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?
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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).
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Randi Cartmill
- Numero di telefono: 608-263-9316
- Email: cartmill@wisc.edu
Luoghi di studio
-
-
Wisconsin
-
Madison, Wisconsin, Stati Uniti, 53792
- University of Wisconsin
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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. |
|
Comparatore attivo: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of participants who attend POSH
Lasso di tempo: 90 days
|
The number of eligible participants who attend POSH will be compared across arms. |
90 days
|
|
Number of surgeons who refer to POSH
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Anticholinergic Burden Score
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 90 days
|
The number of eligible participants compared to participants who receive a PT referral. |
90 days
|
|
Advanced care planning (ACP) on file
Lasso di tempo: 90 days
|
Number of participants with ACP on file before surgery will be compared to number of eligible participants. |
90 days
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Julia Berian, University of Wisconsin, Madison
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- 2026-0832
- UWMSN | SMPH | Surgery - Colon (Altro identificatore: UW Madison)
- Protocol Version 5/29/26 (Altro identificatore: UW Madison)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
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).
Periodo di condivisione IPD
Scientific data will be available once the primary results are published. Data will be available indefinitely.
Criteri di accesso alla condivisione IPD
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.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- CODICE_ANALITICO
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .