Clinical trial NCT06184724: Implementation Pilot of Preoperative CGA Before Major Surgery
Official title: Preparing Older Adults for Major Surgery: Pilot Trial to Test and Refine the Implementation Package for Preoperative Comprehensive Geriatric Assessments
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Surgery
Geriatric Assessment
Health Services Research
Implementation Science
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-12-28
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Participants will be recruited from two surgery clinics in a pre-post trial. The comparison group is a historic baseline for routine care.
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Number of patients referred divided by number of eligible patients
timeFrame: 6 and 12 months after implementation
measure: Number of surgeons placing referral orders divided by the number of surgeons
timeFrame: 6 and 12 months
Secondary outcomes:
measure: Fidelity: Percent of completed CGA components per visit
timeFrame: 30 days after visit
measure: Feasibility of Intervention Measure (FIM) Score
timeFrame: 6 and 12 months
measure: Acceptability of Intervention Measure (AIM) Score
timeFrame: 6 and 12 months
measure: Intervention Appropriateness Measure (IAM) Score
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Julia R Berian, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.