Hybrid III Trial of Automated Referral to Comprehensive Geriatric Assessment for Frail Older Surgical Patients
Leveraging the Learning Health System to Enhance Age-Friendly Surgical Care: A Hybrid Type III Randomized Trial to Optimize Preoperative Readiness
The goal of this observational study is to learn about automated referrals to Perioperative Optimization of Senior Health (POSH). The main question it aims to answer is:
- Do automated referrals to POSH increase the number of people who attend the clinic?
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Preoperative comprehensive geriatric assessment (pCGA) is an existing clinical intervention (herein referred to by the clinic that delivers the intervention, as Perioperative Optimization for Senior Health, POSH) to address frailty among older adults before elective surgery; however, this highly effective intervention is resource-intensive and variably delivered to a limited number of eligible patients. The researchers will conduct a 12-month trial embedded in the electronic health record that will test the effect of automated referrals to the POSH clinic on implementation outcomes (reach and adoption) of POSH and secondarily on the delivery of age-friendly process measures for surgical care (effectiveness). The primary hypothesis is that randomizing frail older adults (age 80 years and older) who are planning major surgery to an automated referral will increase the reach of POSH, and the adoption among surgeons while simultaneously improving processes associated with age-friendly care (decreasing potentially inappropriate medication use as measured by anticholinergic burden (ACB) score, increasing documentation of baseline cognitive status, increasing use of physical therapy (PT) referrals, and improving the percentage of patients with advanced care planning paperwork on file before surgery).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Randi Cartmill
- Phone Number: 608-263-9316
- Email: cartmill@wisc.edu
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53792
- University of Wisconsin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 80 or older
- Scheduled for an elective surgery with a planned overnight stay
- Scores indicate frailty
Exclusion Criteria:
- Scheduled for transplant or cardiothoracic surgery
- Undergoing emergency or urgent surgery
- POSH clinic evaluation within the past 6 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Automated referrals
Participants will receive an automated referral to POSH when screened by the electronic frailty index (a clinical decision support device built into the EHR) |
Participants who screen for frailty (using the frailty score calculator device embedded in the EHR) will receive an automated referral to POSH clinic through their electronic health record. |
|
Active Comparator: Usual care
Participants will receive usual care in which surgeons can choose to directly refer patients to POSH. |
Surgeons will be notified of frailty score (as calculated using the frailty score calculator device embedded in the EHR). Surgeons can choose to refer patients directly to POSH. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants who attend POSH
Time Frame: 90 days
|
The number of eligible participants who attend POSH will be compared across arms. |
90 days
|
|
Number of surgeons who refer to POSH
Time Frame: 90 days
|
The number of surgeons who refer patients to POSH will be compared to those in the same clinical departments for both arms. |
90 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anticholinergic Burden Score
Time Frame: 90 days
|
Anticholinergic Burden (ACB) score measures the degree to which the patient's prescribed medications block the neurotransmitter acetylcholine. Median scores will be compared for the intervention and control groups. Higher scores in older adults correlate with increased risks of confusion, functional impairment, falls, and mortality. |
90 days
|
|
Documentation of preoperative cognitive status
Time Frame: 90 days
|
Number of eligible participants will be compared with number who have documented cognitive status according to a validated cognitive screening instrument. |
90 days
|
|
Physical therapy (PT) referrals
Time Frame: 90 days
|
The number of eligible participants compared to participants who receive a PT referral. |
90 days
|
|
Advanced care planning (ACP) on file
Time Frame: 90 days
|
Number of participants with ACP on file before surgery will be compared to number of eligible participants. |
90 days
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Julia Berian, University of Wisconsin, Madison
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2026-0832
- UWMSN | SMPH | Surgery - Colon (Other Identifier: UW Madison)
- Protocol Version 5/29/26 (Other Identifier: UW Madison)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
The researchers will share a deidentified participant-level dataset containing the information collected in this study and outcome measures, except for protected health information (PHI).
IPD Sharing Time Frame
Scientific data will be available once the primary results are published. Data will be available indefinitely.
IPD Sharing Access Criteria
Data are available on request from the principal investigator with a DUA. Supporting materials will be available on a public website that will be created for this purpose.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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