Comparison of Patient Centered Outcomes for People With Sickle Cell Disease in the Acute Care Setting (ESCAPED)
14 de junio de 2019 actualizado por: Johns Hopkins University
Patient Centered Outcomes Research Institute (PCORI) ESCAPED Study: Comparison of Patient Centered Outcomes for People With SCD in the Acute Care Setting
The Emergency Department has been the standard location where patients with Sickle Cell Disease (SCD) go to seek care for the treatment of acute painful events. Vaso- Occlusive Crisis (VOC) is the most common complication of SCD,
The purpose of this study is to compare patient centered outcomes for patients being treated for an uncomplicated VOC in Infusion Centers (IC) and Emergency Departments (ED) in four locations around the United States.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
Emergency Department care is marked by long delays, lack of efficacy, and conflict. A sub-specialty Infusion Center staffed by expert clinicians and delivering individualized care can improve care quality while reducing costs. The study will examine whether care provided in an Infusion Center (IC) is more patient centered and efficient than care provided in an Emergency Department (ED) for adults with Sickle Cell Disease (SCD) and uncomplicated Vaso-Occlusive Crisis (VOC).
Sites will prospectively enroll patients in VOC seen in participating centers from either the EDs or the ICs. Specific data from the acute visits (e.g. Times of arrival, time to first dose of analgesic, etc) will be captured. This study will compare: pain management, disposition of subjects (home or admission) and patient experiences of care delivery in both settings. Subjects will complete surveys/questionnaires to asses subjects' experiences in the setting where care was provided.
The four sites to participate in the study are Baltimore, Maryland (Johns Hopkins Hospital), Cleveland, Ohio (Cleveland Medical Center), Milwaukee, Wisconsin (Medical College of Wisconsin), and Baton Rouge, Louisiana (Our Lady of the Lake Hospital). A maximum of 500 subjects will participate in the study. Participants will be enrolled for 18 months.
Tipo de estudio
De observación
Inscripción (Actual)
483
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.
Ubicaciones de estudio
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Louisiana
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Baton Rouge, Louisiana, Estados Unidos, 70809
- Our Lady of the Lake Hospital
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Ohio
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Cleveland, Ohio, Estados Unidos, 44106
- Cleveland Medical Center at University Hospitals
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Wisconsin
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Milwaukee, Wisconsin, Estados Unidos, 53201
- Medical College of Wisconsin, Blood Center
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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
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Adult subjects with SCD inclusive of genotypes homozygous and compound heterozygous sickle hemoglobin.
In the United States, SCD primarily afflicts African-American and Hispanic-American populations.
Patients will be enrolled prior to a vaso-occlusive crisis and data will be collected from patients' acute visit(s) at either the Emergency Department or at an Infusion center (4 participating sites).
Descripción
Inclusion Criteria:
- Confirmed Sickle Cell Disease patients who live within 60 miles of the study center or who already receive regular care at the participating centers.
Exclusion Criteria:
- Stable patients who have been on chronic transfusion therapy and have not had a painful episode within two years of enrollment.
- Patients who are pregnant.
- Patients who are unwilling or unable to sign consent.
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
Cohortes e Intervenciones
Grupo / Cohorte |
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Patients With SCD
Patients treated for uncomplicated VOC in ICs and EDs.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Time (Minutes) From Arrival to Center to Time First Dose of Parenteral Pain Medication Administered
Periodo de tiempo: Within 6 hours after arrival
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Time is recorded from the time the patient arrives for pain treatment at either the ED or IC until the time the patient is dosed with pain medication administered parenterally.
Guideline recommendations are that patients receive non-oral pain medication within 60 minutes of arrival.
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Within 6 hours after arrival
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Disposition From Acute Care Visit
Periodo de tiempo: Day 1 of admission
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Odds for admission to the hospital versus discharge to home (ED vs IC)
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Day 1 of admission
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Pain Reassessment Within 30 Minutes of First Dose of Parenteral Pain Medication Administered
Periodo de tiempo: 30 minutes after administration
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Odds of being re-assessed for pain within 30 minutes of receiving first dose of pain medication in ED vs IC.
NHLBI guidelines recommend that patients are re-assessed for adequacy of pain management 30 minutes after receiving pain medication.
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30 minutes after administration
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Patient Reported Satisfaction With Care Received
Periodo de tiempo: within 72 hours of acute visit
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Survey to capture patient satisfaction with the quality of care in either the ED or IC.
Validated a new tool to assess satisfaction with care in the acute care setting.
The new tool was developed based on existing tools that assessed several domains: adequacy of pain management, communication with providers, interpersonal aspects of care, provider competence, involvement of family/friends, and access to care.
The final 15 item validated Patient Satisfaction with Pain Management in Sickle Cell Disease (SCD) (PSPS) scale was used to compare satisfaction of care comparing ED to IC acute visits.
Overall mean satisfaction scores ranged from 0-7 with higher scores signifying greater satisfaction
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within 72 hours of acute visit
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Patient Reported Perception of Risk From Visit
Periodo de tiempo: within 72 hours of acute visit
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One question on the survey asked patients to rate the overall level of medical safety they felt during their visit to the ED or IC.
Choices for responses: Excellent, Very Good, Good, Fair or Poor.
Excellent and Very Good were determined as having greater feelings of overall safety while patients who chose Good, Fair or Poor were determined having lesser feelings of overall safety.
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within 72 hours of acute visit
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Sophie Lanzkron, MD, MHS, Johns Hopkins University, Division of Hematology
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
- Platt OS, Brambilla DJ, Rosse WF, Milner PF, Castro O, Steinberg MH, Klug PP. Mortality in sickle cell disease. Life expectancy and risk factors for early death. N Engl J Med. 1994 Jun 9;330(23):1639-44. doi: 10.1056/NEJM199406093302303.
- Lanzkron S, Carroll CP, Haywood C Jr. The burden of emergency department use for sickle-cell disease: an analysis of the national emergency department sample database. Am J Hematol. 2010 Oct;85(10):797-9. doi: 10.1002/ajh.21807.
- Hassell KL. Population estimates of sickle cell disease in the U.S. Am J Prev Med. 2010 Apr;38(4 Suppl):S512-21. doi: 10.1016/j.amepre.2009.12.022.
- McClish DK, Penberthy LT, Bovbjerg VE, Roberts JD, Aisiku IP, Levenson JL, Roseff SD, Smith WR. Health related quality of life in sickle cell patients: the PiSCES project. Health Qual Life Outcomes. 2005 Aug 29;3:50. doi: 10.1186/1477-7525-3-50.
- Bediako SM. Predictors of employment status among African Americans with sickle cell disease. J Health Care Poor Underserved. 2010 Nov;21(4):1124-37. doi: 10.1353/hpu.2010.0945.
- Lanzkron S, Carroll CP, Hill P, David M, Paul N, Haywood C Jr. Impact of a dedicated infusion clinic for acute management of adults with sickle cell pain crisis. Am J Hematol. 2015 May;90(5):376-80. doi: 10.1002/ajh.23961. Epub 2015 Feb 25.
- Haywood C Jr, Tanabe P, Naik R, Beach MC, Lanzkron S. The impact of race and disease on sickle cell patient wait times in the emergency department. Am J Emerg Med. 2013 Apr;31(4):651-6. doi: 10.1016/j.ajem.2012.11.005. Epub 2013 Feb 4.
- Lanzkron S, Little J, Wang H, Field JJ, Shows JR, Haywood C Jr, Saheed M, Proudford M, Robertson D, Kincaid A, Burgess L, Green C, Seufert R, Brooks J, Piehet A, Griffin B, Arnold N, Frymark S, Wallace M, Abu Al Hamayel N, Huang CY, Segal JB, Varadhan R. Treatment of Acute Pain in Adults With Sickle Cell Disease in an Infusion Center Versus the Emergency Department : A Multicenter Prospective Cohort Study. Ann Intern Med. 2021 Sep;174(9):1207-1213. doi: 10.7326/M20-7171. Epub 2021 Jul 6. Erratum In: Ann Intern Med. 2021 Aug 3;:
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 abril de 2015
Finalización primaria (Actual)
1 de junio de 2018
Finalización del estudio (Actual)
1 de junio de 2018
Fechas de registro del estudio
Enviado por primera vez
30 de marzo de 2015
Primero enviado que cumplió con los criterios de control de calidad
2 de abril de 2015
Publicado por primera vez (Estimar)
8 de abril de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de junio de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
14 de junio de 2019
Última verificación
1 de junio de 2019
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB00054029
- PCORI-1403-11888 (Otro número de subvención/financiamiento: PCORI)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
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. .
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