Acceptability of the Long-Term In-Home Ventilator Engagement virtual intervention for home mechanical ventilation patients during the COVID-19 pandemic: A qualitative evaluation.

Background: Clinical management of ventilator-assisted individuals (VAIs) was challenged by social distancing rules during the COVID-19 pandemic. In May 2020, the Long-Term In-Home Ventilator Engagement (LIVE) Program was launched in Ontario, Canada to provide intensive digital care case management to VAIs. The purpose of this qualitative study was to explore the acceptability of the LIVE Program hosted via a digital platform during the COVID-19 pandemic from diverse perspectives. Methods: We conducted a qualitative descriptive study (May 2020-April 2021) comprising semi-structured interviews with participants from eight home ventilation specialty centers in Ontario, Canada. We purposively recruited patients, family caregivers, and providers enrolled in LIVE. Content analysis and the theoretical concepts of acceptability, feasibility, and appropriateness were used to interpret findings. Results: A total of 40 individuals (2 VAIs, 18 family caregivers, 20 healthcare providers) participated. Participants described LIVE as acceptable as it addressed a longstanding imperative to improve care access, ease of use, and training provided; feasible for triaging problems and sharing information; and appropriate for timeliness of provider responses, workflows, and perceived value. Negative perceptions of acceptability among healthcare providers concerned digital workload and fit with existing clinical workflows. Perceived benefits accorded to LIVE included enhanced physical and psychological safety in the home, patient-provider relations, and VAI engagement in their own care. Conclusions: Study findings identify factors influencing the LIVE Program's acceptability by patients, family caregivers, and healthcare providers during pandemic conditions including enhanced access to care, ease of case management triage, and VAI safety. Findings may inform the implementation of digital health services to VAIs in non-pandemic circumstances.

Opening the digital front door for individuals using long-term in-home ventilation (LIVE) during a pandemic- implementation, feasibility and acceptability.

Background: The COVID-19 pandemic led to an unprecedented need for virtual healthcare that was safe, acceptable and feasible to deliver. In May 2020, we launched the Long-term In-Home Ventilator Engagement (LIVE) program for ventilator assisted individuals using ventilators hosted on an e-platform in Ontario, Canada. Objectives: To assess the acceptability, appropriateness, feasibility and usability of the LIVE program reported by patients, family caregivers, and healthcare providers (HCP). Design and Methods: We conducted a cross-sectional study. We provided HCPs participating in the LIVE program anonymized questionnaires (Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), Feasibility of Intervention Measure (FIM), and mHealth App Usability (MAUQ). Patients and family caregivers completed the AIM and MAUQ. Questionnaires were administered via an e-platform. Results: We recruited 105/251 (42%) patients and family caregivers and 42/48 (87.5%) HCPs. Patients and caregivers rated a mean (SD) overall AIM score of 4.3 (0.7) (maximum score 5; higher scores indicate greater acceptability) and a mean (SD) overall MAUQ score of 5.8 (1.5) (maximum score 7; higher scores indicate greater useability). HCPs rated a mean (SD) overall AIM score of 4.3 (0.7), IAM score of 4.3 (0.8), FIM score of 4.2 (0.7) and overall MAUQ score of 5.6 ± 1.5. There were no differences in AIM ((4.3 (0.7) vs 4.3 (0.8), p = 1) or MAUQ (5.8 (1.5) vs 5.6 (1.5), p = 0.5) scores between patients/ family caregivers and HCPs. Interpretation: This study suggests that the LIVE program was acceptable, appropriate, feasible, and usable from the perspective of patients, family caregivers and HCPs.

The Transitions to Long-term In Home Ventilator Engagement Study (Transitions to LIVE): study protocol for a pragmatic randomized controlled trial.

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.

Health Care Use, Costs, and Survival Trajectory of Home Mechanical Insufflation-Exsufflation.

BACKGROUND: Despite expert recommendations for use, limited evidence identifies effectiveness of mechanical insufflation-exsufflation (MI-E) in addressing respiratory morbidity and resultant health care utilization and costs for individuals with neuromuscular disorders. We examined the impact of provision of publicly funded MI-E devices on health care utilization, health care costs, and survival trajectory. METHODS: This is a retrospective pre/post cohort study linking data on prospectively recruited participants using MI-E to health administrative databases to quantify outcomes. RESULTS: We linked data from 106 participants (8 age < 15 y) and determined annualized health care use pre/post device. We found no difference in emergency department (ED) visit or hospital admission rates. Following MI-E approval, participants required fewer hospital days (median [interquartile range] [IQR]) 0 [0-9] vs 0 [0-4], P = .03). Rates of physician specialist visits also decreased (median IQR 7 [4-11] vs 4 [2-7], P < .001). Conversely, rates of home care nursing and homemaking/personal support visits increased. Following MI-E, total costs were lower for 59.4%, not different for 13.2%, and higher for 27.4%. Physician billing costs decreased whereas home care costs increased. Regression modeling identified pre-MI-E costs were the most important predictor of costs after approval. At 12 months, 23 (21.7%) participants had died. Risk of death was higher for those using more medical devices (hazard ratio 1.12, [95% CI 1.02-1.22]) in the home. CONCLUSIONS: Provision of publicly funded MI-E devices did not influence rates of ED visits or hospital admission but did shift health care utilization and costs from the acute care to community sector. Although increased community costs negated cost savings from physician billings, evidence suggests costs savings from reduced hospital days and fewer specialist visits. Risk of death was highest in individuals requiring multiple medical technologies.

Home mechanical ventilation: A retrospective review of safety incidents using the World Health Organization International Patient Safety Event classification.

BACKGROUND: There is a paucity of patient safety information from the community sector related to the medically fragile population requiring home mechanical ventilation (HMV). To improve safety, the risks HMV patients encounter must first be understood. OBJECTIVES: To describe patient safety incidents within the HMV population and discuss opportunities for preventing harm. METHODS: A retrospective observational review of on-call logs from the Ontario Ventilator Equipment Pool (VEP) was conducted. Classification of 248 on-call logs from April 1, 2011 to March 21, 2012 was completed using the standardized tool of the World Health Organization's (WHO) Patient Safety Taxonomy - International Classification System to quantitatively describe the types of incidents arising. Analysis of data classification was completed using descriptive and nonparametric statistics. RESULTS: Patient incidents were positive in 188 on-call logs; emerging from these were 227 incident types. Patient incident types included medical device issues (99 device failures, 41 user errors, 12 equipment availability), documentation (20 unavailable labels/prescriptions, four unclear information), clinical processes (16 inadequate treatment or general care) and clinical administration (10 inadequate handover or transfer of care). Patient incidents were associated with mild harm in 87 cases. CONCLUSIONS: The on-call logs were a good source of quality improvement data to understand harm and patient safety issues emerging in the HMV population. However, establishing a formal incident review and reporting system is required to provide a more comprehensive understanding.

La ventilation mécanique à domicile : une analyse rétrospective des incidents de sécurité au moyen de la Classification internationale pour la sécurité des patients de l'Organisation mondiale de la Santé. HISTORIQUE: Peu d'information sur la sécurité des patients provenant du secteur communautaire porte sur la population fragilisée sous ventilation mécanique à domicile (VMD). Pour améliorer la sécurité, il faut d'abord comprendre les risques que courent ces patients. OBJECTIFS: Décrire les incidents de sécurité des patients au sein de la population sous VMD et examiner des possibilités de prévenir les dommages. MÉTHODOLOGIE: Les chercheurs ont réalisé une étude d'observation rétrospective des registres d'appel de l'Ontario Ventilator Equipment Pool (VEP). Ils ont classé 248 registres d'appel prélevés du 1er avril 2011 au 21 mars 2012 au moyen de l'outil standardisé Taxonomie pour la sécurité des patients ­Système de classification internationale de l'Organisation mondiale de la Santé (OMS) afin d'effectuer une description quantitative du type d'incidents. L'analyse de la classification des données a été effectuée au moyen de statistiques descriptives et non paramétriques. RÉSULTATS: Les incidents des patients étaient positifs dans 188 des registres d'appel, et 227 types d'incidents en ont émergé. Les types d'incidents des patients incluaient des problèmes avec les dispositifs médicaux (99 défaillances de dispositifs, 41 erreurs des utilisateurs, 12 problèmes de disponibilité de l'équipement), la consignation (20 étiquettes ou prescriptions non disponibles, quatre renseignements nébuleux), les processus cliniques (16 traitements ou soins généraux inadéquats) et l'administration clinique (10 transferts de soins inadéquats). Dans 87 cas, les incidents se sont associés à de légers dommages. CONCLUSIONS: Les registres d'appel étaient une bonne source de données d'amélioration de la qualité pour comprendre les dommages et les problèmes liés à la sécurité des patients émergeant au sein de la population sous VMD. Cependant, il faut créer un système officiel d'analyse et de signalement des incidents pour mieux les comprendre.