Implementation Pilot of Preoperative CGA Before Major Surgery

Not Applicable

Not yet recruiting

• Conditions: Implementation Science; Surgery; Geriatric Assessment; Health Services Research
• Interventions: Other: Implementation Package for CGA; Other: Routine Clinical Care

• Registration Number: NCT06184724
• Lead Sponsor: University of Wisconsin, Madison

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 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).

Study Timeline

• Study First Submitted: 2023-12-14
• Study First Submitted QC: 2023-12-14
• Study First Posted: 2023-12-28
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-12
• Last Update Posted: 2024-11-13
• Study Start: 2026-04
• Primary Completion: 2028-04
• Study Completion: 2029-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Post Implementation	Routine Clinical Care	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.
Post Implementation	Implementation Package for CGA	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.

Primary Outcome Measures

Name	Time	Method
Number of patients referred divided by number of eligible patients	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	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 Outcome Measures

Name	Time	Method
Acceptability of Intervention Measure (AIM) Score	6 and 12 months	Satisfaction with implementation package will be measured by the 4-item validated Acceptability of Intervention Measure. Mean scores between 1 and 5 will be reported, where higher scores increased acceptability.
Fidelity: Percent of completed CGA components per visit	30 days after visit	Fidelity of the intervention or degree to which the CGA is delivered as intended will be measured by the percent of completed CGA components per visit.
Feasibility of Intervention Measure (FIM) Score	6 and 12 months	Perceived ease of use of implementation package will be measured by the 4-item validated Feasibility of Intervention Measure. Mean scores between 1 and 5 will be reported, where higher scores increased feasibility.
Intervention Appropriateness Measure (IAM) Score	6 and 12 months	Fit and relevance of the implementation package will be measure by the 4-item validated Intervention Appropriateness Measure. Mean scores between 1 and 5 will be reported, where higher scores increased appropriateness.

Trial Locations

Locations (1)

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States