Pilot Study: Post-Recovery LibEration From Oxygen in Exacerbated COPD
NCT ID: NCT04854967
Last Updated: 2023-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2022-04-18
2023-05-15
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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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).
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.
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.
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.
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.
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.
Usual Care
The patient receives usual care from their assigned clinical provider.
No interventions assigned to this group
Interventions
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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.
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.
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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
ALL
No
Sponsors
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VA Office of Research and Development
FED
Responsible Party
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Principal Investigators
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Laura Cecere Feemster, MD MS
Role: PRINCIPAL_INVESTIGATOR
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Locations
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VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States
Countries
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Other Identifiers
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IIR 17-263
Identifier Type: -
Identifier Source: org_study_id
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