- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00836433
CONNECT for Better Falls Prevention in VA Community Living Centers (CONNECT)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Background:
The current standard to improve resident outcomes in VA nursing homes combines educational programs and quality improvement processes. These educational programs typically focus on individual staff members' behavior and mastery of content, and use such instructional techniques as didactic modules, audit and feedback of individual performance, and academic detailing by influential peers. However, social constructivism theory and complexity science suggests that learning is a social process that occurs within the context of the relationships and interactions of the individual in their environment. Thus, traditional QI educational programs will not result in optimal changes in staff behavior unless a context is present which allows social learning to occur.
Objectives:
Based on social constructivist theory, complexity science, and prior research we have developed an educational intervention (CONNECT) that teaches staff to improve connections within and between disciplines, improve information flow, and seek out cognitive diversity in problem-solving about resident issues. The objectives of this study are to: (a) determine whether CONNECT improves staff interaction measures, fall-related process measures, and fall rates when combined with standard training on fall risk factor reduction, and (b) use the insights gained about social constructivist learning in CLCs to develop other educational interventions that address multi-factorial geriatric syndromes and system issues such as patient safety in VA nursing homes.
Methods:
To achieve these objectives we are conducting a randomized, controlled, single-blind study in which nursing homes receive either CONNECT plus a falls QI educational intervention (FALLS) or FALLS alone. Four VA CLCs in VISN-6 will participate, with an estimated n=144 participating staff members, and n=340 unique individuals with falls. The CONNECT intervention will be delivered over 3 months, and includes interactive in-class learning sessions, unit-based mentoring, and relationship mapping, all focused on helping staff build networks and relationships for problem-solving. The FALLS intervention will be delivered over 3 months either alone or after the CONNECT intervention. It includes web-based modules, audit and feedback, and academic detailing, all focused on individual fall reduction behaviors. Measurement is performed prior to intervention (all measures), at the conclusion of intervention (staff interaction measures, work environment measures, and social constructivist learning focus groups), and 6 months after the intervention (fall-related process and outcome measures). Analysis will use mixed models to account for the complex nesting of patients and staff within facilities.
Status:
Funding will begin on August 1, 2009 with anticipated intervention start time of January, 2010.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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North Carolina
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Asheville, North Carolina, Estados Unidos, 28805
- VA Medical Center, Asheville
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Durham, North Carolina, Estados Unidos, 27705
- Durham VA Medical Center, Durham, NC
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Virginia
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Richmond, Virginia, Estados Unidos, 23249
- Hunter Holmes McGuire VA Medical Center
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Salem, Virginia, Estados Unidos, 24153
- VA Medical Center, Salem VA
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- All clinical and support staff in participating VA Community Living Centers
Exclusion Criteria:
- Inability to speak and understand English
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: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: FALLS only
Traditional falls educational intervention, including self-study modules, audit and feedback, falls team training, academic detailing, and toolkit.
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FALLS is a traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions
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Experimental: CONNECT and FALLS
CONNECT educational intervention is designed to improve relationship-building and communication.
The intervention includes 2 in-class session, group mapping exercise, individual relationship mapping exercises, Self-monitoring of interactions, individual staff coaching sessions.
FALLS is a traditional falls educational intervention, including self-study modules, audit and feedback, falls team training, academic detailing, and toolkit.
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FALLS is a traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions
The CONNECT educational intervention is a training program for staff to improve communication with a more dense network of co-workers, in order to improve resident problem-solving.
Includes in class sessions, group and individual mapping exercises, self-monitoring of interactions, and individual staff coaching.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Fall-related Process Measures
Periodo de tiempo: 6 months
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The proportion of applicable fall quality indicators documented for residents with falls during the study period.
Quality indicators are specific fall risk assessment or prevention activities including orthostatic blood pressure assessment, vision assessment, environmental modification (bedroom, bathroom), footwear change, physical or occupational therapy referral, psychoactive medication reduction.
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6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in Facility Fall Rates
Periodo de tiempo: 6 months
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Change in the risk-adjusted facility fall rates in the 6 months post intervention(s) compared to the 6 months before the intervention(s).
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6 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Cathleen S. Colon-Emeric, MD, Durham VA Medical Center, Durham, NC
Publicaciones y enlaces útiles
Publicaciones Generales
- Anderson RA, Corazzini K, Porter K, Daily K, McDaniel RR Jr, Colon-Emeric C. CONNECT for quality: protocol of a cluster randomized controlled trial to improve fall prevention in nursing homes. Implement Sci. 2012 Feb 29;7:11. doi: 10.1186/1748-5908-7-11.
- Colon-Emeric CS, Lyles KW, Su G, Pieper CF, Magaziner JS, Adachi JD, Bucci-Rechtweg CM, Haentjens P, Boonen S; HORIZON Recurrent Fracture Trial. Clinical risk factors for recurrent fracture after hip fracture: a prospective study. Calcif Tissue Int. 2011 May;88(5):425-31. doi: 10.1007/s00223-011-9474-4. Epub 2011 Feb 18.
Enlaces Útiles
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 (Estimar)
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
- EDU 08-417
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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Ensayos clínicos sobre FALLS educational intervention
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University of MichiganNational Heart, Lung, and Blood Institute (NHLBI)Terminado
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University of OxfordOxford University Hospitals NHS TrustDesconocidoSíntomas de comportamientoReino Unido
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Shiraz University of Medical SciencesTerminado
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Heidelberg UniversityDesconocidoRetraso de idioma | Trastornos del desarrollo del lenguajeAlemania
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Munich Municipal HospitalTechnical University of Munich; University of RegensburgDesconocido
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Portland VA Medical CenterOregon Health and Science UniversityTerminadoEsclerosis múltipleEstados Unidos
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Ottawa Heart Institute Research CorporationCanadian Institutes of Health Research (CIHR)Activo, no reclutandoDependencia a la nicotina, cigarrillos | Abstinencia de nicotinaCanadá