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.

Study Overview

• Status: Not yet recruiting
• Conditions: Malignant Solid Neoplasm; Endocrine Gland Neoplasms; Breast Carcinoma; Malignant Female Reproductive System Neoplasm; Malignant Thoracic Neoplasm; Malignant Head and Neck Neoplasm; Malignant Digestive System Neoplasm; Central Nervous System Neoplasm; Soft Tissue Neoplasm; Skin Neoplasm; Malignant Genitourinary System Neoplasm; Malignant Nervous System Neoplasm
• Intervention / Treatment: Behavioral: Serious Illness Conversation Program training; Other: ACS Geriatric Surgery Verification Program Implementation

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Estimated): 4000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: The Ohio State University Comprehensive Cancer Center; Phone Number: 800-293-5066; Email: OSUCCCClinicaltrials@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center
      • Principal Investigator: Samilia Obeng-Gyasi, MD, MPH
      • Contact: Samilia Obeng-Gyasi, MD, MPH; Phone Number: 812-361-6787; Email: Samilia.Obeng-Gyasi@osumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	Behavioral: 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.; Other: 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.; Other Names: GSV implementation
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).	Behavioral: 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.; Other: 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.; Other Names: GSV implementation
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).	Behavioral: 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.; Other: 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.; Other Names: GSV implementation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	From admission for the index surgical hospitalization until hospital discharge, assessed up to 30 days after surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	From admission for the index surgical hospitalization until hospital discharge, assessed up to 30 days after surgery.

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Samilia Obeng-Gyasi, MD, MPH, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: May 2, 2026
• First Submitted That Met QC Criteria: May 18, 2026
• First Posted (Actual): May 26, 2026

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: oncogeriatrics; geriatric surgery verification
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Nervous System Diseases; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Skin Diseases; Breast Diseases; Nervous System Neoplasms; Skin and Connective Tissue Diseases; Breast Neoplasms; Gastrointestinal Neoplasms; Head and Neck Neoplasms; Central Nervous System Neoplasms; Skin Neoplasms; Urogenital Neoplasms; Soft Tissue Neoplasms; Endocrine Gland Neoplasms
• Other Study ID Numbers: OSU-26031; NCI-2026-02917 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No