Implementation Pilot of Preoperative CGA Before Major Surgery

NCT06184724 | Recruiting

• 3 other identifiers: 2025-16921K23AG081487A539707
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery; Geriatric Assessment; Health Services Research; Implementation Science

Outcome Measures

Primary Outcomes (2)

• Number of patients referred divided by number of eligible patients

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

  6 and 12 months after implementation

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

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

  6 and 12 months

Secondary Outcomes (4)

• Fidelity: Percent of completed CGA components per visit

  30 days after visit

• Feasibility of Intervention Measure (FIM) Score

  6 and 12 months

• Acceptability of Intervention Measure (AIM) Score

  6 and 12 months

• Intervention Appropriateness Measure (IAM) Score

  6 and 12 months

Study Arms (1)

Post Implementation

EXPERIMENTAL

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.

Other: Implementation Package for CGA; Other: Routine Clinical Care

Interventions

Implementation Package for CGA OTHER

The Implementation Package will include streamlined referral processes and education for surgeons and staff about the new processes. These strategies will be applied after surgery is ordered to help increase the reach and adoption of the CGA.

Post Implementation

Routine Clinical Care OTHER

Routine care may or may not include the use of the CGA before surgery. The use of CGA in clinical care is up to the medical and surgical healthcare providers.

Post Implementation

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

RECRUITING

Related Publications (4)

• Eamer G, Taheri A, Chen SS, Daviduck Q, Chambers T, Shi X, Khadaroo RG. Comprehensive geriatric assessment for older people admitted to a surgical service. Cochrane Database Syst Rev. 2018 Jan 31;1(1):CD012485. doi: 10.1002/14651858.CD012485.pub2.

  PMID: 29385235 BACKGROUND

• McDonald SR, Heflin MT, Whitson HE, Dalton TO, Lidsky ME, Liu P, Poer CM, Sloane R, Thacker JK, White HK, Yanamadala M, Lagoo-Deenadayalan SA. Association of Integrated Care Coordination With Postsurgical Outcomes in High-Risk Older Adults: The Perioperative Optimization of Senior Health (POSH) Initiative. JAMA Surg. 2018 May 1;153(5):454-462. doi: 10.1001/jamasurg.2017.5513.

  PMID: 29299599 BACKGROUND

• Partridge JS, Harari D, Martin FC, Peacock JL, Bell R, Mohammed A, Dhesi JK. Randomized clinical trial of comprehensive geriatric assessment and optimization in vascular surgery. Br J Surg. 2017 May;104(6):679-687. doi: 10.1002/bjs.10459. Epub 2017 Feb 15.

  PMID: 28198997 BACKGROUND

• Chow WB, Rosenthal RA, Merkow RP, Ko CY, Esnaola NF; American College of Surgeons National Surgical Quality Improvement Program; American Geriatrics Society. Optimal preoperative assessment of the geriatric surgical patient: a best practices guideline from the American College of Surgeons National Surgical Quality Improvement Program and the American Geriatrics Society. J Am Coll Surg. 2012 Oct;215(4):453-66. doi: 10.1016/j.jamcollsurg.2012.06.017. Epub 2012 Aug 21. No abstract available.

  PMID: 22917646 BACKGROUND

Study Officials

• Julia R Berian, MD, MS

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia R Berian, MD, MS

CONTACT

6082634224; berian@wisc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be recruited from surgery clinics in a pre-post trial. The comparison group is a historic baseline for routine care.

Study Record Dates

• First Submitted: December 14, 2023
• First Posted: December 28, 2023
• Study Start: January 28, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2029
• Last Updated: March 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 1 year after study completion
• Access Criteria: Deidentified, by request only with IRB approval

Locations

US (1)