Prueba de implementación-efectividad inteligente 2 (SMART SIMPLE)
Estrategias de mantenimiento único y terapia de relevantes para la implementación y efectividad (inteligente y simple) ensayo
While single maintenance and reliever therapy (SMART) has been the preferred management strategy for Step 3 and 4 (moderate/severe) asthma management since the 2020 NIH asthma guideline updates, adoption of SMART has not been rigorously assessed. This study will test population health management (PHM; asthma community health worker, asthma nurse care manager) implementation strategies building on electronic medical record clinical decision support and education implementation strategies (CDS+), to increase adoption of SMART. This is the second of two related records.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Asthma is a leading cause of childhood morbidity nationwide. Limited provider adoption of and patient adherence to the prevailing evidence-based recommendations for chronic management represent tractable areas for care improvement and implementation focus. In their 2020 Focused Updates, the NHLBI codified a new paradigm of asthma management - single maintenance and reliever therapy (SMART) - as the preferred management strategy for Steps 3 and 4 (moderate/severe) asthma management. In addition to its efficacy and safety, SMART has demonstrated real-world effectiveness in international settings, likely due in part to better adherence to daily therapy and less inhaler confusion. However, SMART has not been widely implemented in practice in the U.S. This hybrid type II implementation-effectiveness study will sequentially compare the effects of usual care to (1) electronic health record-based clinical decision support plus education (CDS+) (Study 1) and then (2) CDS+ with population health management (PHM) strategies (community health worker and nurse care manager) on SMART adoption (Study 2 - current study). Randomization for this study is at the clinic-level. Results will be reported at visit-, patient-, and clinic-levels.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Chén Kenyon, MD, MSHP
- Número de teléfono: 267-426-6339
- Correo electrónico: kenyonc@chop.edu
Ubicaciones de estudio
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Reclutamiento
- Children's Hospital of Philadelphia
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Contacto:
- Chén Kenyon, MD, MSHP
- Número de teléfono: 267-426-6339
- Correo electrónico: kenyonc@chop.edu
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Clinic Inclusion Criteria:
- The clinic is a pediatric primary care clinic that is part of the Children's Hospital of Philadelphia (CHOP) Pediatric Research Consortium (PeRC).
- The clinic agrees to participate in SMART & SIMPLE study.
Patient Inclusion Criteria:
- Ages 5-18 years;
- Has clinic visit at participating practice during study interval (sick, well, or follow-up)
- Prescribed at least one prescription for an inhaled corticosteroid (ICS) or ICS-long-acting beta agonist (ICS-LABA) for maintenance asthma therapy in the past year;
- Evidence of uncontrolled asthma as determined by: (1) uncontrolled Asthma Control Tool score in the past 6 months OR (2) two or more systemic corticosteroids prescribed for an asthma exacerbation in the past 12 months (one occurring in the past 6 months)
Clinic Exclusion Criteria:
- The clinic is not willing to participate in SMART & SIMPLE study interventions.
Patient Exclusion Criteria:
- Transferred clinics or left the CHOP Pediatric Care Network.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Control
Clinics in Arm 2 will not be exposed to the interventions. |
Clinics in Arm 2 will not be exposed to the interventions. |
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Experimental: Intervention
Clinics in Arm 1 will receive the interventions in Intervals 1 and 2. Interval 1 intervention: clinical decision support and education (CDS+). Interval 2 interventions: CDS and education (CDS+) and population health management (community health worker and nurse care manager) (PHM). |
In Interval 1, intervention clinic providers will experience nudges in the electronic medical record to encourage prescribing SMART where clinically-appropriate and intervention clinic providers, families/patients, and nurses will receive education (collectively CDS+). In Interval 2, intervention clinics will have CDS+ and population health management (PHM) strategies, including an asthma community health worker and an asthma nurse care manager.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in the Rate of Visit-Level SMART Adoption
Periodo de tiempo: Assessment of rates from two study intervals: Interval 1 (CDS+; 11 months), Interval 2 (CDS+ and PHM; 11 months). There will be a one month ramp up period at the start of each study interval (ramp up period data will not be included in analyses).
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The difference in the rate of SMART prescribing (initiation) among eligible primary care visits (i.e., when a child is eligible to start SMART) where SMART is first prescribed (initiated) comparing the second intervention period (Interval 2) and the first intervention period (Interval 1). Adoption is visit-level. The denominator represents eligible primary care visits, and the numerator represents visits where SMART is first prescribed (initiated). |
Assessment of rates from two study intervals: Interval 1 (CDS+; 11 months), Interval 2 (CDS+ and PHM; 11 months). There will be a one month ramp up period at the start of each study interval (ramp up period data will not be included in analyses).
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in the Proportion of Patient-Level SMART Sustainment
Periodo de tiempo: Assessment of proportions from two study intervals: Interval 1 (CDS+; 11 months), Interval 2 (CDS+ and PHM; 11 months). There will be a one month ramp up period at the start of each study interval (ramp up period data will not be included in analyses).
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The difference in the proportion of patients who are prescribed (initiated) SMART who continue on SMART for at least 6 months comparing the second intervention period (Interval 2) and the first intervention period (Interval 1). Sustainment is patient-level. The denominator represents patients who are prescribed (initiated) SMART, and the numerator represents patients who continue on SMART for at least 6 months. |
Assessment of proportions from two study intervals: Interval 1 (CDS+; 11 months), Interval 2 (CDS+ and PHM; 11 months). There will be a one month ramp up period at the start of each study interval (ramp up period data will not be included in analyses).
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in the Proportion of Clinic-Level SMART Penetration
Periodo de tiempo: Assessment of proportions from two study intervals: Interval 1 (CDS+; 11 months), Interval 2 (CDS+ and PHM; 11 months). There will be a one month ramp up period at the start of each study interval (ramp up period data will not be included in analyses).
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The difference in the clinic-level proportion of SMART-eligible patients who are prescribed (initiated) and not subsequently discontinued from SMART by the end of the interval comparing the second intervention period (Interval 2) and the first intervention period (Interval 1). Penetration is clinic-level. The denominator represents patients who are SMART-eligible in each interval, and the numerator represents patients who are prescribed (initiated) during the interval and still on SMART at the end of the interval. |
Assessment of proportions from two study intervals: Interval 1 (CDS+; 11 months), Interval 2 (CDS+ and PHM; 11 months). There will be a one month ramp up period at the start of each study interval (ramp up period data will not be included in analyses).
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Prestación de atención médica
- Calidad, acceso y evaluación de la atención médica
- Factores socioeconómicos
- Características de la población
- Tecnología, industria y agricultura
- Tecnología
- Medios audiovisuales
- Tecnología educativa
- Televisión
- Grabación de videodisc
- Dispositivos de almacenamiento óptico
- Estado educativo
- Discos compactos
- Gestión de la salud de la población
Otros números de identificación del estudio
- 23-021702 B
- R01HL173600 (Subvención/contrato del NIH de EE. UU.)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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