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

NCT07606287 | Not Yet Recruiting

• 2 other identifiers: OSU-26031NCI-2026-02917
• Study Type: interventional
• Target: 4,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Carcinoma; Malignant Digestive System Neoplasm; Malignant Female Reproductive System Neoplasm; Malignant Genitourinary System Neoplasm; Malignant Head and Neck Neoplasm; Malignant Nervous System Neoplasm; Malignant Solid Neoplasm; Malignant Thoracic Neoplasm; Skin Neoplasm; Soft Tissue Neoplasm; Central Nervous System Neoplasm; Endocrine Gland Neoplasms

Keywords

geriatric surgery verification; oncogeriatrics

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (12)

• Completion of Goals-of-Care Documentation

  From ACS GSV implementation through study completion, up to 3 years.

• Completion of G8 Geriatric Vulnerability Screening

  From ACS GSV implementation through study completion, up to 3 years.

• Implementation Cost

  From pre-implementation planning through study completion, up to 3 years.

• Referral or Documented Deferral for Positive G8 Screens

  From ACS GSV implementation through study completion, up to 3 years.

• ACS GSV Fidelity Index Score

  From ACS GSV implementation through study completion, up to 3 years.

Study Arms (3)

Group 1 (months 3-6 ACS GSV)

EXPERIMENTAL

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

Group 2 (months 8-11 ACS GSV)

EXPERIMENTAL

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

Group 3 (months 13-16 ACS GSV)

EXPERIMENTAL

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

Interventions

Serious Illness Conversation Program training BEHAVIORAL

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.

Group 1 (months 3-6 ACS GSV); Group 2 (months 8-11 ACS GSV); Group 3 (months 13-16 ACS GSV)

ACS Geriatric Surgery Verification Program Implementation OTHER

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

Group 1 (months 3-6 ACS GSV); Group 2 (months 8-11 ACS GSV); Group 3 (months 13-16 ACS GSV)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Breast Neoplasms; Gastrointestinal Neoplasms; Urogenital Neoplasms; Head and Neck Neoplasms; Skin Neoplasms; Soft Tissue Neoplasms; Central Nervous System Neoplasms; Endocrine Gland Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Nervous System Neoplasms; Nervous System Diseases; Endocrine System Diseases

Study Officials

• Samilia Obeng-Gyasi, MD, MPH

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State University Comprehensive Cancer Center

CONTACT

800-293-5066; OSUCCCClinicaltrials@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Stepped-wedge cluster randomized implementation study. Twelve surgical oncology services are randomized into three rollout groups. Groups cross over from usual care/pre-implementation to ACS GSV implementation at prespecified time periods until all services receive the intervention.

Study Record Dates

• First Submitted: May 2, 2026
• First Posted: May 26, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)