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GAPcare: The Geriatric Acute & Post-acute Care Coordination Program for Fall Prevention in the Emergency Department (GAPcare)

7 de julio de 2020 actualizado por: Elizabeth Goldberg, Rhode Island Hospital
GAPcare (Geriatric Acute & Post-acute Care Coordination Program for Fall Prevention) is an early stage investigation that enrolls older adults who present to the Emergency Department after a fall to determine the feasibility of an Emergency Department (ED)-based multidisciplinary intervention for preventing recurrent falls in older adults.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Falls are the leading cause of fatal and non-fatal injury among older adults. EDs frequently evaluate older adults after their falls, but the typical evaluation consists of an injury assessment alone. There is a critical need for an ED-based intervention that addresses reasons for the fall and provides on-the-spot assessment and guidance to prevent subsequent falls. Failure to prevent subsequent falls will result in increased morbidity, mortality, healthcare utilization, loss of independence, and rising health care costs as the population of older adults increases.

Participants in GAPcare will be older adults (≥65 years-old) who present to the ED for a fall. We will pursue the following specific aims to test and further refine the GAPcare intervention: (1) Examine the feasibility of recruitment and retention of eligible patients into the GAPcare intervention, (2) determine the initial efficacy of the GAPcare intervention in reducing subsequent falls and healthcare utilization at 6 months. Our long-term goal is to prevent the early morbidity and mortality of older adults who present to the ED after a fall. The overall objective of this survey is to gather preliminary data on the feasibility of an ED based fall prevention project.

Tipo de estudio

Intervencionista

Inscripción (Actual)

110

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

  • Estados Unidos
    • Rhode Island
      • Providence, Rhode Island, Estados Unidos, 02906
        • The Miriam Hospital
      • Providence, Rhode Island, Estados Unidos, 02903
        • Rhode Island Hospital

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:

  • Community-dwelling adult (non-institutionalized) 65 years-old or older presenting to ED after a fall
  • Able to communicate in English
  • Fall not due to syncope or external force (i.e., struck by car or assault)
  • Fall not due to serious illness (i.e. stroke, acute myocardial infarction)
  • Will be discharged to home, assisted living, or rehabilitation at completion of ED visit (i.e., not admitted)
  • Legally authorized representative present to give informed consent if patient has cognitive impairment on Six Item Screener (score of less than four)

Exclusion Criteria:

  • Unable to give informed consent due to intoxication or altered mental status
  • Presence of injuries that prevent mobilization (i.e., pelvic or lower extremity fractures)

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: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Usual care
The ED clinician will perform a standard medical evaluation. This evaluation includes a focused history and exam to identify injuries. Laboratory tests and radiologic imaging may be ordered. If necessary, the patient will receive consultation with specialty services (e.g., orthopedics). The research assistant (RA) will read the CDC STEADI brochure to the patient and provide them with a printed copy at the conclusion of their visit. The RA will solicit feedback from the clinician and the patient at the conclusion of the visit using the post-visit survey.
Experimental: Intervention
  1. ED clinician will perform standard medical evaluation, including focused history and exam to identify injuries. RA will solicit feedback from clinician and patient via post-visit survey at conclusion of visit.
  2. PT will perform services, including integrative mobility training and lower extremity strength training and recommending outpatient services/referrals. Specific assessments and treatments will be tailored to patient.
  3. Pharmacist will perform a medication review using the updated BEERS criteria and CDC's STEADI instrument and recommend changes to potential fall risk increasing medication. Recommendations will be communicated to ED treatment team.
  4. Seniors will return home with standardized checklist containing details of their assessment and action plan. The checklist addresses patient's personal risk factors for the fall and required further actions.
Conductual: GAPcare intervention
Subjects will receive PT and pharmacist evaluation. PT will help determine whether subject may benefit from doing exercises to improve strength or balance. PT may also supply subject with an assist device. A pharmacist will ask patient about any medication they are taking and will make recommendations on how their medication could be changed to prevent falls. Pharmacists will communicate this information to subject's doctors. Subjects will receive a fall calendar for home, where they will record any falls they have after their discharge from the ED. They will receive a phone call at home asking about any recent falls and health care interactions. Study personnel will call subjects every 2 weeks for 6 months. Subjects may receive a referral for outpatient or home-based physical and occupational therapy at the end of the visit.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Feasibility of Implementing Intervention in Emergency Department
Periodo de tiempo: 12 Months
Assess the feasibility of implementing this intervention in an ED setting. We will report enrollment, reasons for accepting or declining enrollment, and drop-out from the study using the CONSORT approach. We will compare the demographic characteristics of the GAPcare participants in both arms using Chi-square or Fisher's exact test for categorical variables and Student's t-test or Wilcoxon's test for continuous variables, as appropriate. We will use Wilcoxon's test to compare the median ED length of stay between participants of both study arms.
12 Months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Initial efficacy
Periodo de tiempo: 12 Months
Determine if the GAPcare intervention versus usual care reduces subsequent falls and all-cause and fall-related ED visits and hospital admissions in the six-month follow-up. We will compare the proportion and number of falls, ED visits, and hospital admissions in each group using chi-square (proportions) and Wilcoxon's and Student's t-tests (occurrence). If sample size permits, we will conduct survival analysis to do a time-to-event analysis. Survival time will be defined as the time from randomization to the time of the first recurrent fall, next ED visit, and hospital admission. First, we will use the Kaplan-Meier method to estimate the cumulative probability of fall-free and visit-free survival time. Next, we will use the log-rank test to test differences between survival curves for the intervention vs. usual care arm. Finally, hazard ratios and 95% confidence intervals will be calculated using the Cox Proportional Hazards model.
12 Months
Feedback
Periodo de tiempo: 21-24 Months
We will gather feedback from clinicians and patients on the utility and barriers of the GAPcare intervention versus usual care. We will assess 1) patient satisfaction with the care delivered, 2) barriers and facilitators of the intervention, 3) suggestions for improvement, and 4) specific feedback from clinicians on the suitability of the intervention to an ED setting. Researchers will review and code each transcript independently. A consensus process will follow, in which the researchers will categorize data into common themes within each of the 4 domains.
21-24 Months

Colaboradores e Investigadores

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

Patrocinador

Rhode Island Hospital

Colaboradores

National Institutes of Health (NIH)
National Institute on Aging (NIA)

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

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)

25 de enero de 2018

Finalización primaria (Actual)

29 de marzo de 2019

Finalización del estudio (Actual)

31 de octubre de 2019

Fechas de registro del estudio

Enviado por primera vez

27 de noviembre de 2017

Primero enviado que cumplió con los criterios de control de calidad

27 de noviembre de 2017

Publicado por primera vez (Actual)

4 de diciembre de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

9 de julio de 2020

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

7 de julio de 2020

Última verificación

1 de julio de 2020

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • GAPcare
  • R03AG056349 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

No

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

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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