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- Ensayo clínico NCT03774797
Feasibility of Immediate Postpartum Long-acting Reversible Contraception Implementation
11 de febrero de 2021 actualizado por: Michelle H. Moniz, University of Michigan
Immediate Postpartum LARC Implementation: Pilot Study at Michigan Medicine
The objective of this study is to test and disseminate tools that drive successful immediate postpartum Long-Acting Reversible Contraception (LARC) implementation.
The long-term goal is to reduce unintended pregnancy soon after childbirth by increasing access to immediate postpartum LARC for women who desire it.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Based on previous work, the investigators have generated a toolkit to guide the integration of immediate postpartum LARC services into widespread clinical practice.
In the proposed work, this toolkit will be used to initiate immediate postpartum LARC services in a single site with low baseline immediate postpartum LARC uptake (Michigan Medicine).
The investigators will conduct a feasibility study using mixed methods to assess acceptability and appropriateness of toolkit items; patient experience of care; immediate postpartum LARC utilization rate; and prenatal contraceptive counseling rate.
Tipo de estudio
De observación
Inscripción (Actual)
592
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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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- Michigan Medicine
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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
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
Study population includes women receiving prenatal care and maternity providers working at the study site.
The patient populations includes approximately 5000 women annually.
The provider population includes approximately 400 maternity providers.
Descripción
Inclusion Criteria:
- Female (patients)
- Pregnant (patients)
- Receiving obstetrical care at Michigan Medicine (patients)
- L&D provider at Michigan Medicine (providers)
Exclusion Criteria:
- non-English speaking
- unable to provide informed consent
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
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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Pre-Implementation Patients
Enrolled patients will take online surveys following a prenatal or a postpartum visit.
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Post-Implementation Patients
All enrolled patients will take online surveys following a prenatal or a postpartum visit.
A subset will be interviewed after the postpartum survey.
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Post-implementation patients and providers will be assessed after the implementation toolkit has been used to improve service delivery at the study site.
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Post-Implementation Providers
All enrolled providers will take online surveys at 6-12 months after program implementation, and a subset will be interviewed.
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Post-implementation patients and providers will be assessed after the implementation toolkit has been used to improve service delivery at the study site.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Patient experience of care
Periodo de tiempo: Surveys will be collected from pregnant or postpartum women, during the 6-12 months after implementation of a new protocol for peripartum contraceptive care
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Patient online surveys about their experience of care during prenatal visits, hospital stay, or postpartum office visit
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Surveys will be collected from pregnant or postpartum women, during the 6-12 months after implementation of a new protocol for peripartum contraceptive care
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Acceptability of care process - patients
Periodo de tiempo: Surveys will be collected from pregnant or postpartum women, during the 6-12 months after implementation of a new protocol for peripartum contraceptive care
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Online survey assessing experience of care, acceptability and appropriateness of implementation tools
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Surveys will be collected from pregnant or postpartum women, during the 6-12 months after implementation of a new protocol for peripartum contraceptive care
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Appropriateness of care process - patients
Periodo de tiempo: Surveys will be collected from pregnant or postpartum women, during the 6-12 months after implementation of a new protocol for peripartum contraceptive care
|
Online survey assessing experience of care, acceptability and appropriateness of implementation tools
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Surveys will be collected from pregnant or postpartum women, during the 6-12 months after implementation of a new protocol for peripartum contraceptive care
|
Acceptability of implementation process - study site maternity care providers
Periodo de tiempo: Surveys will be collected during the 6-12 months after implementation of a new protocol for peripartum contraceptive care
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Online survey assessing overall experience of care delivery, acceptability and appropriateness of implementation tools
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Surveys will be collected during the 6-12 months after implementation of a new protocol for peripartum contraceptive care
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Appropriateness of implementation process - study site maternity care providers
Periodo de tiempo: Surveys will be collected during the 6-12 months after implementation of a new protocol for peripartum contraceptive care
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Online survey assessing overall experience of care delivery, acceptability and appropriateness of implementation tools
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Surveys will be collected during the 6-12 months after implementation of a new protocol for peripartum contraceptive care
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Acceptability of implementation toolkit items - patients
Periodo de tiempo: Interviews will take place after the survey is completed, during the 6-18 months after implementation of a new protocol for peripartum contraceptive care
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30-minute follow-up in-person interview of subgroup of patients who completed surveys
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Interviews will take place after the survey is completed, during the 6-18 months after implementation of a new protocol for peripartum contraceptive care
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Appropriateness of implementation toolkit items - patients
Periodo de tiempo: Interviews will take place after the survey is completed, during the 6-18 months after implementation of a new protocol for peripartum contraceptive care
|
30-minute follow-up in-person interview of subgroup of patients who completed surveys
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Interviews will take place after the survey is completed, during the 6-18 months after implementation of a new protocol for peripartum contraceptive care
|
Acceptability of implementation toolkit items - providers
Periodo de tiempo: Interviews will take place after the survey is completed, during the 6-18 months after implementation of a new protocol for peripartum contraceptive care
|
30-minute follow-up in-person interview of subgroup of providers who completed survey
|
Interviews will take place after the survey is completed, during the 6-18 months after implementation of a new protocol for peripartum contraceptive care
|
Appropriateness of implementation toolkit items - providers
Periodo de tiempo: Interviews will take place after the survey is completed, during the 6-18 months after implementation of a new protocol for peripartum contraceptive care
|
30-minute follow-up in-person interview of subgroup of providers who completed survey
|
Interviews will take place after the survey is completed, during the 6-18 months after implementation of a new protocol for peripartum contraceptive care
|
Perinatal contraceptive counseling rate
Periodo de tiempo: Measured monthly, up to 24 months after toolkit implementation
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Proportion of delivered patients with documentation of prenatal counseling about postpartum contraception
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Measured monthly, up to 24 months after toolkit implementation
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Immediate postpartum LARC provision rate
Periodo de tiempo: Measured monthly, up to 24 months after toolkit implementation
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Proportion of delivered patients with documentation of preference for immediate postpartum LARC who receive a LARC device
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Measured monthly, up to 24 months after toolkit implementation
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Michelle H. Moniz, MD, MSc, University of Michigan
- Investigador principal: Vanessa K. Dalton, MD, MPH, University of Michigan
- Investigador principal: Michelle Heisler, MD, MPH, University of Michigan
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 (Actual)
1 de septiembre de 2018
Finalización primaria (Actual)
16 de agosto de 2020
Finalización del estudio (Actual)
16 de agosto de 2020
Fechas de registro del estudio
Enviado por primera vez
20 de noviembre de 2018
Primero enviado que cumplió con los criterios de control de calidad
11 de diciembre de 2018
Publicado por primera vez (Actual)
13 de diciembre de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
12 de febrero de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
11 de febrero de 2021
Última verificación
1 de febrero de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- HUM00126810
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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. .
Ensayos clínicos sobre Implementation Toolkit
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University of MichiganThe Craig H. Neilsen FoundationReclutamientoLesiones de la médula espinalEstados Unidos
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University of Massachusetts, WorcesterAgency for Healthcare Research and Quality (AHRQ); Omnicare Clinical Research; ...TerminadoUso fuera de etiqueta de fármacos antipsicóticos atípicosEstados Unidos