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DIVAs Perception: Difficult IV Access - Assessment of Patient Understanding (DIVAs 2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01929304
Recruitment Status : Completed
First Posted : August 27, 2013
Last Update Posted : January 11, 2017
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment
Understanding Emergency Room Procedures Other: Survey

Study Design
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Study Type : Observational
Actual Enrollment : 1180 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of Patient Understanding and Preference of Rescue Venous Access When Shown a Narrated Video Vignette Versus Traditional Paper Information Sheet
Study Start Date : August 2013
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016
Groups and Cohorts
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Group/Cohort Intervention/treatment
Video
Patients in this group will be shown an informational video, narrated in English.
 Other: Survey
Other Name: Patients will complete a survey to assess their understanding and preferences.
Text
Patients in this group will read a single-page printed information sheet in English.
 Other: Survey
Other Name: Patients will complete a survey to assess their understanding and preferences.


Outcome Measures
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Primary Outcome Measures :
  1. Patient Understanding [ Time Frame: Baseline ]
    Assess patients' understanding of and preferences regarding emergency department procedures: ultrasound-guided IV access and intra-osseous access.


Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01929304


Locations
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United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
More Information
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01929304    
Other Study ID Numbers: 818394b
First Posted: August 27, 2013    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017
Additional relevant MeSH terms:
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Emergencies
Disease Attributes
Pathologic Processes