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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Video - Control | No Intervention | This group does not watch the 10 minute "code status" video before having the knowledge base video administered. | |
| Code Status Video | Experimental | This group views a 10 minute video about "code status" prior to knowledge base survey administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Code Status Video | Other | 10 minute video about "Code Status" |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | after admission to ICU, approx one hour |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Reported Comfort With Video Intervention | Patient's were surveyed about "How comfortable were you watching the video?" | immediately after intervention |
| Perception of Utility of Video |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kianoush B Kashani, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9214246 | Background | Hofmann JC, Wenger NS, Davis RB, Teno J, Connors AF Jr, Desbiens N, Lynn J, Phillips RS. Patient preferences for communication with physicians about end-of-life decisions. SUPPORT Investigators. Study to Understand Prognoses and Preference for Outcomes and Risks of Treatment. Ann Intern Med. 1997 Jul 1;127(1):1-12. doi: 10.7326/0003-4819-127-1-199707010-00001. | |
| 10809456 |
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| ID | Title | Description |
|---|---|---|
| FG000 | No Video - Control | This group does not watch the 10 minute "code status" video before having the knowledge base video administered. |
| FG001 | Code Status Video | This group views a 10 minute video about "code status" prior to knowledge base survey administration Code Status Video: 10 minute video about "Code Status" |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | No Video - Control | This group does not watch the 10 minute "code status" video before having the knowledge base video administered. |
| BG001 | Code Status Video | This group views a 10 minute video about "code status" prior to knowledge base survey administration Code Status Video: 10 minute video about "Code Status" |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | points | after admission to ICU, approx one hour |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Video - Control | This group does not watch the 10 minute "code status" video before having the knowledge base video administered. |
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In this study the patient outcomes were not addressed as the primary outcome was patient and family knowledge of CPR.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kianoush Kashani; Principal Investigator | Mayo Clinic | 5072667093 | kashani.kianoush@mayo.edu |
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| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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
| 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 | immediately after intervention |
| Wenger NS, Phillips RS, Teno JM, Oye RK, Dawson NV, Liu H, Califf R, Layde P, Hakim R, Lynn J. Physician understanding of patient resuscitation preferences: insights and clinical implications. J Am Geriatr Soc. 2000 May;48(S1):S44-51. doi: 10.1111/j.1532-5415.2000.tb03140.x. |
| 7790978 | Background | Teno JM, Hakim RB, Knaus WA, Wenger NS, Phillips RS, Wu AW, Layde P, Connors AF Jr, Dawson NV, Lynn J. Preferences for cardiopulmonary resuscitation: physician-patient agreement and hospital resource use. The SUPPORT Investigators. J Gen Intern Med. 1995 Apr;10(4):179-86. doi: 10.1007/BF02600252. |
| 11122596 | Background | von Gunten CF, Ferris FD, Emanuel LL. The patient-physician relationship. Ensuring competency in end-of-life care: communication and relational skills. JAMA. 2000 Dec 20;284(23):3051-7. doi: 10.1001/jama.284.23.3051. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| OG001 | Code Status Video | This group views a 10 minute video about "code status" prior to knowledge base survey administration Code Status Video: 10 minute video about "Code Status" |
|
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| Secondary | Participant Reported Comfort With Video Intervention | Patient's were surveyed about "How comfortable were you watching the video?" | Patient's surveyed about | Posted | Number | participants | immediately after intervention |
|
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| Secondary | 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 | Posted | Number | participants | immediately after intervention |
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| Secondary | 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 | Posted | Number | participants | immediately after intervention |
|
|
|
| 0 |
| 103 |
| 0 |
| 103 |
| EG001 | Code Status Video | This group views a 10 minute video about "code status" prior to knowledge base survey administration Code Status Video: 10 minute video about "Code Status" | 0 | 105 | 0 | 105 |
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