Trial Outcomes & Findings for Video Discharge Instructions for Fever and ED Recidivism (NCT NCT01655251)
NCT ID: NCT01655251
Last Updated: 2025-10-14
Results Overview
Number of repeat visits to the ED within 72 hours of initial visit for fever
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
273 participants
Primary outcome timeframe
72 hours
Results posted on
2025-10-14
Participant Flow
Participant milestones
| Measure |
Intervention
Video (DVD) discharge instructions
Intervention
|
Control
Written instructions only
|
|---|---|---|
|
Overall Study
STARTED
|
140
|
133
|
|
Overall Study
COMPLETED
|
140
|
133
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Video Discharge Instructions for Fever and ED Recidivism
Baseline characteristics by cohort
| Measure |
Intervention
n=140 Participants
Video (DVD) discharge instructions
|
Control
n=133 Participants
Written instructions only
|
Total
n=273 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age
|
2.7 years
STANDARD_DEVIATION 3.0 • n=5 Participants
|
2.1 years
STANDARD_DEVIATION 2.4 • n=7 Participants
|
2.4 years
STANDARD_DEVIATION 2.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
72 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
68 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
22 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
72 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 72 hoursNumber of repeat visits to the ED within 72 hours of initial visit for fever
Outcome measures
| Measure |
Intervention
n=140 Participants
Video (DVD) discharge instructions
|
Control
n=133 Participants
Written instructions only
|
|---|---|---|
|
Recidivism
|
6 number of return visits within 72 ho
|
3 number of return visits within 72 ho
|
SECONDARY outcome
Timeframe: 1 weekPopulation: Parents were not considered enrolled but contributed to the assessment.
Rating of how useful the parents found the discharge instructions
Outcome measures
| Measure |
Intervention
n=140 Participants
Video (DVD) discharge instructions
|
Control
n=133 Participants
Written instructions only
|
|---|---|---|
|
Usefulness
|
94 number of parents found useful
|
94 number of parents found useful
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Sharon R. Smith
Connecticut Children's Medical Center
Phone: 860-545-9000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place