Pre-surgery comprehensive geriatric evaluation to reduce postoperative delirium
Does Perioperative Comprehensive Geriatric Assessment Reduce the Incidence of Postoperative Delirium in Older, Frail Patients Undergoing Elective Inpatient Surgery?
This study will test whether ongoing, detailed care from a geriatrician after planned inpatient surgery can lower delirium in frail older adults having general anesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT07059585 on ClinicalTrials.gov |
What this trial studies
This interventional trial compares ongoing postoperative follow-up by a geriatrician using a comprehensive geriatric assessment (CGA) versus simply flagging a patient as frail in the electronic medical record. Eligible participants are frail adults identified by the 5-item modified frailty index (5-mFI ≥ 2) who are scheduled for elective inpatient surgery with expected length of stay over one day and will receive general anesthesia. The main goal is to see if the geriatrician-led, continuous evaluation after surgery reduces the incidence of postoperative delirium and related complications. The study is led by the University of Miami with collaboration from the Anesthesia Patient Safety Foundation and enrolls patients at the University of Miami hospital in Miami, Florida.
Who should consider this trial
Good fit: Frail older adults (5-mFI ≥ 2) scheduled for elective inpatient surgery under general anesthesia with an expected stay greater than one day—including those who require a proxy to consent—are the ideal candidates.
Not a fit: Patients who are not frail, those having emergency or outpatient procedures, those not receiving general anesthesia, or those with current delirium are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could lower rates of postoperative delirium, shorten hospital stays, and improve recovery for frail older surgical patients.
How similar studies have performed: Geriatric co-management and comprehensive geriatric assessments in surgical populations have reduced delirium and complications in some prior studies, but results have varied and specific postoperative geriatrician-led models remain incompletely established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Frailty as measured by the 5-modified frailty index (5-mFI) during the anesthesia preoperative assessment. The 5-mFI consists of 5 elements: 1-dependency for activities of daily living, 2-congestive heart failure within 30 days, 3-chronic obstructive pulmonary disease or pneumonia currently treated with antibiotics, 4-diabetes, and 5-hypertension. The diagnosis of frailty by the 5-mFI is based upon the presence of 2 or more of the elements. 2. Elective inpatient surgery with an expected LOS \> 1 day; 3. Receiving general anesthesia 4. Adults who are unable to consent if they have a designated proxy able to consent Exclusion Criteria: 1. Absence or withdrawal of informed consent, 2. Presence of current delirium 3. prisoners
Where this trial is running
Miami, Florida
- University of Miami — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Elizabeth Gabrielli, MD — University of Miami
- Study coordinator: Elizabeth Gabrielli, MD
- Email: exm1044@med.miami.edu
- Phone: 7868784943
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.