Recruiting

pMTM

Sponsor:

University of Colorado, Denver

Code:

NCT05761847

Conditions

Child, Only

Disabilities Multiple

Medication Interaction

Medication Compliance

Medication Administered in Error

Eligibility Criteria

Sex: All

Age: 2 - 18

Healthy Volunteers: Not accepted

Interventions

Pediatric Medication Therapy Management (pMTM)

Study Details

Brief summary:

The purpose of this study is to evaluate whether an intervention called Pediatric Medication Therapy Management (pMTM) improves the identification and management of medication-related problems among children with medical complexity and polypharmacy.

Conditions

Child, Only

Disabilities Multiple

Medication Interaction

Medication Compliance

Medication Administered in Error

Study ID

NCT05761847

Start date

Sep 11, 2023

Status verified date

Apr, 2026

Completion date

Jan 31, 2028

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 18

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

371 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

no intervention: Usual Care

The usual care group will receive standard-of-care medication management practices delivered during the course of a routine clinical visit.

experimental: Intervention

The intervention group will receive the pMTM study intervention before a routine clinical visit.

Interventions

Pediatric Medication Therapy Management (pMTM)

The pMTM intervention is comprised of 3 activities: comprehensive review of the medication regimen; optimization of the medication regimen; and creation of the medication action plan.

Primary outcome measure

  • Medication-Related Problem (MRP) Count [ Time Frame: 90 Days ]

Central Contacts and Locations

Central contacts

James A Feinstein, MD, MPH

303-724-4186james.feinstein@cuanschutz.edu

Anowara Begum, MPH

303-757-8051anowara.begum@cuanschutz.edu

Locations

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

Contacts

James A Feinstein, MD, MPH

303-724-4186james.feinstein@cuanschutz.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

Apr 28, 2026

Last verified

Apr, 2026

Keywords

  • Children with Medical Complexity
  • Polypharmacy
  • Medication Safety

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-04-28.