Neurologic DisorderPRSANCT03849066
Parent-Reported Symptom Assessments in Children Taking Multiple Medications
An observational study of Neurologic Disorder and Chronic Disease, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 17 years
- Conditions the study is for
- Neurologic Disorder, Chronic Disease, Pediatric Disorder
- What is being tested?
- Parent-Reported Symptom Assessment
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2019to 1 Aug 2022
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Neurological impairment
- 5 or more scheduled medications
- English- or Spanish-speaking
Who cannot join
- Receives primary care outside outside of the Children's Hospital Colorado Network of Care
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
Official title: 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. This study asks parents to report any symptoms their child is currently experiencing.
Read the 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.
- Conditions
- Neurologic Disorder, Chronic Disease, Pediatric Disorder
- Being tested
- Parent-Reported Symptom Assessment
- Keywords
- Neurological Impairment, Pediatric Complex Chronic Condition, Children with Medical Complexity, Pediatric Polypharmacy
- Medical subject headings
- Nervous System Diseases, Chronic Disease, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent-Reported Symptom AssessmentOther
Also called PRSA
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).
| Study group | Role | What they receive |
|---|---|---|
| Cross-Sectional PRSA | This will be a cross-sectional analysis of children with neurological impairment and polypharmacy. Receives: Other: Parent-Reported Symptom Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline
Secondary outcomes (2)
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).
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start1 Apr 2019
- Primary completion1 Aug 2022
- Study completion1 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Neurologic DisorderStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- James A Feinstein, MD MPH, Principal investigator, Associate Professor of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03849066
- Sponsor's protocol ID
- 16-2538
- Other IDs
- 5K23HD091295
- Acronym
- PRSA
- Status last verified
- Jan 2023
- First submitted
- 14 Feb 2019
- Last updated
- 21 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 26248529Feinstein 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.
PubMed 25511114Feinstein 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.
PubMed 24843054Berry 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.
PubMed 22272190Dussel 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.
PubMed 25640275Wolfe 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.
PubMed 24616307Feinstein 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.
PubMed 27893067Feinstein 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.
PubMed 36332769Marquez 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.
PubMed 35527209Feinstein 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.
PubMed 34436607Feinstein 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.
PubMed 33306117Feinstein 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.
PubMed 33044500Feinstein 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.
PubMed 36252865
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Medication Safety in Children With Polypharmacy Using Parent- Reported Symptom Assessments
- ClinicalTrials.gov ID
- NCT03849066
- Acronym / sponsor ID
- PRSA / 16-2538
- Conditions
- Neurologic Disorder, Chronic Disease, Pediatric Disorder
- Keywords
- Neurological Impairment, Pediatric Complex Chronic Condition, Children with Medical Complexity, Pediatric Polypharmacy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 1 Aug 2022 (actual)
- First posted
- 21 Feb 2019 (actual)
- Results
- Posted 21 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cross-Sectional PRSA | – | Other: Parent-Reported Symptom AssessmentThis will be a cross-sectional analysis of children with neurological impairment and polypharmacy. |
Who may qualify
- Ages
- 1 day to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- Neurological impairment
- 5 or more scheduled medications
- English- or Spanish-speaking
Key exclusion criteria (1 listed)
- Receives primary care outside outside of the Children's Hospital Colorado Network of Care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parent-Reported Symptom AssessmentAlso: PRSAAs 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 | Cross-Sectional PRSA |
Primary outcome
Global Symptom Score
Time frame: Baseline
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).
2 secondary outcomes
Medication Count
Time frame: Baseline
Medication Regimen Complexity Index Score (MRCI)
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 26248529Feinstein 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.
- Background: PubMed 25511114Feinstein 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.
- Background: PubMed 24843054Feinstein 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.
- Background: PubMed 22272190Berry 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.
- Background: PubMed 25640275Dussel 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.
- Background: PubMed 24616307Wolfe 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.
- Background: PubMed 27893067Feinstein 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.
- Results publication: PubMed 36332769Feinstein 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.
- Results publication: PubMed 35527209Marquez 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.
- Results publication: PubMed 34436607Feinstein 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.
- Results publication: PubMed 33306117Feinstein 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.
- Results publication: PubMed 33044500Feinstein 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.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James A Feinstein, MD MPH principal investigator
Associate Professor of Pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurologic Disorder and Chronic Disease, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global Symptom Score (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03849066, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.