跳至主要内容
临床试验/NCT04247841
NCT04247841Unknown不适用

Remembering Risk: Using Visual Risk Display of MINS to Obtain Informed Consent to Undergo Elective Surgery

Dr. Michael McMullen1 个研究点 分布在 1 个国家目标入组 456 人开始时间: 2020年1月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
456
试验地点
1
主要终点
Immediate Recall of Perioperative Risk of Myocardial Injury (MINS)

研究概览

简要总结

Disclosure of anticipated risks to individuals considering undergoing an operative procedure is an important aspect of informed consent process. Recent Canadian Guidelines have highlighted the importance of perioperative risk discussion within the context of preoperative assessment but there is little prior research into potential interventions to optimize the communication of risks. Myocaridal injury (MINS) is the most common complication and this study is focused on determining the effectiveness of current communication strategies in our presurgical consultations and to quantifying the impact of introducing a visual aid and scripted risk discussions has on patients ability to recall their individualized perioperative risk of myocardial injury.

详细描述

Informed consent is an important aspect of the patient-physician relationship. Prior to agreeing to undergo treatment patients must have risks and benefits disclosed to a "reasonable patient" standard.1 The 2016 Canadian Cardiovascular Society Guidelines on Perioperative Cardiac Risk Assessment strongly recommend the communication of perioperative cardiac risk to patients.2 Myocardial injury is the most common post-operative complications and has significant impact on patient outcomes including survival.2. However, very few studies have examined the communication of risk to patients, particularly when communicating perioperative cardiac risk.

The aim of this study is a 2-stage research project to address current practice in perioperative risk communication and examine opportunity to improve communication and patient education.

Phase One is structured to assess the current practices with respect to cardiac risk discussion at our academic center. During this initial phase, a survey will be offered after the PSS consultation to patients > 45 years old, seen in consult prior to elective orthopedic surgery requiring an overnight admission to KHSC. The survey will assess current risk discussion practices, patient satisfaction with cardiac risk discussion, ability to recall cardiac risk, importance of cardiac risk disclosure, and seek general feedback from participants.

Phase Two of this study is structured to assess the effectiveness of incorporating the use of structured, scripted risk discussion with and without the use of a visual aid. The patients will complete the survey instrument immediately after their PSS consultation to assess patient satisfaction with cardiac risk discussion, recall of risk, importance of cardiac risk discussion from the patients' perspective, and general feedback will be sought regarding perioperative education.

A subset of consenting patients during both Phase I and II will be followed-up post operatively (within 48h) to assess recall of preoperative cardiac risk discussion.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Participants will be masked to the primary purpose of the study during their preoperative consultation. Upon receiving and completing the survey responses they will be asked to recall their individualized risk of myocardial injury and provide feedback on the risk discussion they had with the anesthesiologist.

入排标准

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

入选标准

  • •Patients 45 years of age or older who are seen in Presurgical Screening Clinic by an anesthesiologist prior to elective hip or knee arthroplasty at Kingston Health Sciences Centre.

排除标准

  • •Unable to provide consent due to communication/language barrier
  • •Prior enrollment in this study
  • •No planned admission to hospital ( Same - Day joint arthroplasty)

研究组 & 干预措施

Phase I: Current Practice

No Intervention

This represents the first phase of the study in which a prospective cohort of patients will complete the survey to define baseline rates of recall of perioperative risk and level of patient satisfaction with risk discussion

Phase II Visual Aid & Scripted Risk Discussion

Experimental

This will involve a group of patients randomized to receive their perioperative risk discussion supplemented with the use of a visual aid in addition to a scripted discussion of their personalized perioperative risk of myocardial injury (MINS) during their consultation with an anesthesiologist in the PSS clinic.

干预措施: Visual Aid (Other)

Phase II Visual Aid & Scripted Risk Discussion

Experimental

This will involve a group of patients randomized to receive their perioperative risk discussion supplemented with the use of a visual aid in addition to a scripted discussion of their personalized perioperative risk of myocardial injury (MINS) during their consultation with an anesthesiologist in the PSS clinic.

干预措施: Scripted Risk Discussion (Other)

Phase II Scripted Risk Discussion

Active Comparator

This will involve a group of patients randomized to receive a scripted discussion of their personalized perioperative risk of myocardial injury (MINS) during their consultation with an anesthesiologist in the PSS clinic.

干预措施: Scripted Risk Discussion (Other)

结局指标

主要结局

Immediate Recall of Perioperative Risk of Myocardial Injury (MINS)

时间窗: Within 60 minutes of completing consultation with anesthesiologist in PSS clinic

This will be calculated as the patients who can state their risk estimate within the 95% CI for the risk estimate given their rCRI score (as outlined in the 2016 CCS Guidelines) when completing the survey.

次要结局

  • Demographics and Immediate Recall of Perioperative Risk of Myocardial Injury(Within 60 min of completing preoperative consultation)
  • Postoperative Recall of Perioperative Risk of Myocardial Injury (MINS)(Within 48 hours of undergoing their elective joint arthroplasty)
  • Satisfaction with Risk Discussion(Within 60 min completing preoperative consultation)
  • Correlation between subjective rating of individual risk and numeric risk estimate(Within 60 min completing preoperative consultation)
  • Recommendation of Use of Risk Discussion Tool in Future(Within 60 min completing preoperative consultation)

研究者

发起方
Dr. Michael McMullen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dr. Michael McMullen

Assistant Professor

Queen's University

研究点 (1)

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