Pediatric Medication Therapy Management Trial (pMTM)

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

Study Overview

• Status: Recruiting
• Conditions: Child, Only; Medication Compliance; Medication Administered in Error; Disabilities Multiple; Medication Interaction
• Intervention / Treatment: Other: Pediatric Medication Therapy Management (pMTM)

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.

• Study Type: Interventional
• Enrollment (Estimated): 371
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: James A Feinstein, MD, MPH; Phone Number: 303-724-4186; Email: james.feinstein@cuanschutz.edu
• Study Contact Backup: Name: Anowara Begum, MPH; Phone Number: 303-757-8051; Email: anowara.begum@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • Children's Hospital Colorado
      • Contact: James A Feinstein, MD, MPH; Phone Number: 303-724-4186; Email: james.feinstein@cuanschutz.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; The usual care group will receive standard-of-care medication management practices delivered during the course of a routine clinical visit.
Experimental: Intervention; The intervention group will receive the pMTM study intervention before a routine clinical visit.	Other: Pediatric 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: James A Feinstein, MD, MPH, University of Colorado, Denver

Publications and helpful links

General Publications

• Feinstein JA, Friedman H, Orth LE, Feudtner C, Kempe A, Samay S, Blackmer AB. Complexity of Medication Regimens for Children With Neurological Impairment. JAMA Netw Open. 2021 Aug 2;4(8):e2122818. doi: 10.1001/jamanetworkopen.2021.22818.
• Marquez C, Thompson R, Feinstein JA, Orth LE. Identifying opportunities for pediatric medication therapy management in children with medical complexity. J Am Pharm Assoc (2003). 2022 Sep-Oct;62(5):1587-1595.e3. doi: 10.1016/j.japh.2022.04.005. Epub 2022 Apr 12.
• Feinstein JA, Hall M, Antoon JW, Thomson J, Flores JC, Goodman DM, Cohen E, Azuine R, Agrawal R, Houtrow AJ, DeCourcey DD, Kuo DZ, Coller R, Gaur DS, Berry JG. Chronic Medication Use in Children Insured by Medicaid: A Multistate Retrospective Cohort Study. Pediatrics. 2019 Apr;143(4):e20183397. doi: 10.1542/peds.2018-3397.
• Feinstein JA, Feudtner C, Blackmer AB, Valuck RJ, Fairclough DL, Holstein J, Gregoire L, Samay S, Kempe A. Parent-Reported Symptoms and Medications Used Among Children With Severe Neurological Impairment. JAMA Netw Open. 2020 Dec 1;3(12):e2029082. doi: 10.1001/jamanetworkopen.2020.29082.
• Feinstein JA, Feudtner C, Valuck RJ, Fairclough DL, Holstein JA, Samay S, Kempe A. Identifying Important Clinical Symptoms in Children With Severe Neurological Impairment Using Parent-Reported Outcomes of Symptoms. JAMA Pediatr. 2020 Nov 1;174(11):1114-1117. doi: 10.1001/jamapediatrics.2020.2987.
• Orth LE, Feudtner C, Kempe A, Morris MA, Colborn KL, Gritz RM, Linnebur SA, Begum A, Feinstein JA. A coordinated approach for managing polypharmacy among children with medical complexity: rationale and design of the Pediatric Medication Therapy Management (pMTM) randomized controlled trial. BMC Health Serv Res. 2023 Apr 29;23(1):414. doi: 10.1186/s12913-023-09439-y.

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2023
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): January 31, 2028

Study Registration Dates

• First Submitted: February 27, 2023
• First Submitted That Met QC Criteria: February 27, 2023
• First Posted (Actual): March 9, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Polypharmacy; Medication Safety; Children with Medical Complexity
• Other Study ID Numbers: 22-2423; 1R01HS028979-01A1 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No