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.|
|ClinicalTrials.gov Identifier: NCT01610076|
Recruitment Status : Completed
First Posted : June 1, 2012
Results First Posted : April 4, 2016
Last Update Posted : May 13, 2016
|Condition or disease||Intervention/treatment||Phase|
|Critical Illness||Other: Code Status Video||Phase 1 Phase 2|
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|
|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|
|Primary Completion Date :||June 2013|
|Study Completion Date :||June 2013|
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"
- 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.
- Participant Reported Comfort With Video Intervention [ Time Frame: immediately after intervention ]Patient's were surveyed about "How comfortable were you watching the video?"
- 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
- 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
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): NCT01610076
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Kianoush B Kashani, MD||Mayo Clinic|