An interventional study of Serious Illness Conversation Program training and ACS Geriatric Surgery Verification Program Implementation in Breast Carcinoma, Malignant Digestive System Neoplasm and Malignant Female Reproductive System Neoplasm, sponsored by Ohio State University Comprehensive Cancer Center. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by Ohio State University Comprehensive Cancer Center · Not applicable, Interventional, and Health services research
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.
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).
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This study's planned enrollment of 4,000 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
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Exclusion Criteria:
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).
Behavioral: Serious Illness Conversation Program training · Other: ACS Geriatric Surgery Verification Program Implementation
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).
Behavioral: Serious Illness Conversation Program training · Other: ACS Geriatric Surgery Verification Program Implementation
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).
Behavioral: Serious Illness Conversation Program training · Other: ACS Geriatric Surgery Verification Program Implementation
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.
Also known as: GSV implementation
Adoption of the Core ACS GSV Care Bundle
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.
Time frame: From ACS GSV implementation through study completion, up to 3 years.
Hospital Length of Stay
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.
Time frame: From admission for the index surgical hospitalization until hospital discharge, assessed up to 30 days after surgery.
Completion of Goals-of-Care Documentation
Percentage of eligible patients with completed goals-of-care documentation in the electronic health record using the institutional goals-of-care documentation workflow.
Time frame: From ACS GSV implementation through study completion, up to 3 years.
Completion of G8 Geriatric Vulnerability Screening
Percentage of eligible patients who complete G8 geriatric vulnerability screening as part of the ACS GSV implementation workflow.
Time frame: From ACS GSV implementation through study completion, up to 3 years.
Implementation Cost
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.
Time frame: From pre-implementation planning through study completion, up to 3 years.
Referral or Documented Deferral for Positive G8 Screens
Among patients with a positive G8 screen, percentage with documented referral to the Cancer Aging and Resiliency Clinic or documented rationale for referral deferral.
Time frame: From ACS GSV implementation through study completion, up to 3 years.
ACS GSV Fidelity Index Score
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.
Time frame: From ACS GSV implementation through study completion, up to 3 years.
Acceptability of ACS GSV Implementation
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.
Time frame: Assessed during each stepped-wedge rollout period and after implementation, up to 3 years.
Appropriateness of ACS GSV Implementation
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.
Time frame: Assessed during each stepped-wedge rollout period and after implementation, up to 3 years.
Feasibility of ACS GSV Implementation
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.
Time frame: Assessed during each stepped-wedge rollout period and after implementation, up to 3 years.
Thirty-Day Unplanned Readmission
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.
Time frame: Within 30 days after discharge from the index surgical hospitalization.
Postoperative Complications
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.
Time frame: Within 30 days after surgery.
Mortality
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.
Time frame: Within 30 days after surgery.
Discharge Disposition
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.
Time frame: From admission for the index surgical hospitalization until hospital discharge, assessed up to 30 days after surgery.
Plan to share: No — 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.
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Ohio State University Comprehensive Cancer Center