Discharge Medication Counseling in Hospitalized Children

Medication Management Clinical Trial

Official title:

Development and Evaluation of a Health Literacy-Informed Communication Intervention for Discharge Medication Counseling in Hospitalized Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05143047
• Other study ID #: 8194
• Status: Completed
• Phase: N/A
• Start date: June 25, 2021
• Est. completion date: August 20, 2022

Study information

• Verified date: February 2023
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: August 20, 2022
• Est. primary completion date: August 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Medication Management

Intervention

Behavioral:
• Medication counseling
Participants will receive a customized written medication instruction sheet which includes a picture of an oral dosing syringe indicating the patient's dose as well as a chart showing medication name, dose, route, frequency, duration, next dose due, side effects, and storage information. In addition, participants will be shown how to draw up their child's dose using an oral syringe and then will be asked to practice this task ("show-back"). "Teach-back" will be used to ensure participant's understanding of medication details.

Locations

Country	Name	City	State
United States	Monroe Carell Jr. Children's Hospital - Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	The Gerber Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Caregiver medication duration comprehension	Caregivers will be asked in a follow-up survey to provide the total duration of their child's discharge medication. This will be scored as correct if it matches the duration of the medication prescribed in the electronic health record.	During follow-up survey assessment 48-72 hours following patient/child discharge from the hospital
Other	Caregiver medication side effects comprehension	Caregivers will be asked in a follow-up survey to provide the medication side effects of their child's discharge medication. Caregivers will receive 1 point for every correctly identified side effect as it matches a list of pre-specified side effects determined by the study team. Caregivers will receive no points if they are unable to name any side effects on the prespecified list.	During follow-up survey assessment 48-72 hours following patient/child discharge from the hospital
Other	Caregiver medication frequency adherence	Caregivers will be asked in a follow-up survey to provide the medication frequency of their child's discharge medication. Caregivers will receive a score of 0 for any error in reported medication frequency.	During follow-up survey assessment 48-72 hours following patient/child discharge from the hospital
Other	Caregiver medication duration adherence	Caregivers will be asked in a follow-up survey to provide the medication duration of their child's discharge medication. Caregivers will receive a score of 0 for any error in reported medication duration.	During follow-up survey assessment 48-72 hours following patient/child discharge from the hospital
Primary	Observed dosing accuracy	Caregivers will be asked to draw up a dose of their child's liquid medication using the provided oral dosing syringe and send a secure picture of the syringe via myCap (secure phone application designed to collect patient-centered outcomes for research studies) to research study staff. The primary outcome will be assessed as a continuous percent difference from the prescribed dose (in milliliters) documented in the electronic health record.	During follow-up survey assessment 48-72 hours following patient/child discharge from the hospital
Primary	Reported dosing accuracy	Caregivers will be asked to report the prescribed volume (in milliliters) of medication to be given with each dose during the follow-up myCap survey. This will be compared to the prescribed dose in the electronic medical record.	During follow-up survey assessment 48-72 hours following patient/child discharge from the hospital
Secondary	Caregiver medication name comprehension	Caregivers will be asked in a follow-up survey to provide the name of their child's discharge medication. This will be scored as correct if it matches the name of the medication prescribed in the electronic health record.	During follow-up survey assessment 48-72 hours following patient/child discharge from the hospital
Secondary	Caregiver medication indication comprehension	Caregivers will be asked in a follow-up survey to provide the indication for their child's discharge medication. This will be scored as correct if it matches the indication for the medication prescribed in the electronic health record.	During follow-up survey assessment 48-72 hours following patient/child discharge from the hospital
Secondary	Caregiver medication frequency comprehension	Caregivers will be asked in a follow-up survey to provide the frequency of their child's discharge medication. This will be scored as correct if it matches the frequency of the medication prescribed in the electronic health record.	During follow-up survey assessment 48-72 hours following patient/child discharge from the hospital