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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kianoush B. Kashani, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01610076
First received: January 31, 2012
Last updated: April 7, 2016
Last verified: April 2016
  Purpose
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.

Condition Intervention Phase
Critical Illness
Other: Code Status Video
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Pilot Study to Determine Effectiveness and Acceptance of a Code Status Video in the ICU

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 12 Question Resuscitation Status Survey (Question 4 Has 4 Sub-questions) [ Time Frame: after admission to ICU, approx one hour ] [ Designated as safety issue: No ]

    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 [ Time Frame: immediately after intervention ] [ Designated as safety issue: No ]
    Patient's were surveyed about "How comfortable were you watching the video?"

  • Perception of Utility of Video [ Time Frame: immediately after intervention ] [ Designated as safety issue: No ]

    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 [ Time Frame: immediately after intervention ] [ Designated as safety issue: No ]

    Participants were surveyed, "Would you recommend this video to other patients?" Three options were provided:

    Definitely recommend Probably recommend Do not recommend



Enrollment: 208
Study Start Date: November 2010
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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"

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01610076

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Kianoush B Kashani, MD Mayo Clinic
  More Information

Publications:
Responsible Party: Kianoush B. Kashani, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01610076     History of Changes
Other Study ID Numbers: 10-003628 
Study First Received: January 31, 2012
Results First Received: August 22, 2015
Last Updated: April 7, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Code Status
Do not resuscitate (DNR)
Do not intubate (DNI)
CPR
Cardiopulmonary resuscitation
video
advanced directives

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on August 25, 2016