Improving medication management for children with complex health needs
Official title: Optimizing the Clinical Management of Polypharmacy for Children With Medical Complexity: The Pediatric Medication Therapy Management (pMTM) Trial
Run by University of Colorado, Denver · NCT05761847 · Data updated 2026-11-12
This study tests if a special program for managing medications can help children with complex health needs who take multiple medicines feel better and stay safe.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 2 Years to 18 Years |
| Sex | All |
| Enrollment | 371 (estimated) |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Status | Recruiting |
| Started | September 11, 2023 |
| Main results expected | September 30, 2027 |
| Study ends | January 31, 2028 |
| Registry record updated | April 28, 2026 |
| Trial ID | NCT05761847 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 2-18 years with at least one complex chronic condition and currently taking five or more medications.
✕Probably not a fit
Patients who are non-English speaking or have a sibling already enrolled in the study may not benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of Pediatric Medication Therapy Management (pMTM) in enhancing the identification and management of medication-related issues in children with medical complexity and polypharmacy. Eligible participants, aged 2 to 18 years with at least one complex chronic condition and currently taking five or more medications, will be randomized to receive either usual care or the pMTM intervention. The study aims to involve both patients and their parents in the process to ensure comprehensive care and support.
Why it matters
Potential benefit: If successful, this intervention could significantly improve medication safety and adherence for children with complex health needs.
How similar studies have gone: Other studies have shown promising results with similar medication management approaches, indicating potential for success in this intervention.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 2-18 years old * ≥1 complex chronic condition (CCC) * ≥5 current medications (including prescription, as needed, and over-the-counter medications) * Receives primary care at Children's Hospital Colorado Exclusion Criteria: * Non-English speaking * Sibling or family member already enrolled in this study
Where it's running
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Children's Hospital Colorado
Aurora, Colorado, United States Recruiting
Study contacts
- Principal investigator: James A Feinstein, MD, MPH — University of Colorado, Denver
- Study coordinator: James A Feinstein, MD, MPH
- Email: james.feinstein@cuanschutz.edu
- Phone: 303-724-4186
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.