Pediatric Medication Therapy Management (pMTM) Trial

Sponsor

University of Colorado, Denver (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05761847

Collaborator

(none)

371

Enrollment

Location

Arms

Anticipated Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Child, Only Disabilities Multiple Medication Interaction Medication Compliance Medication Administered in Error	Other: Pediatric Medication Therapy Management (pMTM)	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

371 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Hybrid Type 2 Randomized Controlled Trial (RCT)Hybrid Type 2 Randomized Controlled Trial (RCT)

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

Apr 1, 2023

Anticipated Primary Completion Date :

Sep 30, 2027

Anticipated Study Completion Date :

Mar 31, 2028

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Medication-Related Problem (MRP) Count [90 Days]
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.

Secondary Outcome Measures

Change in Parent-Reported Outcomes of Symptoms (PRO-Sx) Global Symptom Score [Baseline and 90 Days]
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.
Acute Healthcare Visit Count [90 Days]
Unplanned acute healthcare visits include: ambulatory sick visits; emergency room visits; and, inpatient hospitalizations.

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Children's Hospital Colorado	Aurora	Colorado	United States	80045

Sponsors and Collaborators

University of Colorado, Denver

Investigators

Principal Investigator: James A Feinstein, MD, MPH, University of Colorado, Denver

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

University of Colorado, Denver

ClinicalTrials.gov Identifier:

NCT05761847

Other Study ID Numbers:

22-2423

First Posted:

Mar 9, 2023

Last Update Posted:

Mar 9, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Colorado, Denver

Children with Medical Complexity

Polypharmacy

Medication Safety

Study Results

No Results Posted as of Mar 9, 2023