Chronic Obstructive Pulmonary DiseaseNCT05497999
Racial Inequality in Inhaler Fills for COPD - A Trial of Reduced Cost-Sharing
A study testing Proactive Outreach and No Proactive Outreach in people with Chronic Obstructive Pulmonary Disease, run by Harvard Medical School (HMS and HSDM) at 3 sites in United States.
Trial summary
In partnership with a large Medicare Advantage (MA) insurer (Humana, Inc.) and as part of a Center for Medicare and Medicaid Innovation demonstration program of Value-Based Insurance Design (VBID), the investigators propose to study a randomized controlled quality improvement trial in which Humana randomized MA… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Proactive Outreach and No Proactive Outreach
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19,113 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 Jan 2020to 31 Dec 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Has COPD diagnosis
- Receives health services and prescription drug benefits through a Humana Medicare Advantage plan that includes Part D coverage
- Has at least one prior fill of a COPD maintenance inhaler in the prior 12 months
- Not fully adherent to maintenance inhaler (PDC < 80%) in year prior to randomization
Who cannot join
- Enrolled in Part D Low-Income Subsidy program
- On hospice
- Has end-stage renal disease
- Has mild COPD (i.e., COPD diagnosis but no maintenance inhaler fill, no pulmonary function tests in year prior year, and no acute care use for COPD)
- Enrolled in Humana plan for less than 3 months
- In the coverage gap phase of MA plan at time of assignment
- Receives primary care at select locations of Humana subsidiaries (CenterWell or Conviva)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Harvard Medical School
Boston, Massachusetts, 02115
University of Chicago
Chicago, Illinois, 60637
Humana, Inc.
Louisville, Kentucky, 40202
About this study
In partnership with a large Medicare Advantage (MA) insurer (Humana, Inc.) and as part of a Center for Medicare and Medicaid Innovation demonstration program of Value-Based Insurance Design (VBID), the investigators propose to study a randomized controlled quality improvement trial in which Humana randomized MA beneficiaries with COPD to receive proactive outreach for a VBID benefit that provided large reductions in cost-sharing for their maintenance inhalers and telephone-based COPD medication management services in 2020 and 2021. The investigators will analyze changes in racial disparities for inhaler fills, clinical outcomes, health care spending, and acute care utilization.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Proactive Outreach, No Proactive Outreach
- Keywords
- Cost sharing, Health insurance, Inhalers, Adherence, Disparities
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proactive OutreachOther
The treatment is proactive outreach that sought to enroll individuals in a VBID program available to all enrollees that provided: 1) large reductions in cost-sharing for maintenance inhalers, and 2) telephone-based COPD medication management services.
Proactive outreach for those randomized to the treatment arm included, at a minimum, a phone call and letter in the mail from Humana. Proactive outreach could also have included an email, text message, and/or provider referral.
No Proactive OutreachOther
Control group participants received no proactive outreach but could call to enroll themselves in the VBID program if they learned about it through traditional means, such as the benefits description manual.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | With Black and White Subgroups Receives: Other: Proactive Outreach |
| Control Group | Active comparator | With Black and White Subgroups Receives: Other: No Proactive Outreach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maintenance inhaler adherence
A maintenance inhaler is defined as any inhaler with an inhaled corticosteroid, long-acting beta-agonist, and/or long-acting antimuscarinic antagonist. The proportion of days covered (PDC), a common claims-based measure of adherence, is calculated by dividing number of days covered by a prescription by the total number of days eligible for the medication. In constructing the measure, days covered (numerator) will be number of days on any maintenance inhaler (whether one of a single class, multiple of differing classes, or changes between inhalers), and the days eligible (denominator) will be number of days in the observation period. The primary analysis will treat PDC as a continuous measure.
Measured: 1 Year
Secondary outcomes (3)
Frequency of acute moderate-to-severe exacerbations
An exacerbation is defined as any acute worsening of symptoms that requires antibiotics or systemic steroids. Moderate exacerbations are those that do not result in hospitalization or death and therefore captures those exacerbations treated on an outpatient basis. Severe exacerbations are exacerbations that result in hospitalization.
Measured: 1 Year
Number of short-acting inhaler filled
A short-acting inhaler is defined as any inhaler with a short-acting beta agonist and/or short-acting antimuscarinic antagonist.
Measured: 1 Year
Total spending
Total spending includes both the insurer's payments and beneficiary's out-of-pocket payments over the course of the calendar year. It includes spending across types of service (e.g., drugs) and settings (e.g., acute care).
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2022
- Study start7 Jan 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19,113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard Medical School (HMS and HSDM)
- Sponsor type
- University, hospital or other
- Collaborators
- Humana Co.Ltd.
- Responsible party
- Principal investigator, Sumit Agarwal, Harvard Medical School (HMS and HSDM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05497999
- Sponsor's protocol ID
- 22-0916
- Status last verified
- Mar 2023
- First submitted
- 8 Aug 2022
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Agarwal SD, Metzler E, Chernew M, Thomas E, Press VG, Boudreau E, Powers BW, McWilliams JM. Reduced Cost Sharing and Medication Management Services for COPD: A Randomized Clinical Trial. JAMA Intern Med. 2024 Oct 1;184(10):1186-1194. doi: 10.1001/jamainternmed.2024.3499.
PubMed 39073823
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Racial Inequality in Inhaler Fills for COPD - A Trial of Reduced Cost-Sharing
- ClinicalTrials.gov ID
- NCT05497999
- Acronym / sponsor ID
- 22-0916
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Cost sharing, Health insurance, Inhalers, Adherence, Disparities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19,113 participants (actual)
- Lead sponsor
- Harvard Medical School (HMS and HSDM)University, hospital or other
- Collaborators
- Humana Co.Ltd.
- Study start
- 7 Jan 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 11 Aug 2022 (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.
In partnership with a large Medicare Advantage (MA) insurer (Humana, Inc.) and as part of a Center for Medicare and Medicaid Innovation demonstration program of Value-Based Insurance Design (VBID), the investigators propose to study a randomized controlled quality improvement trial in which Humana randomized MA beneficiaries with COPD to receive proactive outreach for a VBID benefit that provided large reductions in cost-sharing for their maintenance inhalers and telephone-based COPD medication management services in 2020 and 2021. The investigators will analyze changes in racial disparities for inhaler fills, clinical outcomes, health care spending, and acute care utilization.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Other: Proactive OutreachWith Black and White Subgroups |
| Control Group | Active comparator | Other: No Proactive OutreachWith Black and White Subgroups |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Has COPD diagnosis
- Receives health services and prescription drug benefits through a Humana Medicare Advantage plan that includes Part D coverage
- Has at least one prior fill of a COPD maintenance inhaler in the prior 12 months
- Not fully adherent to maintenance inhaler (PDC < 80%) in year prior to randomization
Key exclusion criteria (7 listed)
- Enrolled in Part D Low-Income Subsidy program
- On hospice
- Has end-stage renal disease
- Has mild COPD (i.e., COPD diagnosis but no maintenance inhaler fill, no pulmonary function tests in year prior year, and no acute care use for COPD)
- Enrolled in Humana plan for less than 3 months
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 |
|---|---|---|
| Proactive OutreachThe treatment is proactive outreach that sought to enroll individuals in a VBID program available to all enrollees that provided: 1) large reductions in cost-sharing for maintenance inhalers, and 2) telephone-based COPD medication management services. Proactive outreach for those randomized to the treatment arm included, at a minimum, a phone call and letter in the mail from Humana. Proactive outreach could also have included an email, text message, and/or provider referral. | Other | Treatment Group |
| No Proactive OutreachControl group participants received no proactive outreach but could call to enroll themselves in the VBID program if they learned about it through traditional means, such as the benefits description manual. | Other | Control Group |
Primary outcome
Maintenance inhaler adherence
Time frame: 1 Year
A maintenance inhaler is defined as any inhaler with an inhaled corticosteroid, long-acting beta-agonist, and/or long-acting antimuscarinic antagonist. The proportion of days covered (PDC), a common claims-based measure of adherence, is calculated by dividing number of days covered by a prescription by the total number of days eligible for the medication. In constructing the measure, days covered (numerator) will be number of days on any maintenance inhaler (whether one of a single class, multiple of differing classes, or changes between inhalers), and the days eligible (denominator) will be number of days in the observation period. The primary analysis will treat PDC as a continuous measure.
3 secondary outcomes
Frequency of acute moderate-to-severe exacerbations
Time frame: 1 Year
Number of short-acting inhaler filled
Time frame: 1 Year
Total spending
Time frame: 1 Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Derived from this study: PubMed 39073823Agarwal SD, Metzler E, Chernew M, Thomas E, Press VG, Boudreau E, Powers BW, McWilliams JM. Reduced Cost Sharing and Medication Management Services for COPD: A Randomized Clinical Trial. JAMA Intern Med. 2024 Oct 1;184(10):1186-1194. doi: 10.1001/jamainternmed.2024.3499.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proactive Outreach and No Proactive Outreach in people with Chronic Obstructive Pulmonary Disease, run by Harvard Medical School (HMS and HSDM) at 3 sites 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maintenance inhaler adherence (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05497999, which also lists 1 linked publication.
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 14 Mar 2023.