Discharge Medication Counseling in Hospitalized Children

NCT05143047 | Completed Results

• 1 other identifier: 8194
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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.

Conditions

Medication Management

Outcome Measures

Primary Outcomes (1)

• Observed Dosing Accuracy

  Participants (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. Study staff assessing amount in picture are blinded to group assignment.

  During follow-up survey assessment 48-72 hours following hospital discharge

Secondary Outcomes (5)

• Reported Dosing Accuracy

  During follow-up survey assessment 48-72 hours following hospital discharge

• Correct Medication Name

  During follow-up survey assessment 48-72 hours following hospital discharge

• Correct Medication Indication

  During follow-up survey assessment 48-72 hours following hospital discharge

• Correct Medication Dose

  During follow-up survey assessment 48-72 hours following hospital discharge

• Correct Medication Frequency

  During follow-up survey assessment 48-72 hours following hospital discharge

Other Outcomes (3)

• Correct Medication Duration

  During follow-up survey assessment 48-72 hours following hospital discharge

• Correct Medication Side Effects

  During follow-up survey assessment 48-72 hours following hospital discharge

• Correct Medication Storage

  During follow-up survey assessment 48-72 hours following hospital discharge

Study Arms (2)

Control

NO INTERVENTION

Participants in the usual care group will receive standard-of-care discharge communications per unit routine, including counseling regarding prescribed medications and post-discharge instructions, return precautions, and follow-up appointments by the pediatric nursing staff.

Intervention

EXPERIMENTAL

Participants in the intervention group will receive supplementary medication discharge instructions in addition to the standard communications. They will receive instructions on how to submit information and complete study surveys securely through their cellphones during their child's home treatment period.

Behavioral: Medication counseling

Interventions

Medication counseling BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• The Gerber Foundation: collaborator

Study Sites (1)

Monroe Carell Jr. Children's Hospital - Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• Carroll AR, Johnson JA, Stassun JC, Greevy RA, Mixon AS, Williams DJ. Health Literacy-Informed Communication to Reduce Discharge Medication Errors in Hospitalized Children: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2350969. doi: 10.1001/jamanetworkopen.2023.50969.

  PMID: 38227315 DERIVED

Results Point of Contact

• Title: Alison Carroll, MD, MPH
• Organization: Vanderbilt University Medical Center

alison.carroll@vumc.org

615-875-5025

Study Officials

• Alison Carroll, MD, MPH

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Instructor in Pediatrics

Model Details: Participants are randomized to control or intervention group.

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: December 3, 2021
• Study Start: June 22, 2021
• Primary Completion: August 20, 2022
• Study Completion: August 20, 2022
• Last Updated: August 19, 2024
• Results First Posted: August 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)