Code Status Video in the Intensive Care Unit: Video Assisted Patient Education
Primary Purpose
Critical Illness
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Code Status Video
Sponsored by
About this trial
This is an interventional health services research trial for Critical Illness focused on measuring Code Status, Do not resuscitate (DNR), Do not intubate (DNI), CPR, Cardiopulmonary resuscitation, video, advanced directives
Eligibility 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
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
No Video - Control
Code Status Video
Arm Description
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Participant Reported Comfort With Video Intervention
Patient's were surveyed about "How comfortable were you watching the video?"
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01610076
Brief Title
Code Status Video in the Intensive Care Unit: Video Assisted Patient Education
Official Title
Pilot Study to Determine Effectiveness and Acceptance of a Code Status Video in the ICU
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Critical Illness
Keywords
Code Status, Do not resuscitate (DNR), Do not intubate (DNI), CPR, Cardiopulmonary resuscitation, video, advanced directives
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
208 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No Video - Control
Arm Type
No Intervention
Arm Description
This group does not watch the 10 minute "code status" video before having the knowledge base video administered.
Arm Title
Code Status Video
Arm Type
Experimental
Arm Description
This group views a 10 minute video about "code status" prior to knowledge base survey administration
Intervention Type
Other
Intervention Name(s)
Code Status Video
Intervention Description
10 minute video about "Code Status"
Primary Outcome Measure Information:
Title
12 Question Resuscitation Status Survey (Question 4 Has 4 Sub-questions)
Description
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
Secondary Outcome Measure Information:
Title
Participant Reported Comfort With Video Intervention
Description
Patient's were surveyed about "How comfortable were you watching the video?"
Time Frame
immediately after intervention
Title
Perception of Utility of Video
Description
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
Title
Willingness to Recommend Video to Other Patients
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kianoush B Kashani, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
9214246
Citation
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.
Results Reference
background
PubMed Identifier
10809456
Citation
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.
Results Reference
background
PubMed Identifier
7790978
Citation
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.
Results Reference
background
PubMed Identifier
11122596
Citation
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.
Results Reference
background
Learn more about this trial
Code Status Video in the Intensive Care Unit: Video Assisted Patient Education
We'll reach out to this number within 24 hrs