- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01326637
Human Factors Intervention to Reduce Risk in Primary Care of the Elderly (SAFE-C)
A Human Factors Intervention to Reduce Risk in Primary Care of the Elderly
Human factors engineering literature makes clear that appropriate, well-designed and well-timed information improves decision making and can reduce mental workload. Data from a previous study showed that appropriate, well-designed and well-timed information is not present in many primary care encounters with elderly patients. This puts primary care physicians at risk of higher mental workload and poor decision making which can affect the quality and safety of care delivered to patients. Elderly patients are at particular risk because they are more likely to have more comorbidities, medications, and cognitive impairments.
Dr. Karsh and his research team will test an intervention to improve the performance of primary care physicians and, thus the safety of primary care of the elderly. The investigators will use a randomized experiment, with random assignment at the level of patient, to test and evaluate the intervention. The evaluation will involve 4 primary care clinics, with 4 primary care physicians per clinic. The investigators will collect data from 768 patient visits pre-intervention and 1536 patient visits during the intervention. Intervention patients will be randomly assigned to the intervention or care as usual.
The Intervention has two components:
Pre-visit care coordination:
- 5-7 days prior to a study patient's appointment with his/her doctor, the doctor's nurse/MA will call the study patient and collect pertinent clinical information about the patient using a data collection form the investigators call a Patient Overview Document or POD.
- The nurse/MA will ensure that any lab results, consultant reports, ER reports, imaging studies, etc., that will be needed by the physician are available to the doctor.
Team Meeting:
On the day of the patient's appointment and prior to the beginning of the clinic session, the nurse/MA will meet briefly with the doctor to jointly review the POD.
Hypotheses:
H1. Primary Care Physician (PCP): The intervention will increase situation awareness, reduce PCP mental workload, reduce PCP perceived likelihood of error, and improve PCP visit satisfaction. PCP efficiency, as measured by encounter problem density during a visit, will also improve.
H2. Patient: The intervention will improve patients' perceptions of their visits on a variety of AHRQ CAHPS measures, such as physician knowledge of patient history.
H3. Patient: The intervention will not impact the number or types of problems addressed during the visit.
H4. Clinic: The intervention will not affect visit RVUs
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Wisconsin
-
Madison, Wisconsin, Estados Unidos, 53705
- University of Wisconsin, Madison
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Must be greater than or equal to 65 years of age
- Must be patients of participating physicians
Exclusion Criteria:
- Cannot speak English
- Cannot hear well enough to respond to questions via the telephone or do not have a caregiver who can respond to questions on their behalf
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: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: intervention
Received the intervention: previsit planning phone call with filled out patient overview document & clinician huddle
|
The Intervention has two components:
On the day of the patient's appointment, prior to the beginning of the clinic session, the nurse/MA and doctor will jointly review the POD. |
Sin intervención: observation
Received usual care
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Number and types of problems discussed during visit
Periodo de tiempo: 04/12
|
There are no outcome measures for individual patients. We will review the dictated clinic note for each study patient visit in order to
We will compare the number of problems and the kind of problems found in the intervention patient group with the number and kind of problems found in the care-as-usual group. |
04/12
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Resource utilization
Periodo de tiempo: 04/12
|
There are no outcome measures for individual patients.
We will look at the resource utilization (RVUs) during care-as-usual visits compared to resource utilization during intervention visits.
To assess resource utilization, we will collect E&M/CPT codes for each study visit and calculate the RVUs.
A study patient is seen only once.
|
04/12
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ben-Tzion Karsh, PhD, University of Wisconsin, Madison
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 (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 2010-0447
- R18HS017899 (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. .
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