NCT04854967

Pilot Study: Post-Recovery LibEration From Oxygen in Exacerbated COPD

Post-REcovery LIbEration From Oxygen in Exacerbated COPD (RELIEF)

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

Type	Name	Description
OTHER	Rescind home oxygen order	A note will be entered in the medical record describing the participants randomization into the intervention group. The note will be signed by study staff and will accompany the discontinuation of the patient's home oxygen by a study clinician.
BEHAVIORAL	Provider Education	A note will be entered in the medical record informing the patient's individual medical providers (i.e. primary care provider, pulmonologist) of their randomization into the intervention group. The note will include the evidence-base for oxygen use among patients with COPD.
BEHAVIORAL	Patient Education	The patient will receive a patient education page about discontinuation of home oxygen after recovery from a hospitalization that was developed by Consumer Reports in conjunction with the "Choosing Wisely" Campaign.
BEHAVIORAL	Teach-to-goal inhaler training	Teach-to-goal (TTG) inhaler training is a patient-centered education strategy that has been shown to decrease inhaler misuse and decrease acute care utilization. The training is tailored to the patient and meets guideline recommendations for assessment and instruction of inhaler technique. The rounds of assessment and demonstration can be completed until acceptable skill level is attained and tailored to the specific medication prescribed.
BEHAVIORAL	Pursed lip breathing	Pursed lip-breathing will be taught to the participants randomized to the intervention arm. This simple technique relieves breathlessness and has been shown to improve functional capacity in patients with COPD. Participants will be given an instructional handout to refer to after the visit.

Timeline

• Start date: 2022-04-18
• Primary completion: 2023-05-15
• Completion: 2023-05-15
• First posted: 2021-04-22
• Last updated: 2023-06-05

Locations

1 site across 1 country: United States