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Medication Education for Dosing Safety

NCT ID: NCT03223246

Last Updated: 2020-11-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-01

Study Completion Date

2018-08-28

Brief Summary

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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

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Conditions

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Pain Fever

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Additional teaching

Group Type EXPERIMENTAL

Additional teaching

Intervention Type OTHER

A brief safety intervention, combining a pictorial handout, dosing demonstration with dispensed syringe, and teach-back for confirmation of understanding.

Interventions

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Additional teaching

A brief safety intervention, combining a pictorial handout, dosing demonstration with dispensed syringe, and teach-back for confirmation of understanding.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Margaret Samuels-Kalow

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Margaret Samuels-Kalow, MD MSHP

Role: PRINCIPAL_INVESTIGATOR

MGH

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 32807539 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2017P001482

Identifier Type: -

Identifier Source: org_study_id