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

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness
• Intervention / Treatment: Other: Code Status 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.

• Study Type: Interventional
• Enrollment (Actual): 208
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Kianoush B Kashani, MD, Mayo Clinic

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (ACTUAL): June 1, 2013
• Study Completion (ACTUAL): June 1, 2013

Study Registration Dates

• First Submitted: January 31, 2012
• First Submitted That Met QC Criteria: May 31, 2012
• First Posted (ESTIMATE): June 1, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): May 13, 2016
• Last Update Submitted That Met QC Criteria: April 7, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: CPR; video; Cardiopulmonary resuscitation; Code Status; Do not resuscitate (DNR); Do not intubate (DNI); advanced directives
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 10-003628