Discharge Medication Counseling in Hospitalized Children
NCT ID: NCT05143047
Last Updated: 2024-08-19
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
198 participants
INTERVENTIONAL
2021-06-22
2022-08-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Decreasing Medication Errors by Caregivers Using a Health Literacy Intervention
NCT01294501
Evaluating a Low-Literacy Discharge Medication Education Tool
NCT00408733
Minimizing Harm From ADEs by Improving Nurse-Physician Communication
NCT00574990
Text Messages for Liver Transplant Recipients
NCT04995770
Effectiveness of the Consent Process
NCT00630136
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control
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.
No interventions assigned to this group
Intervention
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Caregivers must speak English or Spanish
* Participants' children must be discharged home on new scheduled liquid medication for minimum 3 days.
Exclusion Criteria
* Child is in state/protected custody
* Medication prescription is prescribed to pharmacy other than hospital outpatient pharmacy
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Gerber Foundation
OTHER
Vanderbilt University Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Alison Carroll
Clinical Instructor in Pediatrics
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Alison Carroll, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Monroe Carell Jr. Children's Hospital - Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
8194
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.