Video Discharge Instructions for Fever and ED Recidivism

July 30, 2012 updated by: Sharon Smith, Connecticut Children's Medical Center
To evaluate the effect of video discharge instructions on return visits to the ER or ED within 72 hours of the original visit for children with febrile illnesses.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a randomized prospective convenience study of children presenting to the ED. Children greater than 8 weeks and up to and including their 18th birthday are enrolled. Patients were randomly assigned to one of two study groups: video + written fever specific discharge instructions and only written fever specific discharge instructions. Parents assigned to the video group watched the DVD in the emergency department (ED) and take it home along with the written instructions. At 72 hours both groups received a phone call asking whether they returned to the ED and the usefulness of discharge instructions (DVD and/or written). Critically ill children and those with chronic medical conditions were excluded. The primary outcome is a return ED visit for fever confirmed in our electronic medical record and questionnaire response. The secondary outcome is reported parental usefulness of the discharge instructions.

Study Type

Interventional

Enrollment (Actual)

273

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Connecticut Children's Medical Center
      • Hartford, Connecticut, United States, 06016
        • Connecticut Children's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children ages 8 weeks to 18 years
  • Presented to the ED with a chief complaint of fever. Fever was defined as a temperature greater than or equal to 100.4⁰F
  • English or Spanish speaking
  • Working telephone for follow-up call
  • Venue to view DVD at home (TV, computer, etc)

Exclusion Criteria:

  • Children with a chronic medical illness
  • Children with immune-compromising conditions
  • Allergies to acetaminophen or ibuprofen
  • Previously enrolled
  • Admitted at the time of their index ED visit

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Intervention
Video (DVD) discharge instructions
Behavioral: Intervention
Other Names:
  • Video (DVD) discharge instructions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
recidivism
Time Frame: 72 hours
Proportion of subjects who returned to the ED within 72 hours of index visit for fever
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
usefulness
Time Frame: 1 week
Rating of how useful the parents found the discharge instructions
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Connecticut Children's Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

July 30, 2012

First Submitted That Met QC Criteria

July 30, 2012

First Posted (Estimate)

August 1, 2012

Study Record Updates

Last Update Posted (Estimate)

August 1, 2012

Last Update Submitted That Met QC Criteria

July 30, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-098-CCMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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