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

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:
  • 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 Names:
  • Patients will complete a survey to assess their understanding and preferences.

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.

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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