- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01929304
Difficult Intravenous Access Perception: Difficult IV Access - Assessment of Patient Understanding (DIVA)
October 2, 2023 updated by: University of Pennsylvania
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
1180
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
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Hospital of the University of Pennsylvania
-
-
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
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- greater than or equal to 18 years of age
- fluent in English
- hemodynamically stable emergency department patient
Exclusion Criteria:
- history of or current status of difficult intravenous access
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Video
Patients in this group will be shown an informational video, narrated in English.
|
Other Names:
|
|
Text
Patients in this group will read a single-page printed information sheet in English.
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient Understanding
Time Frame: Baseline
|
Assess patients' understanding of and preferences regarding emergency department procedures: ultrasound-guided IV access and intra-osseous access.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
August 1, 2013
Primary Completion (Actual)
July 1, 2016
Study Completion (Actual)
July 1, 2016
Study Registration Dates
First Submitted
August 22, 2013
First Submitted That Met QC Criteria
August 22, 2013
First Posted (Estimated)
August 27, 2013
Study Record Updates
Last Update Posted (Actual)
October 5, 2023
Last Update Submitted That Met QC Criteria
October 2, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 818394b
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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