Risk Clinical Trial
Official title:
Remembering Risk: Using Visual Risk Display of MINS to Obtain Informed Consent to Undergo Elective Surgery
Verified date | March 2021 |
Source | Queen's University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 456 |
Est. completion date | September 1, 2021 |
Est. primary completion date | June 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 45 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Canada | Kingston Health Sciences Centre | Kingston | Ontario |
Lead Sponsor | Collaborator |
---|---|
Dr. Michael McMullen |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Immediate Recall of Perioperative Risk of Myocardial Injury (MINS) | 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. | Within 60 minutes of completing consultation with anesthesiologist in PSS clinic | |
Secondary | Postoperative Recall of Perioperative Risk of Myocardial Injury (MINS) | 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. | Within 48 hours of undergoing their elective joint arthroplasty | |
Secondary | Demographics and Immediate Recall of Perioperative Risk of Myocardial Injury | We will compare the impact sex, age and level of education have on the percentage of patients able to recall their risk estimate within the 95% CI outlined in CCS guidelines | Within 60 min of completing preoperative consultation | |
Secondary | Correlation between subjective rating of individual risk and numeric risk estimate | Patients subjective responses to their level of risk (minimal, low, moderate, high, very high) will be compared with their numeric risk estimate ( rate / 100 persons) | Within 60 min completing preoperative consultation | |
Secondary | Satisfaction with Risk Discussion | Subjects will be asked to rate their level of satisfaction with the preoperative risk discussion on a 5 point Likehert Scale and the difference between 3 arms will be examined | Within 60 min completing preoperative consultation | |
Secondary | Recommendation of Use of Risk Discussion Tool in Future | Patients will be asked to rate their likelihood (0-10) to use a similar format of risk discussion to family or friends coming for surgery. | Within 60 min completing preoperative consultation |
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