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NCT Number: NCT06184724

Implementation Pilot of Preoperative CGA Before Major Surgery

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.

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Key information

Conditions

Surgery Geriatric Assessment Health Services Research Implementation Science

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location status: Recruiting

Location contact

Randi Cartmill

CONTACT

[email protected]

608-263-9316

About this study

The goal of this clinical trial is to test a new implementation package, which will be applied at the system-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. The implementation package will include streamlined referral processes and education for surgeons and staff about the new processes. 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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient aged 80 or older who is scheduled for an elective inpatient major surgery
  • Providers working in a clinic (aged 18 and older) where pCGA is performed or a related anesthesia pre-operative clinic
  • Surgeons (adults older than 18) with a patient aged 80 or older who is scheduled for an elective inpatient major surgery

Exclusion criteria

  • None

Treatment and study plan

Implementation Package for CGA

Other

The Implementation Package will include streamlined referral processes and education for surgeons and staff about the new processes. These strategies will be applied after surgery is ordered to help increase the reach and adoption of the CGA.

Routine Clinical Care

Other

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.

Primary outcomes

  1. Number of patients referred divided by number of eligible patients

    Time frame: 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.

  2. Number of surgeons placing referral orders divided by the number of surgeons

    Time frame: 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 outcomes

  1. Fidelity: Percent of completed CGA components per visit

    Time frame: 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.

  2. Feasibility of Intervention Measure (FIM) Score

    Time frame: 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.

  3. Acceptability of Intervention Measure (AIM) Score

    Time frame: 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.

  4. Intervention Appropriateness Measure (IAM) Score

    Time frame: 6 and 12 months

    Fit and relevance of the implementation package will be measured by the 4-item validated Intervention Appropriateness Measure. Mean scores between 1 and 5 will be reported, where higher scores increased appropriateness.

Study contacts

Contact information is provided by the study sponsor or research team.

Julia R Berian, MD, MS

CONTACT

[email protected]

6082634224

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Implementation Pilot of Preoperative CGA Referral Process for Older Patients Undergoing Major Surgery

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Dec 28, 2023
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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