- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00674375
Risk Score Alerts for Chest Pain Care
Can Risk Score Alerts Improve Office Care for Chest Pain?
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The evaluation of ambulatory patients with chest pain is a challenging and serious problem, accounting for a significant proportion of all outpatient visits. High risk patients may go undetected, resulting in missed diagnoses of acute myocardial ischemia, while low risk patients may be subject to unnecessary evaluations. To substantially improve the evaluation and treatment of outpatients with acute chest pain syndromes, new strategies need to be developed in the primary care setting to risk stratify symptomatic patients and direct appropriate care. Our prior work demonstrates that an elevated Framingham Risk Score (at least 10%) reliably identifies patients with chest pain in the primary care setting who are at high risk for acute myocardial infarction.
This study will implement and evaluate electronic risk alerts to risk stratify outpatients with chest pain and present this information to primary care clinicians within the context of an electronic health record. The intervention will take place within Harvard Vanguard Medical Associates, a multispecialty integrated group practice with 140 primary care physicians caring for approximately 300,000 patients at 14 centers in eastern Massachusetts. With a randomized, controlled study design, the study has three specific aims:
- To identify predictors of risk-appropriate evaluation and treatment of patients presenting to primary care offices with acute chest pain, including race and sex.
- To determine whether rates of appropriate evaluation and treatment of patients with acute chest pain can be improved through the use of point-of-care electronic risk alerts that provide individual patient cardiac risk profiles and tailored evaluation and treatment recommendations to primary care clinicians.
- To perform a cost analysis for the provision of electronic decision support for patients with acute chest pain.
This study has important implications for determining how the treatment of outpatients with chest pain syndromes can be optimized through the innovative use of electronic decision support, while documenting the cost implications of such a strategy. This work will also provide a model for how ambulatory practices across the country can use electronic health records to present real-time patient risk information to clinicians with the goal of improving patient safety and quality, which has important implications for both acute and chronic care.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Massachusetts
-
Boston, Massachusetts, Estados Unidos, 02115
- Brigham and Women's Hospital
-
Newton, Massachusetts, Estados Unidos, 02466
- Harvard Vanguard Medical Associates
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Adults 30 years and older presenting to one of 14 ambulatory health centers and their evaluating primary care clinician will be eligible for this study.
Exclusion Criteria:
- Prior history of coronary heart disease
- Age <30 years
- Presentation for an annual physical examination
- Prior hospital admission or emergency department visit for evaluation of chest pain within 30 days of their presentation to primary care clinician
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 |
---|---|
Experimental: 1
Primary care clinicians (physicians, nurse practitioners, and physician assistants) randomized to the intervention arm will receive electronic alerts within the electronic medical record system during office visits with patients complaining of chest pain.
|
Electronic risk alerts within the electronic medical record system will automatically calculate a patient's Framingham Risk Score during office visits for chest pain.
These alerts will recommend electrocardiogram performance and aspirin therapy for patients with Framingham Risk Score at least 10%, and will recommend against exercise stress testing for patients with a Framingham Risk Score less than 10%.
|
Sin intervención: 2
Primary care clinicians randomized to the 'no intervention' arm will evaluate and treat patients complaining of chest pain without the aid of electronic risk alerts.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Performance of electrocardiogram for patients with Framingham Risk Score greater than or equal to 10%.
Periodo de tiempo: During office visit
|
During office visit
|
Administration of aspirin therapy for patients with Framingham Risk Score greater than or equal to 10%
Periodo de tiempo: During office visit
|
During office visit
|
Performance of exercise stress testing for patients with Framingham Risk Score less than 10%
Periodo de tiempo: Within 2 months of office visit
|
Within 2 months of office visit
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
EKG and aspirin therapy for patients with Framingham Risk Score at least 10% among intervention and control clinicians according to clinician risk tolerance. Hypothesis: Intervention effect will be greatest among clinicians with a high risk tolerance.
Periodo de tiempo: During office visit
|
During office visit
|
Exercise stress testing for patients with Framingham Risk Score less than 10% among intervention and control clinicians according to clinician risk tolerance. Hypothesis: Intervention effect will be greatest among clinicians with lowest risk tolerance.
Periodo de tiempo: Within 2 months
|
Within 2 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Thomas D Sequist, MD, MPH, Brigham and Women's Hospital
Publicaciones y enlaces útiles
Publicaciones Generales
- Sequist TD, Marshall R, Lampert S, Buechler EJ, Lee TH. Missed opportunities in the primary care management of early acute ischemic heart disease. Arch Intern Med. 2006 Nov 13;166(20):2237-43. doi: 10.1001/archinte.166.20.2237.
- Sequist TD, Morong SM, Marston A, Keohane CA, Cook EF, Orav EJ, Lee TH. Electronic risk alerts to improve primary care management of chest pain: a randomized, controlled trial. J Gen Intern Med. 2012 Apr;27(4):438-44. doi: 10.1007/s11606-011-1911-6. Epub 2011 Oct 13.
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1R18HS017075-01 (Subvención/Contrato de la AHRQ de EE. UU.)
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 Electronic risk alerts
-
University Hospitals Cleveland Medical CenterSomaLogic, Inc.TerminadoImpacto pragmático de la estratificación del riesgo proteómico en la diabetes mellitus (PORTRAIT-DM)Diabetes tipo 2Estados Unidos
-
China Medical University HospitalTerminado
-
Ottawa Hospital Research InstituteThe Hospital for Sick Children; Hopital Montfort; Unity Health Toronto; The Ottawa... y otros colaboradoresInscripción por invitaciónCiencia de la implementación | Poner en pantalla | Cuidado terminal | Terapia paliativaCanadá
-
Centre Hospitalier Universitaire de BesanconDesconocidoNeoplasias Renales | Cáncer renal | Metastásico de carcinoma renalFrancia
-
University of PittsburghRetiradoAdherencia a la medicación | Reacción adversa a la droga | Incumplimiento de la medicaciónEstados Unidos
-
Cairo UniversityTerminado
-
Taiwan Resonant Waves Research CorporationTerminado
-
Cairo UniversityTerminadoAnestesia general | Rehabilitación bucal completa | Relación de superposición caninaEgipto
-
EpividianViiV Healthcare; AIDS Healthcare FoundationTerminado
-
Jinan Military General HospitalDesconocidoVulva intraepitelial no neoplásicaPorcelana