Studying the Workflow of the American College of Surgeons Geriatric Surgery Program to Improve Clinical Outcomes in Older Adults Undergoing Surgery at the James Cancer Hospital

Официальное название

Implementation of the American College of Surgeons Geriatric Surgery Verification Program at the James Cancer Hospital

Обзор

This study examines how the American College of Surgeons Geriatric Surgery Verification Program, also called the ACS GSV Program, is implemented at the James Cancer Hospital. The program is designed to improve surgical care for adults age 65 and older by helping care teams identify and address age-related needs before, during, and after surgery. Older adults with cancer may have concerns related to physical function, memory or thinking, medications, social support, and goals of care. If these needs are not recognized, patients may be at higher risk for complications, longer hospital stays, readmission, or discharge to a facility instead of home. The ACS GSV Program includes standards for geriatric surgery leadership, goals-of-care discussions, screening for age-related vulnerabilities, care plans for identified needs, age-friendly perioperative care, and regular review of surgical outcomes. This study will evaluate how well these standards are adopted across surgical oncology services and whether implementation is associated with better outcomes, such as shorter hospital stays, fewer complications, fewer readmissions, and improved discharge outcomes. The results may help improve surgical care workflows for older adults undergoing cancer surgery.

Подробное описание

PRIMARY OBJECTIVES:

I. To determine adoption, fidelity, sustainability, acceptability, and appropriateness/feasibility of implementing the American College of Surgeons Geriatric Surgery Verification (ACS GSV) Program at the James Cancer Hospital.

II. To compare clinical outcomes before and after ACS GSV implementation at the James Cancer Hospital.

SECONDARY OBJECTIVES:

I. To estimate the costs and incremental cost effectiveness of implementing each of the six ACS GSV standards.

II. To develop and validate a Geriatric Surgery Verification (GSV) fidelity index and examine dose response relationships with patient outcomes.

III. To use the Capability, Opportunity, Motivation-Behavior (COM-B) model paired with the Theoretical Domains Framework (TDF) to identify determinants of referrals to the Cancer and Aging Resiliency (CARE) clinic and also to determine the use of the GSV goals of care dot phrase among surgeons.

OUTLINE: Surgical services are randomized to 1 of 3 groups and participants are assigned to the group to which their service was randomized.

GROUP 1: Participants complete the Serious Illness Conversation Program (SICP) over two months (months 1-2). Participants then implement the ACS GSV program into surgical services over four months (months 3-6) followed by a transition period over 1 month (month 7) and continued maintenance implementation of the ACS GSV program over 9 months (months 8-16).

GROUP 2: Participants complete the SICP workshop over two months (months 6-7). Participants then implement the ACS GSV program into surgical services over four months (months 8-11) followed by a transition period over 1 month (month 12) and continued maintenance implementation of the ACS GSV program over 4 months (months 13-16).

GROUP 3: Participants complete the SICP workshop over two months (months 11-12). Participants then implement the ACS GSV program into surgical services over four months (months 13-16).

Вмешательства

• Поведенческое Serious Illness Conversation Program training
  Surgeons and advanced practice providers complete Serious Illness Conversation Program training to support elicitation and documentation of goals of care for older adults undergoing oncologic surgery.
• Другое ACS Geriatric Surgery Verification Program Implementation
  Implementation of the American College of Surgeons Geriatric Surgery Verification Age-Friendly Level standards across surgical oncology services, supported by tailored implementation strategies informed by the Capability, Opportunity, Motivation-Behavior model, Theoretical Domains Framework, and Behavior Change Wheel. Components include goals-of-care documentation workflows, G8 geriatric vulnerability screening, referral pathways for patients with positive screens, age-friendly perioperative car

Первичные конечные точки

• Adoption of the Core ACS GSV Care Bundle [Срок оценки: From ACS GSV implementation through study completion, up to 3 years.]
• Hospital Length of Stay [Срок оценки: From admission for the index surgical hospitalization until hospital discharge, assessed up to 30 days after surgery.]

Вторичные конечные точки (12)

• Completion of Goals-of-Care Documentation [Срок оценки: From ACS GSV implementation through study completion, up to 3 years.]
• Completion of G8 Geriatric Vulnerability Screening [Срок оценки: From ACS GSV implementation through study completion, up to 3 years.]
• Implementation Cost [Срок оценки: From pre-implementation planning through study completion, up to 3 years.]
• Referral or Documented Deferral for Positive G8 Screens [Срок оценки: From ACS GSV implementation through study completion, up to 3 years.]
• ACS GSV Fidelity Index Score [Срок оценки: From ACS GSV implementation through study completion, up to 3 years.]
• Acceptability of ACS GSV Implementation [Срок оценки: Assessed during each stepped-wedge rollout period and after implementation, up to 3 years.]
• Appropriateness of ACS GSV Implementation [Срок оценки: Assessed during each stepped-wedge rollout period and after implementation, up to 3 years.]
• Feasibility of ACS GSV Implementation [Срок оценки: Assessed during each stepped-wedge rollout period and after implementation, up to 3 years.]
• Thirty-Day Unplanned Readmission [Срок оценки: Within 30 days after discharge from the index surgical hospitalization.]
• Postoperative Complications [Срок оценки: Within 30 days after surgery.]
• Mortality [Срок оценки: Within 30 days after surgery.]
• Discharge Disposition [Срок оценки: From admission for the index surgical hospitalization until hospital discharge, assessed up to 30 days after surgery.]

Критерии участия

Критерии включения

• Patient records for adults aged 65 years or older
• Patient records with a surgical encounter or preoperative evaluation within participating James Cancer Hospital surgical oncology services during the rollout period
• Patient records with data available in institutional electronic health record or institutional data systems
• Clinical staff age 18 years or older who are employed or credentialed at The Ohio State University Wexner Medical Center and work within clinical areas affected by ACS Geriatric Surgery Verification implementation

Критерии исключения

• Patient records for encounters occurring only at outside institutions or non-James hospitals within the enterprise
• Patient records missing all primary outcome fields after data quality checks
• Clinical staff who are trainees, including medical students, physician assistant students, nursing students, resident physicians, or fellows
• Clinical staff whose employment, visa, or institutional status would make participation sensitive under institutional policy, if applicable

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

США · 1 центр

• Ohio State University Comprehensive Cancer Center — Columbus

Идентификаторы

NCT: NCT07606287 · OSU-26031 · NCI-2026-02917

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗