Implementation Pilot of Preoperative CGA Before Major Surgery

University of Wisconsin (UW)

Status: Begins enrollment in 1 month

Conditions: Geriatric Assessment; Implementation Science; Surgery; Health Services Research

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06184724

2025-1692

A539707 (Other Identifier)

1K23AG081487 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

The goal of this clinical trial is to test a new implementation package, which will be applied at the clinic-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. Participants will be recruited from two surgery clinics. The implementation package will include a set of strategies that can be applied at the system level to improve reach and adoption of the CGA. 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).

Enrollment: 40 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patient aged 85 years or older who is referred for pCGA by a surgeon prior to an elective major surgery
2. Patient aged 60 years and over with comorbid conditions (vision/hearing loss; concern for cognitive impairment, functional impairment, and/or poor nutrition; and/or two or more medical comorbidities) who is referred for pCGA by a surgeon prior to an elective major surgery
3. Provider working in clinic where pCGA is performed
4. Surgeon from select participating clinics

Exclusion criteria

• Patients category 1 or 2 who are

  1. not fluent in English or
  2. do not have a caregiver present and are incapable of giving consent because of limited cognitive capacity.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Post Implementation

Experimental group

Description:

Participants will be recruited from two surgery clinics in the Post-Implementation group. They will receive care using an implementation package for CGA use 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.

Treatment:

Other: Routine Clinical Care

Other: Implementation Package for CGA