- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07606287
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
Implementation of the American College of Surgeons Geriatric Surgery Verification Program at the James Cancer Hospital
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.
연구 개요
상태
정황
상세 설명
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).
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: The Ohio State University Comprehensive Cancer Center
- 전화번호: 800-293-5066
- 이메일: OSUCCCClinicaltrials@osumc.edu
연구 장소
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Ohio
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Columbus, Ohio, 미국, 43210
- Ohio State University Comprehensive Cancer Center
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수석 연구원:
- Samilia Obeng-Gyasi, MD, MPH
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연락하다:
- Samilia Obeng-Gyasi, MD, MPH
- 전화번호: 812-361-6787
- 이메일: Samilia.Obeng-Gyasi@osumc.edu
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-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Group 1 (months 3-6 ACS GSV)
Participants complete the Serious Illness Conversation Program (SICP) workshop 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).
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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.
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 care processes, and data surveillance/quality monitoring.
다른 이름들:
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실험적: Group 2 (months 8-11 ACS GSV)
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).
|
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.
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 care processes, and data surveillance/quality monitoring.
다른 이름들:
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실험적: Group 3 (months 13-16 ACS GSV)
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).
|
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.
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 care processes, and data surveillance/quality monitoring.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Adoption of the Core ACS GSV Care Bundle
기간: From ACS GSV implementation through study completion, up to 3 years.
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Patient-level completion of the core ACS GSV care bundle, defined as completed goals-of-care documentation, completed G8 geriatric vulnerability screening, and, among patients with a positive G8 screen, documented referral to the Cancer Aging and Resiliency Clinic or documented rationale for referral deferral. Measured as the percentage of eligible patients who complete the core ACS GSV care bundle. The bundle is defined as completed goals-of-care documentation, completed G8 geriatric vulnerability screening, and, among patients with a positive G8 screen, documented referral to the Cancer Aging and Resiliency Clinic or documented rationale for referral deferral. |
From ACS GSV implementation through study completion, up to 3 years.
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Hospital Length of Stay
기간: From admission for the index surgical hospitalization until hospital discharge, assessed up to 30 days after surgery.
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Patient hospital length of stay after surgery, measured in days using electronic health record data.Measured in days from admission to discharge for the index surgical hospitalization using electronic health record data.
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From admission for the index surgical hospitalization until hospital discharge, assessed up to 30 days after surgery.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Completion of Goals-of-Care Documentation
기간: From ACS GSV implementation through study completion, up to 3 years.
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Percentage of eligible patients with completed goals-of-care documentation in the electronic health record using the institutional goals-of-care documentation workflow.
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From ACS GSV implementation through study completion, up to 3 years.
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Completion of G8 Geriatric Vulnerability Screening
기간: From ACS GSV implementation through study completion, up to 3 years.
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Percentage of eligible patients who complete G8 geriatric vulnerability screening as part of the ACS GSV implementation workflow.
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From ACS GSV implementation through study completion, up to 3 years.
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Implementation Cost
기간: From pre-implementation planning through study completion, up to 3 years.
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Cost of ACS GSV implementation estimated using a micro-costing approach, including personnel time, training, workflow development, electronic health record optimization, and other implementation-related resources.
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From pre-implementation planning through study completion, up to 3 years.
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Referral or Documented Deferral for Positive G8 Screens
기간: From ACS GSV implementation through study completion, up to 3 years.
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Among patients with a positive G8 screen, percentage with documented referral to the Cancer Aging and Resiliency Clinic or documented rationale for referral deferral.
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From ACS GSV implementation through study completion, up to 3 years.
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ACS GSV Fidelity Index Score
기간: From ACS GSV implementation through study completion, up to 3 years.
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Composite fidelity score based on a structured checklist mapped to ACS GSV Standards 2 through 5. Checklist elements are coded as present or absent, weighted by clinical importance, and scaled from 0 to 100, with higher scores indicating greater fidelity to ACS GSV implementation. Measured as a composite fidelity score on a 0 to 100 scale, with higher scores indicating greater fidelity to ACS GSV implementation. The score is based on a structured checklist mapped to ACS GSV Standards 2 through 5. Checklist elements are coded as present or absent and weighted by clinical importance. |
From ACS GSV implementation through study completion, up to 3 years.
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Acceptability of ACS GSV Implementation
기간: Assessed during each stepped-wedge rollout period and after implementation, up to 3 years.
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Clinician and staff acceptability of ACS GSV implementation measured using the Acceptability of Intervention Measure. Higher scores indicate greater perceived acceptability. Measured using the Acceptability of Intervention Measure, a validated four-item implementation outcome instrument. Scores range from 1 to 5, with higher scores indicating greater perceived acceptability among clinicians and staff. |
Assessed during each stepped-wedge rollout period and after implementation, up to 3 years.
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Appropriateness of ACS GSV Implementation
기간: Assessed during each stepped-wedge rollout period and after implementation, up to 3 years.
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Clinician and staff perceived appropriateness of ACS GSV implementation measured using the Intervention Appropriateness Measure.
Higher scores indicate greater perceived appropriateness.
Measured using the Intervention Appropriateness Measure, a validated four-item implementation outcome instrument.
Scores range from 1 to 5, with higher scores indicating greater perceived appropriateness among clinicians and staff.
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Assessed during each stepped-wedge rollout period and after implementation, up to 3 years.
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Feasibility of ACS GSV Implementation
기간: Assessed during each stepped-wedge rollout period and after implementation, up to 3 years.
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Clinician and staff perceived feasibility of ACS GSV implementation measured using the Feasibility of Intervention Measure.
Higher scores indicate greater perceived feasibility.
Measured using the Feasibility of Intervention Measure, a validated four-item implementation outcome instrument.
Scores range from 1 to 5, with higher scores indicating greater perceived feasibility among clinicians and staff.
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Assessed during each stepped-wedge rollout period and after implementation, up to 3 years.
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Thirty-Day Unplanned Readmission
기간: Within 30 days after discharge from the index surgical hospitalization.
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Percentage of patients with an unplanned hospital readmission within 30 days after discharge from the index surgical hospitalization.
Measured as the percentage of patients with an unplanned hospital readmission within 30 days after discharge from the index surgical hospitalization.
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Within 30 days after discharge from the index surgical hospitalization.
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Postoperative Complications
기간: Within 30 days after surgery.
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Percentage of patients with one or more postoperative complications after surgery, identified from electronic health record data.
Measured as the percentage of patients with one or more postoperative complications within 30 days after surgery, identified from electronic health record data.
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Within 30 days after surgery.
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Mortality
기간: Within 30 days after surgery.
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Percentage of patients who die after surgery, identified from electronic health record data.
Measured as the percentage of patients who die within 30 days after surgery, identified from electronic health record data.
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Within 30 days after surgery.
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Discharge Disposition
기간: From admission for the index surgical hospitalization until hospital discharge, assessed up to 30 days after surgery.
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Patient discharge destination after the index surgical hospitalization, categorized as home, home with services, inpatient rehabilitation, skilled nursing facility, long-term acute care facility, hospice, or other discharge destination.Measured as the percentage of patients discharged to each destination category after the index surgical hospitalization, including home, home with services, inpatient rehabilitation, skilled nursing facility, long-term acute care facility, hospice, or other discharge destination.
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From admission for the index surgical hospitalization until hospital discharge, assessed up to 30 days after surgery.
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공동 작업자 및 조사자
수사관
- 수석 연구원: Samilia Obeng-Gyasi, MD, MPH, Ohio State University Comprehensive Cancer Center
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- OSU-26031
- NCI-2026-02917 (레지스트리 식별자: CTRP (Clinical Trial Reporting Program))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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