Comprehensive Geriatric Assessment for Postoperative Delirium

Overseen By Elizabeth Gabrielli, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Current delirium, prisoners, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to identify the best method to reduce confusion and concentration problems (delirium) in frail, older patients after surgery. It compares two approaches: one involves a specialist in elderly care regularly checking in with patients (Comprehensive Geriatric Assessment, or CGA), and the other involves doctors noting the patient's frailty in their electronic records. Participants should have at least two conditions, such as needing help with daily tasks, recent heart issues, or chronic breathing problems, and they should plan to undergo surgery requiring an overnight hospital stay. As an unphased trial, this study allows participants to contribute to valuable research that could enhance post-surgery care for older adults.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this protocol is safe for frail, older patients undergoing surgery?

Research has shown that a Comprehensive Geriatric Assessment (CGA) can lower the risk of confusion or delirium in older adults after surgery. Previous studies found that CGA reduces the chance of delirium by about 8%. For every 13 people who receive CGA, one person might avoid experiencing delirium.

These studies reported no serious safety issues. CGA involves a thorough check-up by a doctor specializing in the care of older adults. This method is considered safe and aims to support the health of frail, older patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Comprehensive Geriatric Assessment (CGA) for postoperative delirium because it offers a tailored approach to elderly patients after surgery. Unlike the standard of care, which typically involves general medical management and monitoring, CGA provides a thorough evaluation of a patient’s health, including physical, psychological, and social aspects. This personalized assessment aims to identify specific risks and needs, potentially leading to better prevention and management of delirium. By focusing on the whole patient rather than just the symptoms, CGA could improve recovery outcomes and enhance overall quality of life for older adults.

What evidence suggests that this method is effective for reducing postoperative delirium?

Research has shown that a Comprehensive Geriatric Assessment (CGA), which participants in this trial may receive, can reduce confusion and concentration difficulties after surgery in older adults. Studies have demonstrated that CGA lowered the rate of these issues from 37% to 28.5%, meaning fewer people experienced these problems post-surgery. CGA involves a thorough check-up by a geriatrician, a doctor specializing in the care of older adults. Specifically, the research found an 8.28% absolute risk reduction, indicating that for every 13 people who received CGA, one case of confusion was prevented. This evidence suggests that CGA is a promising method to reduce these issues in frail, older patients after surgery. ^{1 5 6 7 8}

Who Is on the Research Team?

Elizabeth Gabrielli, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for frail, older patients who are scheduled for planned surgery. It aims to see if a detailed evaluation by a Geriatrician after surgery can better reduce the risk of delirium compared to just noting the patient's frailty in their medical records.

Inclusion Criteria

Frailty as measured by the 5-modified frailty index (5-mFI) during the anesthesia preoperative assessment, based on the presence of 2 or more 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

Adults who are unable to consent if they have a designated proxy able to consent

I am scheduled for surgery that requires a hospital stay of more than one day.

Exclusion Criteria

Absence or withdrawal of informed consent

Prisoners

I am currently experiencing confusion or altered mental state.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the CGA intervention or standard care for up to 2 weeks

2 weeks

Follow-up

Participants are monitored for postoperative delirium and other outcomes

up to 18 days

What Are the Treatments Tested in This Trial?

Interventions

• CGA

Trial Overview The study is testing whether a Comprehensive Geriatric Assessment (CGA) conducted postoperatively by a specialist reduces delirium more effectively than standard care where only the patient's frailty status is recorded.

How Is the Trial Designed?

Group I: Control Group Experimental Treatment 1 Intervention

Participants will receive standard of care treatment for up to 2 weeks

Group II: CGA group Experimental Treatment 1 Intervention

Participants will receive the CGA intervention for up to 2 weeks

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Anesthesia Patient Safety Foundation (APSF)

Collaborator

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11356442/

The impact of comprehensive geriatric assessment on ... Comprehensive geriatric assessment reduced the rate of postoperative delirium (28.5% vs. 37.0%; OR: 0.63; CI: 0.47–0.85; I2: 54%; P = 0.003) based on pooled ...

2. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0306308

A systematic review and meta-analysis | PLOS One Comprehensive geriatric assessment reduced the rate of postoperative delirium (28.5% vs. 37.0%; OR: 0.63; CI: 0.47–0.85; I2: 54%; P = 0.003) ...

3. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2025.1473459/full

Comprehensive Geriatric Assessment as a predictor model ... Results: Total of 370 subjects that met the criteria were analyzed. The incidence of post-operative delirium was 6.8%. The predictor factors ...

4. nature.com nature.com/articles/s41598-024-78940-z

Comprehensive geriatric assessment for predicting ... This study aims to identify geriatric screening tools to predict preoperative delirium and explore the high-risk elderly patients undergoing oral maxillofacial ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8061210/

Effects of comprehensive geriatric care models on ... The absolute risk reduction for the prevalence of delirium is 8.28% (95% CI: 3.9, 12.6), and the number needed to treat is 13 (95% CI: 7.9, 25).

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07059585?lastUpdPost=2020-10-10_

Preoperative Comprehensive Geriatric Assessment (CGA) ... After the surgery, participants will receive assessment questionnaires regarding perioperative delirium, twice daily in the hospital for a duration of up to 7 ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0007091220305663

Postoperative delirium: perioperative assessment, risk ... Postoperative delirium is a relatively common and serious complication. It increases hospital stay by 2–3 days and is associated with a 30-day mortality of ...

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2836119

Postoperative Delirium in Older Adults Undergoing ... The incidence of postoperative delirium was 10.5% in the ACS National Surgical Quality Improvement Program geriatric surgery pilot project.