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?
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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).
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Randi Cartmill
- Telefonnummer: 608-263-9316
- E-post: cartmill@wisc.edu
Studiesteder
-
-
Wisconsin
-
Madison, Wisconsin, Forente stater, 53792
- University of Wisconsin
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
|
Aktiv komparator: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of participants who attend POSH
Tidsramme: 90 days
|
The number of eligible participants who attend POSH will be compared across arms. |
90 days
|
|
Number of surgeons who refer to POSH
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Anticholinergic Burden Score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 90 days
|
The number of eligible participants compared to participants who receive a PT referral. |
90 days
|
|
Advanced care planning (ACP) on file
Tidsramme: 90 days
|
Number of participants with ACP on file before surgery will be compared to number of eligible participants. |
90 days
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Julia Berian, University of Wisconsin, Madison
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 2026-0832
- UWMSN | SMPH | Surgery - Colon (Annen identifikator: UW Madison)
- Protocol Version 5/29/26 (Annen identifikator: UW Madison)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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-delingstidsramme
Scientific data will be available once the primary results are published. Data will be available indefinitely.
Tilgangskriterier for IPD-deling
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-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ANALYTIC_CODE
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