Children Who Present to the ED With Minor Febrile IllnessesNCT01655251
Video Discharge Instructions for Fever and ED Recidivism
A study testing Intervention in people with Children Who Present to the ED With Minor Febrile Illnesses, run by Connecticut Children's Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 weeks to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Children Who Present to the ED With Minor Febrile Illnesses
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 273 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2011to May 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 weeks to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Connecticut Children's Medical Center
Hartford, Connecticut, 06016
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
About this study
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.
Read the 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.
- Being tested
- Intervention
- Keywords
- children, fever, emergency department
- Medical subject headings
- Fever, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
Also called Video (DVD) discharge instructions
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Video (DVD) discharge instructions Receives: Behavioral: Intervention |
| Control | No intervention | Written instructions only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recidivism
Number of repeat visits to the ED within 72 hours of initial visit for fever
Measured: 72 hours
Secondary outcomes (1)
Usefulness
Rating of how useful the parents found the discharge instructions
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2012 (estimated)
- Study startFeb 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Children Who Present to the ED With Minor Febrile IllnessesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 273 participants (actual)
Sponsor and investigators
- Lead sponsor
- Connecticut Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sharon Smith, Connecticut Children's Medical Center
- Investigators
- Sharon R Smith, MD, Principal investigator, Connecticut Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01655251
- Sponsor's protocol ID
- 10-098-CCMC
- Status last verified
- Sep 2025
- First submitted
- 30 Jul 2012
- Last updated
- 14 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Discharge Instructions for Fever and ED Recidivism
- ClinicalTrials.gov ID
- NCT01655251
- Acronym / sponsor ID
- 10-098-CCMC
- Keywords
- children, fever, emergency department
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 273 participants (actual)
- Lead sponsor
- Connecticut Children's Medical CenterUniversity, hospital or other
- Study start
- Feb 2011 (actual)
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 1 Aug 2012 (estimated)
- Results
- Posted 14 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: InterventionVideo (DVD) discharge instructions |
| Control | No intervention | –Written instructions only |
Who may qualify
- Ages
- 8 weeks to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionAlso: Video (DVD) discharge instructions | Behavioural | Intervention |
Primary outcome
Recidivism
Time frame: 72 hours
Number of repeat visits to the ED within 72 hours of initial visit for fever
1 secondary outcome
Usefulness
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon R Smith, MD principal investigator
Connecticut Children's Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Children Who Present to the ED With Minor Febrile Illnesses, run by Connecticut Children's Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recidivism (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2025.