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- Ensayo clínico NCT01900470
Effectiveness of Patient-centered Community Health Worker Support to Help Patients Control Chronic Disease
2 de mayo de 2017 actualizado por: University of Pennsylvania
Community Health Worker Support to Help Patients Control Chronic Disease
The purpose of this proposal is to compare the effectiveness of community health worker (CHW) support vs. usual primary care for helping chronically-ill, low-SES patients to improve control of chronic conditions.
Upon enrollment each patient will select one of their multiple chronic conditions as a focus for the trial and work with his/her PCP to set a chronic disease management goal.
Patients are then randomized to receive usual primary care vs. CHW support for moving towards that goal.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
302
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
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- University of Pennsylvania
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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
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Patient of target practices for at least 1 yr defined as having one office visit within preceding 12 month
- Home ZIP code including ANY of the following: 1. 19104 2. 19131 3. 19139 4. 19143 5. 19146
- 2 or more of the following conditions: 1. Obesity (BMI greater than 30), 2. HTN (ICD9 relating to HTN in EMR), 3. DM (ICD9 relating to DM in EMR), 4. Asthma/COPD and tobacco dependence (ICD9 for asthma or COPD in EMR AND documentation of tobacco use)
- Uninsured, insured by Medicaid or dually eligible for Medicaid/Managed Medicare
- Patients who have scheduled appointments in the future.
Exclusion Criteria:
- Will not provide informed consent for this study.
- Does not have the capacity to provide informed consent for this study.
- Previously enrolled in this study
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: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: CHW Goal Support
IMPaCT CHWs will perform the following functions, depending on the needs of the participants: 1) Deconstructing Distal Goals into Proximal Goals: IMPaCT CHWs will help patients to deconstruct collaborative distal clinical goals into patient driven proximal goals and develop strategies for achieving each proximal goal.2) Creating Roadmaps: Roadmaps are individualized strategies for achieving each proximal goal identified by patients.
3) IMPaCT CHWs conduct weekly follow-up with patients through either telephone or home visit in order to support the achievement of proximal goals.
As part of these followup encounters, CHWs ask patients to measure their chronic disease control during their weekly followup calls/visits.
4) Group: CHWs and their Project Manager run a group session for patients in the IMPaCT arm.
This group meets weekly and is a forum for patients to discuss common issues around chronic disease management and form a social support network.
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IMPaCT CHWs will perform the following functions, depending on the needs of the participants: 1) Deconstructing Distal Goals into Proximal Goals: IMPaCT CHWs will help patients to deconstruct collaborative distal clinical goals into patient driven proximal goals and develop strategies for achieving each proximal goal.2) Creating Roadmaps: Roadmaps are individualized strategies for achieving each proximal goal identified by patients.
3) IMPaCT Partners conduct weekly follow-up with patients through either telephone or home visit in order to support the achievement of proximal goals.
As part of these followup encounters, CHWs ask patients to measure their chronic disease control during their weekly followup calls/visits.
4) Group: CHWs and their Project Manager run a group session for patients in the IMPaCT arm.
This group meets weekly and is a forum for patients to discuss common issues around chronic disease management and form a social support network.
Otros nombres:
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Sin intervención: Usual Primary Care
Patients will be encouraged to make follow-up appointments as needed with their primary care clinic for support towards their health goals.
During these appointments, clinicians will help patients determine progress made on existing proximal goals, adjust goals based on self-efficacy, and help patients to create new proximal goals as needed.
They will also work with PCPs to adjust medications when appropriate, provide health behavior education and make referrals to community-based services based on patient need.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in standardized score
Periodo de tiempo: Six months after enrollment
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Six months after enrollment, the IMPaCT arm will have a higher (more negative) mean change in standardized score for chronic disease outcome of interest compared with usual care
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Six months after enrollment
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Goal achievement
Periodo de tiempo: Six months after enrollment
|
Six months after enrollment, patients in the IMPaCT group will have higher proportion of patients who achieve their individualized chronic disease management goal compared with usual care
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Six months after enrollment
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SF-12
Periodo de tiempo: Six months after enrollment,
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Six months after enrollment, patients in the IMPaCT group will greater improvements in their self-rated health (as measured by mean change in MCS and PCS of the SF-12) than patients receiving usual care.
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Six months after enrollment,
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CAHPS PCMH (Communication, Self-Management Support, Comprehensiveness of Care)
Periodo de tiempo: Six months after enrollment
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Six months after enrollment, the IMPaCT arm will have higher perceived quality of patient-centered medical care (as measured by the Consumer Assessment of Healthcare Providers and Systems Patient-Centered Medical Home (CAHPS PCMH) survey) than the usual care arm.
Specifically, we will measure the CAHPS PCMH domains pertaining to Self-Management Support and Comprehensiveness of Care.
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Six months after enrollment
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Hospitalization
Periodo de tiempo: 6 months after enrollment
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Patients in the IMpaCT arm with have a lower rate of hospitalizations than the usual care arm at 6 months after enrollment.
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6 months after enrollment
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Patient Activation
Periodo de tiempo: Six months after enrollment
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Six months after enrollment, patients in the IMPaCT arm will have greater improvements in their activation (as measured by mean change in PAM score) compared with patients in the usual care arm.
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Six months after enrollment
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Hospitalizations at 12 months
Periodo de tiempo: 12 months after enrollment
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Patients in the IMpaCT arm with have a lower rate of hospitalizations than the usual care arm at 12 months after enrollment.
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12 months after enrollment
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Medical Adherence
Periodo de tiempo: Six months after enrollment
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Six months after enrollment, patients in the IMPaCT arm will have higher levels of adherence to medical recommendations than the usual care arm, as measured by the Medical Outcomes Study (MOS) Measures of Patient Adherence.
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Six months after enrollment
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Shreya Kangovi, University of Pennsylvania
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
- Kangovi S, Mitra N, Grande D, Huo H, Smith RA, Long JA. Community Health Worker Support for Disadvantaged Patients With Multiple Chronic Diseases: A Randomized Clinical Trial. Am J Public Health. 2017 Oct;107(10):1660-1667. doi: 10.2105/AJPH.2017.303985. Epub 2017 Aug 17.
- Kangovi S, Mitra N, Turr L, Huo H, Grande D, Long JA. A randomized controlled trial of a community health worker intervention in a population of patients with multiple chronic diseases: Study design and protocol. Contemp Clin Trials. 2017 Feb;53:115-121. doi: 10.1016/j.cct.2016.12.009. Epub 2016 Dec 10.
- Kangovi S, Mitra N, Smith RA, Kulkarni R, Turr L, Huo H, Glanz K, Grande D, Long JA. Decision-making and goal-setting in chronic disease management: Baseline findings of a randomized controlled trial. Patient Educ Couns. 2017 Mar;100(3):449-455. doi: 10.1016/j.pec.2016.09.019. Epub 2016 Sep 25.
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
1 de julio de 2013
Finalización primaria (Actual)
1 de mayo de 2015
Finalización del estudio (Actual)
1 de febrero de 2017
Fechas de registro del estudio
Enviado por primera vez
11 de julio de 2013
Primero enviado que cumplió con los criterios de control de calidad
11 de julio de 2013
Publicado por primera vez (Estimar)
16 de julio de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
3 de mayo de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
2 de mayo de 2017
Última verificación
1 de mayo de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IRB 817488
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. .