Parent-Reported Symptom Assessments in Children Taking Multiple Medications
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Chronic Disease
- Neurologic Disorder
- Pediatric Disorder
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Younger than 17 years
- Gender
- Both males and females
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 medica...
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. Thus, the investigator will carry out the following research studies, specifically focusing on the high-risk population of children with neurological impairment (NI) and polypharmacy: Part 1: Conduct cross-sectional parent-reported symptom assessments (PRSA). In a clinic population of 300 children, the investigator will administer an electronic validated symptom inventory to parents to advance the understanding of signal-to-noise and signal detection challenges in this population. Part 2: Conduct a prospective cohort study to quantify the detection of known ADEs using PRSA. The investigator will follow 50 children expected to have medication changes (empaneled in Aim 1) and assess whether using PRSA prior to and after specific medication changes detects known and expected side effects.
Tracking Information
- NCT #
- NCT03849066
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Investigators
- Principal Investigator: James A Feinstein, MD MPH Assistant Professor of Pediatrics