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NCT05497999 · ClinicalTrials.gov registry record · NA

Racial Inequality in Inhaler Fills for COPD - A Trial of Reduced Cost-Sharing

A NA study, sponsored by Harvard Medical School (HMS and HSDM).

Completed
Registry status
NA
Development phase
19,113
Enrollment target

NCT05497999: Completed NA study, sponsored by Harvard Medical School (HMS and HSDM).

NCT05497999 is a NA study that has completed, run by Harvard Medical School (HMS and HSDM). The registered enrollment target is 19,113 participants, above the 1,403-participant average among 58,714 other NA trials with a reported enrollment target (1262% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05497999, a NA study, has completed, sponsored by Harvard Medical School (HMS and HSDM).

COMPLETED
Registry status
NA
Development phase
19,113 participants
Enrollment target

Study 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 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.

Primary Outcome

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, multip

Interventions

  • OTHER Proactive Outreach
  • OTHER No Proactive Outreach

Trial Details

FieldValue
Enrollment Target 19,113 participants
Start Date 2020-01-07
Est. Completion 2022-12-31
Phase NA

What the finished NCT05497999 record still lists

NCT05497999 is an interventional study that assigns participants to a tested intervention. Its 19,113 participants enrollment target places it among the larger protocols in the corpus, above the 1,403-participant average among 58,714 other NA trials with a reported enrollment target (1262% higher).

The record links to 0 conditions, and to 2 interventions - of which Proactive Outreach is the first listed.

NCT05497999 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05497999 about?

NCT05497999 is a clinical study titled "Racial Inequality in Inhaler Fills for COPD - A Trial of Reduced Cost-Sharing". 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 r...

What is the current status of trial NCT05497999?

This trial is currently completed. It is a NA study. The enrollment target is 19,113 participants. The study started on 2020-01-07. Estimated completion is 2022-12-31.

What interventions are being tested in trial NCT05497999?

The interventions under investigation include: Proactive Outreach (OTHER), No Proactive Outreach (OTHER).

Who is sponsoring clinical trial NCT05497999?

This trial is sponsored by Harvard Medical School (HMS and HSDM), which has 26 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05497999's enrollment target sits among peer trials

19,113 11th of 2000 higher than 1,990 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05497999, the US trial registry maintained by the National Library of Medicine. NCT05497999 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.