Pediatric Medication Management for Complex Medical Regimens

(pMTM Trial)

Overseen By Anowara Begum, MPH

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Disqualifiers: Non-English speaking, Family enrolled, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

371 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new approach, called Pediatric Medication Therapy Management (pMTM), can help manage medication-related problems in children with complex health needs who take multiple medications. The trial compares the pMTM approach with usual care to assess effectiveness. Children with at least one chronic condition, who take five or more medications, and receive primary care at Children's Hospital Colorado may be eligible to join. As an unphased trial, this study offers a unique opportunity for patients to contribute to innovative research that could enhance medication management for children.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your current medications since the study focuses on managing multiple medications.

What prior data suggests that Pediatric Medication Therapy Management (pMTM) is safe for children with medical complexity?

Research shows that Pediatric Medication Therapy Management (pMTM) is generally safe and well-tolerated. Studies on similar services for adults have shown positive results, improving patient health without major safety issues. Although direct safety data for children is not yet available, this approach aims to organize and manage medications effectively, suggesting it is low risk. This trial phase is labeled "Not Applicable," indicating a focus on evaluating the process rather than testing a new drug's safety. Since no new medications are introduced, it presents a low-risk option for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Pediatric Medication Therapy Management (pMTM) because it offers a personalized approach to managing complex medical regimens in children. Unlike the usual care, which involves standard medication management during routine visits, pMTM provides a tailored intervention that takes place before these visits. This proactive method aims to optimize medication effectiveness and safety by addressing individual needs and potential issues in advance. By focusing on customization, pMTM has the potential to improve health outcomes and enhance the overall care experience for children with complex medical conditions.

What evidence suggests that Pediatric Medication Therapy Management (pMTM) is effective for managing medication-related problems in children with medical complexity?

Research has shown that Pediatric Medication Therapy Management (pMTM), which participants in this trial may receive, can help manage complex medication plans for children. Studies have found that when pharmacists lead a structured pMTM approach, they can identify medication-related issues and simplify medication plans. This method manages the use of multiple medications more effectively. It also aims to make handling medications easier and more efficient, which is crucial for children with complex health needs. Overall, early evidence suggests that pMTM could improve outcomes for children taking multiple medications. ^{1 2 3 4 6}

Who Is on the Research Team?

James A Feinstein, MD, MPH

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for children aged 2-18 with complex chronic conditions who take 5 or more medications and receive care at Children's Hospital Colorado. It's not open to non-English speakers.

Inclusion Criteria

≥1 complex chronic condition (CCC)

Receives primary care at Children's Hospital Colorado

I am currently taking 5 or more medications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization

Participants are randomized to either usual care or the pMTM intervention

1 day

Intervention

The intervention group receives the pMTM study intervention before a routine clinical visit

90 days

Follow-up

Participants are monitored for changes in medication-related problems and parent-reported outcomes

90 days

What Are the Treatments Tested in This Trial?

Interventions

• Pediatric Medication Therapy Management (pMTM)

Trial Overview The study tests Pediatric Medication Therapy Management (pMTM) to see if it helps spot and handle medication-related issues in kids with multiple health problems taking many meds.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

The intervention group will receive the pMTM study intervention before a routine clinical visit.

Group II: Usual Care Active Control 1 Intervention

The usual care group will receive standard-of-care medication management practices delivered during the course of a routine clinical visit.

Pediatric Medication Therapy Management (pMTM) is already approved in United States for the following indications:

Approved in United States as Pediatric Medication Therapy Management (pMTM) for:

• Management of medication-related problems among children with medical complexity and polypharmacy

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Published Research Related to This Trial

A study of 480 Iraqi community pharmacists revealed that only about 26.5% had good knowledge, 30.4% had a positive attitude, and 30.8% were ready to provide Medication Therapy Management (MTM) services for ADHD patients, indicating a significant gap in preparedness.

The results suggest an urgent need for educational programs to enhance pharmacists' knowledge and attitudes towards MTM services, as these factors are crucial for improving the quality of care for ADHD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Knowledge, attitude, and readiness of pharmacists toward medication therapy management for patients with attention deficit hyperactivity disorder: a cross-sectional quantitative study. Al-Dujaili, Z., Hallit, S., Al Faraj, A.[2023]

Medication therapy management (MTM) has shown economic benefits and improved clinical outcomes, such as better medication adherence and prescribing habits, based on a review of nearly 300 studies.

Despite these positive findings, the overall quality of research on MTM is inconsistent, with many studies lacking strong designs, indicating a need for more rigorous evaluations to fully understand its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication therapy management programs: promises and pitfalls. Ai, AL., Carretta, H., Beitsch, LM., et al.[2023]

Children under 18 represent a significant portion of tuberculosis cases globally, but current treatments face challenges like high pill counts and long treatment durations, highlighting the need for child-friendly formulations.

An international panel recommends that children should be included in early-phase clinical trials for new tuberculosis drugs, ensuring they are part of the development process rather than being an afterthought once drugs are approved for adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Towards early inclusion of children in tuberculosis drugs trials: a consensus statement. Nachman, S., Ahmed, A., Amanullah, F., et al.[2023]

Recent advancements in pediatric tuberculosis research are leading to the evaluation of new drugs and treatment regimens, including shorter courses that may have fewer side effects, which is crucial given the significant burden of the disease in children.

There is ongoing investigation into tailoring treatments for children based on disease severity, as well as exploring weekly dosing for preventive therapy, indicating a shift towards more personalized and potentially effective approaches in managing pediatric tuberculosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent Developments and Future Opportunities in the Treatment of Tuberculosis in Children. Seddon, JA., McKenna, L., Shah, T., et al.[2022]

The rise in chronic diseases among children and adolescents is leading to increased medication use, which raises the risk of medication errors and adverse drug events, especially for those on multiple medications.

The paper proposes a model for delivering medication therapy management (MTM) services specifically for pediatric patients, aiming to enhance safety and quality of care in the context of ongoing healthcare reforms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Establishment of Pediatric Medication Therapy Management: A Proposed Model. Benavides, S., Madzhidova, S., Hernandez, A., et al.[2023]

The implementation of a collaborative medication therapy management (MTM) model in a pediatric health system led to 409 interventions in the first 6 months, significantly improving medication safety and appropriateness for patients.

Pharmacists played a crucial role in identifying and resolving drug-related problems, with intervention rates of 39% for comprehensive medication reviews and 44% for targeted medication reviews, demonstrating the effectiveness of the MTM services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of a medication therapy management collaborative within a pediatric health system. Sneed, G., Kappeler, K., Gilmore, T., et al.[2019]

In a study of 100 complex pediatric patients taking at least 5 medications, a standardized medication therapy management (MTM) model identified an average of 3.4 medication-related concerns per patient, highlighting the need for better medication oversight.

The proposed interventions from the MTM model could significantly reduce medication regimen complexity, with a mean decrease of 4.9 points in the Medication Regimen Complexity Index (MRCI) scores, indicating that pharmacist-guided MTM services could greatly benefit children with complex medical needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Identifying opportunities for pediatric medication therapy management in children with medical complexity. Marquez, C., Thompson, R., Feinstein, JA., et al.[2023]

In a study involving 651 children with lower-risk B-lineage acute lymphoblastic leukemia (ALL), both treatment regimens (IV methotrexate alone and IV methotrexate combined with IV mercaptopurine) resulted in similar high remission rates, with 82.1% and 82.2% respectively, indicating that adding mercaptopurine did not improve outcomes.

Both treatment regimens were associated with a risk of serious neurotoxicity, with 7.6% of patients experiencing severe side effects like seizures, highlighting the need for careful monitoring during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intensification with intermediate-dose intravenous methotrexate is effective therapy for children with lower-risk B-precursor acute lymphoblastic leukemia: A Pediatric Oncology Group study. Mahoney, DH., Shuster, JJ., Nitschke, R., et al.[2017]

A randomized controlled trial involving 296 children with medical complexity aims to evaluate the effectiveness of a pharmacist-led Pediatric Medication Therapy Management (pMTM) intervention in reducing medication-related problems (MRPs) over 90 days.

The study will assess whether pMTM can also improve symptom burden and decrease acute healthcare visits, highlighting the potential role of pharmacists in managing complex medication regimens for children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A coordinated approach for managing polypharmacy among children with medical complexity: rationale and design of the Pediatric Medication Therapy Management (pMTM) randomized controlled trial. Orth, LE., Feudtner, C., Kempe, A., et al.[2023]

Over the past 30 years, clinical trials in pediatric oncology have significantly improved treatment outcomes, allowing most newly diagnosed children with cancer to be effectively treated, although 30-40% still face mortality from their disease.

To enhance survival rates and quality of life for children with cancer, there is a pressing need for new anti-cancer agents, necessitating well-structured Phase I and II trials to determine maximum tolerated doses and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The importance of phase I/II trials in pediatric oncology. MacArthur, CA., Vietti, T.[2019]

A randomized trial showed that adding metronomic maintenance therapy (MMT) with vinorelbine and cyclophosphamide significantly improved overall and event-free survival in children with rhabdomyosarcoma.

This study suggests that MMT could be a promising treatment strategy for pediatric patients with high-risk rhabdomyosarcoma, although the exact mechanism of action is still not fully understood.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metronomic Maintenance Therapy for Rhabdomyosarcoma. André, N., Corradini, N., Shaked, Y.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37120509/

rationale and design of the Pediatric Medication Therapy ... The aim of this randomized controlled trial is to determine if a structured pharmacist-led Pediatric Medication Therapy Management (pMTM) intervention reduces ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9464681/

Identifying Opportunities for Pediatric Medication Therapy ... A standardized pediatric medication therapy management (MTM) model identifies potential interventions and their impact on Medication Regimen Complexity Index ( ...

3. bmchealthservres.biomedcentral.com bmchealthservres.biomedcentral.com/articles/10.1186/s12913-023-09439-y

A coordinated approach for managing polypharmacy among ... The aim of this randomized controlled trial is to determine if a structured pharmacist-led Pediatric Medication Therapy Management (pMTM) intervention reduces ...

4. news.cuanschutz.edu news.cuanschutz.edu/accords/pediatric-pharmacy-plays-a-key-role-in-complex-care-for-children

Pediatric Pharmacy Plays a Key Role in Complex Care for ... Lucas Orth, PharmD, and Jamie Feinstein, MD, MPH, play an important role in care of children with complex medical conditions. 6 minute read.

5. childrenscolorado.org childrenscolorado.org/advances-answers/recent-articles/polypharmacy-medication-management/

Polypharmacy and Medication Management How to make medication management easier, cheaper and more effective for kids with complex conditions.

6. medschool.cuanschutz.edu medschool.cuanschutz.edu/pediatrics/colorado-pediatric-medication-safety-program/pmtm-study

pMTM Study - CU School of Medicine - CU Anschutz The purpose of this study (ClinicalTrials.gov: #NCT05761847) is to evaluate whether an intervention called Pediatric Medication Therapy Management (pMTM) ...