Improving medication management for children with complex health needs
Optimizing the Clinical Management of Polypharmacy for Children With Medical Complexity: The Pediatric Medication Therapy Management (pMTM) Trial
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 371 (estimated) |
| Ages | 2 Years to 18 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT05761847 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 2-18 years with at least one complex chronic condition and currently taking five or more medications.
Not a fit: Patients who are non-English speaking or have a sibling already enrolled in the study may not benefit from this intervention.
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 performed: Other studies have shown promising results with similar medication management approaches, indicating potential for success in this intervention.
Eligibility criteria
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 this trial is running
Aurora, Colorado
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.