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.
調査の概要
状態
条件
詳細な説明
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).
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：The Ohio State University Comprehensive Cancer Center
- 電話番号：800-293-5066
- メール：OSUCCCClinicaltrials@osumc.edu
研究場所
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Ohio
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Columbus、Ohio、アメリカ、43210
- Ohio State University Comprehensive Cancer Center
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主任研究者：
- Samilia Obeng-Gyasi, MD, MPH
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コンタクト：
- Samilia Obeng-Gyasi, MD, MPH
- 電話番号：812-361-6787
- メール：Samilia.Obeng-Gyasi@osumc.edu
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
他の名前：
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実験的：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.
他の名前：
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実験的：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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Adoption of the Core ACS GSV Care Bundle
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Completion of Goals-of-Care Documentation
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Samilia Obeng-Gyasi, MD, MPH、Ohio State University Comprehensive Cancer Center
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- OSU-26031
- NCI-2026-02917 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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