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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
371
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.
Children's Hospital Colorado
Aurora, Colorado, United States
RECRUITINGMedication-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
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
Acute Healthcare Visit Count
Unplanned acute healthcare visits include: ambulatory sick visits; emergency room visits; and, inpatient hospitalizations.
Time frame: 90 Days
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