Discharge Medication Counseling in Hospitalized Children

NCT ID: NCT05143047

Last Updated: 2024-08-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-22

Study Completion Date

2022-08-20

Brief Summary

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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

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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.

Conditions

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Medication Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are randomized to control or intervention group.
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type NO_INTERVENTION

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.

Group Type EXPERIMENTAL

Medication counseling

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Gerber Foundation

OTHER

Sponsor Role collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Alison Carroll

Clinical Instructor in Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alison Carroll, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

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

Nashville, Tennessee, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38227315 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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8194

Identifier Type: -

Identifier Source: org_study_id

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