Urinary Tract InfectionNCT02882256
Video Discharge Instructions (VDI) as Adjuncts to Written Discharge Instructions in the Emergency Department
A study testing Video discharge instructions in people with Urinary Tract Infection and Head Injury, run by George Washington University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urinary Tract Infection, Head Injury, Laceration
- What is being tested?
- Video discharge instructions
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is ≥ 18 years of age
- Patient speaks English fluently
- Patient was diagnosed with Urinary Tract Infection, Laceration, or Minor Head Injury
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
George Washington University Hospital
Washington D.C., District of Columbia, 20037
About this study
Official title: 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.
Read the 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.
- Conditions
- Urinary Tract Infection, Head Injury, Laceration
- Being tested
- Video discharge instructions
- Keywords
- laceration, urinary tract infection, minor head injury, concussion
- Medical subject headings
- Urinary Tract Infections, Craniocerebral Trauma, Lacerations, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video discharge instructionsOther
Discharge instructions provided in video form
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients will receive video discharge instructions in addition to standard written discharge instructions. Receives: Other: Video discharge instructions |
| Control | No intervention | Patients will receive standard written discharge instructions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Understanding of discharge diagnosis using questionnaire
Right after the provider who discharges the patient goes over the discharge instructions with the subject, the investigators will administer the discharge questionnaire.
Measured: Immediately before leaving the emergency department for discharge home.
Secondary outcomes (4)
Patient satisfaction of overall care in ED using questionnaire
Subjects will complete a telephone follow-up interview 5-7 days after ED discharge.
Measured: Five to seven days after the index ED visit.
Self-reported compliance with post-discharge care using questionnaire
Subjects will complete a telephone follow-up interview 5-7 days after ED discharge.
Measured: Five to seven days after the index ED visit.
Comprehension of return precautions using questionnaire
Subjects will complete a telephone follow-up interview 5-7 days after ED discharge.
Measured: Five to seven days after the index ED visit.
Retention of understanding of discharge diagnosis using questionnaire
Subjects will complete a telephone follow-up interview 5-7 days after ED discharge.
Measured: Five to seven days after the index ED visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study startJun 2016
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Urinary Tract InfectionStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa McCarthy, George Washington University
- Investigators
- Griffin Davis, MD, Principal investigator, GW Medical Faculty Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02882256
- Sponsor's protocol ID
- 061612
- Status last verified
- Dec 2018
- First submitted
- 4 Aug 2016
- Last updated
- 7 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 23714763Atzema 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.
PubMed 24244272
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Video Discharge Instructions (VDI) as Adjuncts to Written Discharge Instructions for 3 Common Chief Complaints in the Emergency Department (ED)
- ClinicalTrials.gov ID
- NCT02882256
- Acronym / sponsor ID
- 061612
- Conditions
- Urinary Tract Infection, Head Injury, Laceration
- Keywords
- laceration, urinary tract infection, minor head injury, concussion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 29 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Video discharge instructionsPatients will receive video discharge instructions in addition to standard written discharge instructions. |
| Control | No intervention | –Patients will receive standard written discharge instructions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient is ≥ 18 years of age
- Patient speaks English fluently
- Patient was diagnosed with Urinary Tract Infection, Laceration, or Minor Head Injury
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Video discharge instructionsDischarge instructions provided in video form | Other | Intervention |
Primary outcome
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.
4 secondary outcomes
Patient satisfaction of overall care in ED using questionnaire
Time frame: 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.
Comprehension of return precautions using questionnaire
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2018.
- Background: PubMed 23714763Bloch 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.
- Results publication: PubMed 24244272Atzema 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.
- Individual participant dataSharing planned: No
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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.
Griffin Davis, MD principal investigator
GW Medical Faculty Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video discharge instructions in people with Urinary Tract Infection and Head Injury, run by George Washington University at 1 site 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 3 inclusion and 4 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 7 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Understanding of discharge diagnosis using questionnaire (time frame: Immediately before leaving the emergency department for discharge home.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02882256, which also lists 2 linked publications.
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 7 Dec 2018.