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OpenTrials
Completed

NCT Number: NCT01610076

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Code Status Video

Other

10 minute video about "Code Status"

Primary outcomes

  1. 12 Question Resuscitation Status Survey (Question 4 Has 4 Sub-questions)

    Time frame: after admission to ICU, approx one hour

    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 outcomes

  1. Participant Reported Comfort With Video Intervention

    Time frame: immediately after intervention

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

  2. Perception of Utility of Video

    Time frame: immediately after intervention

    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

  3. Willingness to Recommend Video to Other Patients

    Time frame: immediately after intervention

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

    Definitely recommend Probably recommend Do not recommend

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jun 1, 2012
Registry last updated
May 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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