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NCT05497999
Racial Inequality in Inhaler Fills for COPD - A Trial of Reduced Cost-Sharing
NA trial testing Proactive Outreach in Chronic Obstructive Pulmonary Disease in 19,113 participants. Completed in 31 December 2022.
31 December 2022
Quick facts
| Lead sponsor | Harvard Medical School (HMS and HSDM) |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | health services research |
| Enrollment | 19,113 |
| Start date | 7 January 2020 |
| Primary completion | 31 December 2022 |
| Estimated completion | 31 December 2022 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- Proactive Outreach
- No Proactive Outreach
Conditions studied
- Chronic Obstructive Pulmonary Disease — all drugs for Chronic Obstructive Pulmonary Disease →
Sponsor
Harvard Medical School (HMS and HSDM)
Who can join
Eligibility, any sex, with Chronic Obstructive Pulmonary Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Reduced Cost Sharing and Medication Management Services for COPD: A Randomized Clinical Trial.
Agarwal SD, Metzler E, Chernew M, Thomas E, et al · · 2024 · cited 4× · PMID 39073823 · DOI 10.1001/jamainternmed.2024.3499 -
Abstracts from the 2024 Annual Meeting of the Society of General Internal Medicine
· 2024
Verify or expand the search:
- PubMed search for NCT05497999
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Proactive Outreach
Trials testing the same drug.
- NCT04462289 — Electronic Proactive Outreach for Smokers With COPD · NA · completed
Other recruiting trials for Chronic Obstructive Pulmonary Disease
Currently open trials in the same condition.
- NCT06749262 — Inclined Versus Standard Exercise for COPD Patients · NA · recruiting
- NCT07406659 — Different Inspiratory Muscle Trainings in Patients With COPD · NA · recruiting
- NCT07051707 — Evaluating the Safety and Efficacy of dNerva Lung Denervation System in Patients With COPD · NA · recruiting
- NCT07418736 — A Phase II Study of CM326 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease · Phase 2 · recruiting
- NCT07069829 — Study of Clinical and Patient-reported Outcomes in Adults With Moderate to Severe COPD Treated With Breztri/Trixeo · recruiting
Other Harvard Medical School (HMS and HSDM) trials
Trials by the same sponsor.
- NCT07440303 — Star Matrix vs Autogenous Graft for Gingival Augmentation: Split-Mouth RCT · NA · recruiting
- NCT07203885 — AI-Assisted Acute Myeloid Leukemia Evaluation With the Leukemia End-to-End Analysis Platform (LEAP) Versus Clinician-Onl · NA · completed
- NCT07090863 — Additively Versus Subtractively Manufactured Implant Supported Fixed Dental Prostheses · NA · not yet recruiting
- NCT07307157 — Head-to-Head Evaluation of the Cancer Ontology Supervised Multimodal Orchestration (COSMO) AI System Versus Pathologist- · enrolling by invitation
- NCT06651502 — Efficacy of a Dental Implant System for Immediate Restoration · NA · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05497999 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Harvard Medical School (HMS and HSDM)
- Last refreshed: 14 March 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05497999.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing