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

Pilot Study to Determine Effectiveness and Acceptance of a Code Status Video in the ICU

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01610076
Enrollment
208
Registered
2012-06-01
Start date
2010-11-30
Completion date
2013-06-30
Last updated
2016-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness

Keywords

Code Status, Do not resuscitate (DNR), Do not intubate (DNI), CPR, Cardiopulmonary resuscitation, video, advanced directives

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.

Interventions

OTHERCode Status Video

10 minute video about Code Status

Sponsors

Mayo Clinic
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
12 Question Resuscitation Status Survey (Question 4 Has 4 Sub-questions)after admission to ICU, approx one hour12 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

MeasureTime frameDescription
Participant Reported Comfort With Video Interventionimmediately after interventionPatient's were surveyed about How comfortable were you watching the video?
Perception of Utility of Videoimmediately after interventionParticipants 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 Patientsimmediately after interventionParticipants were surveyed, Would you recommend this video to other patients? Three options were provided: Definitely recommend Probably recommend Do not recommend

Countries

United States

Participant flow

Participants by arm

ArmCount
No Video - Control
This group does not watch the 10 minute code status video before having the knowledge base video administered.
103
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
105
Total208

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up34
Overall StudyTechnical issue with video01

Baseline characteristics

CharacteristicNo Video - ControlCode Status VideoTotal
Age, Continuous62 years58 years60 years
Region of Enrollment
United States
103 participants105 participants208 participants
Sex: Female, Male
Female
52 Participants53 Participants105 Participants
Sex: Female, Male
Male
51 Participants52 Participants103 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 1030 / 105
serious
Total, serious adverse events
0 / 1030 / 105

Outcome results

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.

Time frame: after admission to ICU, approx one hour

ArmMeasureValue (MEDIAN)
No Video - Control12 Question Resuscitation Status Survey (Question 4 Has 4 Sub-questions)6.5 points
Code Status Video12 Question Resuscitation Status Survey (Question 4 Has 4 Sub-questions)9 points
Secondary

Participant Reported Comfort With Video Intervention

Patient's were surveyed about How comfortable were you watching the video?

Time frame: immediately after intervention

Population: Patient's surveyed about

ArmMeasureGroupValue (NUMBER)
No Video - ControlParticipant Reported Comfort With Video InterventionVery Comfortable Watching the Video75 participants
No Video - ControlParticipant Reported Comfort With Video InterventionSomewhat Comfortable Watching the video24 participants
No Video - ControlParticipant Reported Comfort With Video InterventionNot Comfortable watching the video1 participants
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

Time frame: immediately after intervention

ArmMeasureGroupValue (NUMBER)
No Video - ControlPerception of Utility of VideoVery helpful70 participants
No Video - ControlPerception of Utility of VideoNot helpful2 participants
No Video - ControlPerception of Utility of VideoSomewhat helpful28 participants
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

Time frame: immediately after intervention

ArmMeasureGroupValue (NUMBER)
No Video - ControlWillingness to Recommend Video to Other PatientsDefinitely recommend70 participants
No Video - ControlWillingness to Recommend Video to Other PatientsProbably recommend29 participants
No Video - ControlWillingness to Recommend Video to Other PatientsDo not recommend1 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026