NCT01655251

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
273

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2011

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 30, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 1, 2012

Completed
13.2 years until next milestone

Results Posted

Study results publicly available

October 14, 2025

Completed
Last Updated

October 14, 2025

Status Verified

September 1, 2025

Enrollment Period

1.2 years

First QC Date

July 30, 2012

Results QC Date

July 9, 2025

Last Update Submit

September 25, 2025

Conditions

Keywords

childrenfeveremergency department

Outcome Measures

Primary Outcomes (1)

  • Recidivism

    Number of repeat visits to the ED within 72 hours of initial visit for fever

    72 hours

Secondary Outcomes (1)

  • Usefulness

    1 week

Study Arms (2)

Intervention

EXPERIMENTAL

Video (DVD) discharge instructions

Behavioral: Intervention

Control

NO INTERVENTION

Written instructions only

Interventions

InterventionBEHAVIORAL
Also known as: Video (DVD) discharge instructions
Intervention

Eligibility Criteria

Age8 Weeks - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Connecticut Children's Medical Center

Hartford, Connecticut, 06016, United States

Location

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

MeSH Terms

Conditions

FeverEmergencies

Interventions

MethodsVideotape Recording

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Intervention Hierarchy (Ancestors)

Investigative TechniquesTape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Results Point of Contact

Title
Dr. Sharon R. Smith
Organization
Connecticut Children's Medical Center

Study Officials

  • Sharon R Smith, MD

    Connecticut Children's Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ED Research Director

Study Record Dates

First Submitted

July 30, 2012

First Posted

August 1, 2012

Study Start

February 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

October 14, 2025

Results First Posted

October 14, 2025

Record last verified: 2025-09

Locations