Preoperative Comprehensive Geriatric Assessment (CGA) and Postoperative Delirium

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT07059585
Status
Recruiting

Conditions

  • CGA

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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.

Key Dates

Start date
Jul 29, 2025
Status verified
Aug 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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

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

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Chandrama Shrestha
3052437677
Elizabeth Gabrielli, MD (PRINCIPAL_INVESTIGATOR)

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