Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04206735
Recruitment Status : Terminated (Complications to recruiting due to COVID-19 pandemic)
First Posted : December 20, 2019
Last Update Posted : March 21, 2022
Sponsor:
Collaborators:
University of Illinois at Chicago
University of North Carolina, Chapel Hill
Premier Inc.
Tufts Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Mihaela Stefan, MD, PhD, Baystate Medical Center

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.

Condition or disease Intervention/treatment Phase
Copd Other: Interprofessional Education (IPE) Other: Usual care Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Implementation of Interprofessional Training to Improve Uptake of Noninvasive Ventilation in Patients Hospitalized With Severe COPD Exacerbation
Actual Study Start Date : December 8, 2019
Actual Primary Completion Date : February 12, 2022
Actual Study Completion Date : March 4, 2022

Arm Intervention/treatment
Experimental: Interprofessional Education (IPE)
Each hospital needs to assign a 'COPD-NIV' team of champions to lead the implementation strategy at the local level. We will provide virtual or in-person (if safety permits) training for the COPD-NIV teams (one RT, one RN, and one MD). The training will consist of NIV knowledge and skills through the principles of IPE and teamwork. We will use the train the trainer method; after we train the COPD-NIV team champions, the champions will promote and hold training sessions for their peers in person (if safety permits, 2-3 times a month for 4 months). At present, we are providing these training sessions as prerecorded content available whenever the clinician is available. Champions will promote the training to their clinicians for the first 4 months and then at 6 and 12 months for new staff.
Other: Interprofessional 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.

Other: Usual care
Usual care of patients hospitalized with severe COPD exacerbation




Primary Outcome Measures :
  1. Changes in the use of NIV [ Time Frame: At baseline and 18 months after baseline ]
    Hospitals' rate of NIV among ventilated COPD patients at 18 and 36 months

  2. Sustainability [ Time Frame: 36 months after training is completed ]
    Hospitals' 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.

  3. Acceptability and feasibility of the educational training [ Time Frame: At 18 months after baseline ]
    Interviews with providers will be conducted to determine the acceptability and feasibility of the educational training

  4. Penenetration of training [ Time Frame: 18 months after training is completed ]
    Proportion of providers completing the training (assessed using participation logs)

  5. Changes in Respiratory Therapist Job Autonomy [ Time Frame: Pre-training (baseline), 12 months after training, 36 months after training ]
    Survey of RTs regarding their belief on how autonomous they are in delivering NIV

  6. Changes in team functionality [ Time Frame: Pre-training (baseline), 12 months after training, 36 months after training ]
    Survey of physicians, RTs and nurses regarding team functionality in delivering NIV


Secondary Outcome Measures :
  1. Changes in NIV failure rates [ Time Frame: Pre-training (baseline), 12 months after training, 36 months after training ]
    Hospitals' rate of NIV failure among all COPD patients

  2. Changes in hospital length of stay [ Time Frame: Pre-training (baseline), 12 months after training, 36 months after training ]
    Median Hospital length of stay among all COPD patients



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   23 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04206735


Locations
Layout table for location information
United States, Massachusetts
Baystate Medical Center (Institute for Healthcare and Population Science)
Springfield, Massachusetts, United States, 01107
Sponsors and Collaborators
Baystate Medical Center
University of Illinois at Chicago
University of North Carolina, Chapel Hill
Premier Inc.
Tufts Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Layout table for investigator information
Principal Investigator: Mihaela Stefan, Phd. MD Baystate Medical Center
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Mihaela Stefan, MD, PhD, Associate Professor of Medicine at University of Massachusetts Medical School-Baystate, Baystate Medical Center
ClinicalTrials.gov Identifier: NCT04206735    
Other Study ID Numbers: 1351436
R01HL146615 ( U.S. NIH Grant/Contract )
First Posted: December 20, 2019    Key Record Dates
Last Update Posted: March 21, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: one year after the study completion
Access Criteria: By request from investigators. The protocol will be published

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mihaela Stefan, MD, PhD, Baystate Medical Center:
Interprofessional training
Education
Noninvasive ventilation
Mechanical ventilation
Non-randomized open cohort step-wedge