Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

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

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

    • Michigan
      • Ann Arbor, Michigan, Estados Unidos, 48109
        • Michigan Medicine

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
Pre-Implementation Patients
Enrolled patients will take online surveys following a prenatal or a postpartum visit.
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.
Post-implementation patients and providers will be assessed after the implementation toolkit has been used to improve service delivery at the study site.
Post-Implementation Providers
All enrolled providers will take online surveys at 6-12 months after program implementation, and a subset will be interviewed.
Post-implementation patients and providers will be assessed after the implementation toolkit has been used to improve service delivery at the study site.

¿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
Patient online surveys about their experience of care during prenatal visits, hospital stay, or postpartum office visit
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 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
Surveys will be collected from pregnant or postpartum women, during the 6-12 months after implementation of a new protocol for peripartum contraceptive care
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
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
Online survey assessing overall experience of care delivery, acceptability and appropriateness of implementation tools
Surveys will be collected during the 6-12 months after implementation of a new protocol for peripartum contraceptive care
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
Online survey assessing overall experience of care delivery, acceptability and appropriateness of implementation tools
Surveys will be collected during the 6-12 months after implementation of a new protocol for peripartum contraceptive care

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
30-minute follow-up in-person interview of subgroup of patients who completed surveys
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 - 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
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
Proportion of delivered patients with documentation of prenatal counseling about postpartum contraception
Measured monthly, up to 24 months after toolkit implementation
Immediate postpartum LARC provision rate
Periodo de tiempo: Measured monthly, up to 24 months after toolkit implementation
Proportion of delivered patients with documentation of preference for immediate postpartum LARC who receive a LARC device
Measured monthly, up to 24 months after toolkit implementation

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

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

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

3
Suscribir