DE-RESTRICT: Deimplementing Activity Restriction for Preterm Birth Prevention
5 de agosto de 2026 actualizado por: Beth Pineles, University of Pennsylvania
Deimplementation of Activity Restriction for Preterm Birth Prevention in High-Risk Pregnancy (DE-RESTRICT): A Pilot Single-Arm Hybrid Effectiveness-Deimplementation Trial
DE-RESTRICT is a pilot study testing whether a strategy to reduce the use of activity restriction and bedrest in pregnancy is acceptable, appropriate, and feasible for prenatal care providers, and whether it changes how often activity restriction is recommended.
Activity restriction and bedrest are commonly advised to try to prevent preterm birth, but they do not prevent it and may cause harm, and national guidelines recommend against them.
The study takes place at two prenatal care settings within one health system and unfolds across four periods.
In the pre-deimplementation period the study team develops a local clinical guideline and measures baseline outcomes.
In the run-in period most provider education is delivered through interactive sessions with feedback, and audit and feedback begins.
In the maintenance period audit and feedback continues.
In the post-deimplementation period audit and feedback continues and outcomes are measured again.
The study measures provider acceptability, appropriateness, and feasibility, the rate of activity restriction recommendations, patient-reported wellbeing and care experience, and the preterm birth rate.
Descripción general del estudio
Estado
Reclutamiento
Intervención / Tratamiento
Descripción detallada
This pilot single-arm hybrid effectiveness-deimplementation trial evaluates a multicomponent strategy to deimplement activity restriction and bedrest prescribed for preterm birth prevention among prenatal care providers and patients at high risk for preterm birth. All participating practices receive the strategy; there is no control arm. The strategy comprises a locally developed clinical guideline aligning with national recommendations, interactive provider education with feedback, and audit and feedback on the rate of activity restriction recommendations.
The four periods are sequential. The guideline is developed during the pre-deimplementation period, when baseline outcomes are also measured. Most provider education is delivered during the run-in period through interactive educational sessions with feedback, and audit and feedback begins. Audit and feedback continues through the maintenance and post-deimplementation periods. Outcomes are measured in the pre-deimplementation and post-deimplementation periods, and the rate of activity restriction recommendations is tracked continuously through an existing clinical text-messaging platform to support audit and feedback.
Primary outcomes are provider-reported acceptability, appropriateness, and feasibility. Secondary outcomes are the penetration of activity restriction recommendations and patient-reported outcomes. The preterm birth rate is an exploratory outcome. Analyses compare the pre-deimplementation and post-deimplementation periods, with nonresponse weighting and adjustment for patient age, race, parity, and qualifying diagnosis, and a hospital by period interaction for hospital-level estimates.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
237
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.
Estudio Contacto
- Nombre: Beth Pineles, MD, PhD
- Número de teléfono: 267-283-8210
- Correo electrónico: Beth.Pineles@Pennmedicine.upenn.edu
Copia de seguridad de contactos de estudio
- Nombre: Kelli Jackson
- Correo electrónico: Kelli.Jackson@PennMedicine.upenn.edu
Ubicaciones de estudio
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19107
- Reclutamiento
- Pennsylvania Hospital
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Contacto:
- Beth L Pineles, MD, PhD
- Correo electrónico: Beth.Pineles@Pennmedicine.upenn.edu
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- Reclutamiento
- Hospital of the University of Pennsylvania
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Contacto:
- Beth L Pineles, MD, PhD
- Correo electrónico: Beth.Pineles@Pennmedicine.upenn.edu
-
-
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
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
Inclusion Criteria:
- For Providers: Physicians, midwives, physician assistants, nurse practitioners, nurses, nursing assistants, medical assistants, and other healthcare staff who provide or participate in prenatal or high-risk pregnancy care or consultation at a participating site.
- For Patients: Secondary patient-reported outcomes draw on pregnant individuals at high risk for preterm birth (qualifying diagnoses include short cervix, cervical insufficiency, multiple gestation, preterm labor, preterm contractions, vaginal bleeding, placental conditions, or a history of prior preterm birth), between 0 and 12 weeks postpartum for the survey measures. The activity restriction recommendation measure is collected through the Take Home Electronic Assessment (THEA) and therefore reaches only patients enrolled in THEA, at 33 weeks of gestation, across all periods; in the pre-deimplementation and post-deimplementation periods the additional survey battery is sent only to patients with a qualifying high-risk diagnosis.
Exclusion Criteria:
- For Providers: Staff who self-exclude by choosing not to interact with deimplementation meetings and communications
- For Patients: Patients are excluded if they are unable to walk or are hospitalized without discharge home before delivery after the qualifying diagnosis is made.
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: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Deimplementation strategy
All participating practices and providers receive the multicomponent deimplementation strategy.
There is a single group and no control arm.
The strategy comprises a locally developed clinical guideline aligning with national recommendations (developed in the pre-deimplementation period), interactive educational sessions with feedback delivered to providers (most delivered in the run-in period), and audit and feedback on the rate of activity restriction recommendations (delivered continuously from the run-in period through the post-deimplementation period).
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A multicomponent strategy to reduce provider-recommended activity restriction and bedrest for preterm birth prevention, comprising development of a local clinical guideline aligned with national recommendations and identification of site champions; interactive educational sessions for providers with feedback; periodic audit and feedback to practices on the rate of activity restriction recommendations; and patient educational materials on safe physical activity in pregnancy that are made available to clinicians, who may choose to share them with patients.
Delivered across the run-in, maintenance, and post-deimplementation periods and linked to the single study arm.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Acceptability of Intervention Measure (AIM)
Periodo de tiempo: Post-deimplementation period (approximately months 13 to 14)
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Mean provider score on the 4-item AIM, 5-point scale; higher scores indicate greater acceptability of the deimplementation strategy.
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Post-deimplementation period (approximately months 13 to 14)
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Intervention Appropriateness Measure (IAM)
Periodo de tiempo: Post-deimplementation period (approximately months 13 to 14)
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Mean provider score on the 4-item IAM, 5-point scale; higher scores indicate greater perceived appropriateness.
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Post-deimplementation period (approximately months 13 to 14)
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Feasibility of Intervention Measure (FIM)
Periodo de tiempo: Post-deimplementation period (approximately months 13 to 14)
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Mean provider score on the 4-item FIM, 5-point scale; higher scores indicate greater perceived feasibility.
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Post-deimplementation period (approximately months 13 to 14)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Penetration of activity restriction recommendations
Periodo de tiempo: Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
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Proportion of patients enrolled in THEA who, at 33 weeks, report a provider recommendation for activity restriction or bedrest, measured through the clinical text-messaging platform.
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Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
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Generalized anxiety (GAD-7)
Periodo de tiempo: Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
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Patient score on the GAD-7.
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Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
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Depressive symptoms (EPDS)
Periodo de tiempo: Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
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Patient score on the Edinburgh Postnatal Depression Scale.
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Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
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Perceived stress (PSS-10)
Periodo de tiempo: Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
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Patient score on the Perceived Stress Scale.
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Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
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Patient and clinician relationship (PDRQ-9)
Periodo de tiempo: Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
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Patient score on the Patient Doctor Relationship Questionnaire.
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Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
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Quality of prenatal care (QPCQ)
Periodo de tiempo: Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
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Patient score on the Quality of Prenatal Care Questionnaire across its six subscales.
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Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Preterm birth rate
Periodo de tiempo: Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
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Deliveries before 37 weeks divided by total deliveries at the included hospitals; no participant identifiers collected.
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Change from pre-deimplementation (months 0 to 2) to post-deimplementation (months 13 to 14)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Beth L Pineles, MD, PhD, University of Pennsylvania
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)
16 de julio de 2026
Finalización primaria (Estimado)
31 de agosto de 2027
Finalización del estudio (Estimado)
31 de agosto de 2027
Fechas de registro del estudio
Enviado por primera vez
30 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
7 de julio de 2026
Publicado por primera vez (Actual)
13 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
10 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
5 de agosto de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 26-6387
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
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
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