Child, Only, Disabilities Multiple, Medication Administered in Error, Medication Compliance, Medication Interaction
Conditions
Keywords
Children with Medical Complexity, Polypharmacy, Medication Safety
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.
Interventions
OTHERPediatric Medication Therapy Management (pMTM)
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.
Sponsors
University of Colorado, Denver
Agency for Healthcare Research and Quality (AHRQ)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Hybrid Type 2 Randomized Controlled Trial (RCT)
Eligibility
Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No
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 * Sibling or family member already enrolled in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTJames A Feinstein, MD, MPH
CONTACTAnowara Begum, MPH
PRINCIPAL_INVESTIGATORJames A Feinstein, MD, MPH
University of Colorado, Denver
Outcome results
None listed