Preoperative Comprehensive Geriatric Assessment (CGA) and Postoperative Delirium

NCT07059585 | Recruiting

• 1 other identifier: 20230790
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Proportion of patients of postoperative delirium (POD) as measured by confusion assessment measure (CAM)

  The CAM score ranges from 1-4. Each score means the following: 1. \- acute onset or fluctuating course, 2. \- inattention, 3. \- altered mental status 4. \- disorganized thinking. The diagnosis of delirium by the CAM is based on the presence of features 1 and 2 and either 3 or 4.

  up to 7 days

Secondary Outcomes (4)

• The proportion of patients who had a non-escalation of discharge level of care

  1 day (at the end of the intervention)

• length of stay (LOS)

  1 day (at the end of the intervention)

• prolonged length of stay (LOS)

  1 day (at the end of the intervention)

• home delirium measured by CAM

  up to 18 days

Study Arms (2)

CGA group

EXPERIMENTAL

Participants will receive the CGA intervention for up to 2 weeks

Behavioral: CGA

Control Group

OTHER

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

Other: control

Interventions

CGA 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.

CGA group

control 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.

Control Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Elective inpatient surgery with an expected LOS \> 1 day;
• Receiving general anesthesia
• Adults who are unable to consent if they have a designated proxy able to consent

You may not qualify if:

• Absence or withdrawal of informed consent,
• Presence of current delirium
• prisoners

Sponsors & Collaborators

• University of Miami: lead
• Anesthesia Patient Safety Foundation (APSF): collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

Study Officials

• Elizabeth Gabrielli, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Gabrielli, MD

CONTACT

7868784943; exm1044@med.miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Anesthesiology

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 11, 2025
• Study Start: July 29, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)