Preoperative Geriatric Assessment for Surgery

Overseen By Julia R Berian, MD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Non-English speakers, No caregiver, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the treatment Implementation Package for CGA, Routine Clinical Care?

Research shows that Comprehensive Geriatric Assessment (CGA) in the surgical setting can lead to better outcomes for older patients, especially those undergoing hip fracture surgery. Recent studies suggest that CGA models are beneficial for non-orthopedic surgeries as well, improving patient care and influencing current recommendations for older surgical patients. ^{1 2 3 4 5}

Is the Preoperative Geriatric Assessment for Surgery safe for humans?

Comprehensive Geriatric Assessment (CGA) is generally safe and is used to identify risks in older adults undergoing surgery. It helps predict and manage potential adverse events like delirium and infections, improving overall surgical outcomes. ^{4 5 6 7 8}

How is the Preoperative Geriatric Assessment for Surgery treatment different from other treatments?

This treatment is unique because it uses a Comprehensive Geriatric Assessment (CGA) to evaluate and optimize older surgical patients before surgery, focusing on medical, functional, social, and psychological aspects. Unlike traditional preoperative assessments, CGA aims to improve postoperative outcomes by addressing age-related issues and frailty, making it particularly beneficial for older adults. ^{1 2 4 5 9}

What is the purpose of this trial?

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.

Research Team

Julia R Berian, MD, MS

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

This trial is for older adults who are preparing for major surgery. It aims to see if a new program (implementation package) can help them get ready and improve their access to pre-surgery assessments.

Inclusion Criteria

I am 85 or older and a surgeon has referred me for a pre-surgery assessment.

I am over 60 with health issues like vision/hearing loss or poor nutrition, referred for a pre-surgery assessment.

Provider working in clinic where pCGA is performed

Exclusion Criteria

Patients category 1 or 2 who are not fluent in English

I am unable to give consent due to cognitive issues and do not have a caregiver.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Participants receive care using an implementation package for CGA use before surgery

6-12 months

Regular visits as per clinic schedule

Follow-up

Participants are monitored for adoption and reach of the CGA implementation package

6-12 months

Treatment Details

Interventions

• Implementation Package for CGA
• Routine Clinical Care

Trial Overview The study is testing an 'implementation package' designed to assist in the preparation of older adults for major surgery, comparing its effectiveness with routine clinical care against past data.

Participant Groups

Group I: Post Implementation Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Perioperative comprehensive geriatric assessment: what do we need to know? [2019]

2. United States pubmed.ncbi.nlm.nih.gov

A Description of Interventions Prompted by Preoperative Comprehensive Geriatric Assessment and Optimization in Older Elective Noncardiac Surgical Patients. [2022]

3. Singapore pubmed.ncbi.nlm.nih.gov

Perioperative Medicine for Older People. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Comprehensive Geriatric Assessment in the perioperative setting; where next? [2020]

5. England pubmed.ncbi.nlm.nih.gov

New horizons in the perioperative care of older adults. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

Comprehensive geriatric assessment to predict adverse events in elderly patients undergoing posterior lumbar fusion surgery. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Comprehensive geriatric assessment can predict postoperative morbidity and mortality in elderly patients undergoing elective surgery. [2014]

8. United States pubmed.ncbi.nlm.nih.gov

Geriatric Events Among Older Adults Undergoing Nonelective Surgery Are Associated with Poor Outcomes. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Comprehensive geriatric assessment (CGA) in perioperative care: a systematic review of a complex intervention. [2022]