- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02355262
CATCH-UP Intervention in Increasing Cancer Screening and Prevention Care in Uninsured Patients at Community Health Centers
Community-Based HIT Tools for Cancer Screening and Health Insurance Promotion (CATCH-UP)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
PRIMARY OBJECTIVES:
I. Evaluate the effect of the CATCH-UP intervention on up-to-date status of cancer screening and preventive care received by patients.
II. Evaluate the effect of the CATCH-UP intervention on patients? insurance coverage rates.
III. Evaluate the intervention implementation process, patient and community health center (CHC) staff acceptance and use of the CATCH-UP tools, and the patient-, provider-, and system-level factors associated with successful implementation and sustainability of the tools, using mixed methods.
OUTLINE: CHC clinics are randomized to 1 of 2 groups. We compare between groups and with a matched-comparison group.
GROUP I (INTERVENTION ARM 1): Participants receive CATCH-UP tools which include a panel management/data aggregator system that identifies patients who may be eligible for public coverage but are not yet insured, or who are nearing coverage expiration, coupled with automated patient outreach and communication at baseline.
GROUP II (INTERVENTION ARM 2): Participants receive CATCH-UP tools which include a panel management/data aggregator system that identifies patients who may be eligible for public coverage but are not yet insured, or who are nearing coverage expiration, coupled with automated patient outreach and communication. Participants also receive additional implementation support such as trainings, assistance with workflows, and practice facilitation.
Matched-comparison group: A clinic-level matched comparison group will be derived from the OCHIN membership by using propensity score matching techniques. Comparison group clinics will not participate actively in any study activities but, as part of their member business associate agreement with OCHIN, have already agreed to provide data through OCHIN for pre- and post-implementation analysis in the study.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Oregon
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Portland, Oregon, Estados Unidos, 97239
- OHSU Knight Cancer Institute
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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:
- Established patients at CHC sites
- Low-income
- Ethnically diverse populations with lower rates of cancer screening compared to national rates
- Uninsured patients
- Patients 18 to 64 years of age
- Clinics must be primary care sites, with greater than 1,000 adult patients in the past year, be located in a state that expanded Medicaid, and have implemented the OCHIN EHR prior to January 1, 2012
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Arm I (Independent Tool Implementation)
Participants receive CATCH-UP tools which include a panel management/data aggregator system that identifies patients who may be eligible for public coverage but are not yet insured, or who are nearing coverage expiration, coupled with automated patient outreach and communication at baseline.
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Receive CATCH-UP intervention
|
|
Arm II (Tool Implementation with Interactive Facilitation)
Participants receive CATCH-UP tools which include a panel management/data aggregator system that identifies patients who may be eligible for public coverage but are not yet insured, or who are nearing coverage expiration, coupled with automated patient outreach and communication.
Participants also receive additional implementation support such as trainings, assistance with workflows, and practice facilitation.
|
Receive CATCH-UP intervention
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Changes in the proportion of clinic patients who receive age- and gender-appropriate recommended cancer screening and preventive care (clinic-level)
Periodo de tiempo: Baseline to up to 6 years
|
Pre- and post-implementation differences in proportion of patients with insurance continuity will be calculated between implementation and control community health centers (?difference-in-differences? analysis).
Generalized linear/non-linear mixed models will be used, which offer flexible regression modeling to accommodate different sources of correlations (serial and intra-clinic), categorical and continuous covariates, and fixed and time-dependent covariates.
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Baseline to up to 6 years
|
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Changes in the proportion of clinic patients with insurance continuity
Periodo de tiempo: Baseline to up to 6 years
|
Pre- and post-implementation differences in proportion of patients with insurance continuity will be calculated between implementation and control community health centers (?difference-in-differences? analysis).
Generalized linear/non-linear mixed models will be used, which offer flexible regression modeling to accommodate different sources of correlations (serial and intra-clinic), categorical and continuous covariates, and fixed and time-dependent covariates.
Serial and intra-clinic correlations will be modeled as random effects.
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Baseline to up to 6 years
|
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Total number of months uninsured (total gap months)
Periodo de tiempo: Up to 6 years
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The Community-based Health Information Technology (HIT) Tools for Cancer Screening and Health Insurance Promotion tool?s impact on total number of months uninsured (total gap months) will be evaluated.
The distribution of total gap months will be examined before selecting a specific model to use for the analysis.
Analytic models will be refined through an iterative process, guided by the hypotheses and preliminary analyses.
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Up to 6 years
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jennifer DeVoe, OHSU Knight Cancer Institute
Publicaciones y enlaces útiles
Publicaciones Generales
- Hoopes MJ, Angier H, Gold R, Bailey SR, Huguet N, Marino M, DeVoe JE. Utilization of Community Health Centers in Medicaid Expansion and Nonexpansion States, 2013-2014. J Ambul Care Manage. 2016 Oct-Dec;39(4):290-8. doi: 10.1097/JAC.0000000000000123.
- Hatch B, Tillotson C, Angier H, Marino M, Hoopes M, Huguet N, DeVoe J. Using the electronic health record for assessment of health insurance in community health centers. J Am Med Inform Assoc. 2016 Sep;23(5):984-90. doi: 10.1093/jamia/ocv179. Epub 2016 Jan 23.
- DeVoe JE, Tillotson CJ, Marino M, O'Malley J, Angier H, Wallace LS, Gold R. Trends in Type of Health Insurance Coverage for US Children and Their Parents, 1998-2011. Acad Pediatr. 2016 Mar;16(2):192-9. doi: 10.1016/j.acap.2015.06.009. Epub 2015 Aug 18.
- DeVoe JE, Huguet N, Likumahuwa-Ackman S, Angier H, Nelson C, Marino M, Cohen D, Sumic A, Hoopes M, Harding RL, Dearing M, Gold R. Testing health information technology tools to facilitate health insurance support: a protocol for an effectiveness-implementation hybrid randomized trial. Implement Sci. 2015 Aug 25;10:123. doi: 10.1186/s13012-015-0311-4.
- Angier H, Hoopes M, Gold R, Bailey SR, Cottrell EK, Heintzman J, Marino M, DeVoe JE. An early look at rates of uninsured safety net clinic visits after the Affordable Care Act. Ann Fam Med. 2015 Jan-Feb;13(1):10-6. doi: 10.1370/afm.1741.
- Heintzman J, Marino M, Hoopes M, Bailey SR, Gold R, O'Malley J, Angier H, Nelson C, Cottrell E, Devoe J. Supporting health insurance expansion: do electronic health records have valid insurance verification and enrollment data? J Am Med Inform Assoc. 2015 Jul;22(4):909-13. doi: 10.1093/jamia/ocv033. Epub 2015 Apr 17.
- DeVoe JE, Angier H, Burdick T, Gold R. Health information technology: an untapped resource to help keep patients insured. Ann Fam Med. 2014 Nov-Dec;12(6):568-72. doi: 10.1370/afm.1721.
- Gold R, Burdick T, Angier H, Wallace L, Nelson C, Likumahuwa-Ackman S, Sumic A, DeVoe JE. Improve Synergy Between Health Information Exchange and Electronic Health Records to Increase Rates of Continuously Insured Patients. EGEMS (Wash DC). 2015 Aug 6;3(1):1158. doi: 10.13063/2327-9214.1158. eCollection 2015.
- Huguet N, Hoopes MJ, Angier H, Marino M, Holderness H, DeVoe JE. Medicaid Expansion Produces Long-Term Impact on Insurance Coverage Rates in Community Health Centers. J Prim Care Community Health. 2017 Oct;8(4):206-212. doi: 10.1177/2150131917709403. Epub 2017 May 17.
- Huguet N, Valenzuela S, Marino M, Moreno L, Hatch B, Baron A, Cohen DJ, DeVoe JE. Effectiveness of an insurance enrollment support tool on insurance rates and cancer prevention in community health centers: a quasi-experimental study. BMC Health Serv Res. 2021 Oct 30;21(1):1186. doi: 10.1186/s12913-021-07195-5. Erratum In: BMC Health Serv Res. 2022 May 2;22(1):587.
- Hatch B, Tillotson C, Huguet N, Marino M, Baron A, Nelson J, Sumic A, Cohen D, E DeVoe J. Implementation and adoption of a health insurance support tool in the electronic health record: a mixed methods analysis within a randomized trial. BMC Health Serv Res. 2020 May 15;20(1):428. doi: 10.1186/s12913-020-05317-z.
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 (Estimar)
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
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Enfermedades de la piel
- Enfermedades virales
- Infecciones
- Neoplasias por tipo histológico
- Neoplasias por sitio
- Neoplasias Glandulares y Epiteliales
- Neoplasias Gastrointestinales
- Neoplasias del Sistema Digestivo
- Enfermedades Gastrointestinales
- Enfermedades de los senos
- Enfermedades del Colon
- Enfermedades intestinales
- Infecciones por virus de ADN
- Neoplasias Intestinales
- Enfermedades Rectales
- Infecciones por virus tumorales
- Neoplasias
- Neoplasias de mama
- Carcinoma
- Neoplasias colorrectales
- Infecciones por virus del papiloma
Otros números de identificación del estudio
- IRB00009862 (Otro identificador: OHSU Knight Cancer Institute)
- NCI-2014-02326 (Identificador de registro: CTRP (Clinical Trial Reporting Program))
- CR00024554
- 5219
- MR00042926
- MR00044877
- R01CA181452 (Subvención/contrato del NIH de EE. UU.)
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