Clinical trial NCT04854967: Pilot Study: Post-Recovery LibEration From Oxygen in Exacerbated COPD
Official title: Post-REcovery LIbEration From Oxygen in Exacerbated COPD (RELIEF)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Pulmonary Disease, Chronic Obstructive
Lung Diseases
Oxygen Therapy
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2021-04-22
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to receive either usual care or an oxygen de-implementation intervention. The oxygen de-implementation intervention will consist of: 1) an order to rescind the patient's home oxygen 2) an "unlearning" component targeting provider and patient education and 3) a "substitution" component that introduces alternative evidence-based therapies to treat dyspnea (e.g. teach-to-goal inhaler teaching and pursed lip breathing).
Primary purpose: OTHER

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 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.

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-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.

Eligibility criteria: 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

Primary outcomes:
measure: Discontinuation of Oxygen at 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Clinical COPD Questionnaire (CCQ) Total Score
timeFrame: Through study completion, an average of 12 weeks
measure: tele-six minute walk test distance (tele-6MWT)
timeFrame: Through study completion, an average of 12 weeks
measure: Post tele-six minute walk test (tele-6MWT) Borg Dyspnea scale
timeFrame: Through study completion, an average of 12 weeks
measure: Cost of intervention
timeFrame: At study completion, an average of 12 weeks
measure: Proportion of potentially eligible participants randomized
timeFrame: At study completion, an average of 12 weeks
measure: Proportion of randomized participants completing 12 week follow up
timeFrame: At study completion, an average of 12 weeks
measure: Proportion of participants completing in-home spirometry
timeFrame: At study completion, an average of 12 weeks
measure: Proportion of participants completing tele-6MWT
timeFrame: At study completion, an average of 12 weeks
measure: Rate of completion of all visits
timeFrame: Through study completion, an average of 12 weeks
measure: Acceptability to patients
timeFrame: At study completion, an average of 12 weeks
measure: Acceptability to providers
timeFrame: At study completion, an average of 12 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
state: Massachusetts
Study officials:
affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
name: Laura Cecere Feemster, MD MS
role: PRINCIPAL_INVESTIGATOR
References: