Implementation Pilot of Preoperative CGA Before Major Surgery

Официальное название

Implementation Pilot of Preoperative CGA Referral Process for Older Patients Undergoing Major Surgery

Обзор

The goal of this clinical trial is to test whether a new implementation package can help older adults prepare for major surgery. The main question it aims to answer is: Can the implementation package help give more people access to this resource? Participants will be in two groups: older adults who are planning a major surgery and their medical and surgical healthcare providers. The results will be compared to a historic baseline.

Подробное описание

The goal of this clinical trial is to test a new implementation package, which will be applied at the system-level, to see whether it can help more older adults prepare for major surgery. The study will evaluate whether the implementation package (1) improves the number of older adults who get a full "comprehensive geriatric assessment" (CGA) before surgery compared to the number of older adults who would be eligible for it, also called "reach"; and (2) increases the use of CGA by the medical and surgical providers who are taking care of these older adults, also called "adoption".

Participants will be in two groups: older adults who are planning a major surgery and their medical and surgical healthcare providers. The implementation package will include streamlined referral processes and education for surgeons and staff about the new processes. The results will be compared to a historic baseline

Findings from this study will help the lead researcher design a larger trial that will test both the implementation (or how something is done) at the same time as it tests the effectiveness (how well it works).

Вмешательства

• Другое Implementation Package for CGA
  The Implementation Package will include streamlined referral processes and education for surgeons and staff about the new processes. These strategies will be applied after surgery is ordered to help increase the reach and adoption of the CGA.
• Другое Routine Clinical Care
  Routine care may or may not include the use of the CGA before surgery. The use of CGA in clinical care is up to the medical and surgical healthcare providers.

Первичные конечные точки

• Number of patients referred divided by number of eligible patients [Срок оценки: 6 and 12 months after implementation]
• Number of surgeons placing referral orders divided by the number of surgeons [Срок оценки: 6 and 12 months]

Вторичные конечные точки (4)

• Fidelity: Percent of completed CGA components per visit [Срок оценки: 30 days after visit]
• Feasibility of Intervention Measure (FIM) Score [Срок оценки: 6 and 12 months]
• Acceptability of Intervention Measure (AIM) Score [Срок оценки: 6 and 12 months]
• Intervention Appropriateness Measure (IAM) Score [Срок оценки: 6 and 12 months]

Критерии участия

Критерии включения

• Patient aged 80 or older who is scheduled for an elective inpatient major surgery
• Providers working in a clinic (aged 18 and older) where pCGA is performed or a related anesthesia pre-operative clinic
• Surgeons (adults older than 18) with a patient aged 80 or older who is scheduled for an elective inpatient major surgery

Критерии исключения

• None

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• University of Wisconsin — Madison

Публикации

• Eamer G, Taheri A, Chen SS, Daviduck Q, Chambers T, Shi X, Khadaroo RG. Comprehensive geriatric assessment for older people admitted to a surgical service. Cochrane Database Syst Rev. 2018 Jan 31;1(1):CD012485. doi: 10.1002/14651858.CD012485.pub2. PMID 29385235
• McDonald SR, Heflin MT, Whitson HE, Dalton TO, Lidsky ME, Liu P, Poer CM, Sloane R, Thacker JK, White HK, Yanamadala M, Lagoo-Deenadayalan SA. Association of Integrated Care Coordination With Postsurgical Outcomes in High-Risk Older Adults: The Perioperative Optimization of Senior Health (POSH) Initiative. JAMA Surg. 2018 May 1;153(5):454-462. doi: 10.1001/jamasurg.2017.5513. PMID 29299599
• Partridge JS, Harari D, Martin FC, Peacock JL, Bell R, Mohammed A, Dhesi JK. Randomized clinical trial of comprehensive geriatric assessment and optimization in vascular surgery. Br J Surg. 2017 May;104(6):679-687. doi: 10.1002/bjs.10459. Epub 2017 Feb 15. PMID 28198997
• Chow WB, Rosenthal RA, Merkow RP, Ko CY, Esnaola NF; American College of Surgeons National Surgical Quality Improvement Program; American Geriatrics Society. Optimal preoperative assessment of the geriatric surgical patient: a best practices guideline from the American College of Surgeons National Surgical Quality Improvement Program and the American Geriatrics Society. J Am Coll Surg. 2012 Oct;21 PMID 22917646

Идентификаторы

NCT: NCT06184724 · 2025-1692 · 1K23AG081487 · A539707

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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