Parent-Reported Symptom Assessments in Children Taking Multiple Medications
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | Any - 17 |
| Updated: | 2/23/2019 |
| Start Date: | March 1, 2019 |
| End Date: | July 31, 2022 |
| Contact: | James A Feinstein, MD, MPH |
| Email: | james.feinstein@gmail.com |
| Phone: | 303-724-4186 |
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.
Part 1 of this study asks parents to report any symptoms their child is currently
experiencing. A certain number of people will be asked to participate in Part 2 of this
study. The investigators will select these people based on the types of medicines the child
takes.
Part 2 of this study asks parents to report any symptoms their child experiences before and
after the start of a new medication or before and after the dose of an existing medication is
changed.
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.
Part 1 of this study asks parents to report any symptoms their child is currently
experiencing. A certain number of people will be asked to participate in Part 2 of this
study. The investigators will select these people based on the types of medicines the child
takes.
Part 2 of this study asks parents to report any symptoms their child experiences before and
after the start of a new medication or before and after the dose of an existing medication is
changed.
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.
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.
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
We found this trial at
1
site
13123 E 16th Ave
Aurora, Colorado 80045
Aurora, Colorado 80045
(720) 777-1234
Phone: 303-724-4186
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
Click here to add this to my saved trials
