Preoperative Comprehensive Geriatric Assessment (CGA) and Postoperative Delirium

Официальное название

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

Обзор

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.

Вмешательства

• Поведенческое 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
• Другое 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.

Первичные конечные точки

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

Вторичные конечные точки (4)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• University of Miami — Miami

Идентификаторы

NCT: NCT07059585 · 20230790

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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