Pediatric Medication Therapy Management Trial

Not Applicable

Recruiting

• Conditions: Child, Only; Medication Interaction; Medication Administered in Error; Disabilities Multiple; Medication Compliance
• Interventions: Other: Pediatric Medication Therapy Management (pMTM)

• Registration Number: NCT05761847
• Lead Sponsor: University of Colorado, Denver

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2023-02-27
• Study First Submitted QC: 2023-02-27
• Study First Posted: 2023-03-09
• Study Start: 2023-09-11
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-12
• Last Update Posted: 2024-07-16
• Primary Completion: 2027-09-30
• Study Completion: 2028-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 371

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

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Exclusion Criteria

• Non-English speaking
• Sibling or family member already enrolled in this study

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Pediatric Medication Therapy Management (pMTM)	The intervention group will receive the pMTM study intervention before a routine clinical visit.

Primary Outcome Measures

Name	Time	Method
Medication-Related Problem (MRP) Count	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 Outcome Measures

Name	Time	Method
Change in Parent-Reported Outcomes of Symptoms (PRO-Sx) Global Symptom Score	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.
Acute Healthcare Visit Count	90 Days	Unplanned acute healthcare visits include: ambulatory sick visits; emergency room visits; and, inpatient hospitalizations.

Trial Locations

Locations (1)

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States