Protocol for two-arm pragmatic cluster randomized hybrid implementation-effectiveness trial comparing two education strategies for improving the uptake of noninvasive ventilation in patients with severe COPD exacerbation

Mihaela S Stefan,Ashley M Hughes,Penelope S Pekow,Christopher M Shea,Nicholas S Hill,Jay S Steingrub,Peter K Lindenauer

doi:10.1186/s43058-020-00028-2

Abstract

BackgroundCOPD is the fourth leading cause of death in the US, and COPD exacerbations result in approximately 700,000 hospitalizations annually. Patients with acute respiratory failure due to severe COPD exacerbation are treated with invasive (IMV) or noninvasive mechanical ventilation (NIV). Although IMV reverses hypercapnia/hypoxia, it causes significant morbidity and mortality. There is strong evidence that patients treated with NIV have better outcomes, and NIV is recommended as first line therapy in these patients. Yet, several studies have demonstrated substantial variation in the use of NIV across hospitals, leading to preventable morbidity and mortality. Through a series of mixed-methods studies, we have found that successful implementation of NIV requires physicians, respiratory therapists (RTs), and nurses to communicate and collaborate effectively, suggesting that efforts to increase the use of NIV in COPD need to account for the complex and interdisciplinary nature of NIV delivery and the need for team coordination. Therefore, we propose to compare two educational strategies: online education (OLE) and interprofessional education (IPE) which targets complex team-based care in NIV delivery.Methods and designTwenty hospitals with low baseline rates of NIV use will be randomized to either the OLE or IPE study arm. The primary outcome of the trial is change in the hospital rate of NIV use among patients with COPD requiring ventilatory support. In aim 1, we will compare the uptake change over time of NIV use among patients with COPD in hospitals enrolled in the two arms. In aim 2, we will explore mediators’ role (respiratory therapist autonomy and team functionality) on the relationship between the implementation strategies and implementation effectiveness. Finally, in aim 3, through interviews with providers, we will assess acceptability and feasibility of the educational training.DiscussionsThis study will be among the first to carefully test the impact of IPE in the inpatient setting. This work promises to change practice by offering approaches to facilitate greater uptake of NIV and may generalize to other interventions directed to seriously-ill patients.Trial registrationName of registry: ClinicalTrials.govTrial registration number: NCT04206735Date of Registration: December 20, 2019

Highlights

Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death in the US, and COPD exacerbations result in approximately 700,000 hospitalizations annually
We identified the following contextual factors and strategies associated with successful noninvasive mechanical ventilation (NIV) implementation: provider buy-in, respiratory therapists (RT) autonomy to deliver NIV independently, interdisciplinary teamwork, collegial, trusting relationships between RTs, physicians, and nurses, and ongoing staff education [15]
Hospitals that demonstrate interest in participating in the study will be asked to commit to form a COPD-NIV team composed of one physician, one RT, and one nurse that will be in close contact with the investigators and are responsible for delivering the educational intervention in their institution

Summary

Introduction

COPD is the fourth leading cause of death in the US, and COPD exacerbations result in approximately 700,000 hospitalizations annually. Multiple randomized controlled trials [3, 4], meta-analysis [5, 6], and analyses of real-world data [7, 8] have demonstrated that treatment with NIV, when added to usual care, reduces the risk of intubation, lowers the incidence of ventilator associated complications, and results in better short-term survival. Based on this evidence, NIV receives a grade A recommendation in current Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines [9]. The European Respiratory Society and American Thoracic Society joint guidelines [10] as well as British Thoracic Society guidelines [11] make a strong recommendation for the use of NIV as a first-line treatment for patients with COPD exacerbation and acute respiratory failure

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