- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02206386
Homecare Agency-Randomized Trial of Web Implementation Strategy for Depression
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
MHTraining-Net uses a web-based platform and several long distance tools (e.g., e-learning modules, telephone or web consultation, telephone calls, toolkits, and discussion boards) to deliver four types of implementation activities: infrastructure development, training and education, quality improvement, and social networking. MHTraining-Net was developed to ensure that the Depression CAREPATH (CARE for PATients at Home), specifically, and evidence-based practices, generally, can be implemented widely and successfully across independent organizations within a sector of care.
PROCEDURES: The effectiveness of MHTraining-Net on the implementation of the Depression CAREPATH will be tested in an agency-randomized trial of 160 HHAs. All HHAs are clients of Brightree (formerly CareAnyware, Inc), a software company that offers web-based point-of-care clinical management and administrative support for HHA nationwide. HHA clinicians record relevant data that is transmitted directly to Brightree for clinical and administrative purposes, including quality improvement initiatives. As part of each HHA's contract with Brightree is permission for using these data for performance enhancement research.
Brightree has already programmed Cornell's Depression CAREPATH, a depression care management protocol, into its clinical management system so that all nurses use the protocol. To promote the use of the protocol, Brightree has posted two relevant videos (archived Patient Health Questionnaire-9 training web seminar training); demonstration of how to navigate the protocol within the software) on its user education website.
Brightree will randomize HHAs to either MHTraining-Net, (N=100) or to Enhanced Support (N=60). Enhanced Support will have access to only the two training videos until the end of the study when they will be invited to MHTraining-Net. These procedures represent Brightree's typical "roll-out" approach on introducing new training and products to their client HHAs.
The study will test its hypotheses using three sets of data:
- Summary statistics describing the size and type of the 160 HHAs as well as their average nurse productivity over the 12 months preceding and following the study;
- Routinely collected administrative data on patients age >65 who screen positive for depression over one year, including Medicare-mandated assessments, medication lists, transaction files, indicators of whether the depression care management protocol was used, and Medicare case-mix adjustment and reimbursement indicators. We are using to term 'patients' to refer to a full episode of patient care, defined from the Start-of-Care date to Discharge, recognizing that a small proportion of unique individuals may have more than one full episode of care. We will not be able to identify such individuals. These data will be aggregated at the patient level in preparation for performance enhancement analyses using Brightree's routine procedures. Brightree will code the data, remove identifiers, and transmit them to Weill Cornell on a regular basis using the Weill Cornell ITS Department secure servers and protocols.
- Agency-level data on the use of the MHTraining-Net website (e.g., summary reports on 'hits' of each webpage) and agency-initiated contacts (telephone, email) through records maintained by Cornell project staff.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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New York
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White Plains, New York, Estados Unidos, 10605
- Weill Cornell Medical College
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Geriatric patients 65 and older
- Patients screened for depression using the Patient Health Questionnaire-2
Exclusion Criteria:
- Geriatric patients under age 65
- Patients who were not screened for depression using the Patient Health Questionnaire-2
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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Experimental: MentalHealthTraining-Net
MHTraining-Net is an implementation strategy that uses a web-based platform with several long distance tools (e.g.
e-learning modules, consultation, telephone calls, toolkits, and discussion boards) to deliver four types of implementation activities: infrastructure development, training and education, quality improvement, and social networking.
|
See Arm Description for more details.
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Comparador activo: Enhanced Support
Nurses in agencies randomized to Enhanced Support have full access to the study protocol and to recorded trainings in the use of the protocol and depression screening posted by Brightree.
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Nurses in agencies randomized to Enhanced Support have full access to the study protocol and to recorded training in the use of the protocol and depression screening posted by Brightree.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Nurse adherence to the depression care management protocol (Depression CAREPATH intervention).
Periodo de tiempo: one episode (60 days)
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At least one follow-up depression assessment and evidence of case coordination (e.g., contacting the patient's physician or a specialist) to evaluate treatment needs.
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one episode (60 days)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Patient reduction in depression symptoms
Periodo de tiempo: one episode of care (60 days)
|
Patient Health Questionnaire (two item version and nine item version)
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one episode of care (60 days)
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Martha L Bruce, PhD, MPH, Weill Medical College of Cornell University
Publicaciones y enlaces útiles
Publicaciones Generales
- Bruce ML, Raue PJ, Sheeran T, Reilly C, Pomerantz JC, Meyers BS, Weinberger MI, Zukowski D. Depression Care for Patients at Home (Depression CAREPATH): home care depression care management protocol, part 2. Home Healthc Nurse. 2011 Sep;29(8):480-9. doi: 10.1097/NHH.0b013e318229d75b.
- Bruce ML, Sheeran T, Raue PJ, Reilly CF, Greenberg RL, Pomerantz JC, Meyers BS, Weinberger MI, Johnston CL. Depression care for patients at home (Depression CAREPATH): intervention development and implementation, part 1. Home Healthc Nurse. 2011 Jul-Aug;29(7):416-26. doi: 10.1097/NHH.0b013e31821fe9f7.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- R01MH096441 (Subvención/contrato del NIH 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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