University of Miami
Miami, Florida, 33136, United States
Location status: Recruiting
Location contact
Chandrama Shrestha
CONTACT
Elizabeth Gabrielli, MD
PRINCIPAL_INVESTIGATOR
Recruiting
NCT Number: NCT07059585
Preoperative Comprehensive Geriatric Assessment (CGA) and Postoperative Delirium
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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
60 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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
Exclusion criteria
- Absence or withdrawal of informed consent,
- Presence of current delirium
- prisoners
Treatment and study plan
CGA
BehavioralParticipants 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
OtherParticipants 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 outcomes
-
Proportion of patients of postoperative delirium (POD) as measured by confusion assessment measure (CAM)
Time frame: up to 7 days
The CAM score ranges from 1-4. Each score means the following:
- - acute onset or fluctuating course,
- - inattention,
- - altered mental status
- - disorganized thinking. The diagnosis of delirium by the CAM is based on the presence of features 1 and 2 and either 3 or 4.
Secondary outcomes
-
The proportion of patients who had a non-escalation of discharge level of care
Time frame: 1 day (at the end of the intervention)
The proportion of patients with non-escalation of discharge of level of care will be assessed by comparing the level of care of the location that the patient was living preoperatively to the level care to the location that the patient is discharged and will be considered present if the discharge level of care is the same or lower. Levels of care from highest to lowest are: long term acute care hospital > skilled nursing facility > rehabilitation center > assisted living > unassisted home living.
-
length of stay (LOS)
Time frame: 1 day (at the end of the intervention)
measured in number of days
-
prolonged length of stay (LOS)
Time frame: 1 day (at the end of the intervention)
measured in number of days
-
home delirium measured by CAM
Time frame: up to 18 days
measured by confusion assessment measure (CAM).Scores range from 1 through 4. Higher scores indicated higher confusion
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
University of Miami
Other
Collaborators
- Anesthesia Patient Safety Foundation (APSF)
Registry information
Official study title
Does Perioperative Comprehensive Geriatric Assessment Reduce the Incidence of Postoperative Delirium in Older, Frail Patients Undergoing Elective Inpatient Surgery?
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Jul 11, 2025
- Registry last updated
- Aug 21, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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