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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

ConditionsBreast CarcinomaMalignant Digestive System NeoplasmMalignant Female Reproductive System NeoplasmMalignant Genitourinary System NeoplasmMalignant Head and Neck NeoplasmMalignant Nervous System NeoplasmMalignant Solid NeoplasmMalignant Thoracic NeoplasmSkin NeoplasmSoft Tissue NeoplasmCentral Nervous System NeoplasmEndocrine Gland Neoplasms
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOhio State University Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • ACS Geriatric Surgery Verification Program Implementation

    Other intervention

    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.

Treatment groups

4,000 Participants
are divided into 3 treatment groups
Group A: Group 1 (months 3-6 ACS GSV)Experimental treatment 2 interventions
Group B: Group 2 (months 8-11 ACS GSV)Experimental treatment 2 interventions
Group C: Group 3 (months 13-16 ACS GSV)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.
2

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.

Secondary outcomes

1

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.
2

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.
3

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.
4

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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ohio State University Comprehensive Cancer Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: