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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kianoush B. Kashani, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01610076
First received: January 31, 2012
Last updated: March 28, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Critical Illness
Other: Code Status Video
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Pilot Study to Determine Effectiveness and Acceptance of a Code Status Video in the ICU

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • test their knowledge using 16 testing questions [ Time Frame: after admission to ICU, approx one hour ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • testing level of discomfort using a satisfaction questionaire assessed with numeric scale. [ Time Frame: after admission to ICU, approx one hour ] [ Designated as safety issue: No ]

Enrollment: 208
Study Start Date: November 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No Video - Control
This group does not watch the 10 minute "code status" video before having the knowledge base video administered.
Experimental: Code Status Video
This group views a 10 minute video about "code status" prior to knowledge base survey administration
Other: Code Status Video
10 minute video about "Code Status"

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01610076

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Kianoush B Kashani, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Kianoush B. Kashani, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01610076     History of Changes
Other Study ID Numbers: 10-003628
Study First Received: January 31, 2012
Last Updated: March 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Code Status
DNR
DNI
CPR
Cardiopulmonary resuscitation
video
advanced directives

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on October 16, 2014