Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
371 participants
INTERVENTIONAL
2023-09-11
2028-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Usual Care
The usual care group will receive standard-of-care medication management practices delivered during the course of a routine clinical visit.
No interventions assigned to this group
Intervention
The intervention group will receive the pMTM study intervention before a routine clinical visit.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* ≥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
* Sibling or family member already enrolled in this study
2 Years
18 Years
ALL
No
Sponsors
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Agency for Healthcare Research and Quality (AHRQ)
FED
University of Colorado, Denver
OTHER
Responsible Party
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Principal Investigators
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James A Feinstein, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
University of Colorado, Denver
Locations
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Children's Hospital Colorado
Aurora, Colorado, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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22-2423
Identifier Type: -
Identifier Source: org_study_id
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