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Completed

NCT Number: NCT05143047

Discharge Medication Counseling in Hospitalized Children

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.

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Key information

Conditions

Medication Management

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Nashville, Tennessee, 37232, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Observed Dosing Accuracy

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

    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.

Secondary outcomes

  1. Reported Dosing Accuracy

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

    Participants (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.

  2. Correct Medication Name

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

    Participants (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.

  3. Correct Medication Indication

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

    Participants (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.

  4. Correct Medication Dose

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

    Participants (caregivers) will be asked in a follow-up survey to provide the dosage 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.

  5. Correct Medication Frequency

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

    Participants (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.

Other outcomes

  1. Correct Medication Duration

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

    Participants (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.

  2. Correct Medication Side Effects

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

    Participants (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.

  3. Correct Medication Storage

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

    Participants (caregivers) will be asked in a follow-up survey to provide the correct recommended storage location of their child's discharge medication. This will be scored as correct if it matches the recommended storage location of the medication prescribed in the electronic health record.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Collaborators

  • The Gerber Foundation

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 3, 2021
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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