Parent-Reported Symptom Assessments in Children Taking Multiple Medications

NCT03849066 | Completed Results

• 2 other identifiers: 16-25385K23HD091295
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neurologic Disorder; Chronic Disease; Pediatric Disorder

Keywords

Neurological Impairment; Pediatric Complex Chronic Condition; Children with Medical Complexity; Pediatric Polypharmacy

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline

Secondary Outcomes (2)

• Medication Count

  Baseline

• Medication Regimen Complexity Index Score (MRCI)

  Baseline

Study Arms (1)

Cross-Sectional PRSA

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

Other: Parent-Reported Symptom Assessment

Interventions

Parent-Reported Symptom Assessment OTHER

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

Cross-Sectional PRSA

Eligibility Criteria

• Age: 1 Day - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• Neurological impairment
• or more scheduled medications
• English- or Spanish-speaking

You may not qualify if:

• Receives primary care outside outside of the Children's Hospital Colorado Network of Care

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Related Publications (13)

• Feinstein JA, Feudtner C, Valuck RJ, Kempe A. The depth, duration, and degree of outpatient pediatric polypharmacy in Colorado fee-for-service Medicaid patients. Pharmacoepidemiol Drug Saf. 2015 Oct;24(10):1049-57. doi: 10.1002/pds.3843. Epub 2015 Aug 7.

  PMID: 26248529 BACKGROUND

• Feinstein J, Dai D, Zhong W, Freedman J, Feudtner C. Potential drug-drug interactions in infant, child, and adolescent patients in children's hospitals. Pediatrics. 2015 Jan;135(1):e99-108. doi: 10.1542/peds.2014-2015. Epub 2014 Dec 15.

  PMID: 25511114 BACKGROUND

• Feinstein JA, Feudtner C, Kempe A. Adverse drug event-related emergency department visits associated with complex chronic conditions. Pediatrics. 2014 Jun;133(6):e1575-85. doi: 10.1542/peds.2013-3060. Epub 2014 May 19.

  PMID: 24843054 BACKGROUND

• Berry JG, Poduri A, Bonkowsky JL, Zhou J, Graham DA, Welch C, Putney H, Srivastava R. Trends in resource utilization by children with neurological impairment in the United States inpatient health care system: a repeat cross-sectional study. PLoS Med. 2012 Jan;9(1):e1001158. doi: 10.1371/journal.pmed.1001158. Epub 2012 Jan 17.

  PMID: 22272190 BACKGROUND

• Dussel V, Orellana L, Soto N, Chen K, Ullrich C, Kang TI, Geyer JR, Feudtner C, Wolfe J. Feasibility of Conducting a Palliative Care Randomized Controlled Trial in Children With Advanced Cancer: Assessment of the PediQUEST Study. J Pain Symptom Manage. 2015 Jun;49(6):1059-69. doi: 10.1016/j.jpainsymman.2014.12.010. Epub 2015 Jan 30.

  PMID: 25640275 BACKGROUND

• Wolfe J, Orellana L, Cook EF, Ullrich C, Kang T, Geyer JR, Feudtner C, Weeks JC, Dussel V. Improving the care of children with advanced cancer by using an electronic patient-reported feedback intervention: results from the PediQUEST randomized controlled trial. J Clin Oncol. 2014 Apr 10;32(11):1119-26. doi: 10.1200/JCO.2013.51.5981. Epub 2014 Mar 10.

  PMID: 24616307 BACKGROUND

• Feinstein JA, Morrato EH, Feudtner C. Prioritizing Pediatric Drug Research Using Population-Level Health Data. JAMA Pediatr. 2017 Jan 1;171(1):7-8. doi: 10.1001/jamapediatrics.2016.3462. No abstract available.

  PMID: 27893067 BACKGROUND

• Feinstein JA, Feudtner C, Kempe A, Orth LE. Anticholinergic Medications and Parent-Reported Anticholinergic Symptoms in Neurologically Impaired Children. J Pain Symptom Manage. 2023 Feb;65(2):e109-e114. doi: 10.1016/j.jpainsymman.2022.10.013. Epub 2022 Nov 2.

  PMID: 36332769 RESULT

• Marquez C, Thompson R, Feinstein JA, Orth LE. Identifying opportunities for pediatric medication therapy management in children with medical complexity. J Am Pharm Assoc (2003). 2022 Sep-Oct;62(5):1587-1595.e3. doi: 10.1016/j.japh.2022.04.005. Epub 2022 Apr 12.

  PMID: 35527209 RESULT

• Feinstein JA, Friedman H, Orth LE, Feudtner C, Kempe A, Samay S, Blackmer AB. Complexity of Medication Regimens for Children With Neurological Impairment. JAMA Netw Open. 2021 Aug 2;4(8):e2122818. doi: 10.1001/jamanetworkopen.2021.22818.

  PMID: 34436607 RESULT

• Feinstein JA, Feudtner C, Blackmer AB, Valuck RJ, Fairclough DL, Holstein J, Gregoire L, Samay S, Kempe A. Parent-Reported Symptoms and Medications Used Among Children With Severe Neurological Impairment. JAMA Netw Open. 2020 Dec 1;3(12):e2029082. doi: 10.1001/jamanetworkopen.2020.29082.

  PMID: 33306117 RESULT

• Feinstein JA, Feudtner C, Valuck RJ, Fairclough DL, Holstein JA, Samay S, Kempe A. Identifying Important Clinical Symptoms in Children With Severe Neurological Impairment Using Parent-Reported Outcomes of Symptoms. JAMA Pediatr. 2020 Nov 1;174(11):1114-1117. doi: 10.1001/jamapediatrics.2020.2987.

  PMID: 33044500 RESULT

• Feinstein JA, Orth LE. Making Polypharmacy Safer for Children with Medical Complexity. J Pediatr. 2023 Mar;254:4-10. doi: 10.1016/j.jpeds.2022.10.012. Epub 2022 Oct 15.

  PMID: 36252865 RESULT

MeSH Terms

Conditions

Nervous System Diseases; Chronic Disease; Neurologic Manifestations

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Limitations and Caveats

13 participants enrolled but did not complete the study activities and were excluded from analysis.

Results Point of Contact

• Title: James Feinstein, MD, MPH, Principal Investigator
• Organization: University of Colorado Denver

james.feinstein@cuanschutz.edu

303-724-4186

Study Officials

• James A Feinstein, MD MPH

  Associate Professor of Pediatrics

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: February 21, 2019
• Study Start: April 1, 2019
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2022
• Last Updated: February 21, 2023
• Results First Posted: February 21, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)