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NCT Number: NCT05761847

Pediatric Medication Therapy Management Trial

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.

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Key information

Conditions

Child, Only Behavior Disabilities Multiple Health Behavior Medication Adherence Medication Administered in Error Medication Compliance Medication Interaction Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

2 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

James A Feinstein, MD, MPH

CONTACT

[email protected]

303-724-4186

About this study

Patients and their parents who meet the study eligibility requirements will be invited to participate in the study. After being informed about the study and potential risks, all patients and their parents giving written informed consent (and assent, when appropriate) will be randomized in a 1:1 ratio to usual care or to the Pediatric Medication Therapy Management (pMTM) intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pediatric Medication Therapy Management (pMTM)

Other

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 outcomes

  1. Medication-Related Problem (MRP) Count

    Time frame: 90 Days

    A MRP is a clearly defined event involving medication therapy that interferes with an optimum outcome for a specific patient, including: inappropriate or unnecessary therapy; suboptimal therapy; undertreated symptom; adverse drug event; major drug-drug interaction; duplication of therapy; or, unclear prescription instruction.

Secondary outcomes

  1. Change in Parent-Reported Outcomes of Symptoms (PRO-Sx) Global Symptom Score

    Time frame: Baseline and 90 Days

    The PRO-Sx instrument assesses 28 physical and psychological symptoms over the past week. The study instrument is designed to be completed by a full-proxy parent and contains 28 symptom items, each with 4-point scores for domains of frequency, severity, and extent of bother. Based on these components, a global symptom score and individual symptom scores can be calculated (0-100 scale, with 100 being the worst). Change equals the 90-day score minus the baseline score.

  2. Acute Healthcare Visit Count

    Time frame: 90 Days

    Unplanned acute healthcare visits include: ambulatory sick visits; emergency room visits; and, inpatient hospitalizations.

Study contacts

Contact information is provided by the study sponsor or research team.

Anowara Begum, MPH

CONTACT

[email protected]

303-757-8051

James A Feinstein, MD, MPH

CONTACT

[email protected]

303-724-4186

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Official study title

Optimizing the Clinical Management of Polypharmacy for Children With Medical Complexity: The Pediatric Medication Therapy Management (pMTM) Trial

Acronym: pMTM

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Mar 9, 2023
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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