An observational study in Neurologic Disorder, Chronic Disease and Pediatric Disorder, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 1 Day to 17 Years. Per ClinicalTrials.gov, last updated 2023-02-21.
Sponsored by University of Colorado, Denver · Observational
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.
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.
975 studies on the registry are indexed under Nervous System Diseases; 252 are open to participants now.
This study's enrollment of 136 is close to the median of 127 across 318 observational studies indexed under Nervous System Diseases.
Browse Nervous System Diseases studies →University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.
Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.
Counted across the registry records on this site, refreshed daily.
All patients with neurological impairment and 5 or more scheduled medications aged 0-17 years-old (inclusive) and their parents will be included.
Exclusion Criteria:
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).
Also known as: PRSA
Global Symptom Score
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).
Time frame: Baseline
Medication Count
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).
Time frame: Baseline
Medication Regimen Complexity Index Score (MRCI)
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.
Time frame: Baseline
We obtained parental written informed consent and enrolled and assessed English-speaking and Spanish-speaking children aged 0 to 17 years with SNI and polypharmacy (≥5 medications) who received primary care in a large, hospital-based special health care needs clinic.
| Milestone | Parent Reported Symptom Assessment (PRSA) |
|---|---|
| Started | 136 |
| Completed | 123 |
| Not completed | 13 |
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).
| score on a scale | Parent Reported Symptom Assessment (PRSA) |
|---|---|
| Global Symptom Score | 12.1 (5.4 to 20.8) |
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).
| Participants | Parent Reported Symptom Assessment (PRSA) |
|---|---|
| 5-9 Medications | 25 |
| 10-14 Medications | 44 |
| 15 or More Medications | 54 |
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.
| score on a scale | Parent Reported Symptom Assessment (PRSA) |
|---|---|
| Medication Regimen Complexity Index Score (MRCI) | 46 (8 to 139) |
Collected over This was a cross-sectional analysis and adverse events were not monitored/assessed longitudinally after completion of the study visit.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Parent Reported Symptom Assessment (PRSA) | — | — | — |
13 participants enrolled but did not complete the study activities and were excluded from analysis.
| Age, Continuous(years) | Parent Reported Symptom Assessment (PRSA) |
|---|---|
| Median | 9 (5 to 12) |
| Sex: Female, Male(Participants) | Parent Reported Symptom Assessment (PRSA) |
|---|---|
| Female | 50 |
| Male | 73 |
| Ethnicity (NIH/OMB)(Participants) | Parent Reported Symptom Assessment (PRSA) |
|---|---|
| Hispanic or Latino | 29 |
| Not Hispanic or Latino | 94 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Parent Reported Symptom Assessment (PRSA) |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 5 |
| White | 94 |
| More than one race | 17 |
| Unknown or Not Reported | 6 |
| Region of Enrollment(participants) | Parent Reported Symptom Assessment (PRSA) |
|---|---|
| United States | 123 |
| Complex Chronic Condition (CCC) Count(Participants) | Parent Reported Symptom Assessment (PRSA) |
|---|---|
| 1-2 | 49 |
| 3-4 | 55 |
| 5 or More | 19 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — 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.
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University of Colorado, Denver