Shared Decision Making in the Emergency Department: Chest Pain Choice Trial (CPC)
10 de noviembre de 2017 actualizado por: Erik P. Hess, Mayo Clinic
Shared Decision Making in the Emergency Department: The Chest Pain Choice Trial
Our long-term goal is to promote evidence-based patient-centered evaluation in the acute setting to more closely tailor testing to disease risk. To compare the use of risk stratification tools with usual clinical approaches to treatment selection or administration, we propose the following:
Test if Chest Pain Choice safely improves validated patient-centered outcome measures in a pragmatic parallel patient randomized trial.
Hypothesis: The intervention will significantly increase patient knowledge, engagement, and satisfaction with no increase in adverse events.
- Test if the decision aid has an effect on healthcare utilization within 30 days after enrollment.
Hypothesis: The intervention will significantly reduce the rate of hospital admission, rate of cardiac testing, and total healthcare utilization.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
898
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.
Ubicaciones de estudio
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California
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Sacramento, California, Estados Unidos, 95817
- University of California, Davis
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Florida
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Jacksonville, Florida, Estados Unidos, 32224
- Mayo Clinic
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202
- Indiana University Hospital: IU
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Minnesota
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Rochester, Minnesota, Estados Unidos, 55905
- Mayo Clinic
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19107
- Thomas Jefferson University
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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
Descripción
Inclusion Criteria:
- 18+ years of age (at least 18).
- Admitted to emergency department for chest pain.
- Being considered by the treating clinician for admission for cardiac testing.
Exclusion Criteria:
- Ischemic changes on the electrocardiogram not known to be old as determined by the treating clinician in real time.
- Elevated cardiac troponin (cTn) above the 99th percentile reference limit.
- Known coronary artery disease as defined by consensus guidelines on risk stratification studies for emergency department patients with potential acute coronary syndrome (≥ 50% stenosis on cardiac catheterization; prior electrocardiographic changes indicative of ischemia, e.g., ST-segment depression, T-wave inversion, or left bundle branch block; perfusion defects or wall motion abnormalities on previous exercise, pharmacological, or rest imaging studies; previous documentation of acute myocardial infarction; or, if no records are available, patient self-report of coronary artery disease).
- Cocaine use within the previous 72 hours by clinician history.
- Pregnancy.
- Referral to the emergency department by a personal physician for admission.
- Patients who indicate that a hospital different than the site hospital is his or her "hospital of choice" in the event of a return emergency department visit.
- Patients undergoing medical clearance for a detox center or any involuntary court or magistrate order.
- Homelessness, out-of-town residence or other condition known to preclude follow-up.
- Patients in police custody or currently incarcerated individuals.
- Patients who have, in their clinician's best judgment, major communication barriers such as visual or hearing impairment or dementia that would compromise their ability to give written informed consent (or use the decision aid).
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: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: Chest Pain Choice Decision Aid
Patients randomized to the decision aid arm.
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The clinician will review the decision aid with the patient.
The decision aid will be used as a tool to facilitate discussion and educate the patient regarding the rationale for their evaluation up to that point in the emergency department visit and their individual risk for a heart attack or pre-heart attack.
The clinician will provide the patient with management options consistent with both the patient's values and preferences and the clinician's level of comfort.
Otros nombres:
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Sin intervención: Usual Care
Patients randomized to the usual care arm (no decision aid used)
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Test if Chest Pain Choice Safely Improves Patient Knowledge.
Periodo de tiempo: Directly following intervention (on day 1)
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Patient knowledge was measured by immediate post-visit survey that included 8 questions about the patient's risk for acute coronary syndrome and the available management options.
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Directly following intervention (on day 1)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Test if the Decision Aid Has an Effect on Healthcare Utilization Within 30 Days After Enrollment.
Periodo de tiempo: Within 30 days of study enrollment
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We will measure the effect of the decision aid on the frequency of hospital admission and cardiac testing within 30 days of enrollment.
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Within 30 days of study enrollment
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Test if the Decision Aid Safely Improves Patient Engagement.
Periodo de tiempo: Immediately after the intervention (on day 1)
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1) Patient engagement in the decision-making process as measured by the OPTION scale.
The OPTION scale is composed of 12 items with a value of 0-4; they are summed, divided by 48, and then multiplied by 100.
Scores range from 0-100, where higher scores are reflective of higher levels of patient engagement.
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Immediately after the intervention (on day 1)
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Major Adverse Cardiac Event (MACE)
Periodo de tiempo: within 30 days of enrollment
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A MACE was defined as acute myocardial infarction, death due to a cardiac or unknown cause, emergency revascularization, ventricular arrhythmia, or cardiogenic shock.
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within 30 days of enrollment
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Total Testing Within 45 Days (a Component of Healthcare Utilization)
Periodo de tiempo: 45 days
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In addition to measuring the effect of the decision aid on the frequency of hospital admission and cardiac testing within 30 days, we measured the total number of tests of any type within 45 days.
Although we pre-specified 30-day healthcare utilization, on further discussion among the investigative team the consensus was that we collected utilization data out to 45 days and reporting testing utilization at 45 days will provide more robust results.
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45 days
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Decisional Conflict
Periodo de tiempo: Immediately after the visit (day 1)
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Decisional conflict, which represents the degree of uncertainty patients experience related to feeling uninformed about the management options, is measured by the decisional conflict scale.
The decisional conflict scale includes 16 items that are scored from 0-4; the items are summed, divided by 16, and then multiplied by 25.
The scale is from 0-100, where higher scores are reflective of increased patient uncertainty about the choice.
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Immediately after the visit (day 1)
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Physician Trust
Periodo de tiempo: Immediately after the visit (day 1)
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The trust in physician scale consists of 9 items scored from 1-5; the items are subtracted by 1, summed, divided by 9, and then multiplied by 25.
The scale ranges from 0-100, where higher values are reflective of higher levels of patient trust in their physician.
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Immediately after the visit (day 1)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Erik Hess, MD, MSc, Mayo Clinic, Rochester, MN
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
- Hess EP, Hollander JE, Schaffer JT, Kline JA, Torres CA, Diercks DB, Jones R, Owen KP, Meisel ZF, Demers M, Leblanc A, Shah ND, Inselman J, Herrin J, Castaneda-Guarderas A, Montori VM. Shared decision making in patients with low risk chest pain: prospective randomized pragmatic trial. BMJ. 2016 Dec 5;355:i6165. doi: 10.1136/bmj.i6165.
- Anderson RT, Montori VM, Shah ND, Ting HH, Pencille LJ, Demers M, Kline JA, Diercks DB, Hollander JE, Torres CA, Schaffer JT, Herrin J, Branda M, Leblanc A, Hess EP. Effectiveness of the Chest Pain Choice decision aid in emergency department patients with low-risk chest pain: study protocol for a multicenter randomized trial. Trials. 2014 May 10;15:166. doi: 10.1186/1745-6215-15-166.
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
1 de octubre de 2013
Finalización primaria (Actual)
1 de agosto de 2015
Finalización del estudio (Actual)
1 de diciembre de 2015
Fechas de registro del estudio
Enviado por primera vez
17 de octubre de 2013
Primero enviado que cumplió con los criterios de control de calidad
21 de octubre de 2013
Publicado por primera vez (Estimar)
25 de octubre de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
6 de agosto de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
10 de noviembre de 2017
Última verificación
1 de noviembre de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 13-001359
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
A link to the pre-test probability web tool and the Chest Pain Choice decision aid (DA) can be accessed at the Mayo Clinic Shared Decision Making National Resource Center at http://shareddecisions.mayoclinic.org/decision-aid-information/chest-pain-choice-decision-aid/.
De-identified patient level data and statistical code can be requested from the corresponding author at hess.erik@mayo.edu and provided to investigators who agree to adhere to a signed research data use agreement with the Mayo Clinic after 12/31/2017.
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. .