NCT04206735: COPD-NIV

The Impact of Interprofessional Training to Improve the Uptake of Noninvasive Ventilation in Patients Hospitalized With Severe COPD Exacerbation

Withdrawn NA Last updated 23 May 2023

What this trial tests

NA trial testing Interprofessional Education (IPE) in Copd. Withdrawn.

Timeline

8 December 2019

Primary endpoint
12 February 2022

4 March 2022

Quick facts

Lead sponsor	Baystate Medical Center
Phase	NA
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	health services research
Start date	8 December 2019
Primary completion	12 February 2022
Estimated completion	4 March 2022
Sites	1 location across United States

Drugs / interventions tested

• Interprofessional Education (IPE)
• Usual care

Conditions studied

• Copd — all drugs for Copd →

Sponsor

Baystate Medical Center

Who can join

Adults 23 to 80, any sex, with Copd. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Educational interventions for health professionals managing chronic obstructive pulmonary disease in primary care.
   Cross AJ, Thomas D, Liang J, Abramson MJ, et al · · 2022 · cited 15× · PMID 35514131 · DOI 10.1002/14651858.cd012652.pub2
2. 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.
   Stefan MS, Pekow PS, Shea CM, Hughes AM, et al · · 2020 · cited 3× · PMID 32435762 · DOI 10.1186/s43058-020-00028-2
3. Update to the study protocol for an implementation-effectiveness trial comparing two education strategies for improving the uptake of noninvasive ventilation in patients with severe COPD exacerbation.
   Stefan MS, Pekow PS, Shea CM, Hughes AM, et al · · 2021 · cited 2× · PMID 34915905 · DOI 10.1186/s13063-021-05855-9