Implementation Pilot of Preoperative CGA Before Major Surgery

Preparing Older Adults for Major Surgery: Pilot Trial to Test and Refine the Implementation Package for Preoperative Comprehensive Geriatric Assessments

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Surgery; Implementation Science; Geriatric Assessment; Health Services Research
• Intervention / Treatment: Other: Implementation Package for CGA; Other: Routine Clinical Care

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julia R Berian, MD, MS; Phone Number: 6082634224; Email: berian@wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Post Implementation; 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.

Other: Implementation Package for CGA; The Implementation Package will include a set of implementation strategies to improve the use of CGA before surgery. These strategies will be applied at the clinic-level to help increase the reach and adoption of the CGA.; Other: Routine Clinical Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Julia R Berian, MD, MS, University of Wisconsin, Madison

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: December 14, 2023
• First Submitted That Met QC Criteria: December 14, 2023
• First Posted (Actual): December 28, 2023

Study Record Updates

• Last Update Posted (Actual): December 28, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: CGA Pilot: IRB Pending; A539707 (Other Identifier: UW Madison); 1K23AG081487 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified, by request only with IRB approval
• IPD Sharing Time Frame: 1 year after study completion
• IPD Sharing Access Criteria: Deidentified, by request only with IRB approval
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No