Clinical trial NCT04247841: Remembering Risk: Using Visual Risk Display of MINS to Obtain Informed Consent to Undergo Elective Surgery
Official title: Remembering Risk: Using Visual Risk Display of MINS to Obtain Informed Consent to Undergo Elective Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Risk
Keywords: Risk
Preoperative Assessment
Myocardial Injury
Perioperative Medicine
Personalized Medicine
Communication
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 456
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: During Phase 1 we will be completing data collection on a prospective cohort of patients attending Presurgical Screening (PSS) Clinic in preparation for elective total joint arthroplasty of the hip or knee.

During the Phase 2 we will utilize a randomized approach to generate 2 groups of patients who will have their preoperative risk discussion guided by the use of a structured script or have the risk discussion guided by the use of a structured script and the display of a visual aid outlining the risk of myocardial injury
Primary purpose: OTHER

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.

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)

Primary outcomes:
measure: Immediate Recall of Perioperative Risk of Myocardial Injury (MINS)
timeFrame: Within 60 minutes of completing consultation with anesthesiologist in PSS clinic
Secondary outcomes:
measure: Postoperative Recall of Perioperative Risk of Myocardial Injury (MINS)
timeFrame: Within 48 hours of undergoing their elective joint arthroplasty
measure: Demographics and Immediate Recall of Perioperative Risk of Myocardial Injury
timeFrame: Within 60 min of completing preoperative consultation
measure: Correlation between subjective rating of individual risk and numeric risk estimate
timeFrame: Within 60 min completing preoperative consultation
measure: Satisfaction with Risk Discussion
timeFrame: Within 60 min completing preoperative consultation
measure: Recommendation of Use of Risk Discussion Tool in Future
timeFrame: Within 60 min completing preoperative consultation
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre
state: Ontario
Study officials:
affiliation: Department of Anesthesiology and Perioperative Medicine, Queen's Univerisity
name: Michael McMullen, MD
role: PRINCIPAL_INVESTIGATOR
References: