Pediatric Medication Therapy Management Trial

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age2-18
SponsorUniversity of Colorado, Denver

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Non-English speaking

Sibling or family member already enrolled in this study

Trial design

Design model

Parallel

Treatments tested in this trial

  • Pediatric Medication Therapy Management (pMTM)

    Other intervention

    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.

Treatment groups

371 Participants
are divided into 2 treatment groups
Group A: Usual CareNo intervention 0 interventions
Group B: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Medication-Related Problem (MRP) Count

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.

Time frame
90 Days

Secondary outcomes

1

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

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.

Time frame
Baseline and 90 Days
2

Acute Healthcare Visit Count

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

Time frame
90 Days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Denver

Lead sponsor

Agency for Healthcare Research and Quality (AHRQ)

Collaborator