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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Pediatric Medication Therapy Management (pMTM)
Other interventionThe 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
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
Acute Healthcare Visit Count
Unplanned acute healthcare visits include: ambulatory sick visits; emergency room visits; and, inpatient hospitalizations.
Sponsors and contacts
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University of Colorado, Denver
Lead sponsor
Agency for Healthcare Research and Quality (AHRQ)
Collaborator