Pilot Study: Post-Recovery LibEration From Oxygen in Exacerbated COPD (RELIEF Pilot)
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Details and patient eligibility
About
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 and will instead provide them with training in skills that have been shown to help patients breathe better. Participants will be randomly assigned to receive the intervention program or usual care. After 12 weeks the investigators will determine if the program helped stop unnecessary oxygen prescription. The investigators will also determine if health status, distance walked during six minutes, and symptoms of breathlessness after walking are different between participants who received the program and those who did not. The investigators will meet with participating patients and their providers after the study is complete to find out how they feel about this program and if it would be possible to put this change into practice.
Full 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-implementation intervention. Patients assigned to the oxygen de-implementation intervention group will have their active oxygen prescription discontinued, be educated on pursed lip breathing and receive inhaler training. A follow-up assessment will occur at 12 weeks. The primary outcome at 12 weeks will be discontinuation of oxygen. Secondary outcomes include health status as measured by the Clinical COPD Questionnaire (CCQ), tele-six minute walk test (6MWT) distance, and Borg dyspnea scale assessed after the tele-6MWT. Among the intervention group, the investigators will also assess acceptability and feasibility of the intervention for patient participants and their providers.
Recruitment was expected to begin in November 2021 but was delayed due to the COVID-19 Omicron outbreak. Recruitment officially began on April 18, 2022.
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Volunteers
Inclusion criteria
- 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 criteria
- 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
Trial design
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Interventional model
Masking
0 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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