Pediatric Medication Therapy Management Trial (pMTM)

University of Colorado Denver (CU Denver)

Status: Enrolling

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

Treatments: Other: Pediatric Medication Therapy Management (pMTM)

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT05761847

22-2423

1R01HS028979-01A1 (U.S. AHRQ Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 371 estimated patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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371 participants in 2 patient groups

Usual Care

No Intervention group

Description:

The usual care group will receive standard-of-care medication management practices delivered during the course of a routine clinical visit.

Intervention

Experimental group

Description:

The intervention group will receive the pMTM study intervention before a routine clinical visit.

Treatment:

Other: Pediatric Medication Therapy Management (pMTM)