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Clinical Trials/NCT04247841
NCT04247841
Unknown
Not Applicable

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

Dr. Michael McMullen1 site in 1 country456 target enrollmentJanuary 29, 2020
ConditionsRisk

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Risk
Sponsor
Dr. Michael McMullen
Enrollment
456
Locations
1
Primary Endpoint
Immediate Recall of Perioperative Risk of Myocardial Injury (MINS)
Last Updated
5 years ago

Overview

Brief Summary

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.

Detailed Description

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. Our study group hypothesizes that the use of visual representation of perioperative risk of Myocardial Injury after Non-Cardiac Surgery during the pre-anesthetic assessment will improve the patients' satisfaction with the cardiac risk discussion and their understanding and retention of the risk in the post-operative period.

Registry
clinicaltrials.gov
Start Date
January 29, 2020
End Date
September 1, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Dr. Michael McMullen
Responsible Party
Sponsor Investigator
Principal Investigator

Dr. Michael McMullen

Assistant Professor

Queen's University

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Outcomes

Primary Outcomes

Immediate Recall of Perioperative Risk of Myocardial Injury (MINS)

Time Frame: 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.

Secondary Outcomes

  • Postoperative Recall of Perioperative Risk of Myocardial Injury (MINS)(Within 48 hours of undergoing their elective joint arthroplasty)
  • Demographics and Immediate Recall of Perioperative Risk of Myocardial Injury(Within 60 min of completing preoperative consultation)
  • 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)

Study Sites (1)

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