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

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Chronic Disease; Pediatric Disorder; Neurologic Disorder

Treatments: Other: Parent-Reported Symptom Assessment

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03849066

16-2538

5K23HD091295 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 136 patients

Sex: All

Ages: 1 day to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

136 participants in 1 patient group

Cross-Sectional PRSA

Description:

This will be a cross-sectional analysis of children with neurological impairment and polypharmacy.

Treatment:

Other: Parent-Reported Symptom Assessment