Surgery Clinical Trial
Official title:
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.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | April 2029 |
Est. primary completion date | April 2028 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 60 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Wisconsin | Madison | Wisconsin |
Lead Sponsor | Collaborator |
---|---|
University of Wisconsin, Madison | National Institute on Aging (NIA) |
United States,
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. — View 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. — View 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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