Complications to recruiting due to COVID-19 pandemic

COPD is the fourth leading cause of death in the US, and COPD exacerbations result in approximately 700,000 hospitalizations annually. Patients who do not respond to pharmacotherapy are placed on invasive (IMV) or noninvasive mechanical ventilation (NIV). Studies have shown that patients treated with NIV are less likely to require IMV and have better mortality and length of hospital stay. NIV is recommended in COPD guidelines as the first-line of treatment for patients with severe exacerbation who have failed pharmacologic treatment. Yet, despite compelling evidence of benefit, there is substantial variation in the implementation of NIV across hospitals, leading to preventable morbidity and mortality. The main goal of this project is to determine the impact of inter-professional educational strategies in 20 hospitals with low NIV use in COPD by using a non-randomized stepped-wedge open cohort design. Inter-professional education (IPE) targets complex team-based care in NIV delivery. The central hypothesis is that inter-professional education on how to care for patients with COPD using NIV will lead to improvement in the uptake of NIV, and that respiratory therapist (RT autonomy) and team functionality will act as mediators.

COPD is the fourth leading cause of death in the US, and COPD exacerbations result in approximately 700,000 hospitalizations annually. Patients who do not respond to pharmacotherapy are placed on invasive mechanical ventilation (IMV) or noninvasive mechanical ventilation (NIV). Although IMV reverses hypercapnia/hypoxia, it can cause significant morbidity and mortality. NIV is an alternative ventilatory option for acute respiratory failure that provides positive pressure ventilation via a mask. Multiple randomized controlled trials and analyses of real-world data have shown that patients treated with NIV are less likely to require IMV, and have lower mortality and length of hospital stay. NIV is recommended in COPD guidelines as the first-line treatment for patients with severe exacerbation who have failed pharmacologic treatment. Yet, despite compelling evidence of benefit, we have previously demonstrated substantial variation in the implementation 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 to select appropriate patients for treatment, and to carefully manage patients after NIV initiation. These studies suggest 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. The main goal of this project is to determine the impact of interprofessional educational (IPE) strategies in 20 hospitals with low NIV use in COPD by conducting non-randomized open cohort step wedge trial. The IPE will target complex team-based care in NIV delivery. The primary outcome of the trial is change in the hospital rate of NIV use among patients with COPD requiring ventilatory support. The central hypothesis is that IPE will lead to improvement in the uptake of NIV, and that RT autonomy and team functionality will act as mediators. The goal will be accomplished by completing three specific aims. Aim 1 will compare the change in NIV use over time among patients with COPD in hospitals enrolled by comparing their NIV rates from before the IPE training, to after the training. Aim 2 will explore mediators' role (RT autonomy and team functionality) on the relationship between the implementation strategies and implementation effectiveness. In Aim 3, we will assess the acceptability and feasibility of the educational training through interviews with providers. This proposal is significant because NIV is the only therapy that has been shown to improve short-term survival for patients hospitalized for exacerbation of COPD, yet a large number of hospitals still have not adopted this approach fully.

Inclusion Criteria:

1. Hospitals with low rates of NIV use (lower-half quartiles) among patients with COPD ventilated with invasive or noninvasive mechanical ventilation. Rates are calculated from an administrative database. Hospitals must also have a minimum of 10 ventilated patients over an 18 month period per hospital in which to assess NIV rates. (the above age limits are for patients with COPD included in calculating the rates)
2. The target population of clinicians for the IPE educational training aged 23-80 years includes: physicians (hospitalists, emergency department physicians, critical care or pulmonary), respiratory therapists, and nurses involved in the care of patients with COPD or acute respiratory failure at the participating hospitals.

Exclusion Criteria:

None

7. The dataset submitted to NHLBI will be prepared in accordance with the requirements for NHLBI data repository datasets and associated documentation for submission and the NHLBI Policy for Data Sharing for Clinical Trials and Epidemiological Studies, and in accordance with the Guidelines for NHLBI Data Set Preparation

one year after the study completion

By request from investigators. The protocol will be published