[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07059585":3,"trial-entities:NCT07059585":93,"trial-summary:NCT07059585":97},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":39,"secondary_outcomes":44,"sex":58,"minimum_age":59,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":60,"std_ages":64,"locations":67,"central_contacts":85,"overall_officials":89,"references":91,"see_also_links":92},"NCT07059585","20230790","Preoperative Comprehensive Geriatric Assessment (CGA) and Postoperative Delirium","Does Perioperative Comprehensive Geriatric Assessment Reduce the Incidence of Postoperative Delirium in Older, Frail Patients Undergoing Elective Inpatient Surgery?","RECRUITING","2026-12-31","2026-08","2026-08-18","2025-07-29","University of Miami","OTHER",false,"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.",null,[19],"CGA",[],"INTERVENTIONAL","PREVENTION",[24],"NA",{"count":26,"type":27},200,"ESTIMATED",[29,34],{"type":30,"name":19,"description":31,"armGroupLabels":32},"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.",[33],"CGA group",{"type":14,"name":35,"description":36,"armGroupLabels":37},"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.",[38],"Control Group",[40],{"measure":41,"description":42,"timeFrame":43},"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:\n\n1. \\- acute onset or fluctuating course,\n2. \\- inattention,\n3. \\- altered mental status\n4. \\- 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",[45,49,52,54],{"measure":46,"description":47,"timeFrame":48},"The proportion of patients who had a non-escalation of discharge level of care","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.","1 day (at the end of the intervention)",{"measure":50,"description":51,"timeFrame":48},"length of stay (LOS)","measured in number of days",{"measure":53,"description":51,"timeFrame":48},"prolonged length of stay (LOS)",{"measure":55,"description":56,"timeFrame":57},"home delirium measured by CAM","measured by confusion assessment measure (CAM).Scores range from 1 through 4. Higher scores indicated higher confusion","up to 18 days","ALL","60 Years",{"inclusion":61,"exclusion":62,"raw_text":63},[],[],"Inclusion Criteria:\n\n1. 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.\n2. Elective inpatient surgery with an expected LOS \\> 1 day;\n3. Receiving general anesthesia\n4. Adults who are unable to consent if they have a designated proxy able to consent\n\nExclusion Criteria:\n\n1. Absence or withdrawal of informed consent,\n2. Presence of current delirium\n3. prisoners",[65,66],"ADULT","OLDER_ADULT",[68],{"facility":13,"status":8,"city":69,"state":70,"zip":71,"country":72,"contacts":73,"geoPoint":82},"Miami","Florida","33136","United States",[74,79],{"name":75,"role":76,"phone":77,"email":78},"Chandrama Shrestha","CONTACT","3052437677","cxs1555@med.miami.edu",{"name":80,"role":81},"Elizabeth Gabrielli, MD","PRINCIPAL_INVESTIGATOR",{"lat":83,"lon":84},25.77427,-80.19366,[86],{"name":80,"role":76,"phone":87,"email":88},"7868784943","exm1044@med.miami.edu",[90],{"name":80,"affiliation":13,"role":81},[],[],{"nct_id":4,"conditions":94,"biomarkers":96},[95],"Frailty",[],{"nct_id":4,"found":98,"summary":99,"prompt_version":109},true,{"design":100,"status":101,"heading":102,"summary":103,"follow_up":104,"word_count":105,"commitments":106,"compensation":107,"drugs_mentioned":108},"This is an interventional study planning to enroll 200 participants. It compares two different care approaches after surgery.","completed","Preoperative Comprehensive Geriatric Assessment and Postoperative Delirium","This study is looking for a better way to prevent delirium (a state of confusion) in older, frail patients having planned surgery. Delirium can make a person anxious, sleepy, or confused. Frailty means the body might have trouble recovering from stress like surgery. This study will compare two approaches: one group will receive a detailed evaluation by a Geriatrician (a doctor specializing in older adults) after surgery, which may include sensory aids like eyeglasses. The other group will receive standard care, with their frailty noted in their medical record. The main goal is to see if the Geriatrician's evaluation can reduce the number of patients who experience delirium up to 7 days after surgery. You may be able to join if you are 60 or older and have a certain level of frailty, as measured before surgery. The study aims to enroll 200 participants, but its current status is unclear.","You will be followed for up to 7 days after surgery to assess for postoperative delirium.",150,"You would come once for standard surgery. After surgery, you would have delirium assessments twice daily in the hospital for up to 7 days.","Not stated in the trial record.",[],"v2"]