Evaluating Intervention Allocation Policies for Reducing Hospital Readmissions at Michigan Medicine
1 juillet 2026 mis à jour par: Jenna Wiens, University of Michigan
The researchers are investigating if using a risk-based prediction score or benefit-based prediction score to allocate transition of care (TOC) interventions is more effective in reducing the rate of unplanned hospital readmissions or death within 30 days of hospital discharge.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
The intervention affects only how the TOC bundle is assigned and does not alter how the telephone calls are delivered. For example, both care navigators and pharmacists receive the same patient information and follow the same call procedures before and after the intervention.
Individuals with predicted benefits greater than the 40% quantile are assigned the phone call bundle while others were not assigned the bundle. During the trial the 40% quantile will be dynamically determined using discharge data from the previous week.
Type d'étude
Interventionnel
Inscription (Estimé)
5000
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Stephanie Shepard, PhD
- Numéro de téléphone: 734-647-1098
- E-mail: sdokeefe@umich.edu
Lieux d'étude
-
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Michigan
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Ann Arbor, Michigan, États-Unis, 48109
- The University of Michigan
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Contact:
- Stephanie Shepard, PhD
- Numéro de téléphone: 734-647-1098
- E-mail: sdokeefe@umich.edu
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Chercheur principal:
- Jenna Wiens, PhD
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-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
Inclusion Criteria:
- Patient meets the primary care established rule at Michigan Medicine (MM), AND
- Patient's primary care physician (PCP) Department is one of our General Medicine or Family Medicine or Medical-Pediatrics departments, AND
- Inpatient class is Inpatient or Observation or Obs Greater than 48 hours or Outpatient in a Bed or Extended Recovery or Hospital Care at Home Inpatient or Hospital Care at Home Observation, AND
- Discharged from General Medicine or Family Medicine or Medicine Observation services, AND
- Disposition of home or home with home care
Exclusion Criteria:
- Physician Organization of Michigan Accountable Care Organization (POM ACO)
- Sepsis patients (had a diagnosis of sepsis during admission, active or resolved on the hospital problem list)
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur actif: Control Arm/Standard of care
The Control Arm, in which patients with a LACE Index score of 9 or greater on the day of hospital discharge will receive TOC interventions.
This is the currently implemented allocation policy at Michigan Medicine.
In this setting, approximately 60% of patients receive the TOC intervention.
Thus, we will use a threshold of the 40th percentile for assigning the TOC telephone call bundle.
Note that to maintain the 60% intervention rate throughout the study, the score threshold (LACE 9 or greater) will be monitored and dynamically adjusted.
The LACE Index has four components: Length of Stay (L), Acuity of the Admission (A), Comorbidities (C), and Emergency Department Visits (E), and estimates the risk of a patient having an unplanned hospital readmission after being discharged from their current encounter.
|
The LACE Index has four components: Length of Stay (L), Acuity of the Admission (A), Comorbidities (C), and Emergency Department Visits (E), and estimates the risk of a patient having an unplanned hospital readmission after being discharged from their current encounter.
|
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Expérimental: Experimental Arm
The Experimental Arm, in which Causal-Hospital reAdmission Risk Prediction Model (C-HARP) scores will be used to allocate TOC interventions.
C-HARP is a machine learning model that leverages routinely collected and stored patient data in the electronic health record (EHR) to estimate how much a patient will benefit from receiving MM's TOC telephone call bundle.
The assignment threshold will be defined as the 40th percentile of C-HARP scores within the most recent 100 days of the target cohort, so that approximately 60% of patients are assigned the telephone call bundle.
Based on current retrospective data, this threshold corresponds to a C-HARP score of 18.
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The Experimental Arm will allocate TOC interventions based on scores generated by the Causal-Hospital reAdmission Risk Prediction Model (C-HARP), C-HARP is a linear model that leverages routinely collected and stored patient data in the electronic health record (EHR) to estimate how much a patient will benefit from receiving Michigan Medicine's (MM's) TOC telephone call bundle.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The number of 30-day all-cause unplanned readmission or death
Délai: 30 calendar days following the index discharge
|
An unplanned readmission is defined as any not canceled inpatient, outpatient, or observation hospital admission with an admission type not recorded as "scheduled."
Deaths are determined using the Michigan Death Index and matched to patient records using Social Security numbers.
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30 calendar days following the index discharge
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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The number of 90-day all-cause unplanned readmission or death
Délai: 90 calendar days following the index discharge
|
An unplanned readmission is defined as any not canceled inpatient, outpatient, or observation hospital admission with an admission type not recorded as "scheduled."
Deaths are determined using the Michigan Death Index and matched to patient records using Social Security numbers.
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90 calendar days following the index discharge
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Time to first 90-day all-cause unplanned readmission or death
Délai: 90 calendar days following the index discharge
|
An unplanned readmission is defined as any not canceled inpatient, outpatient, or observation hospital admission with an admission type not recorded as "scheduled."
Deaths are determined using the Michigan Death Index and matched to patient records using Social Security numbers.
|
90 calendar days following the index discharge
|
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TOC telephone call bundle completion (care navigator call)
Délai: 5 calendar days after discharge.
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A care navigator call is considered complete if a completed call record is observed within 5 calendar days after discharge. Calls are considered incomplete if the corresponding completed call record occurs after an all-cause unplanned readmission. |
5 calendar days after discharge.
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TOC telephone call bundle completion (clinical pharmacist call)
Délai: 14 calendar days after discharge
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A clinical pharmacist call is considered complete if a completed call record is observed within 14 calendar days after discharge. Calls are considered incomplete if the corresponding completed call record occurs after an all-cause unplanned readmission. |
14 calendar days after discharge
|
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TOC telephone call bundle completion (both calls)
Délai: 14 calendar days after discharge
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Completed the care navigator call and completed the clinical pharmacist call. Calls are considered incomplete if the corresponding completed call record occurs after an all-cause unplanned readmission. |
14 calendar days after discharge
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chaise d'étude: Jenna Wiens, PhD, University of Michigan
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 juillet 2026
Achèvement primaire (Estimé)
1 août 2027
Achèvement de l'étude (Estimé)
1 septembre 2027
Dates d'inscription aux études
Première soumission
1 juillet 2026
Première soumission répondant aux critères de contrôle qualité
1 juillet 2026
Première publication (Réel)
8 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
8 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
1 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HUM00282075
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Oui
produit fabriqué et exporté des États-Unis.
Non
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