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Video Discharge Instructions for Fever and ED Recidivism

Primary Purpose

Children Who Present to the ED With Minor Febrile Illnesses

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention
Sponsored by
Connecticut Children's Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Children Who Present to the ED With Minor Febrile Illnesses focused on measuring children, fever, emergency department

Eligibility Criteria

8 Weeks - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Connecticut Children's Medical Center
  • Connecticut Children's Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Video (DVD) discharge instructions

Outcomes

Primary Outcome Measures

recidivism
Proportion of subjects who returned to the ED within 72 hours of index visit for fever

Secondary Outcome Measures

usefulness
Rating of how useful the parents found the discharge instructions

Full Information

First Posted
July 30, 2012
Last Updated
July 30, 2012
Sponsor
Connecticut Children's Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01655251
Brief Title
Video Discharge Instructions for Fever and ED Recidivism
Official Title
Video Discharge Instructions for Fever and ED Recidivism
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Connecticut Children's Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Children Who Present to the ED With Minor Febrile Illnesses
Keywords
children, fever, emergency department

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
273 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Video (DVD) discharge instructions
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Intervention
Other Intervention Name(s)
Video (DVD) discharge instructions
Primary Outcome Measure Information:
Title
recidivism
Description
Proportion of subjects who returned to the ED within 72 hours of index visit for fever
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
usefulness
Description
Rating of how useful the parents found the discharge instructions
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Weeks
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Connecticut Children's Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06016
Country
United States
Facility Name
Connecticut Children's Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States

12. IPD Sharing Statement

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Video Discharge Instructions for Fever and ED Recidivism

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