Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-24 @ 10:45 PM
NCT ID:
NCT02623335
Eligibility Criteria:
Surgeons
Inclusion Criteria:
* Consenting surgeons at participating hospital sites who practice vascular, cardiothoracic, hepatobiliary, colorectal, urologic, gynecologic, head and neck or neurosurgery
* Regularly see patients preoperatively in the surgical clinic
* Perform high risk operations on older patients with multiple comorbid conditions
Exclusion Criteria:
* Exclusively perform minimally invasive surgery (laparoscopy), endocrine or breast surgery as these procedures are not typically considered "high risk"
* Patient panel is not generally comprised of older adults considering high risk procedures
Patients
Inclusion Criteria:
* Age 60 and older
* One or more chronic conditions from a list comprised of those included in the Charlson Comorbidity Index with 9 additional conditions included due to their saliency to surgical decision making
* Have an upcoming outpatient consultation with an enrolled surgeon to discuss treatment for a vascular or oncologic problem that can be treated with a high risk operation
* English speaking and Spanish-speaking patients who require an interpreter will be included
Exclusion Criteria:
* Lack decision-making capacity
* Deemed too physically or mentally ill to participate by their surgeon or clinic nurse
* Self-report that their vision or literacy skills are too poor to read a newspaper
* Cannot speak either English or Spanish with the fluency required to have a valid medical decision-making conversation as the QPL is currently only available in English and Spanish (Spanish speaking patients who require an interpreter to speak with their surgeon will be included)
* Participating surgeons may also choose to exclude specific patients for study participation based on their own concerns about the patient participating in the study, for example patients who have urgent surgical needs or don't actually have a surgical problem
Family members
Inclusion Criteria:
* Family member (patient participant) is enrolled in the study
* Present at time of patient enrollment in study
Exclusion Criteria:
* Lack decision-making capacity
* Self-report that their vision or literacy skills are too poor to read a newspaper
* Cannot speak either English or Spanish with the fluency required to have a valid medical decision-making conversation as the QPL is currently only available in English and Spanish (Spanish speaking patients who require an interpreter to speak with the surgeon will be included)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT02623335
Study Brief:
Protocol Section:
NCT02623335