Medication Education for Dosing Safety

Not Applicable

Completed

• Conditions: Fever; Pain
• Interventions: Other: Additional teaching

• Registration Number: NCT03223246
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

Acetaminophen and ibuprofen are two of the most commonly used medication products among children \<12 years old, and these medications are frequently prescribed for patients leaving the emergency department (ED), but previous studies have shown that parents often leave the ED unsure of how to safely dose these medications at home. This study will be a randomized controlled trial of a brief medication safety intervention, and examining parental knowledge and implementation of appropriate weight-based dosing.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-17
• Study First Submitted QC: 2017-07-18
• Study First Posted: 2017-07-21
• Study Start: 2017-10-01
• Primary Completion: 2018-08-28
• Study Completion: 2018-08-28
• Results First Submitted: 2020-09-15
• Status Verified: 2020-10
• Results First Submitted QC: 2020-10-13
• Last Update Submitted: 2020-10-13
• Results First Posted: 2020-11-04
• Last Update Posted: 2020-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

Inclusion Criteria

• parents of children between ages of 90 days to 11.9 years
• being discharged with a plan for use of liquid acetaminophen (any age) or ibuprofen (limited to those >6 months old). The clinical team will determine planned medication use.
• parental fluency in English or Spanish
• ability to be reached by telephone over the next 7 days
• planned discharge home.

Exclusion Criteria

• presence of a complex chronic condition in the child
• planned use of a non-standard weight-based medication dose.
• Families will also be excluded if the adult with the child is not a parent or legal guardian.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Additional teaching	Additional teaching	-

Primary Outcome Measures

Name	Time	Method
Number of Participants Reporting Safe Dosing at 48-72 Hours	48-72 hours	Number of participants reporting dosing within 20% of the weight-based dose for the child at 48-72 hours

Secondary Outcome Measures

Name	Time	Method
Number of Participants Reporting Contact With Other Providers at 48-72 Hours	48-72 hours	Number of participants reporting visit to primary care or emergency department providers at 48-72 hours
Number of Participants Reporting Persistence of Safe Dosing at 5-7 Days	5-7 days	Number of participants reporting dosing within 20% of the weight-based dose for the child at 5-7 days
Number of Participants Reporting Contact With Other Providers at 5-7 Days	5-7 days	Number of participants reporting visit to primary care or emergency department providers at 5-7 days.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States