research Ethics Board approval from SickKids, Children’s Hospital Eastern Ontario, McMaster Children’s Hospital, Children’s Hospital-London Health Sciences, Sunnybrook Hospital, London Health Sciences, West Park Healthcare Centre, and Ottawa Hospital.

Discussion
This pragmatic randomized controlled single-blind trial will determine the effectiveness and cost-effectiveness of the TtLIVE virtual care solution compared to usual care while providing important data on patient and family experience, as well as process measures such as healthcare provider time to deliver the intervention.

Trial registration
ClinicalTrials.gov NCT04180722. Registered on November 27, 2019.