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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

22 lipca 2026 zaktualizowane przez: Samilia Obeng-Gyasi, Ohio State University Comprehensive Cancer Center

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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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).

Typ studiów

Interwencyjne

Zapisy (Szacowany)

4000

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Stany Zjednoczone
    • Ohio
      • Columbus, Ohio, Stany Zjednoczone, 43210
        • Ohio State University Comprehensive Cancer Center
        • Główny śledczy:
          • Samilia Obeng-Gyasi, MD, MPH
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Tak

Opis

Inclusion Criteria:

  1. Patient records for adults aged 65 years or older
  2. Patient records with a surgical encounter or preoperative evaluation within participating James Cancer Hospital surgical oncology services during the rollout period
  3. Patient records with data available in institutional electronic health record or institutional data systems
  4. 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:

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Badania usług zdrowotnych
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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).
Behawioralne: 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.
Inny: 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 care processes, and data surveillance/quality monitoring.
Inne nazwy:
  • GSV implementation
Eksperymentalny: 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).
Behawioralne: 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.
Inny: 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 care processes, and data surveillance/quality monitoring.
Inne nazwy:
  • GSV implementation
Eksperymentalny: 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).
Behawioralne: 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.
Inny: 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 care processes, and data surveillance/quality monitoring.
Inne nazwy:
  • GSV implementation

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Adoption of the Core ACS GSV Care Bundle
Ramy czasowe: From ACS GSV implementation through study completion, up to 3 years.

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.
Hospital Length of Stay
Ramy czasowe: From admission for the index surgical hospitalization until hospital discharge, assessed up to 30 days after surgery.
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.
From admission for the index surgical hospitalization until hospital discharge, assessed up to 30 days after surgery.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Completion of Goals-of-Care Documentation
Ramy czasowe: From ACS GSV implementation through study completion, up to 3 years.
Percentage of eligible patients with completed goals-of-care documentation in the electronic health record using the institutional goals-of-care documentation workflow.
From ACS GSV implementation through study completion, up to 3 years.
Completion of G8 Geriatric Vulnerability Screening
Ramy czasowe: From ACS GSV implementation through study completion, up to 3 years.
Percentage of eligible patients who complete G8 geriatric vulnerability screening as part of the ACS GSV implementation workflow.
From ACS GSV implementation through study completion, up to 3 years.
Implementation Cost
Ramy czasowe: From pre-implementation planning through study completion, up to 3 years.
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.
From pre-implementation planning through study completion, up to 3 years.
Referral or Documented Deferral for Positive G8 Screens
Ramy czasowe: From ACS GSV implementation through study completion, up to 3 years.
Among patients with a positive G8 screen, percentage with 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.
ACS GSV Fidelity Index Score
Ramy czasowe: From ACS GSV implementation through study completion, up to 3 years.

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.
Acceptability of ACS GSV Implementation
Ramy czasowe: Assessed during each stepped-wedge rollout period and after implementation, up to 3 years.

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.
Appropriateness of ACS GSV Implementation
Ramy czasowe: Assessed during each stepped-wedge rollout period and after implementation, up to 3 years.
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.
Assessed during each stepped-wedge rollout period and after implementation, up to 3 years.
Feasibility of ACS GSV Implementation
Ramy czasowe: Assessed during each stepped-wedge rollout period and after implementation, up to 3 years.
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.
Assessed during each stepped-wedge rollout period and after implementation, up to 3 years.
Thirty-Day Unplanned Readmission
Ramy czasowe: Within 30 days after discharge from the index surgical hospitalization.
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.
Within 30 days after discharge from the index surgical hospitalization.
Postoperative Complications
Ramy czasowe: Within 30 days after surgery.
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.
Within 30 days after surgery.
Mortality
Ramy czasowe: Within 30 days after surgery.
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.
Within 30 days after surgery.
Discharge Disposition
Ramy czasowe: From admission for the index surgical hospitalization until hospital discharge, assessed up to 30 days after surgery.
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.
From admission for the index surgical hospitalization until hospital discharge, assessed up to 30 days after surgery.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Ohio State University Comprehensive Cancer Center

Śledczy

  • Główny śledczy: Samilia Obeng-Gyasi, MD, MPH, Ohio State University Comprehensive Cancer Center

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

15 listopada 2026

Zakończenie podstawowe (Szacowany)

31 grudnia 2027

Ukończenie studiów (Szacowany)

31 grudnia 2027

Daty rejestracji na studia

Pierwszy przesłany

2 maja 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

18 maja 2026

Pierwszy wysłany (Rzeczywisty)

26 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

23 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

22 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • OSU-26031
  • NCI-2026-02917 (Identyfikator rejestru: CTRP (Clinical Trial Reporting Program))

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

Individual participant data will not be shared because the study uses institutional EHR-derived clinical data, quality dashboard data, implementation data, and staff survey data that are subject to institutional privacy, IRB, and data governance restrictions. Aggregate findings will be reported publicly, and data access requests may be considered through Ohio State's institutional review and data governance processes.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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