Post-REcovery LIbEration From Oxygen in Exacerbated COPD (RELIEF)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Discontinuation of Oxygen at 12 weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Discontinuation of Oxygen at 12 weeks
时间窗: 12 weeks
The investigators will assess the proportion of participants who have no active prescription for oxygen at 12 weeks.
次要结局
- Proportion of participants completing tele-6MWT(At study completion, an average of 12 weeks)
- Post tele-six minute walk test (tele-6MWT) Borg Dyspnea scale(Through study completion, an average of 12 weeks)
- Cost of intervention(At study completion, an average of 12 weeks)
- Clinical COPD Questionnaire (CCQ) Total Score(Through study completion, an average of 12 weeks)
- Proportion of randomized participants completing 12 week follow up(At study completion, an average of 12 weeks)
- Acceptability to patients(At study completion, an average of 12 weeks)
- Acceptability to providers(At study completion, an average of 12 weeks)
- Proportion of participants completing in-home spirometry(At study completion, an average of 12 weeks)
- tele-six minute walk test distance (tele-6MWT)(Through study completion, an average of 12 weeks)
- Proportion of potentially eligible participants randomized(At study completion, an average of 12 weeks)
- Rate of completion of all visits(Through study completion, an average of 12 weeks)