Evaluating Intervention Allocation Policies for Reducing Hospital Readmissions at Michigan Medicine
1 de julio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
5000
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Stephanie Shepard, PhD
- Número de teléfono: 734-647-1098
- Correo electrónico: sdokeefe@umich.edu
Ubicaciones de estudio
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- The University of Michigan
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Contacto:
- Stephanie Shepard, PhD
- Número de teléfono: 734-647-1098
- Correo electrónico: sdokeefe@umich.edu
-
Investigador principal:
- Jenna Wiens, PhD
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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.
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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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Experimental: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The number of 30-day all-cause unplanned readmission or death
Periodo de tiempo: 30 calendar days following the index discharge
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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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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The number of 90-day all-cause unplanned readmission or death
Periodo de tiempo: 90 calendar days following the index discharge
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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
Periodo de tiempo: 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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TOC telephone call bundle completion (care navigator call)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Silla de estudio: Jenna Wiens, PhD, University of Michigan
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de julio de 2026
Finalización primaria (Estimado)
1 de agosto de 2027
Finalización del estudio (Estimado)
1 de septiembre de 2027
Fechas de registro del estudio
Enviado por primera vez
1 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
1 de julio de 2026
Publicado por primera vez (Actual)
8 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
8 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
1 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HUM00282075
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Sí
producto fabricado y exportado desde los EE. UU.
No
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