Elective SurgeryNCT07836959
Hybrid III Trial of Automated Referral to Comprehensive Geriatric Assessment for Frail Older Surgical Patients
A study testing Automated referral in people with Elective Surgery and Frail Elderly, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
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? Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Elective Surgery, Frail Elderly
- What is being tested?
- Automated referral
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Oct 2027
- Phase
- Interventional
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 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 80 or older
- Scheduled for an elective surgery with a planned overnight stay
- Scores indicate frailty
Who cannot join
- Scheduled for transplant or cardiothoracic surgery
- Undergoing emergency or urgent surgery
- POSH clinic evaluation within the past 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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?
Read the 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).
- Conditions
- Elective Surgery, Frail Elderly
- Being tested
- Automated referral, Usual Care Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated referralDevice
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.
Usual Care GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Automated referrals | Experimental | Participants will receive an automated referral to POSH when screened by the electronic frailty index (a clinical decision support device built into the EHR) Receives: Device: Automated referral |
| Usual care | Active comparator | Participants will receive usual care in which surgeons can choose to directly refer patients to POSH. Receives: Other: Usual Care Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who attend POSH
The number of eligible participants who attend POSH will be compared across arms.
Measured: 90 days
Number of surgeons who refer to POSH
The number of surgeons who refer patients to POSH will be compared to those in the same clinical departments for both arms.
Measured: 90 days
Secondary outcomes (4)
Anticholinergic Burden Score
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.
Measured: 90 days
Documentation of preoperative cognitive status
Number of eligible participants will be compared with number who have documented cognitive status according to a validated cognitive screening instrument.
Measured: 90 days
Physical therapy (PT) referrals
The number of eligible participants compared to participants who receive a PT referral.
Measured: 90 days
Advanced care planning (ACP) on file
Number of participants with ACP on file before surgery will be compared to number of eligible participants.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study startNov 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julia Berian, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836959
- Sponsor's protocol ID
- 2026-0832
- Other IDs
- UWMSN | SMPH | Surgery - Colon, Protocol Version 5/29/26
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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).