Pulmonary Disease, Chronic ObstructiveRELIEF PilotNCT04854967
Pilot Study: Post-Recovery LibEration From Oxygen in Exacerbated COPD
A study testing Rescind home oxygen order, Provider Education and Patient Education in people with Pulmonary Disease, Chronic Obstructive, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Rescind home oxygen order, Provider Education and Patient Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Apr 2022to 15 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.)
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130-4817
About this study
Official title: Post-REcovery LIbEration From Oxygen in Exacerbated COPD (RELIEF)
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.
Read the 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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Rescind home oxygen order, Provider Education, Patient Education, Teach-to-goal inhaler training, Pursed lip breathing
- Keywords
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Oxygen Therapy
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rescind home oxygen orderOther
Also called De-implement 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 EducationBehavioural
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 EducationBehavioural
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 trainingBehavioural
Also called TTG
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 breathingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discontinuation of Oxygen at 12 weeks
The investigators will assess the proportion of participants who have no active prescription for oxygen at 12 weeks.
Measured: 12 weeks
Secondary outcomes (11)
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.
Measured: Through study completion, an average of 12 weeks
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.
Measured: Through study completion, an average of 12 weeks
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.
Measured: Through study completion, an average of 12 weeks
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.
Measured: At study completion, an average of 12 weeks
Proportion of potentially eligible participants randomized
Proportion of potentially eligible participants that are successfully randomized into the study
Measured: At study completion, an average of 12 weeks
Proportion of randomized participants completing 12 week follow up
We will calculate the proportion of randomized patients who complete the 12-week follow-up
Measured: At study completion, an average of 12 weeks
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.
Measured: At study completion, an average of 12 weeks
Proportion of participants completing tele-6MWT
The proportion of participants who are able to complete the tele-6MWT will be calculated.
Measured: At study completion, an average of 12 weeks
Rate of completion of all visits
We will assess the rate of completion of all study visits among randomized participants.
Measured: Through study completion, an average of 12 weeks
Acceptability to patients
Among intervention participants, we will perform semi-structured interviews to assess acceptability of the oxygen de-implementation intervention to patients.
Measured: At study completion, an average of 12 weeks
Acceptability to providers
Among providers of intervention participants, we will perform semi-structured interviews to assess acceptability of the oxygen de-implementation intervention.
Measured: At study completion, an average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start18 Apr 2022
- Primary completion15 May 2023
- Study completion15 May 2023
Why it stopped: No participants were enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Laura Cecere Feemster, MD MS, Principal investigator, VA Puget Sound Health Care System Seattle Division, Seattle, WA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04854967
- Sponsor's protocol ID
- IIR 17-263
- Acronym
- RELIEF Pilot
- Status last verified
- Jun 2023
- First submitted
- 20 Apr 2021
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-REcovery LIbEration From Oxygen in Exacerbated COPD (RELIEF)
- ClinicalTrials.gov ID
- NCT04854967
- Acronym / sponsor ID
- RELIEF Pilot / IIR 17-263
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Oxygen Therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants were enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 18 Apr 2022 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 22 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| De-implementation Intervention | Experimental | Other: Rescind home oxygen order, Behavioral: Provider Education, Behavioral: Patient Education, Behavioral: Teach-to-goal inhaler training, Behavioral: Pursed lip breathingThe 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). |
| Usual Care | No intervention | –The patient receives usual care from their assigned clinical provider. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rescind home oxygen orderAlso: De-implement oxygen orderA 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. | Other | De-implementation Intervention |
| Provider EducationA 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. | Behavioural | De-implementation Intervention |
| Patient EducationThe 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. | Behavioural | De-implementation Intervention |
| Teach-to-goal inhaler trainingAlso: TTGTeach-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. | Behavioural | De-implementation Intervention |
| Pursed lip breathingPursed 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. | Behavioural | De-implementation Intervention |
Primary outcome
Discontinuation of Oxygen at 12 weeks
Time frame: 12 weeks
The investigators will assess the proportion of participants who have no active prescription for oxygen at 12 weeks.
11 secondary outcomes
Clinical COPD Questionnaire (CCQ) Total Score
Time frame: Through study completion, an average of 12 weeks
tele-six minute walk test distance (tele-6MWT)
Time frame: Through study completion, an average of 12 weeks
Post tele-six minute walk test (tele-6MWT) Borg Dyspnea scale
Time frame: Through study completion, an average of 12 weeks
Cost of intervention
Time frame: At study completion, an average of 12 weeks
Proportion of potentially eligible participants randomized
Time frame: At study completion, an average of 12 weeks
Proportion of randomized participants completing 12 week follow up
Time frame: At study completion, an average of 12 weeks
Proportion of participants completing in-home spirometry
Time frame: At study completion, an average of 12 weeks
Proportion of participants completing tele-6MWT
Time frame: At study completion, an average of 12 weeks
Rate of completion of all visits
Time frame: Through study completion, an average of 12 weeks
Acceptability to patients
Time frame: At study completion, an average of 12 weeks
Acceptability to providers
Time frame: At study completion, an average of 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Cecere Feemster, MD MS principal investigator
VA Puget Sound Health Care System Seattle Division, Seattle, WA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rescind home oxygen order, Provider Education and Patient Education in people with Pulmonary Disease, Chronic Obstructive, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discontinuation of Oxygen at 12 weeks (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.