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- Ensayo clínico NCT03245879
Antibiotic Stewardship in Small Hospitals (SCORE)
7 de agosto de 2017 actualizado por: Eddie Stenehjem, Intermountain Health Care, Inc.
Impact of Implementing Antibiotic Stewardship Programs in 15 Small Hospitals: A Cluster-Randomized Trial Intervention
Core elements of effective antibiotic stewardship programs (ASPs) have been identified and evidence-based guidelines have been developed for implementation.
The majority of the evidence used for these guidelines are from published studies on the effectiveness of ASPs in large academic or large community hospitals.
A significant portion of healthcare in the United States, however, takes place in small hospitals.
In 2015, 73% of US hospitals had < 200 beds (4,057 hospitals) and accounted for 29% of all US inpatient bed days.
Limited studies on the effectiveness of antibiotic stewardship implementation have been performed in hospitals with < 200 beds.
Antibiotic use rates and selection patterns in these small hospitals are similar to that of large hospitals and the majority of small hospitals lack formal ASP that meet the CDC's core elements.
The objective of this real-world implementation study was to assess the effectiveness of three ASP strategies of escalating intensity designed specifically for small hospitals within a vertically integrated healthcare delivery system.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
The investigators designed a clustered randomized controlled intervention to evaluate 3 antibiotic stewardship strategies designed for small hospitals.
Each hospital was randomized to one of three ASP interventions with increasing levels of intensity and intervention (Programs 1, 2, 3).
The investigators felt that clinical equipoise about the effect of ASPs did not exist and randomizing to a no-intervention group was unacceptable.
Antibiotic use was compared within each group before and after the intervention.
In keeping with other real-world implementation studies, secondary analyses were planned to include an interrupted time series design to evaluate the impact of each strategy.
Randomization of hospitals was stratified based on patient volume.
Hospital administration and clinical leadership were not blinded to which ASP program they were randomly assigned to, but there were no public announcements.
The intervention started March 2014 and ended June 2015.
Tipo de estudio
Intervencionista
Inscripción (Actual)
30000
Fase
- No aplica
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
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Intermountain Healthcare acute care hospital with < 200 licensed beds
- No formal antibiotic stewardship program in place
Exclusion Criteria:
-All Intermountain Healthcare specialty hospitals, regardless of bed size
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: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: Program 1
Implementation of a basic antibiotic stewardship program focusing on education, access to Infectious Diseases physicians, and availability of antibiotic use data.
|
Program 1 hospitals received a basic curriculum and tools for implementation of basic antibiotic stewardship interventions.
Hospitals required an indication for every antibiotic order.
A daily email was sent to a designated email account when a patient had been on an antibiotic for >48 hours.
Curriculum included implementing antibiotic time-outs, IV to PO conversion, indications, evaluating for bug-drug mismatches, and recommendations on when to call the Infectious Diseases (ID) hotline.
A daily antibiotic stewardship check list was created.
All materials were provided to all pharmacists and remained on-site.
Clinicians had access to an ID telephone hotline to answer clinical questions.
Pharmacy directors and hospital leadership were provided a monthly, hospital-specific, antibiotic use dashboard.
All pharmacy directors and staff received a monthly newsletter.
|
Comparador activo: Program 2
This arm increases antibiotic stewardship education and interventions.
Program 2 hospitals performed audit and feedback of pre-specified antibiotics and implemented locally controlled restrictions.
|
Program 2 hospitals received all the interventions of Program 1.
In addition, Program 2 hospitals received more intense antibiotic stewardship education.
Educational topics included audit and feedback, antibiotic de-escalation, the need for antibiotics targeting anaerobic bacteria, antibiotic allergy verification, and antibiotic restrictions.
Pharmacists in Program 2 hospitals reviewed patients on vancomycin, piperacillin/tazobactam, imipenem, meropenem, and cefepime.
For patients receiving one of these antibiotics, pharmacists reviewed the patients' microbiology data to identify opportunities for antibiotic de-escalation, IV to PO conversion, bug-drug mismatches, and/or indications for calling the ID hotline.
Program 2 hospitals also restricted daptomycin, linezolid, imipenem, meropenem, ceftaroline, tigecycline, and all mold active antifungals.
In Program 2 hospitals, the local pharmacy staff pre-authorized restricted antibiotics based on defined criteria.
|
Comparador activo: Program 3
This arm was the most intensive antibiotic stewardship intervention.
It included signficant audit and feedback, ID controlled restrictions, and ID review of designated culture/lab results.
|
Program 3 hospitals received all the interventions of Program 1 and Program 2. In addition, pharmacists in program 3 hospitals reviewed an expanded list of antibiotics for audit and feedback.
These antibiotics included: Vancomycin, piperacillin/tazobactam, imipenem, meropenem, cefepime, ertapenem, aminoglycosides, ceftriaxone, and fluoroquinolones.
Program 3 hospitals implemented the same antibiotic restrictions as Program 2 but ID pharmacists controlled pre-authorization of restricted antibiotics.
In addition, an ID physician reviewed pre-specified positive cultures (e.g.
all positive blood cultures, cultures with highly resistant Enterobacteraciae) and contacted providers with recommendations as needed.
ID physician review occurred Monday through Friday and alerts were batched daily at 6am.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Total antibiotic use
Periodo de tiempo: Total antibiotic use during the 15 months of Intervention (April 1, 2014 through June 30th 2015) was compared to the antibiotic use during the 12 month baseline period (Jan 1 through Dec 31 2013).
|
Evaluated change in total antibiotic use between the baseline and intervention periods while accounting for the cluster randomized design.
|
Total antibiotic use during the 15 months of Intervention (April 1, 2014 through June 30th 2015) was compared to the antibiotic use during the 12 month baseline period (Jan 1 through Dec 31 2013).
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Broad spectrum antibiotic use
Periodo de tiempo: Broad spectrum antibiotic use during the 15 months of Intervention (April 1, 2014 through June 30th 2015) was compared to the broad spectrum antibiotic use during the 12 month baseline period (Jan 1 through Dec 31 2013).
|
Evaluated change in broad spectrum antibiotic use between the baseline and intervention periods
|
Broad spectrum antibiotic use during the 15 months of Intervention (April 1, 2014 through June 30th 2015) was compared to the broad spectrum antibiotic use during the 12 month baseline period (Jan 1 through Dec 31 2013).
|
Restricted antibiotic use
Periodo de tiempo: Restricted antibiotic use during the 15 months of Intervention (April 1, 2014 through June 30th 2015) was compared to the restricted antibiotic use during the 12 month baseline period (Jan 1 through Dec 31 2013).
|
Evaluated change in restricted antibiotic use between the baseline and intervention periods
|
Restricted antibiotic use during the 15 months of Intervention (April 1, 2014 through June 30th 2015) was compared to the restricted antibiotic use during the 12 month baseline period (Jan 1 through Dec 31 2013).
|
30-day readmission
Periodo de tiempo: 30-day readmission rate during the 15 months of Intervention (April 1, 2014 through June 30th 2015) was compared to the 30-day readmission rate during the 12 month baseline period (Jan 1 through Dec 31 2013).
|
Evaluated change in 30 day readmission rates between the baseline and intervention periods
|
30-day readmission rate during the 15 months of Intervention (April 1, 2014 through June 30th 2015) was compared to the 30-day readmission rate during the 12 month baseline period (Jan 1 through Dec 31 2013).
|
30-day mortality
Periodo de tiempo: 30-day mortality rate during the 15 months of Intervention (April 1, 2014 through June 30th 2015) was compared to the 30-day mortality rate during the 12 month baseline period (Jan 1 through Dec 31 2013).
|
Evaluated change in 30 day mortality rates between the baseline and intervention periods
|
30-day mortality rate during the 15 months of Intervention (April 1, 2014 through June 30th 2015) was compared to the 30-day mortality rate during the 12 month baseline period (Jan 1 through Dec 31 2013).
|
Hospital length of stay
Periodo de tiempo: Average hospital length of stay during the 15 months of Intervention (April 1, 2014 through June 30th 2015) was compared to the average hospital length of stay during the 12 month baseline period (Jan 1 through Dec 31 2013).
|
Evaluated change in hospital length of stay between the baseline and intervention periods
|
Average hospital length of stay during the 15 months of Intervention (April 1, 2014 through June 30th 2015) was compared to the average hospital length of stay during the 12 month baseline period (Jan 1 through Dec 31 2013).
|
Clostridium difficile
Periodo de tiempo: C. difficile rate during the 15 months of Intervention (April 1, 2014 through June 30th 2015) was compared to the C. difficile rate during the 12 month baseline period (Jan 1 through Dec 31 2013).
|
Evaluated change in Clostridium difficile incidence between the baseline and intervention periods
|
C. difficile rate during the 15 months of Intervention (April 1, 2014 through June 30th 2015) was compared to the C. difficile rate during the 12 month baseline period (Jan 1 through Dec 31 2013).
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Stenehjem E, Hersh AL, Sheng X, Jones P, Buckel WR, Lloyd JF, Howe S, Evans RS, Greene T, Pavia AT. Antibiotic Use in Small Community Hospitals. Clin Infect Dis. 2016 Nov 15;63(10):1273-1280. doi: 10.1093/cid/ciw588. Epub 2016 Sep 30.
- Stenehjem E, Hersh AL, Buckel WR, Jones P, Sheng X, Evans RS, Burke JP, Lopansri BK, Srivastava R, Greene T, Pavia AT. Impact of Implementing Antibiotic Stewardship Programs in 15 Small Hospitals: A Cluster-Randomized Intervention. Clin Infect Dis. 2018 Aug 1;67(4):525-532. doi: 10.1093/cid/ciy155.
Enlaces Útiles
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 (Actual)
1 de julio de 2013
Finalización primaria (Actual)
1 de junio de 2015
Finalización del estudio (Actual)
1 de junio de 2015
Fechas de registro del estudio
Enviado por primera vez
3 de agosto de 2017
Primero enviado que cumplió con los criterios de control de calidad
7 de agosto de 2017
Publicado por primera vez (Actual)
10 de agosto de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de agosto de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
7 de agosto de 2017
Última verificación
1 de agosto de 2017
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 1024823
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
No
Descripción del plan IPD
N/A.
No individual patient level data available.
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.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Program 1
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Massachusetts General HospitalActivo, no reclutandoCáncer de pulmón de células no pequeñas | Mesotelioma | Cáncer de pulmón de células pequeñas | Terapia de conducta cognitivaEstados Unidos
-
IWK Health CentreCanadian Institutes of Health Research (CIHR)TerminadoTrastorno de ansiedadCanadá
-
The University of Hong KongSydney Children's Hospitals Network; SAHKReclutamientoDesorden del espectro autistaHong Kong
-
Akdeniz UniversityAún no reclutandoAccidente cerebrovascular isquémico | EntrenamientoPavo
-
Children's HealthActivo, no reclutandoDesorden del espectro autistaEstados Unidos
-
Chinese University of Hong KongReclutamiento
-
Children's Hospital Los AngelesNational Center for Advancing Translational Sciences (NCATS); AltaMed Health...SuspendidoCrianza de los hijos | Problema de comportamiento infantil | Crianza de los hijosEstados Unidos
-
Orasis Pharmaceuticals Ltd.Terminado
-
University of ThessalyTerminado
-
University of Sao Paulo General HospitalTerminadoSíndrome de vejiga hiperactivaBrasil