- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02882256
Video Discharge Instructions (VDI) as Adjuncts to Written Discharge Instructions in the Emergency Department
December 6, 2018 updated by: Melissa McCarthy, George Washington University
Video Discharge Instructions (VDI) as Adjuncts to Written Discharge Instructions for 3 Common Chief Complaints in the Emergency Department (ED)
Patients seen in the ED with either a laceration, minor head injury, or urinary tract infection will be randomized to one of two groups.
Both groups will receive the standard written discharge instructions; in addition, one group will watch video discharge instructions.
Each patient will be asked to complete a short survey with questions related to the discharge instructions received in the ED, and will be called 5-7 days after the ED visit to ask questions about discharge instructions and the ED visit.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Patients will be enrolled in the study at George Washington University Hospital's Emergency Department.
Patients who consent will be randomly assigned to one of two groups; (1) standard Written Discharge Instructions from the nursing staff (2) standard Written Discharge Instructions from the nursing staff AND watching the Video Discharge Instructions on a tablet.
Subjects will complete a survey after they have received their discharge instructions and before leaving the ER.
Several (5-7) days after leaving the Emergency Department, subjects will receive a phone call from one of the investigators staff members asking 2-3 questions about their ED visit and how they treated the condition at home.
The survey questions at discharge and at follow-up will pertain to how to care for the condition and will be based on the discharge instructions.
The study is designed to determine if patients retain health information more accurately if they watch a video in addition to being given written information.
A total sample size of 200 participants will be recruited.
Enrollment for this study will begin June of 2016 and will continue until the investigators have enough participants.
The data analyst will be blinded to treatment assignment when analyzing the data.
Study Type
Interventional
Enrollment (Actual)
193
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
-
-
District of Columbia
-
Washington, District of Columbia, United States, 20037
- George Washington University Hospital
-
-
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
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patient is ≥ 18 years of age
- Patient speaks English fluently
- Patient was diagnosed with Urinary Tract Infection, Laceration, or Minor Head Injury
Exclusion Criteria:
- Patient is presently a prisoner or in police custody
- Patient unable to understand consent
- Patient does not have a cell phone or house line
- Patient is blind or hearing impaired
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: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention
Patients will receive video discharge instructions in addition to standard written discharge instructions.
|
Discharge instructions provided in video form
|
NO_INTERVENTION: Control
Patients will receive standard written discharge instructions.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Understanding of discharge diagnosis using questionnaire
Time Frame: Immediately before leaving the emergency department for discharge home.
|
Right after the provider who discharges the patient goes over the discharge instructions with the subject, the investigators will administer the discharge questionnaire.
|
Immediately before leaving the emergency department for discharge home.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient satisfaction of overall care in ED using questionnaire
Time Frame: Five to seven days after the index ED visit.
|
Subjects will complete a telephone follow-up interview 5-7 days after ED discharge.
|
Five to seven days after the index ED visit.
|
Self-reported compliance with post-discharge care using questionnaire
Time Frame: Five to seven days after the index ED visit.
|
Subjects will complete a telephone follow-up interview 5-7 days after ED discharge.
|
Five to seven days after the index ED visit.
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Comprehension of return precautions using questionnaire
Time Frame: Five to seven days after the index ED visit.
|
Subjects will complete a telephone follow-up interview 5-7 days after ED discharge.
|
Five to seven days after the index ED visit.
|
Retention of understanding of discharge diagnosis using questionnaire
Time Frame: Five to seven days after the index ED visit.
|
Subjects will complete a telephone follow-up interview 5-7 days after ED discharge.
|
Five to seven days after the index ED visit.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Griffin Davis, MD, GW Medical Faculty Associates
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Bloch SA, Bloch AJ. Using video discharge instructions as an adjunct to standard written instructions improved caregivers' understanding of their child's emergency department visit, plan, and follow-up: a randomized controlled trial. Pediatr Emerg Care. 2013 Jun;29(6):699-704. doi: 10.1097/PEC.0b013e3182955480.
- Atzema CL, Austin PC, Wu L, Brzozowski M, Feldman MJ, McDonnell M, Mazurik L. Speak fast, use jargon, and don't repeat yourself: a randomized trial assessing the effectiveness of online videos to supplement emergency department discharge instructions. PLoS One. 2013 Nov 11;8(11):e77057. doi: 10.1371/journal.pone.0077057. eCollection 2013.
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 (ACTUAL)
June 1, 2016
Primary Completion (ACTUAL)
September 1, 2018
Study Completion (ACTUAL)
September 1, 2018
Study Registration Dates
First Submitted
August 4, 2016
First Submitted That Met QC Criteria
August 24, 2016
First Posted (ESTIMATE)
August 29, 2016
Study Record Updates
Last Update Posted (ACTUAL)
December 7, 2018
Last Update Submitted That Met QC Criteria
December 6, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 061612
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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