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.
Visão geral do estudo
Status
Condições
- Neoplasia sólida maligna
- Neoplasias das Glândulas Endócrinas
- Carcinoma de mama
- Neoplasia Maligna do Sistema Reprodutivo Feminino
- Neoplasia Torácica Maligna
- Neoplasia Maligna de Cabeça e Pescoço
- Neoplasia Maligna do Sistema Digestivo
- Neoplasia do Sistema Nervoso Central
- Neoplasia de Tecidos Moles
- Neoplasia de Pele
- Neoplasia Maligna do Sistema Genitourinário
- Malignant Nervous System Neoplasm
Descrição detalhada
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).
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: The Ohio State University Comprehensive Cancer Center
- Número de telefone: 800-293-5066
- E-mail: OSUCCCClinicaltrials@osumc.edu
Locais de estudo
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Ohio
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Columbus, Ohio, Estados Unidos, 43210
- Ohio State University Comprehensive Cancer Center
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Investigador principal:
- Samilia Obeng-Gyasi, MD, MPH
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Contato:
- Samilia Obeng-Gyasi, MD, MPH
- Número de telefone: 812-361-6787
- E-mail: Samilia.Obeng-Gyasi@osumc.edu
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 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).
|
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.
Outros nomes:
|
|
Experimental: 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.
Outros nomes:
|
|
Experimental: 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.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Adoption of the Core ACS GSV Care Bundle
Prazo: 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.
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Hospital Length of Stay
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Completion of Goals-of-Care Documentation
Prazo: 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.
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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
Prazo: 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
Prazo: 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
Prazo: 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.
|
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ACS GSV Fidelity Index Score
Prazo: 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.
|
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Acceptability of ACS GSV Implementation
Prazo: 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
Prazo: 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.
|
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Feasibility of ACS GSV Implementation
Prazo: 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.
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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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Samilia Obeng-Gyasi, MD, MPH, Ohio State University Comprehensive Cancer Center
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças urogenitais
- Doenças do Sistema Endócrino
- Doenças do Sistema Nervoso
- Neoplasias por local
- Neoplasias
- Doenças Urogenitais Masculinas
- Doenças Urogenitais Femininas
- Doenças urogenitais femininas e complicações na gravidez
- Neoplasias do Aparelho Digestivo
- Doenças do aparelho digestivo
- Doenças Gastrointestinais
- Doenças de pele
- Doenças da mama
- Neoplasias do Sistema Nervoso
- Doenças da Pele e do Tecido Conjuntivo
- Neoplasias da Mama
- Neoplasias gastrointestinais
- Neoplasias de Cabeça e Pescoço
- Neoplasias do Sistema Nervoso Central
- Neoplasias Cutâneas
- Neoplasias urogenitais
- Neoplasias de Tecidos Moles
- Neoplasias das Glândulas Endócrinas
Outros números de identificação do estudo
- OSU-26031
- NCI-2026-02917 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
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