Medication Education for Dosing Safety (MEDS)

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.

Study Overview

• Status: Completed
• Conditions: Pain; Fever
• Intervention / Treatment: Other: Additional teaching

• Study Type: Interventional
• Enrollment (Actual): 149
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care
Experimental: Additional teaching	Other: Additional teaching; A brief safety intervention, combining a pictorial handout, dosing demonstration with dispensed syringe, and teach-back for confirmation of understanding.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Reporting Each Direction of Dosing Error at 48-72 Hours	Number of participants reporting dosing error is above and/or below the weight-based dose for the child. Correct dosing was defined as 10mg/kg for ibuprofen and 10-15mg/kg for acetaminophen; dosing was considered incorrect if more than 20% above or below these values. Participants could be counted in more than one category for this outcome if they made more than one type of mistake (i.e. reported dose too high for acetaminophen and too low for ibuprofen).	48-72 hours
Number of Participants Reporting Each Direction of Dosing Error at 5-7 Days	Number of participants reporting dosing error is above and/or below the weight-based dose for the child. Correct dosing was defined as 10mg/kg for ibuprofen and 10-15mg/kg for acetaminophen; dosing was considered incorrect if more than 20% above or below these values. Participants could be counted in more than one category for this outcome if they made more than one type of mistake (i.e. reported dose too high for acetaminophen and too low for ibuprofen).	5-7 days

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Margaret Samuels-Kalow, MD MSHP, MGH

Publications and helpful links

General Publications

• Naureckas Li C, Camargo CA Jr, Faridi M, Espinola JA, Hayes BD, Porter S, Cohen A, Samuels-Kalow M. Medication Education for Dosing Safety: A Randomized Controlled Trial. Ann Emerg Med. 2020 Nov;76(5):637-645. doi: 10.1016/j.annemergmed.2020.07.007. Epub 2020 Aug 15.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): August 28, 2018
• Study Completion (Actual): August 28, 2018

Study Registration Dates

• First Submitted: July 17, 2017
• First Submitted That Met QC Criteria: July 18, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): November 4, 2020
• Last Update Submitted That Met QC Criteria: October 13, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 2017P001482

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No