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?
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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).
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Randi Cartmill
- Numéro de téléphone: 608-263-9316
- E-mail: cartmill@wisc.edu
Lieux d'étude
-
-
Wisconsin
-
Madison, Wisconsin, États-Unis, 53792
- University of Wisconsin
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
|
Comparateur actif: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Number of participants who attend POSH
Délai: 90 days
|
The number of eligible participants who attend POSH will be compared across arms. |
90 days
|
|
Number of surgeons who refer to POSH
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Anticholinergic Burden Score
Délai: 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
Délai: 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
Délai: 90 days
|
The number of eligible participants compared to participants who receive a PT referral. |
90 days
|
|
Advanced care planning (ACP) on file
Délai: 90 days
|
Number of participants with ACP on file before surgery will be compared to number of eligible participants. |
90 days
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Julia Berian, University of Wisconsin, Madison
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 2026-0832
- UWMSN | SMPH | Surgery - Colon (Autre identifiant: UW Madison)
- Protocol Version 5/29/26 (Autre identifiant: UW Madison)
Plan pour les données individuelles des participants (IPD)
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Description du régime 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).
Délai de partage IPD
Scientific data will be available once the primary results are published. Data will be available indefinitely.
Critères d'accès au partage 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.
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- ANALYTIC_CODE
Informations sur les médicaments et les dispositifs, documents d'étude
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produit fabriqué et exporté des États-Unis.
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