A Phase 1/2 interventional study of Code Status Video in Critical Illness, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-13.
Sponsored by Mayo Clinic · Phase 1/2, Interventional, and Health services research
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.
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.
1,881 studies on the registry are indexed under Critical Illness; 462 are open to participants now.
This study's enrollment of 208 is above the median of 90 across 979 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
This group does not watch the 10 minute "code status" video before having the knowledge base video administered.
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)
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.
Time frame: after admission to ICU, approx one hour
Participant Reported Comfort With Video Intervention
Patient's were surveyed about "How comfortable were you watching the video?"
Time frame: immediately after intervention
Perception of Utility of Video
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
Time frame: immediately after intervention
Willingness to Recommend Video to Other Patients
Participants were surveyed, "Would you recommend this video to other patients?" Three options were provided: Definitely recommend Probably recommend Do not recommend
Time frame: immediately after intervention
| Milestone | No Video - Control | Code Status Video |
|---|---|---|
| Started | 103 | 105 |
| Completed | 100 | 100 |
| Not completed | 3 | 5 |
| Withdrew: Technical issue with video | 0 | 1 |
| Withdrew: Lost to follow-up | 3 | 4 |
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.
| points | No Video - Control | Code Status Video |
|---|---|---|
| 12 Question Resuscitation Status Survey (Question 4 Has 4 Sub-questions) | 6.5 (5 to 9.75) | 9 (6 to 12) |
Patient's were surveyed about "How comfortable were you watching the video?"
| participants | Code Status Video |
|---|---|
| Very Comfortable Watching the Video | 75 |
| Somewhat Comfortable Watching the video | 24 |
| Not Comfortable watching the video | 1 |
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
| participants | Code Status Video |
|---|---|
| Very helpful | 70 |
| Somewhat helpful | 28 |
| Not helpful | 2 |
Participants were surveyed, "Would you recommend this video to other patients?" Three options were provided: Definitely recommend Probably recommend Do not recommend
| participants | Code Status Video |
|---|---|
| Definitely recommend | 70 |
| Probably recommend | 29 |
| Do not recommend | 1 |
Collected over Adverse events were monitored throughout the course of the accrual. As investigators believed that watching a video could not cause significant physical damage following the post-video interview, the follow up ended for each individual patient.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| No Video - Control | — | 0/103 (0%) | 0/103 (0%) |
| Code Status Video | — | 0/105 (0%) | 0/105 (0%) |
| Age, Continuous(years) | No Video - Control | Code Status Video | Total |
|---|---|---|---|
| Median | 62 (47 to 73) | 58 (44 to 73) | 60 (45 to 73) |
| Sex: Female, Male(Participants) | No Video - Control | Code Status Video | Total |
|---|---|---|---|
| Female | 52 | 53 | 105 |
| Male | 51 | 52 | 103 |
| Region of Enrollment(participants) | No Video - Control | Code Status Video | Total |
|---|---|---|---|
| United States | 103 | 105 | 208 |
This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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