Pediatric Medication Therapy Management Trial

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Child, Only, Disabilities Multiple, Medication Interaction, Medication Compliance, Medication Administered in Error

Intervention / Treatment
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* Other: Pediatric Medication Therapy Management (pMTM)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Hybrid Type 2 Randomized Controlled Trial (RCT)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>The usual care group will receive standard-of-care medication management practices delivered during the course of a routine clinical visit. | |
| Experimental: Intervention<br>The intervention group will receive the pMTM study intervention before a routine clinical visit. | Other: Pediatric Medication Therapy Management (pMTM)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 90 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and 90 Days | 
| Acute Healthcare Visit Count | Unplanned acute healthcare visits include: ambulatory sick visits; emergency room visits; and, inpatient hospitalizations. | 90 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children with Medical Complexity, Polypharmacy, Medication Safety