Parent-Reported Symptom Assessments in Children Taking Multiple Medications (PRSA)

January 25, 2023 updated by: University of Colorado, Denver

Enhancing Medication Safety in Children With Polypharmacy Using Parent- Reported Symptom Assessments

This study plans to learn about how to measure symptoms (like tiredness or rash) in children with special healthcare needs who take 5 or more medications. Sometimes symptoms change in severity over time or new symptoms develop. This can happen after a new medication is started. This can also happen after the dose of an existing medication is changed. The Investigators believe that parents will be able to provide the best assessment of any symptoms that their child might be experiencing. This study asks parents to report any symptoms their child is currently experiencing.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

An increasing number of children with complex chronic conditions (CCCs) who have intractable illnesses or multi-organ dysfunction are exposed to daily polypharmacy. Parents of children with polypharmacy often administer 5 or more medications each day, sometimes for months, including high-risk medications prescribed by many different specialists in multiple settings of care. While medications can be life-saving, polypharmacy increases the risk of additive adverse effects, drug-drug interactions, and can lead to serious adverse drug events (ADEs). Pediatric ADEs result in over 4.3 million estimated ambulatory visits annually, including >150,000 pediatric emergency room visits. Despite the risks associated with polypharmacy, little is known about how polypharmacy escalates and how polypharmacy should be managed. To enable children to thrive at home using medications while minimizing unwanted symptoms, this proposal aims to implement a prospective, parent-reported symptom assessment system to guide and monitor pharmaceutical care for high-risk children. Strategies to improve recognition of problematic symptoms will have a substantial impact on the health of children.

Study Type

Observational

Enrollment (Actual)

136

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patients with neurological impairment and 5 or more scheduled medications aged 0-17 years-old (inclusive) and their parents will be included.

Description

Inclusion Criteria:

  • Neurological impairment
  • 5 or more scheduled medications
  • English- or Spanish-speaking

Exclusion Criteria:

  • Receives primary care outside outside of the Children's Hospital Colorado Network of Care

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cross-Sectional PRSA
This will be a cross-sectional analysis of children with neurological impairment and polypharmacy.
Other: Parent-Reported Symptom Assessment
As the basis for PRSA, the investigator will use the PediQuest Memorial Symptom Assessment Scale (PQ-MSAS), which is an adapted pediatric-specific version of the validated adult MSAS that assesses 28 physical and psychological symptoms over the past week. The study instrument is designed to be completed by a full-proxy parent, and 2 versions tailored for specific age groups are available (0-3, 3-18 years-old). Spanish versions are available for both instruments. The PQ-MSAS 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).
Other Names:
  • PRSA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Symptom Score
Time Frame: Baseline
As the basis for PRSA, we used the PediQuest Memorial Symptom Assessment Scale (PQ-MSAS), which is an adapted pediatric-specific version of the validated adult MSAS that assesses 28 physical and psychological symptoms over the past week. The study instrument is designed to be completed by a full-proxy parent, and 2 versions tailored for specific age groups are available (0-3, 3-18 years-old). Spanish versions are available for both instruments. The PQ-MSAS 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).
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Medication Count
Time Frame: Baseline
Prescription and over-the-counter medications were counted at the time of the visit. To reflect parent-facing medication complexity, we excluded clinic-administered or inpatient-administered medications (eg, vaccines or botulinum toxin injections).
Baseline
Medication Regimen Complexity Index Score (MRCI)
Time Frame: Baseline
MRCI scores were calculated automatically from EHR data using the MRCI tool, scoring instructions, and examples that are publicly available. Conceptually, the total MRCI score for a CMR is the sum of 3 weighted subscores (dosage form, dose frequency, and specialized instructions), with increasing weights corresponding to the difficulty of administration. The minimum total MRCI score for a participant using a single medication is 1.5. The total MRCI score has no upper limit because it is dependent on the total number of medications, and higher MRCI scores indicate more-complex regimens.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators

  • Principal Investigator: James A Feinstein, MD MPH, Associate Professor of Pediatrics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2019

Primary Completion (Actual)

August 1, 2022

Study Completion (Actual)

August 1, 2022

Study Registration Dates

First Submitted

February 14, 2019

First Submitted That Met QC Criteria

February 19, 2019

First Posted (Actual)

February 21, 2019

Study Record Updates

Last Update Posted (Estimate)

February 20, 2023

Last Update Submitted That Met QC Criteria

January 25, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-2538
  • 5K23HD091295 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Any and all data collected as part of this project will be released in accordance with standard data sharing policies and procedures. All data will be made available in a timely manner to the broader scientific community after study results are published as manuscripts in peer-reviewed journals. All data released will be de-identified, with no information that could be linked to any participating patients or caregivers in order to ensure the confidentiality of all study participants.

The main deliverable of this research will be a parent-reported system assessment system tailored to the needs of children with polypharmacy that will be ready for definitive evaluation. After the results from this study are published, upon request, the investigator will readily and willingly make available any and all data management tools, study instruments, and analytic programs used in the project.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Disease

Clinical Trials on Parent-Reported Symptom Assessment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mali

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe