Pilot Study: Post-Recovery LibEration From Oxygen in Exacerbated COPD
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Other: Rescind home oxygen orderBehavioral: Provider EducationBehavioral: Patient EducationBehavioral: Teach-to-goal inhaler trainingBehavioral: Pursed lip breathing
- Registration Number
- NCT04854967
- Lead Sponsor
- VA Office of Research and Development
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description De-implementation Intervention Pursed lip breathing 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). De-implementation Intervention Provider Education 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). De-implementation Intervention Patient Education 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). De-implementation Intervention Teach-to-goal inhaler training 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). De-implementation Intervention Rescind home oxygen order 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 Outcome Measures
Name Time Method Discontinuation of Oxygen at 12 weeks 12 weeks The investigators will assess the proportion of participants who have no active prescription for oxygen at 12 weeks.
- Secondary Outcome Measures
Name Time Method Proportion of participants completing tele-6MWT At study completion, an average of 12 weeks The proportion of participants who are able to complete the tele-6MWT will be calculated.
Post tele-six minute walk test (tele-6MWT) Borg Dyspnea scale Through study completion, an average of 12 weeks The Borg dyspnea scale assesses the difficulty that a patient is having with breathing at the current moment, and ranges from 0 (nothing at all) to 10 (maximal). Within one minute of completing the tele-6MWT, the participant will be asked to grade the severity of their dyspnea based on the modified Borg dyspnea scale.
Cost of intervention At study completion, an average of 12 weeks The estimate of costs related to the intervention will be obtained by tracking duration of intervention content and processes. The duration of tasks related to identification and evaluation of subject, enrollment and the intervention will be collected. These tasks will be broken down by level of skill required and a cost estimate calculated.
Clinical COPD Questionnaire (CCQ) Total Score Through study completion, an average of 12 weeks The disease-specific health status will be measured by the Clinical COPD Questionnaire (CCQ) total Score. The measurement will be defined as the total score of the CCQ at 12 weeks. The CCQ was developed to assess symptoms, functional status, and COPD control and has been used in clinical trials to assess disease specific health status. The measure has strong internal consistency, reliability and validity, and is responsive to change over short time periods. The CCQ consists of 10 items grouped into three domains (symptoms, functional status and mental state), and one total score. Responses range from 0 (never) to 6 (almost all the time). The total score is calculated by adding all the responses and dividing by the total number of items to produce a final score that ranges from 0-6.
Proportion of randomized participants completing 12 week follow up At study completion, an average of 12 weeks We will calculate the proportion of randomized patients who complete the 12-week follow-up
Proportion of participants completing in-home spirometry At study completion, an average of 12 weeks The proportion of participants who are able to successfully complete in-home spirometry with coaching by study staff will be assessed at the end of the study.
Acceptability to patients At study completion, an average of 12 weeks Among intervention participants, we will perform semi-structured interviews to assess acceptability of the oxygen de-implementation intervention to patients.
Acceptability to providers At study completion, an average of 12 weeks Among providers of intervention participants, we will perform semi-structured interviews to assess acceptability of the oxygen de-implementation intervention.
tele-six minute walk test distance (tele-6MWT) Through study completion, an average of 12 weeks The total distance walked during 6 minutes at the 12 week virtual visit. Participants will be asked to walk for 6 minutes following a premeasured course which was used at the in-person visit and then given to them to take home for the virtual visit.
Proportion of potentially eligible participants randomized At study completion, an average of 12 weeks Proportion of potentially eligible participants that are successfully randomized into the study
Rate of completion of all visits Through study completion, an average of 12 weeks We will assess the rate of completion of all study visits among randomized participants.
Trial Locations
- Locations (1)
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
🇺🇸Boston, Massachusetts, United States