Clinical trial NCT05761847: Pediatric Medication Therapy Management Trial
Official title: Optimizing the Clinical Management of Polypharmacy for Children With Medical Complexity: The Pediatric Medication Therapy Management (pMTM) Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Child, Only
Disabilities Multiple
Medication Interaction
Medication Compliance
Medication Administered in Error
Keywords: Children with Medical Complexity
Polypharmacy
Medication Safety
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2023-03-09
Enrollment: 371
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Hybrid Type 2 Randomized Controlled Trial (RCT)
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Medication-Related Problem (MRP) Count
timeFrame: 90 Days
Secondary outcomes:
measure: Change in Parent-Reported Outcomes of Symptoms (PRO-Sx) Global Symptom Score
timeFrame: Baseline and 90 Days
measure: Acute Healthcare Visit Count
timeFrame: 90 Days
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: James A Feinstein, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.
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.
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 (pMTM) randomized controlled trial. BMC Health Serv Res. 2023 Apr 29;23(1):414. doi: 10.1186/s12913-023-09439-y.