Preoperative Comprehensive Geriatric Assessment (CGA) and Postoperative Delirium

NCT ID: NCT07059585

Last Updated: 2025-08-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-29
• Study Completion Date: 2026-12-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

CGA group

Participants will receive the CGA intervention for up to 2 weeks

Group Type: EXPERIMENTAL

CGA

Intervention Type: BEHAVIORAL

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 Group

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

Group Type: OTHER

control

Intervention Type: OTHER

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.

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anesthesia Patient Safety Foundation (APSF)

UNKNOWN

Sponsor Role: collaborator

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Elizabeth Mahanna Gabrielli

Associate Professor of Clinical Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elizabeth Gabrielli, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Elizabeth Gabrielli, MD

Role: CONTACT

exm1044@med.miami.edu

7868784943

Facility Contacts

Chandrama Shrestha

Role: primary

cxs1555@med.miami.edu

3052437677

Other Identifiers

20230790

Identifier Type: -

Identifier Source: org_study_id