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NCT01610076 Clinical Trial

Code Status Video in the Intensive Care Unit: Video Assisted Patient Education

Critical Illness Clinical Trial

Official title:
Pilot Study to Determine Effectiveness and Acceptance of a Code Status Video in the ICU

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01610076
Other study ID # 10-003628
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received January 31, 2012
Last updated March 28, 2014
Start date November 2010
Est. completion date June 2013

Study information
Verified date March 2014
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This is a single-center, randomized control trial of a code status video as an educational tool in the intensive care unit. Subjects are stratified by patient or surrogate and are randomized to either watch an educational video on code status or not watch the video. They are then asked knowledge base questions regarding code status as well as questions pertaining to comfort regarding code status. Participants randomized to watch the video are also asked questions related to acceptance of the video.

Recruitment information / eligibility
Status Completed
Enrollment 208
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients ages 18 and older admitted to the medical intensive care unit

Exclusion Criteria:

- Institutionalized status (prisoners)

- Pregnancy

- A priori decided comfort care measures

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

Intervention

Other:
• Code Status Video
10 minute video about "Code Status"

Locations
Country Name City State
United States Mayo Clinic Rochester Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary test their knowledge using 16 testing questions after admission to ICU, approx one hour No
Secondary testing level of discomfort using a satisfaction questionaire assessed with numeric scale. after admission to ICU, approx one hour No
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