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Clinical Trials/NCT06184724
NCT06184724
Recruiting
N/A

Implementation Pilot of Preoperative CGA Referral Process for Older Patients Undergoing Major Surgery

University of Wisconsin, Madison1 site in 1 country1,530 target enrollmentJanuary 28, 2026

Overview

Phase
N/A
Intervention
Implementation Package for CGA
Conditions
Surgery
Sponsor
University of Wisconsin, Madison
Enrollment
1530
Locations
1
Primary Endpoint
Number of patients referred divided by number of eligible patients
Status
Recruiting
Last Updated
2 months ago

Overview

Brief Summary

The goal of this clinical trial is to test whether a new implementation package can help older adults prepare for major surgery. The main question it aims to answer is: Can the implementation package help give more people access to this resource? Participants will be in two groups: older adults who are planning a major surgery and their medical and surgical healthcare providers. The results will be compared to a historic baseline.

Detailed Description

The goal of this clinical trial is to test a new implementation package, which will be applied at the system-level, to see whether it can help more older adults prepare for major surgery. The study will evaluate whether the implementation package (1) improves the number of older adults who get a full "comprehensive geriatric assessment" (CGA) before surgery compared to the number of older adults who would be eligible for it, also called "reach"; and (2) increases the use of CGA by the medical and surgical providers who are taking care of these older adults, also called "adoption". Participants will be in two groups: older adults who are planning a major surgery and their medical and surgical healthcare providers. The implementation package will include streamlined referral processes and education for surgeons and staff about the new processes. The results will be compared to a historic baseline Findings from this study will help the lead researcher design a larger trial that will test both the implementation (or how something is done) at the same time as it tests the effectiveness (how well it works).

Registry
clinicaltrials.gov
Start Date
January 28, 2026
End Date
April 1, 2029
Last Updated
2 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patient aged 80 or older who is scheduled for an elective inpatient major surgery
  • Providers working in a clinic (aged 18 and older) where pCGA is performed or a related anesthesia pre-operative clinic
  • Surgeons (adults older than 18) with a patient aged 80 or older who is scheduled for an elective inpatient major surgery

Exclusion Criteria

  • Not provided

Arms & Interventions

Post Implementation

Participants will be recruited from surgery clinics in the post-implementation group. They will go through a streamlined referral process as part of an implementation package for CGA before surgery. The control group will be historic baseline data. That is, older surgical patients who were treated Pre-Implementation. These patients would have received standard, routine clinical care without the use of the implementation package.

Intervention: Implementation Package for CGA

Post Implementation

Participants will be recruited from surgery clinics in the post-implementation group. They will go through a streamlined referral process as part of an implementation package for CGA before surgery. The control group will be historic baseline data. That is, older surgical patients who were treated Pre-Implementation. These patients would have received standard, routine clinical care without the use of the implementation package.

Intervention: Routine Clinical Care

Outcomes

Primary Outcomes

Number of patients referred divided by number of eligible patients

Time Frame: 6 and 12 months after implementation

Reach to potentially eligible patients will be measured by the number of patients referred divided by number of eligible patients.

Number of surgeons placing referral orders divided by the number of surgeons

Time Frame: 6 and 12 months

Adoption by Referring Surgeons will be measured by the number of surgeons placing referral orders divided by the number of surgeons

Secondary Outcomes

  • Acceptability of Intervention Measure (AIM) Score(6 and 12 months)
  • Fidelity: Percent of completed CGA components per visit(30 days after visit)
  • Feasibility of Intervention Measure (FIM) Score(6 and 12 months)
  • Intervention Appropriateness Measure (IAM) Score(6 and 12 months)

Study Sites (1)

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