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临床试验/NCT01610076
NCT01610076已完成1 期

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

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 208 人开始时间: 2010年11月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
Mayo Clinic
入组人数
208
试验地点
2
主要终点
12 Question Resuscitation Status Survey (Question 4 Has 4 Sub-questions)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients ages 18 and older admitted to the medical intensive care unit

排除标准

  • Institutionalized status (prisoners)
  • Pregnancy
  • A priori decided comfort care measures

结局指标

主要结局

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

时间窗: 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.

次要结局

  • Participant Reported Comfort With Video Intervention(immediately after intervention)
  • Perception of Utility of Video(immediately after intervention)
  • Willingness to Recommend Video to Other Patients(immediately after intervention)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kianoush B. Kashani

MD

Mayo Clinic

研究点 (2)

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