RE:RE:VA Pilot studyVA Pilot Study description: https://clinicaltrials.gov/ct2/show/study/NCT04413643
This is a pilot study to evaluate the impact of providing patients admitted with acute exacerbations of COPD (AECOPD) with non-invasive ventilation (NIV)home devices prior to discharge on hospital readmission rates and other secondary outcomes.
Aim 1 To test whether continuation of NIV at home after being initiated during hospitalization for AECOPD improves subsequent admission-free survival in patients with chronic hypercapnic respiratory failure secondary to COPD
Hypothesis 1: The use of targeted NIV during hospitalization with continuation upon discharge to home will improve one-year all-cause mortality as compared to published mortality in the current literature.
Hypothesis 2: The use of targeted NIV during hospitalization with continuation upon discharge to home will reduce readmission rates for AECOPD within-institution historical data.
Aim 2 To evaluate the feasibility of a larger multisite randomized controlled trial in veterans using inclusion and exclusion criteria specified in this pilot.
Outcomes
Primary: Event-free survival (re-hospitalization for AECOPD, time to readmission for AECOPD, and all-cause mortality)
Secondary:
- Unplanned readmission rates (all complications)
- Time to readmissions for admissions other than AECOPD.
- Arterial blood gas/Venous blood gas (ABG/VBG): PaO2, PaCO2 and serum bicarbonate at Baseline, 6 and 12 months
- Pulmonary function (handheld spirometer or in-laboratory based on specific institution resources) at Baseline, 6, and 12 months 5.6 minute walk test at Baseline, 6,and 12 months
This is a prospective 1-year interventional pilot study that will occur at 4 Veterans Affairs (VA) hospitals (Sacramento, Durham, Pittsburgh, and San Francisco).
The total enrollment goal across all sites is 50. Total study period expected includes an enrollment period of approximately 10-12 months and follow-up period of 12 months for a total study duration of approximately 2 years commencing June 1, 2020.
IMHO, assuming the enrollment went smoothly and quickly, the 1-year results will likely be announced in the next six months.
If successful, then a much larger study will be done.