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

NCT04854967 | Withdrawn DMC

• 1 other identifier: IIR 17-263
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Pulmonary Disease, Chronic Obstructive; Lung Diseases; Oxygen Therapy

Outcome Measures

Primary Outcomes (1)

• Discontinuation of Oxygen at 12 weeks

  The investigators will assess the proportion of participants who have no active prescription for oxygen at 12 weeks.

  12 weeks

Secondary Outcomes (11)

• Clinical COPD Questionnaire (CCQ) Total Score

  Through study completion, an average of 12 weeks

• tele-six minute walk test distance (tele-6MWT)

  Through 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

• Proportion of potentially eligible participants randomized

  At study completion, an average of 12 weeks

Study Arms (2)

De-implementation Intervention

EXPERIMENTAL

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).

Other: Rescind home oxygen order; Behavioral: Provider Education; Behavioral: Patient Education; Behavioral: Teach-to-goal inhaler training; Behavioral: Pursed lip breathing

Usual Care

NO INTERVENTION

The patient receives usual care from their assigned clinical provider.

Interventions

Rescind home oxygen order OTHER

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.

Also known as: De-implement oxygen order

De-implementation Intervention

Provider Education BEHAVIORAL

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.

De-implementation Intervention

Patient Education BEHAVIORAL

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.

De-implementation Intervention

Teach-to-goal inhaler training BEHAVIORAL

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.

Also known as: TTG

De-implementation Intervention

Pursed lip breathing BEHAVIORAL

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.

De-implementation Intervention

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130-4817, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Lung Diseases

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Laura Cecere Feemster, MD MS

  VA Puget Sound Health Care System Seattle Division, Seattle, WA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 22, 2021
• Study Start: April 18, 2022
• Primary Completion: May 15, 2023
• Study Completion: May 15, 2023
• Last Updated: June 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)