Preoperative Comprehensive Geriatric Assessment (CGA) and Postoperative Delirium

Official title

Does Perioperative Comprehensive Geriatric Assessment Reduce the Incidence of Postoperative Delirium in Older, Frail Patients Undergoing Elective Inpatient Surgery?

Overview

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.

Interventions

• Behavioral 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 t
• Other 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 measures

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

Secondary outcome measures (4)

• The proportion of patients who had a non-escalation of discharge level of care [Time frame: 1 day (at the end of the intervention)]
• length of stay (LOS) [Time frame: 1 day (at the end of the intervention)]
• prolonged length of stay (LOS) [Time frame: 1 day (at the end of the intervention)]
• home delirium measured by CAM [Time frame: up to 18 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

United States · 1 center

• University of Miami — Miami

Identifiers

NCT: NCT07059585 · 20230790

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗