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

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. Identifier: NCT01610076
Recruitment Status : Completed
First Posted : June 1, 2012
Results First Posted : April 4, 2016
Last Update Posted : May 13, 2016
Information provided by (Responsible Party):
Kianoush B. Kashani, Mayo Clinic

Brief 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.

Condition or disease Intervention/treatment Phase
Critical Illness Other: Code Status Video Phase 1 Phase 2

Detailed Description:

After randomization subjects will be divided into control group and intervention group that will receive video tutorial. All subjects will have unlimited access to printed brochures about Advance Directives available at our institution. Use of those materials will be left to their discretion of patients, surrogates and health care professionals involved in patients care. This study was conducted in the medical ICU of tertiary medical center.

Educational video tutorial to cardiovascular resuscitation, defibrillation, endotracheal intubation and mechanical ventilation. Video presents illustrations of resuscitation performed on actors. It informs about the risk, benefits and statistical outcomes of Cardiopulmonary resuscitation (CPR).

Immediately after admission to ICU patients or their health care surrogates were asked to participate in the study. The time between admission and enrollment varied depending on patient's needs and feasibility of conducting research. Upon enrollment subjects were stratified into two groups. One was composed of patients participating in education and testing and another composed of health care surrogates participating on patient's behalf. Those groups were further divided to intervention group that received video education and control group. Stratified randomization occurred according to computer generated list which will be followed for duration of the study. Patients in all four groups had access to printed brochures about Advance Directives. Those pamphlets were available at the admission desk and at the nursing stations. All participants were tested from their knowledge of the code status and related terminology. Subjects randomized to the control group were tested immediately after obtaining consent. Subject from intervention group were tested immediately after video education. Test was administered by the investigator in the format of interview. Completion of the questionnaire took <10 minutes. Questionnaire contained 17 testing questions. Questionnaire was validated and piloted prior to actual trial.

Satisfaction from education as well as level of discomfort caused by participation in the study were assessed with numeric scales. Following the interview all participants were asked if they would like to discuss Code Status preferences with physician taking care of them. If so, response were noted and appropriate services will be notified immediately. If patients were unable to consent to the study or participate in video education and testing, their health care surrogates were allowed to participate on behalf of the patient. Person giving the consent participated as a subject. Participation of health care proxy were tracked in the collected data. Patient's medical record number was used as personalized code for all the subjects including health care surrogates.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Pilot Study to Determine Effectiveness and Acceptance of a Code Status Video in the ICU
Study Start Date : November 2010
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Arm Intervention/treatment
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"

Primary Outcome Measures :
  1. 12 Question Resuscitation Status Survey (Question 4 Has 4 Sub-questions) [ Time Frame: after admission to ICU, approx one hour ]

    12 question (question 4 has 4 sub-questions) survey previously validated to determine knowledge level about resuscitation status with total score on the scale of 0-15. Possible scores ranged from 0 to 15, with higher scores representing increased medical knowledge.

    The CPR knowledge survey assesses a participants basic understanding of cardiopulmonary resuscitation (CPR). The survey consisted of 12 questions with one point being awarded for each correct response. Question four had a total of four possible correct answers. Thus the scores on the scale of 0-15 points is designed, with higher scores representing increased knowledge.

Secondary Outcome Measures :
  1. Participant Reported Comfort With Video Intervention [ Time Frame: immediately after intervention ]
    Patient's were surveyed about "How comfortable were you watching the video?"

  2. Perception of Utility of Video [ Time Frame: immediately after intervention ]

    Participants were surveyed, "How helpful was this video in helping you understand your options?" There possible answers were provided:

    Very helpful Somewhat helpful Not helpful

  3. Willingness to Recommend Video to Other Patients [ Time Frame: immediately after intervention ]

    Participants were surveyed, "Would you recommend this video to other patients?" Three options were provided:

    Definitely recommend Probably recommend Do not recommend

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT01610076

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

Responsible Party: Kianoush B. Kashani, MD, Mayo Clinic Identifier: NCT01610076     History of Changes
Other Study ID Numbers: 10-003628
First Posted: June 1, 2012    Key Record Dates
Results First Posted: April 4, 2016
Last Update Posted: May 13, 2016
Last Verified: April 2016

Keywords provided by Kianoush B. Kashani, Mayo Clinic:
Code Status
Do not resuscitate (DNR)
Do not intubate (DNI)
Cardiopulmonary resuscitation
advanced directives

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes