Comparison of Two Educational Strategies to Increase the Use of Noninvasive Ventilation
Keywords
Abstract
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). Although IMV reverses hypercapnia/hypoxia, it causes 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 better mortality and length of hospital stay. NIV is recommended in all 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 investigators 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 is to conduct a two-arm pragmatic type III hybrid implementation-effectiveness trial to compare two educational strategies in 20 hospitals with low NIV use in COPD: interprofessional education (IPE) which targets complex team-based care in NIV delivery and on-line education (OLE). 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 outperform OLE, leading to greater 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 uptake change over time of NIV use among patients with COPD in hospitals enrolled in the two arms. Aim 2 will explore mediators' role (RT autonomy and team functionality) on the relationship between the implementation strategies and implementation effectiveness. Finally, Aim 3, will assess 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.
Dates
Last Verified: | 12/31/2019 |
First Submitted: | 12/16/2019 |
Estimated Enrollment Submitted: | 12/18/2019 |
First Posted: | 12/19/2019 |
Last Update Submitted: | 01/28/2020 |
Last Update Posted: | 01/29/2020 |
Actual Study Start Date: | 12/07/2019 |
Estimated Primary Completion Date: | 11/30/2023 |
Estimated Study Completion Date: | 08/31/2024 |
Condition or disease
Intervention/treatment
Other: In-Person Interprofessional Education (IPE)
Other: On-line Education (OLE)
Phase
Arm Groups
Arm | Intervention/treatment |
---|---|
Experimental: In-Person Interprofessional Education (IPE) Each hospital needs to assign a 'COPD-NIV' team of champions who will lead the implementation strategy at the local level. We will provide one day in-person training for the COPD-NIV teams (one RT, one RN, and one MD) at a central location. The training will consist of 2 modules: 1) NIV knowledge and skills 2) principles of IPE and they will practice on how to deliver it. We will use the train the trainer principle; the team will return to their home institutions and hold training sessions for their peers. The sessions will be offered 2-4 times/month for 3 months. All sessions will include mixed groups of RTs, RNs and MDs. Full sessions will be offered once/ month every six months for the new staff. For the entirety of the study, there will be conference calls of the investigators with the teams every other month. | Other: In-Person Interprofessional Education (IPE) Implementation of interprofessional training to improve uptake of noninvasive ventilation in patients hospitalized with severe COPD exacerbation |
Active Comparator: On-line Education (OLE) The COPD-NIV team will be the first at their hospital to complete the on-line educational training and will then encourage the rest of their peers to complete the training. Sites will be given access to free 30 minute continuing education modules customized for each discipline (RN, RT, MD). The training will include 1) knowledge evidence-based indications, contraindication, monitoring and weaning for about NIV in COPD; and 2) skills to manage and monitor patients while on NIV. The training will be offered for the entire period of the study for all staff. The COPD-NIV team will distribute algorithms and printed materials. Conference calls between the investigators and the COPD-NIV team will continue every quarter for the duration of the study with a follow-up call at the end of the study. The calls will discuss distribution of the guidelines and NIV algorithm, problem-cases regarding NIV management, and strategies to recruit clinicians for the educational sessions. | Other: On-line Education (OLE) Online education of noninvasive ventilation (NIV) to increase the use of NIV in patients with COPD |
Eligibility Criteria
Ages Eligible for Study | 23 Years To 23 Years |
Sexes Eligible for Study | All |
Accepts Healthy Volunteers | Yes |
Criteria | Inclusion Criteria: 1. Cluster randomized trial of hospitals with low rates of NIV use (lower quartile) among patients with COPD ventilated with invasive or noninvasive mechanical ventilation. Rates are calculated from an administrative database. 2. Criteria for eligible providers for attending the educational strategies (OLE or IPE) and surveys The target population for the OLE or IPE educational strategies includes: hospitalists, emergency department physicians, respiratory therapists and nurses involved in the care of patients with COPD or acute respiratory failure at the participating hospitals. Exclusion Criteria: None |
Outcome
Primary Outcome Measures
1. Changes in uptake of NIV [At baseline and 18 months after baseline]
2. Change in Sustainability [36 months after training is completed]
3. Changes in acceptability and feasibility of the educational training [At baseline,18 months after baseline, and 36 months after baseline]
4. Change in penetration of training [36 months after training is completed]
5. Changes in Respiratory Therapist Job Autonomy [pre-training (baseline), 12 months after training, 36 months after training]
6. Changes in team functionality [pre-training (baseline), 12 months after training, 36 months after training]
Secondary Outcome Measures
1. Changes in NIV failure [pre-training (baseline), 12 months after training, 36 months after training]
2. Changes in hospital length of stay [pre-training (baseline), 12 months after training, 36 months after training]