Clinical trial NCT05143047: Discharge Medication Counseling in Hospitalized Children
Official title: Development and Evaluation of a Health Literacy-Informed Communication Intervention for Discharge Medication Counseling in Hospitalized Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Management
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: The Gerber Foundation
First posted: 2021-12-03
Enrollment: 198
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized to control or intervention group.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Our objective is to design and test the efficacy of a health-literacy-informed discharge medication counseling intervention in the inpatient setting to reduce medication dosing errors and improve adherence in hospitalized children discharged on a new liquid medication.

Detailed description: The goal of this research is to improve discharge medication adherence and reduce medication dosing errors following pediatric hospitalization. Medication errors are one of the most common healthcare-associated adverse events in pediatrics, with approximately one out-of-hospital medication error occurring every 8 minutes among children \< 6 years of age. Liquid medications account for the majority of pediatric dosing errors which is likely due to liquid medications' inherent dosing complexities, including the need for weight-based dosing, different concentrations of medications, and parental use of unstandardized dosing instruments. The increased stress and exhaustion that many caregivers experience during a hospitalization, coupled with the need to assimilate large amounts of information pertaining to post-discharge care, makes transitioning to home from an inpatient stay a particularly high risk period for medication errors. Communication challenges, particularly failure to consider caregiver health literacy, further compounds the risk for medication errors due to poor caregiver comprehension and adherence to discharge instructions.

Eligibility criteria: Inclusion Criteria:

* Caregivers of children up to 6 years old who are hospitalized on a general inpatient hospital medicine teams
* Caregivers must speak English or Spanish
* Participants' children must be discharged home on new scheduled liquid medication for minimum 3 days.

Exclusion Criteria:

* Medication will be administered by home health nurse
* Child is in state/protected custody
* Medication prescription is prescribed to pharmacy other than hospital outpatient pharmacy

Primary outcomes:
measure: Observed Dosing Accuracy
timeFrame: During follow-up survey assessment 48-72 hours following hospital discharge
Secondary outcomes:
measure: Reported Dosing Accuracy
timeFrame: During follow-up survey assessment 48-72 hours following hospital discharge
measure: Correct Medication Name
timeFrame: During follow-up survey assessment 48-72 hours following hospital discharge
measure: Correct Medication Indication
timeFrame: During follow-up survey assessment 48-72 hours following hospital discharge
measure: Correct Medication Dose
timeFrame: During follow-up survey assessment 48-72 hours following hospital discharge
measure: Correct Medication Frequency
timeFrame: During follow-up survey assessment 48-72 hours following hospital discharge
Other outcomes:
measure: Correct Medication Duration
timeFrame: During follow-up survey assessment 48-72 hours following hospital discharge
measure: Correct Medication Side Effects
timeFrame: During follow-up survey assessment 48-72 hours following hospital discharge
measure: Correct Medication Storage
timeFrame: During follow-up survey assessment 48-72 hours following hospital discharge
Locations:
city: Nashville
country: United States
facility: Monroe Carell Jr. Children's Hospital - Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Alison Carroll, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: