- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03924713
Evaluation of a Community Health Worker (CHW)-Led Program
Evaluation of a Community Health Worker (CHW)-Led Comprehensive Neighborhood-Based Program for Medicaid Enrollees in Detroit
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
This program evaluation examines the effectiveness, barriers and facilitators of implementing a geographically targeted program led by salaried CHWs from three Medicaid health plans in collaboration with the Detroit Health Department and Joy Southfield Community Development Corporation. Beneficiaries who reside in the Cody Rouge neighborhood and had more than 3 Emergency Department (ED) visits or at least 1 ambulatory care-sensitive hospitalization in the prior 12 months are randomized to the CHW program or to usual outreach from the health plans. CHWs reach out to eligible beneficiaries to provide a comprehensive assessment of health, behavioral, and social needs; link them to needed resources; and provide necessary follow-up. At 12- month follow up, health plan claims data on ED visits, ambulatory care-sensitive hospitalizations, primary care visits and all related costs will be compared between participants who participated in this program compared with other participants who would have been eligible but were not offered the program (with no effort to contact them).
The investigators hypothesize that patients enrolled in the CHW intervention will experience a reduction in acute care usage resulting in cost savings compared to those receiving usual health plan CHW outreach. This study is among the first to evaluate the impact on health care utilization of augmented services delivered by health plan CHWs for high-utilizing health plan members. This study will provide important information on the sustainability of future health plan CHW programs and provide insights into effective implementation of such programs.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Michigan
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Ann Arbor, Michigan, Estados Unidos, 48104
- University of Michigan
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Either have had more than 3 ED visits in the prior 12 months, or at least 1 ambulatory care-sensitive hospitalization in the prior 12 months
Exclusion Criteria:
- None if they meet above criteria.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Community Health Worker
|
Assessment of behavioral, medical, and social needs, development of individual goals and action plan, follow-up to assist and work to ensure identified needs/goals are met.
CHWs use their professional judgement to assess how long follow-up is required.
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Usual Health Plan Services
1) receipt of other plan services besides the CHW program for which they are eligible.
|
Assessment of behavioral, medical, and social needs, development of individual goals and action plan, follow-up to assist and work to ensure identified needs/goals are met.
CHWs use their professional judgement to assess how long follow-up is required.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Emergency Department Visits
Periodo de tiempo: 12-month period after participant enrolls in the program
|
Number of Emergency Department visits in health plan claims data
|
12-month period after participant enrolls in the program
|
|
Hospitalizations
Periodo de tiempo: 12-month period after participant enrolls in the program
|
Number and length of stay of hospitalizations in health plan claims data
|
12-month period after participant enrolls in the program
|
|
Primary care visits
Periodo de tiempo: 12-month period after participant enrolls in the program
|
Number of primary care visits in health plan claims data
|
12-month period after participant enrolls in the program
|
Colaboradores e Investigadores
Publicaciones y enlaces útiles
Publicaciones Generales
- Heisler M, Lapidos A, Kieffer E, Henderson J, Guzman R, Cunmulaj J, Wolfe J, Meyer T, Ayanian JZ. Impact on Health Care Utilization and Costs of a Medicaid Community Health Worker Program in Detroit, 2018-2020: A Randomized Program Evaluation. Am J Public Health. 2022 May;112(5):766-775. doi: 10.2105/AJPH.2021.306700. Epub 2022 Mar 24.
- Heisler M, Lapidos A, Henderson J, Guzman RM, Wolfe J, Meyer P, Law D, Kieffer EC, Ernst C, Djelaj V, Khaldun J, Ayanian JZ. Study protocol for a Community Health Worker (CHW)-led comprehensive neighborhood-focused program for medicaid enrollees in detroit. Contemp Clin Trials Commun. 2019 Sep 30;16:100456. doi: 10.1016/j.conctc.2019.100456. eCollection 2019 Dec.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- HUM00136277
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CÓDIGO_ANALÍTICO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA 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. .