Back to resultsPilot Study: Post-Recovery LibEration From Oxygen in Exacerbated COPD (RELIEF Pilot)
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rescind home oxygen order
Provider Education
Patient Education
Teach-to-goal inhaler training
Pursed lip breathing
Sponsored by
About this trial
This is an interventional other trial for Pulmonary Disease, Chronic Obstructive focused on measuring Pulmonary Disease, Chronic Obstructive, Lung Diseases, Oxygen Therapy
Eligibility Criteria
Inclusion Criteria:
- Age 40 years or older
- Diagnosis of COPD
- Discharged within the past 3 months after hospitalization for COPD exacerbation, congestive heart failure exacerbation and/or pneumonia
- Active prescription for supplemental oxygen within 48 hours of discharge that remains active
- 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:
- 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
Sites / Locations
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
De-implementation Intervention
Usual Care
Arm Description
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).
The patient receives usual care from their assigned clinical provider.
Outcomes
Primary Outcome Measures
Discontinuation of Oxygen at 12 weeks
The investigators will assess the proportion of participants who have no active prescription for oxygen at 12 weeks.
Secondary Outcome Measures
Clinical COPD Questionnaire (CCQ) Total Score
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.
tele-six minute walk test distance (tele-6MWT)
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.
Post tele-six minute walk test (tele-6MWT) Borg Dyspnea scale
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
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.
Proportion of potentially eligible participants randomized
Proportion of potentially eligible participants that are successfully randomized into the study
Proportion of randomized participants completing 12 week follow up
We will calculate the proportion of randomized patients who complete the 12-week follow-up
Proportion of participants completing in-home spirometry
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.
Proportion of participants completing tele-6MWT
The proportion of participants who are able to complete the tele-6MWT will be calculated.
Rate of completion of all visits
We will assess the rate of completion of all study visits among randomized participants.
Acceptability to patients
Among intervention participants, we will perform semi-structured interviews to assess acceptability of the oxygen de-implementation intervention to patients.
Acceptability to providers
Among providers of intervention participants, we will perform semi-structured interviews to assess acceptability of the oxygen de-implementation intervention.
Full Information
NCT ID
NCT04854967
First Posted
April 20, 2021
Last Updated
June 1, 2023
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT04854967
Brief Title
Pilot Study: Post-Recovery LibEration From Oxygen in Exacerbated COPD
Acronym
RELIEF Pilot
Official Title
Post-REcovery LIbEration From Oxygen in Exacerbated COPD (RELIEF)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Withdrawn
Why Stopped
No participants were enrolled
Study Start Date
April 18, 2022 (Actual)
Primary Completion Date
May 15, 2023 (Actual)
Study Completion Date
May 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Pulmonary Disease, Chronic Obstructive, Lung Diseases, Oxygen Therapy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
De-implementation Intervention
Arm Type
Experimental
Arm Description
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).
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
The patient receives usual care from their assigned clinical provider.
Intervention Type
Other
Intervention Name(s)
Rescind home oxygen order
Other Intervention Name(s)
De-implement oxygen order
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Provider Education
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Patient Education
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Teach-to-goal inhaler training
Other Intervention Name(s)
TTG
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Pursed lip breathing
Intervention Description
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.
Primary Outcome Measure Information:
Title
Discontinuation of Oxygen at 12 weeks
Description
The investigators will assess the proportion of participants who have no active prescription for oxygen at 12 weeks.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Clinical COPD Questionnaire (CCQ) Total Score
Description
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.
Time Frame
Through study completion, an average of 12 weeks
Title
tele-six minute walk test distance (tele-6MWT)
Description
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.
Time Frame
Through study completion, an average of 12 weeks
Title
Post tele-six minute walk test (tele-6MWT) Borg Dyspnea scale
Description
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.
Time Frame
Through study completion, an average of 12 weeks
Title
Cost of intervention
Description
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.
Time Frame
At study completion, an average of 12 weeks
Title
Proportion of potentially eligible participants randomized
Description
Proportion of potentially eligible participants that are successfully randomized into the study
Time Frame
At study completion, an average of 12 weeks
Title
Proportion of randomized participants completing 12 week follow up
Description
We will calculate the proportion of randomized patients who complete the 12-week follow-up
Time Frame
At study completion, an average of 12 weeks
Title
Proportion of participants completing in-home spirometry
Description
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.
Time Frame
At study completion, an average of 12 weeks
Title
Proportion of participants completing tele-6MWT
Description
The proportion of participants who are able to complete the tele-6MWT will be calculated.
Time Frame
At study completion, an average of 12 weeks
Title
Rate of completion of all visits
Description
We will assess the rate of completion of all study visits among randomized participants.
Time Frame
Through study completion, an average of 12 weeks
Title
Acceptability to patients
Description
Among intervention participants, we will perform semi-structured interviews to assess acceptability of the oxygen de-implementation intervention to patients.
Time Frame
At study completion, an average of 12 weeks
Title
Acceptability to providers
Description
Among providers of intervention participants, we will perform semi-structured interviews to assess acceptability of the oxygen de-implementation intervention.
Time Frame
At study completion, an average of 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Cecere Feemster, MD MS
Organizational Affiliation
VA Puget Sound Health Care System Seattle Division, Seattle, WA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02130-4817
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pilot Study: Post-Recovery LibEration From Oxygen in Exacerbated COPD
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