Trial Outcomes & Findings for Parent-Reported Symptom Assessments in Children Taking Multiple Medications (NCT NCT03849066)

Last Updated: 2023-02-21

Results Overview

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).

Recruitment status

COMPLETED

Target enrollment

136 participants

Primary outcome timeframe

Baseline

Results posted on

2023-02-21

Participant Flow

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.

Participant milestones

Participant milestones
Measure	Parent Reported Symptom Assessment (PRSA) This is a cross-sectional analysis of children with neurological impairment and polypharmacy. 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).
Overall Study STARTED	136
Overall Study COMPLETED	123
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Parent Reported Symptom Assessment (PRSA) n=123 Participants This is a cross-sectional analysis of children with neurological impairment and polypharmacy. 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).
Age, Continuous	9 years n=5 Participants • 13 participants enrolled but did not complete the study activities and were excluded from analysis.
Sex: Female, Male Female	50 Participants n=5 Participants • 13 participants enrolled but did not complete the study activities and were excluded from analysis.
Sex: Female, Male Male	73 Participants n=5 Participants • 13 participants enrolled but did not complete the study activities and were excluded from analysis.
Ethnicity (NIH/OMB) Hispanic or Latino	29 Participants n=5 Participants • 13 participants enrolled but did not complete the study activities and were excluded from analysis.
Ethnicity (NIH/OMB) Not Hispanic or Latino	94 Participants n=5 Participants • 13 participants enrolled but did not complete the study activities and were excluded from analysis.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • 13 participants enrolled but did not complete the study activities and were excluded from analysis.
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants • 13 participants enrolled but did not complete the study activities and were excluded from analysis.
Race (NIH/OMB) Asian	0 Participants n=5 Participants • 13 participants enrolled but did not complete the study activities and were excluded from analysis.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • 13 participants enrolled but did not complete the study activities and were excluded from analysis.
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants • 13 participants enrolled but did not complete the study activities and were excluded from analysis.
Race (NIH/OMB) White	94 Participants n=5 Participants • 13 participants enrolled but did not complete the study activities and were excluded from analysis.
Race (NIH/OMB) More than one race	17 Participants n=5 Participants • 13 participants enrolled but did not complete the study activities and were excluded from analysis.
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants • 13 participants enrolled but did not complete the study activities and were excluded from analysis.
Region of Enrollment United States	123 participants n=5 Participants • 13 participants enrolled but did not complete the study activities and were excluded from analysis.
Complex Chronic Condition (CCC) Count 1-2	49 Participants n=5 Participants • 13 participants enrolled but did not complete the study activities and were excluded from analysis.
Complex Chronic Condition (CCC) Count 3-4	55 Participants n=5 Participants • 13 participants enrolled but did not complete the study activities and were excluded from analysis.
Complex Chronic Condition (CCC) Count 5 or More	19 Participants n=5 Participants • 13 participants enrolled but did not complete the study activities and were excluded from analysis.

PRIMARY outcome

Timeframe: Baseline

Population: We obtained parental written informed consent and enrolled and assessed English-speaking and Spanish-speaking children 0-17 years-old (inclusive) with SNI and polypharmacy (≥5 medications) who received primary care in a large, hospital-based special health care needs clinic.

Outcome measures

Outcome measures
Measure	Parent Reported Symptom Assessment (PRSA) n=123 Participants This is a cross-sectional analysis of children with neurological impairment and polypharmacy. 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).
Global Symptom Score	12.1 score on a scale Interval 5.4 to 20.8

SECONDARY outcome

Timeframe: Baseline

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).

Outcome measures

Outcome measures
Measure	Parent Reported Symptom Assessment (PRSA) n=123 Participants This is a cross-sectional analysis of children with neurological impairment and polypharmacy. 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).
Medication Count 5-9 Medications	25 Participants
Medication Count 10-14 Medications	44 Participants
Medication Count 15 or More Medications	54 Participants

SECONDARY outcome

Timeframe: Baseline

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.

Outcome measures

Outcome measures
Measure	Parent Reported Symptom Assessment (PRSA) n=123 Participants This is a cross-sectional analysis of children with neurological impairment and polypharmacy. 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).
Medication Regimen Complexity Index Score (MRCI)	46 score on a scale Interval 8.0 to 139.0

Adverse Events

Parent Reported Symptom Assessment (PRSA)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

James Feinstein, MD, MPH, Principal Investigator

University of Colorado Denver

Phone: 303-724-4186

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place