Pediatric Medication Therapy Management Trial

Child, Only Clinical Trial

— pMTM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05761847
• Other study ID #: 22-2423
• Secondary ID: 1R01HS028979-01A
• Status: Recruiting
• Phase: N/A
• Start date: September 11, 2023
• Est. completion date: January 31, 2028

Study information

• Verified date: September 2023
• Source: University of Colorado, Denver
• Contact: James A Feinstein, MD, MPH
• Phone: 303-724-4186
• Email: james.feinstein[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 371
• Est. completion date: January 31, 2028
• Est. primary completion date: September 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Child, Only
• Disabilities Multiple
• Medication Administered in Error
• Medication Compliance

Intervention

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.

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Acute Healthcare Visit Count	Unplanned acute healthcare visits include: ambulatory sick visits; emergency room visits; and, inpatient hospitalizations.	90 Days