Recruiting

Geriatrician Care

Sponsor:

University of Miami

Code:

NCT07059585

Conditions

CGA

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

Interventions

CGA

control

Study Details

Brief summary:

The purpose of this research is to find out the best way to reduce delirium in frail, older patients undergoing planned surgery. Delirium is a state of confusion and difficulty concentrating that is temporary. Delirium may make the person anxious, angry, sleepy, not think clearly, or hallucinate. Being frail in medicine means that the body may not easily recover from a stressor, such as surgery. This study will determine if a detailed on-going evaluation by a Geriatrician, doctor who specializes in the care of older adults, after surgery is better at decreasing the risk of delirium than simply highlighting the patient's frailty in the electronic medical record.

Conditions

CGA

Study ID

NCT07059585

Start date

Jul 29, 2025

Status verified date

Aug, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: CGA group

Participants will receive the CGA intervention for up to 2 weeks

other: Control Group

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

Interventions

CGA

Participants will come once in person for the standard of care surgery. After the surgery, participants will receive delirium assessment questionnaires twice daily in the hospital for a duration of up to 7 days after surgery and, up to two sensory aids if required, one pair of eyeglasses as well as frequent orientation of physical and occupational therapy. On postoperative day 14, the subjects will be assessed for the same, whether at home or in-patient. The assessment completion could take up to an hour.

control

Participants will come once in person for the standard of care surgery. After the surgery, participants will receive assessment questionnaires regarding perioperative delirium, twice daily in the hospital for a duration of up to 7 days after surgery. On postoperative day 14, the subjects will be assessed for the same, whether at home or in-patient. The assessment completion could take up to an hour.

Primary outcome measure

  • Proportion of patients of postoperative delirium (POD) as measured by confusion assessment measure (CAM) [ Time Frame: up to 7 days ]

Central Contacts and Locations

Central contacts

Elizabeth Gabrielli, MD

7868784943exm1044@med.miami.edu

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Chandrama Shrestha

3052437677cxs1555@med.miami.edu

Principal Investigator:

Elizabeth Gabrielli, MD

More Information

Sponsor

University of Miami

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-08-18.