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Parent-Reported Symptom Assessments in Children Taking Multiple Medications (PRSA)

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ClinicalTrials.gov Identifier: NCT03849066
Recruitment Status : Recruiting
First Posted : February 21, 2019
Last Update Posted : June 4, 2020
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of Colorado, Denver

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.

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.


Condition or disease Intervention/treatment
Neurologic Disorder Chronic Disease Pediatric Disorder Other: Parent-Reported Symptom Assessment

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. 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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Enhancing Medication Safety in Children With Polypharmacy Using Parent- Reported Symptom Assessments
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : July 31, 2021
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Group/Cohort Intervention/treatment
Part 1: Cross-Sectional PRSA
This will be a cross-sectional analysis of 300 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 24 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 24 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 Name: PRSA

Part 2: Longitudinal PRSA
This will be a 12-month prospective cohort study of 50 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 24 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 24 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 Name: PRSA




Primary Outcome Measures :
  1. Global Symptom Score (Part1: Cross-Sectional PRSA) [ Time Frame: Baseline ]
    The global symptom score (continuous, from 0-100, with 100 being the worst) measures the general symptom burden.

  2. Specific Symptom Scores (Part 1: Cross-Sectional PRSA) [ Time Frame: Baseline ]
    The specific symptom scores (continuous, from 0-100, with 100 being the worst) measure each specific symptom burden (e.g. somnolence).

  3. Change in Global Symptom Score (Part 2: Longitudinal PRSA) [ Time Frame: Change from baseline Global Symptom Score at 2 days after medication change ]
    The global symptom score (continuous, from 0-100, with 100 being the worst) measures the general symptom burden.

  4. Change in Global Symptom Score (Part 2: Longitudinal PRSA) [ Time Frame: Change from baseline Global Symptom Score at 7 days after medication change ]
    The global symptom score (continuous, from 0-100, with 100 being the worst) measures the general symptom burden.

  5. Change in Global Symptom Score (Part 2: Longitudinal PRSA) [ Time Frame: Change from baseline Global Symptom Score at 14 days after medication change ]
    The global symptom score (continuous, from 0-100, with 100 being the worst) measures the general symptom burden.

  6. Change in Specific Symptom Scores (Part 2: Longitudinal PRSA) [ Time Frame: Change from baseline Specific Symptom Scores at 2 days after medication change ]
    The specific symptom scores (continuous, from 0-100, with 100 being the worst) measure each specific symptom burden (e.g. somnolence).

  7. Change in Specific Symptom Scores (Part 2: Longitudinal PRSA) [ Time Frame: Change from baseline Specific Symptom Scores at 7 days after medication change ]
    The specific symptom scores (continuous, from 0-100, with 100 being the worst) measure each specific symptom burden (e.g. somnolence).

  8. Change in Specific Symptom Scores (Part 2: Longitudinal PRSA) [ Time Frame: Change from baseline Specific Symptom Scores at 14 days after medication change ]
    The specific symptom scores (continuous, from 0-100, with 100 being the worst) measure each specific symptom burden (e.g. somnolence).



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03849066


Contacts
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Contact: James A Feinstein, MD, MPH 303-724-4186 james.feinstein@gmail.com
Contact: Jacqueline Holstein, BA 720-777-8956 jacqueline.holstein@childrenscolorado.org

Locations
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United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: James A Feinstein, MD, MPH    303-724-4186    james.feinstein@ucdenver.edu   
Contact: Jacqueline Holstein, BA    720-777-8956    jacqueline.holstein@childrenscolorado.org   
Sponsors and Collaborators
University of Colorado, Denver
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
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Principal Investigator: James A Feinstein, MD MPH Assistant Professor of Pediatrics
  Study Documents (Full-Text)

Documents provided by University of Colorado, Denver:
Publications:

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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03849066    
Other Study ID Numbers: 16-2538
5K23HD091295 ( U.S. NIH Grant/Contract )
First Posted: February 21, 2019    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

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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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Colorado, Denver:
Neurological Impairment
Pediatric Complex Chronic Condition
Children with Medical Complexity
Pediatric Polypharmacy
Additional relevant MeSH terms:
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Nervous System Diseases
Disease
Chronic Disease
Pathologic Processes
Disease Attributes