SurgeryNCT06184724
Implementation Pilot of Preoperative CGA Before Major Surgery
A study testing Implementation Package for CGA and Routine Clinical Care in people with Surgery and Geriatric Assessment, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Surgery, Geriatric Assessment, Health Services Research
- What is being tested?
- Implementation Package for CGA and Routine Clinical Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2026to Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Wisconsin
Madison, Wisconsin, 53792
Randi Cartmill, 608-263-9316, cartmill@surgery.wisc.edu
About this study
Official title: Implementation Pilot of Preoperative CGA Referral Process for Older Patients Undergoing 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.
Read the detailed description
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).
- Being tested
- Implementation Package for CGA, Routine Clinical Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implementation Package for CGAOther
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 CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Post Implementation | Experimental | Participants will be recruited from surgery clinics in the post-implementation group. They will go through a streamlined referral process as part of an implementation package for CGA 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. Receives: Other: Implementation Package for CGA; Other: Routine Clinical Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 6 and 12 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 6 and 12 months
Intervention Appropriateness Measure (IAM) Score
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.
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start28 Jan 2026
- Primary completionApr 2028 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will be recruited from surgery clinics in a pre-post trial. The comparison group is a historic baseline for routine care.
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Julia R Berian, MD, MS, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184724
- Sponsor's protocol ID
- 2025-1692
- Other IDs
- 1K23AG081487, A539707
- Status last verified
- Feb 2026
- First submitted
- 14 Dec 2023
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified, by request only with IRB approval
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.
PubMed 29385235McDonald 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.
PubMed 29299599Partridge 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.
PubMed 28198997Chow 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.
PubMed 22917646
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation Pilot of Preoperative CGA Referral Process for Older Patients Undergoing Major Surgery
- ClinicalTrials.gov ID
- NCT06184724
- Acronym / sponsor ID
- 2025-1692
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 28 Jan 2026 (actual)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 28 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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).
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will be recruited from surgery clinics in a pre-post trial. The comparison group is a historic baseline for routine care.
| Arm | Type | Receives |
|---|---|---|
| Post Implementation | Experimental | Other: Implementation Package for CGA, Other: Routine Clinical CareParticipants will be recruited from surgery clinics in the post-implementation group. They will go through a streamlined referral process as part of an implementation package for CGA 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implementation Package for CGAThe 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. | Other | Post Implementation |
| Routine Clinical CareRoutine 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. | Other | Post Implementation |
Primary outcome
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.
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
4 secondary outcomes
Fidelity: Percent of completed CGA components per visit
Time frame: 30 days after visit
Feasibility of Intervention Measure (FIM) Score
Time frame: 6 and 12 months
Acceptability of Intervention Measure (AIM) Score
Time frame: 6 and 12 months
Intervention Appropriateness Measure (IAM) Score
Time frame: 6 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Background: PubMed 29385235Eamer 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.
- Background: PubMed 29299599McDonald 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.
- Background: PubMed 28198997Partridge 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.
- Background: PubMed 22917646Chow 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.
- Individual participant dataSharing planned: Yes. Deidentified, by request only with IRB approval
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Julia R Berian, MD, MS principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implementation Package for CGA and Routine Clinical Care in people with Surgery and Geriatric Assessment, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Julia R Berian, MD, MS (6082634224, berian@wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients referred divided by number of eligible patients (time frame: 6 and 12 months after implementation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06184724, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.