Breast Carcinoma, Central Nervous System Neoplasm, Endocrine Gland Neoplasms, 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
Conditions
Keywords
geriatric surgery verification, oncogeriatrics
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.
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).
Interventions
BEHAVIORALSerious 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.
OTHERACS 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.
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adoption of the Core ACS GSV Care Bundle | 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. |
| Hospital Length of Stay | From admission for the index surgical hospitalization until hospital discharge, assessed up to 30 days after surgery. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Completion of Goals-of-Care Documentation | 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. |
| Completion of G8 Geriatric Vulnerability Screening | From ACS GSV implementation through study completion, up to 3 years. | Percentage of eligible patients who complete G8 geriatric vulnerability screening as part of the ACS GSV implementation workflow. |
| Implementation Cost | 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. |
| Referral or Documented Deferral for Positive G8 Screens | 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. |
| ACS GSV Fidelity Index Score | 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. |
| Acceptability of ACS GSV Implementation | Assessed during each stepped-wedge rollout period and after implementation, up to 3 years. | 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. |
| Appropriateness of ACS GSV Implementation | 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. |
| Feasibility of ACS GSV Implementation | 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. |
| Thirty-Day Unplanned Readmission | Within 30 days after discharge from the index surgical hospitalization. | 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. |
| Postoperative Complications | Within 30 days after surgery. | 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. |
| Mortality | Within 30 days after surgery. | 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. |
| Discharge Disposition | From admission for the index surgical hospitalization until hospital discharge, assessed up to 30 days after surgery. | 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. |
Countries
United States
Contacts
CONTACTThe Ohio State University Comprehensive Cancer Center
PRINCIPAL_INVESTIGATORSamilia Obeng-Gyasi, MD, MPH
Ohio State University Comprehensive Cancer Center
Outcome results
None listed