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

Implementation of Interprofessional Training to Improve Uptake of Noninvasive Ventilation in Patients Hospitalized With Severe COPD Exacerbation

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04206735
Acronym
COPD-NIV
Enrollment
0
Registered
2019-12-20
Start date
2019-12-08
Completion date
2022-03-04
Last updated
2023-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Copd

Keywords

Interprofessional training, Education, Noninvasive ventilation, Mechanical ventilation, Non-randomized open cohort step-wedge

Brief summary

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.

Detailed 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 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.

Interventions

OTHERUsual care

Usual care of patients hospitalized with severe COPD exacerbation

OTHERInterprofessional Education (IPE)

We will use the training stated in the arm description above. In addition, prerecorded webinars that include evidence-based practice management of COPD will be released every month for the champions and clinicians to watch at their leisure.

Sponsors

University of Illinois at Chicago
CollaboratorOTHER
University of North Carolina, Chapel Hill
CollaboratorOTHER
Premier Inc
CollaboratorINDUSTRY
Tufts Medical Center
CollaboratorOTHER
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Baystate Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Hospitals that agree to participate are offered 3 dates at approximately 6-month intervals. They sign up for a date depending on their readiness to participate. A team of champions: nurses, respiratory therapists (RTs), and physicians from each hospital will attend a virtual one-day training which will include NIV knowledge, skills, and the principles of teamwork. The clinicians in the participating institutions will be then on how to appropriately deliver NIV know and the principles of teamwork by an online course and by the champions teams.

Eligibility

Sex/Gender
ALL
Age
23 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in team functionalityPre-training (baseline), 12 months after training, 36 months after trainingSurvey of physicians, RTs and nurses regarding team functionality in delivering NIV
Penenetration of training18 months after training is completedProportion of providers completing the training (assessed using participation logs)
Changes in Respiratory Therapist Job AutonomyPre-training (baseline), 12 months after training, 36 months after trainingSurvey of RTs regarding their belief on how autonomous they are in delivering NIV
Changes in the use of NIVAt baseline and 18 months after baselineHospitals' rate of NIV among ventilated COPD patients at 18 and 36 months
Sustainability36 months after training is completedHospitals' rate of NIV among ventilated COPD patients/Administrative database.If there are no changes in NIV among ventilated patients after 18 months then we will not examine sustainability of the training at 36 months after training is completed.
Acceptability and feasibility of the educational trainingAt 18 months after baselineInterviews with providers will be conducted to determine the acceptability and feasibility of the educational training

Secondary

MeasureTime frameDescription
Changes in hospital length of stayPre-training (baseline), 12 months after training, 36 months after trainingMedian Hospital length of stay among all COPD patients
Changes in NIV failure ratesPre-training (baseline), 12 months after training, 36 months after trainingHospitals' rate of NIV failure among all COPD patients

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026