Status:
WITHDRAWN
Pilot Study: Post-Recovery LibEration From Oxygen in Exacerbated COPD
Lead Sponsor:
VA Office of Research and Development
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Phase:
NA
Brief Summary
The investigators want to decrease inappropriate oxygen use for patients with COPD. The investigators are testing a new program that will stop oxygen prescriptions for patients that no longer need it ...
Detailed Description
The purpose of this pilot study is to test an intervention designed to decrease inappropriate oxygen use for patients with COPD. Participants will be randomized to usual care vs. an oxygen de-implemen...
Eligibility Criteria
Inclusion
- Age 40 years or older
- Diagnosis of COPD
- Discharged within the past 3 months after hospitalization for COPD exacerbation, CHF exacerbation and/or Pneumonia and Active prescription for supplemental oxygen within 48 hours of discharge that remains active; or Stable COPD with no chronic resting hypoxemia and an active prescription for supplemental oxygen.
- No inpatient or outpatient exacerbations of COPD within the last 30 days
- Smoked at least 10 pack-years of cigarettes
- Room air resting saturation \>88% on room air
- Spirometry consistent with COPD (FEV1/FVC \< 0.70) and/or evidence of emphysema on CT scan
- Willingness on the part of the participant to stop oxygen if randomized to the intervention
- Ability and willingness to participate in virtual video visits with study staff using VA approved software
- Informed consent for participation
Exclusion
- Desaturation during 6MWT \<80% for one minute or more
- Non-COPD lung disease that affects oxygenation or survival (including pulmonary hypertension)
- Prescription of oxygen for alternative condition (e.g. bleed-in with positive airway pressure therapy for obstructive sleep apnea)
- Diagnosis expected to result in death in six months or enrollment in hospice
- Participation in another intervention trial
- Cognitive issues that would preclude participation (dementia, stroke, etc.)
- Residence in skilled nursing facility
- Inability to speak, read, or understand English
- Any safety concerns
- Participants clinical team excludes the participant from recruitment or evaluation
Key Trial Info
Start Date :
April 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04854967
Start Date
April 18 2022
End Date
May 15 2023
Last Update
June 5 2023
Active Locations (1)
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1
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130-4817