Chronic Disease, Neurologic Disorder, Pediatric Disorder
Conditions
Keywords
Neurological Impairment, Pediatric Complex Chronic Condition, Children with Medical Complexity, Pediatric Polypharmacy
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.
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.
Interventions
OTHERParent-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).
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Colorado, Denver
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Days to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Global Symptom Score | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medication Count | 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). |
| Medication Regimen Complexity Index Score (MRCI) | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 123 |
| Total | 123 |
Baseline characteristics
| Characteristic | Parent Reported Symptom Assessment (PRSA) |
|---|---|
| Age, Continuous | 9 years |
| Complex Chronic Condition (CCC) Count 1-2 | 49 Participants |
| Complex Chronic Condition (CCC) Count 3-4 | 55 Participants |
| Complex Chronic Condition (CCC) Count 5 or More | 19 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 29 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 94 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 17 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 94 Participants |
| Region of Enrollment United States | 123 participants |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
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
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Parent Reported Symptom Assessment (PRSA) | Global Symptom Score | 12.1 score on a scale |
Secondary
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
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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Parent Reported Symptom Assessment (PRSA) | Medication Count | 5-9 Medications | 25 Participants |
| Parent Reported Symptom Assessment (PRSA) | Medication Count | 10-14 Medications | 44 Participants |
| Parent Reported Symptom Assessment (PRSA) | Medication Count | 15 or More Medications | 54 Participants |
Secondary
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
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.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Parent Reported Symptom Assessment (PRSA) | Medication Regimen Complexity Index Score (MRCI) | 46 score on a scale |