Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

The Emergency Department Stopping Elderly Accidents, Deaths and Injuries Program (ED-STEADI)

12 de agosto de 2019 actualizado por: Marna Rayl Greenberg, Lehigh Valley Hospital

"ED-STEADI:" The Emergency Department Stopping Elderly Accidents, Deaths and Injuries Program (A Pilot Study)

This study aims to determine if a bedside decision aid used in the ED for mechanical fall prevention can increase patient participation in management options that decrease their fall risk. Additionally, the investigators aim to determine if there are gender differences in patient choices in management options and accomplished goals inspired by the decision tool.

Descripción general del estudio

Descripción detallada

This prospective, randomized controlled study will be conducted when there is a member of the research team available to consent patients at a Level I Trauma Center with approximately 90,000 annual ED visits across all age groups. Each potentially eligible patient will be identified by the research team and approached in the ED. Consented and enrolled patients will be assigned a study identification number and the enrollment documented by a member of the research team in the ED's electronic medical record after subjects are confirmed to meet inclusion and exclusion criteria. Subjects will be assigned randomly (by using a computer generated sequence) to either the control or intervention study arms.

Subjects in the control arm will have demographic data collected, a baseline Falls Efficacy Scale (FES) and Vulnerable Elders Survey (VES) screening completed and two STEADI Tool Kit mobility tests administered (the "TUG" [Timed Up and GO] and the 30-Second Chair Stand test). The FES and VES are validated surveys measuring fall concern and functional decline. The research team will advise them that they have a risk of falling as identified by inclusion criteria and that we are advising them to take action to prevent future falls. They will be given the brochure, "What YOU Can Do to Prevent Falls," that is standardized information recommended in the STEADI Tool Kit for Health Care Providers by the Centers for Disease Control (CDC).

Subjects in the active arm will also have demographic data collected, a baseline FES and VES screening completed, and two STEADI Tool Kit mobility tests administered (the "TUG" [Timed Up and GO] and the 30-Second Chair Stand test). Their risk of falling will be reviewed with them using a bedside decision aid indicating what they can do to decrease their risk. Particular attention will be given to personalizing their fall risk. The fall prevention management options will be presented in a value neutral fashion, along with the advantages and disadvantages of each option. They will have an opportunity to discuss what outcomes are the most important to them and choose the management options from the list provided that are the most valuable to them. Study and treatment team members will then work with this agreed upon selection to provide reliable intervention and outpatient follow up to improve the gains that can be realized in an integrated healthcare system. If the participant chooses to do their own home safety evaluation, they will be provided with a checklist to guide them in looking for hazards in their home and how to fix them. The patient will keep the original copy of their decision aid with their agreed-upon selected treatment options, and a copy of it will be placed in the subject's study file. All actions that are in response to the subject's selected plan (prescriptions, appointments, etc.) will also be documented in the study file.

Both groups will have phone follow-up at 6 weeks post ED visit, and then again at 3, 6, 9 and 12 months to collect self-reported data about goal completion and fall history. The last phone follow-up will include an exit FES and VES reassessment. All participants in both arms will have data collected about their inpatient and outpatient visits throughout the network during the study period to corroborate their self-report (e.g., occupational therapy, physical therapy visits, hospital admissions or ER visits for injuries related to a fall, etc.).

Tipo de estudio

Intervencionista

Inscripción (Actual)

200

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

    • Pennsylvania
      • Bethlehem, Pennsylvania, Estados Unidos, 18017
        • Lehigh Valley Hospital, Emergency Medicine Research

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

65 años y mayores (Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

Patients must:

  • Be 65 years of age or older
  • Be discharged home from the ED
  • Be able to speak English.
  • Be competent and able to give consent (not in critical condition, intoxicated or otherwise incapacitated)
  • Have a mechanical fall risk as defined by one of the following:

Reports to have fallen in the last year Reports worrying about falling Admits they feel unsteady when standing or walking

Exclusion Criteria:

Patients must not:

  • Be younger than 65 years old
  • Be discharged from the ED to anywhere, but home (i.e., must not be discharged to family member's home, personal care facility, nursing home, group home, etc.)
  • Be unable to speak English
  • Be incompetent and unable to give consent (in critical condition, intoxicated or otherwise incapacitated)

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: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Bedside Decision Aid Group
This arm will include study participants who are randomized to the group utilizing the bedside decision aid, which has hospital staff arrange fall-risk reduction interventions (e.g., home safety checks, exercise programs, vision checks, etc.).

This group will have an initial FES and VES screening completed in the ED, the TUG test and Chair 30-Second Stand test, and the participant's risk of falling evaluated using our Bedside Decision worksheets. A study team member explains what subjects can do to decrease their risk of falling and discuss what mobility goals are the most important to them.

Participants will receive a follow-up telephone call approximately six weeks after their discharge from the ED to collect self-reported data about goal completion, and then at four additional times--three, six, nine and 12 months--over the course of a year to collect self-reported data such as fall history.

Comparador activo: Control Arm
Participants in the control/comparator arm will experience the same study procedures with the exception of not using the Bedside Decision Aid and instead being given the Centers for Disease Control (CDC) brochure, "What You Can Do to Prevent Falls," and arranging for their own fall prevention strategies.

This group will also have an initial FES and VES screening completed in the ED and the same two mobility tests (TUG and Chair 30-Second Stand). Study staff will advise subjects on how to take action to prevent falls and give them a brochure, "What YOU Can Do to Prevent Falls," from the CDC's "STEADI Tool Kit for Health Care Providers."

Participants will receive a telephone call approximately six weeks after their discharge from the ED to collect self-reported data about goal completion, and then at four additional times--three, six, nine and 12 months--over the course of a year to collect self-reported data such as fall history.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Efficacy of the bedside decision tool/worksheet
Periodo de tiempo: 12 months
A single sheet bedside decision aid form/worksheet will be used to engage the patient in a discussion about fall prevention, the aim of which is to increase patient interest and participation in different management options that decrease fall risk. Patients will be followed up via phone calls re: their management option choices and how thorough/successful they were in completing them.
12 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Gender differences in use of the decision tool
Periodo de tiempo: 12 months
Responses from the bedside decision tool choices will be grouped by gender to determine if men and women select different management options and/or have different patterns in completing them.
12 months

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Gender differences in fall management choices
Periodo de tiempo: 12 months
Participants in *both* study arms will have phone follow-ups at the same time intervals to determine if men and women have different management option preferences and/or different patterns in completing them.
12 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Marna R. Greenberg, DO, MPH, Lehigh Valley Hospital

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 mayo de 2014

Finalización primaria (Actual)

1 de septiembre de 2018

Finalización del estudio (Actual)

1 de septiembre de 2018

Fechas de registro del estudio

Enviado por primera vez

14 de junio de 2014

Primero enviado que cumplió con los criterios de control de calidad

17 de junio de 2014

Publicado por primera vez (Estimar)

19 de junio de 2014

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

13 de agosto de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

12 de agosto de 2019

Última verificación

1 de agosto de 2019

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • #PRO-00001450

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

No plan to share IPD, just publish the study's results.

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. .

Suscribir