Parent-Reported Symptom Assessments in Children Taking Multiple Medications
Condition: Neurologic Disorder; Chronic Disease; Pediatric Disorder
MeSH terms: Nervous System Diseases; Chronic Disease
Study type: Observational

Summary: 
      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.
    

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.
    

Intervention name(s): Parent-Reported Symptom Assessment
Intervention type(s): Other
Intervention description(s): 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 intervention name(s): PRSA
Observational model: Cohort
Time perspective: Prospective
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.
      
Keywords: Neurological Impairment; Pediatric Complex Chronic Condition; Children with Medical Complexity; Pediatric Polypharmacy