Understanding Emergency Room ProceduresDIVANCT01929304
Difficult Intravenous Access Perception: Difficult IV Access - Assessment of Patient Understanding
An observational study of Understanding Emergency Room Procedures, run by University of Pennsylvania at 1 site in United States.
Trial summary
Aim: Patient Perception: This aim broadly intends to use traditional script versus a brief video education vignette to determine understanding and preferences among general emergency department patients of rescue access techniques. Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Understanding Emergency Room Procedures
- What is being tested?
- Survey
- How many people
- 1,180 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Jul 2016
- Phase
- Observational
- 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 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eligible for enrollment would be any hemodynamically stable adult 18 years of age or older who is a HUP Emergency Department patient, able to provide informed consent, without history of difficult intravenous access, and able to speak, read, hear, and speak English fluently.
Who may be able to join
- greater than or equal to 18 years of age
- fluent in English
- hemodynamically stable emergency department patient
Who cannot join
- history of or current status of difficult intravenous access
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Assessment of Patient Understanding and Preference of Rescue Venous Access When Shown a Narrated Video Vignette Versus Traditional Paper Information Sheet
Aim: Patient Perception: This aim broadly intends to use traditional script versus a brief video education vignette to determine understanding and preferences among general emergency department patients of rescue access techniques. A challenge of emergency care is providing patient education surrounding procedures in a standardized and patient-oriented manner. This data would provide insight on a patient's understanding of the risks and benefits of rescue access, assess patient preference, and potentially influence what rescue technique is employed in the future. This information may also give us insight onto why DIVA patients might refuse randomization.
- Conditions
- Understanding Emergency Room Procedures
- Being tested
- Survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Also called Patients will complete a survey to assess their understanding and preferences.
| Study group | Role | What they receive |
|---|---|---|
| Video | Patients in this group will be shown an informational video, narrated in English. Receives: Other: Survey | |
| Text | Patients in this group will read a single-page printed information sheet in English. Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Understanding
Assess patients' understanding of and preferences regarding emergency department procedures: ultrasound-guided IV access and intra-osseous access.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Understanding Emergency Room ProceduresStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,180 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01929304
- Sponsor's protocol ID
- 818394b
- Acronym
- DIVA
- Status last verified
- Oct 2023
- First submitted
- 22 Aug 2013
- Last updated
- 5 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Patient Understanding and Preference of Rescue Venous Access When Shown a Narrated Video Vignette Versus Traditional Paper Information Sheet
- ClinicalTrials.gov ID
- NCT01929304
- Acronym / sponsor ID
- DIVA / 818394b
- Conditions
- Understanding Emergency Room Procedures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,180 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 27 Aug 2013 (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.
Aim: Patient Perception: This aim broadly intends to use traditional script versus a brief video education vignette to determine understanding and preferences among general emergency department patients of rescue access techniques. A challenge of emergency care is providing patient education surrounding procedures in a standardized and patient-oriented manner. This data would provide insight on a patient's understanding of the risks and benefits of rescue access, assess patient preference, and potentially influence what rescue technique is employed in the future. This information may also give us insight onto why DIVA patients might refuse randomization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video | – | Other: SurveyPatients in this group will be shown an informational video, narrated in English. |
| Text | – | Other: SurveyPatients in this group will read a single-page printed information sheet in English. |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible for enrollment would be any hemodynamically stable adult 18 years of age or older who is a HUP Emergency Department patient, able to provide informed consent, without history of difficult intravenous access, and able to speak, read, hear, and speak English fluently.
Key inclusion criteria (3 listed)
- greater than or equal to 18 years of age
- fluent in English
- hemodynamically stable emergency department patient
Key exclusion criteria (1 listed)
- history of or current status of difficult intravenous access
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 |
|---|---|---|
| SurveyAlso: Patients will complete a survey to assess their understanding and preferences. | Other | Text, Video |
Primary outcome
Patient Understanding
Time frame: Baseline
Assess patients' understanding of and preferences regarding emergency department procedures: ultrasound-guided IV access and intra-osseous access.
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 5 Oct 2023.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Understanding Emergency Room Procedures, run by University of Pennsylvania 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 1 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 5 Oct 2023. 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?
Patient Understanding (time frame: Baseline). 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 5 Oct 2023.