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

NCT04206735 | Withdrawn

• 2 other identifiers: 1351436R01HL146615
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Copd

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Changes in the use of NIV

  Hospitals' rate of NIV among ventilated COPD patients at 18 and 36 months

  At baseline and 18 months after baseline

• Sustainability

  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.

  36 months after training is completed

• Acceptability and feasibility of the educational training

  Interviews with providers will be conducted to determine the acceptability and feasibility of the educational training

  At 18 months after baseline

• Penenetration of training

  Proportion of providers completing the training (assessed using participation logs)

  18 months after training is completed

• Changes in Respiratory Therapist Job Autonomy

  Survey of RTs regarding their belief on how autonomous they are in delivering NIV

  Pre-training (baseline), 12 months after training, 36 months after training

• Changes in team functionality

  Survey of physicians, RTs and nurses regarding team functionality in delivering NIV

  Pre-training (baseline), 12 months after training, 36 months after training

Secondary Outcomes (2)

• Changes in NIV failure rates

  Pre-training (baseline), 12 months after training, 36 months after training

• Changes in hospital length of stay

  Pre-training (baseline), 12 months after training, 36 months after training

Study Arms (1)

Interprofessional Education (IPE)

EXPERIMENTAL

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); Other: Usual care

Interventions

Interprofessional Education (IPE) OTHER

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.

Interprofessional Education (IPE)

Usual care OTHER

Usual care of patients hospitalized with severe COPD exacerbation

Interprofessional Education (IPE)

Eligibility Criteria

• Age: 23 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Baystate Medical Center: lead
• University of Illinois at Chicago: collaborator
• University of North Carolina, Chapel Hill: collaborator
• Premier Inc: collaborator
• Tufts Medical Center: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Baystate Medical Center (Institute for Healthcare and Population Science)

Springfield, Massachusetts, 01107, United States

Location

Related Publications (10)

• Stefan MS, Pekow PS, Shieh MS, Hill NS, Rothberg MB, Fisher KA, Lindenauer PK. Hospital Volume and Outcomes of Noninvasive Ventilation in Patients Hospitalized With an Acute Exacerbation of Chronic Obstructive Pulmonary Disease. Crit Care Med. 2017 Jan;45(1):20-27. doi: 10.1097/CCM.0000000000002006.

  PMID: 27509388 BACKGROUND

• Stefan MS, Shieh MS, Pekow PS, Hill N, Rothberg MB, Lindenauer PK. Trends in mechanical ventilation among patients hospitalized with acute exacerbations of COPD in the United States, 2001 to 2011. Chest. 2015 Apr;147(4):959-968. doi: 10.1378/chest.14-1216.

  PMID: 25375230 BACKGROUND

• Lindenauer PK, Stefan MS, Shieh MS, Pekow PS, Rothberg MB, Hill NS. Outcomes associated with invasive and noninvasive ventilation among patients hospitalized with exacerbations of chronic obstructive pulmonary disease. JAMA Intern Med. 2014 Dec;174(12):1982-93. doi: 10.1001/jamainternmed.2014.5430.

  PMID: 25347545 BACKGROUND

• Fisher KA, Mazor KM, Goff S, Stefan MS, Pekow PS, Williams LA, Rastegar V, Rothberg MB, Hill NS, Lindenauer PK. Successful Use of Noninvasive Ventilation in Chronic Obstructive Pulmonary Disease. How Do High-Performing Hospitals Do It? Ann Am Thorac Soc. 2017 Nov;14(11):1674-1681. doi: 10.1513/AnnalsATS.201612-1005OC.

  PMID: 28719228 BACKGROUND

• Hughes AM, Gregory ME, Joseph DL, Sonesh SC, Marlow SL, Lacerenza CN, Benishek LE, King HB, Salas E. Saving lives: A meta-analysis of team training in healthcare. J Appl Psychol. 2016 Sep;101(9):1266-304. doi: 10.1037/apl0000120. Epub 2016 Jun 16.

  PMID: 27599089 BACKGROUND

• Marlow SL, Hughes AM, Sonesh SC, Gregory ME, Lacerenza CN, Benishek LE, Woods AL, Hernandez C, Salas E. A Systematic Review of Team Training in Health Care: Ten Questions. Jt Comm J Qual Patient Saf. 2017 Apr;43(4):197-204. doi: 10.1016/j.jcjq.2016.12.004. Epub 2017 Feb 16.

  PMID: 28325208 BACKGROUND

• Stefan MS, Nathanson BH, Higgins TL, Steingrub JS, Lagu T, Rothberg MB, Lindenauer PK. Comparative Effectiveness of Noninvasive and Invasive Ventilation in Critically Ill Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease. Crit Care Med. 2015 Jul;43(7):1386-94. doi: 10.1097/CCM.0000000000000945.

  PMID: 25768682 BACKGROUND

• Metcalf AY, Stoller JK, Habermann M, Fry TD. Respiratory Therapist Job Perceptions: The Impact of Protocol Use. Respir Care. 2015 Nov;60(11):1556-9. doi: 10.4187/respcare.04156. Epub 2015 Aug 25.

  PMID: 26306735 BACKGROUND

• Stefan MS, Pekow PS, Shea CM, Hughes AM, Hill NS, Steingrub JS, Farmer MJS, Hess DR, Riska KL, Clark TA, Lindenauer PK. 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. Trials. 2021 Dec 16;22(1):926. doi: 10.1186/s13063-021-05855-9.

  PMID: 34915905 DERIVED

• Stefan MS, Pekow PS, Shea CM, Hughes AM, Hill NS, Steingrub JS, Lindenauer PK. 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. Implement Sci Commun. 2020;1(1):46. doi: 10.1186/s43058-020-00028-2. Epub 2020 May 6.

  PMID: 32435762 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mihaela Stefan, Phd. MD

  Baystate Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 20, 2019
• Study Start: December 8, 2019
• Primary Completion: February 12, 2022
• Study Completion: March 4, 2022
• Last Updated: May 23, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: one year after the study completion
• Access Criteria: By request from investigators. The protocol will be published

Locations

US (1)