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Aún no reclutaNCT07106541Registro de ClinicalTrials.gov

Population Based Strategies for Standardized Surgical Care

Hernia, Abdominal

LO ESENCIAL

De qué trata este estudio

El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.

Tipo de estudio
De intervención
Fase
No aplica
Rango de edad
18 años - No especificado
Sexo admitido
Todos los sexos
Voluntarios sanos
No aceptados
Participantes
68 Estimado

Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.

Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.

Acerca de la investigación

Evidence-based guidelines to improve clinical care for abdominal wall hernia repair are common, but adherence is low. This proposal aims to evaluate a stakeholder informed Replicating Effective Programs (REP) using a randomized controlled Sequential Multiple Assignment Randomized Trial (SMART).

The study team will leverage the 68-hospital Michigan Surgical Quality Collaborative Core Optimization Hernia Registry (MSQCCOHR), a statewide collaborative focused on quality improvement in hernia care. The study team will explore optimal remediation strategies for underperforming sites as well as opportunities to de-intensify interventions for responder sites.

¿Quién podría participar?

La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.

Inclusion Criteria:

\- All hospitals that participate in MSQC-COHR will be eligible to participate in the trial

Exclusion:

\- Institutes that are not in the MSQC-COHR

Entiende la evaluación inicial

Tratamiento, grupos y participación

El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.

Asignación
Asignación al azar
Enmascaramiento
Sin enmascaramiento
Replicating Effective Programs (REP) - baseline program non-randomized

All sites participating will be given this REP. This will be evaluated over 12 months.

Behavioral: Replicating Effective Programs (REP)

REP with facilitation (REP-PLUS) - stage 1 randomized group

Non-responders to the initial baseline program of REP MSQC-COHR hospitals (defined as hospitals that do not demonstrate ≥85% adherence to guidelines) randomized to this arm. This randomized arm will be evaluated over 12 months.

Behavioral: REP with facilitation (REP-PLUS)

Replicating Effective Programs (REP) - stage 1 randomized group

Non-responder to the initial baseline program of MSQC-COHR hospitals (defined as hospitals that do not demonstrate ≥85% adherence to guidelines) randomized to this arm. This randomized arm will be evaluated over 12 months.

Behavioral: Replicating Effective Programs (REP)

Replicating Effective Programs (REP) (non-responders) - stage 2 randomized group

Twelve months after the stage 1, non-responder MSQC-COHR hospitals (defined as hospitals that do not demonstrate ≥85% adherence to guidelines) that were assigned to the REP arm will be re-randomized to this arm or REP-PLUS. This randomized arm will be evaluated over 12 months.

Behavioral: Replicating Effective Programs (REP)

REP with facilitation (REP-PLUS) (non-responders) - stage 2 randomized group

Twelve months after the stage 1, non-responder MSQC-COHR hospitals (defined as hospitals that do not demonstrate ≥85% adherence to guidelines) that were assigned to the REP arm will be re- randomized to this arm REP-PLUS or REP alone. This randomized arm will be evaluated over 12 months.

Behavioral: REP with facilitation (REP-PLUS)

REP-PLUS (responders) - stage 2 randomized group

This group will include the REP-PLUS responders from stage 1. The responding hospitals will that are re-randomized to this group will continue to receive REP-PLUS.

Behavioral: REP with facilitation (REP-PLUS)

Replicating Effective Programs (REP) (responders)- stage 2 randomized group

This group will include the REP-PLUS responders from stage 1. The responding hospitals will that are re-randomized to this group will receive REP alone.

Behavioral: Replicating Effective Programs (REP)

Replicating Effective Programs (REP) BEHAVIORAL

The study team will deploy this stakeholder informed REP package across the 68 sites in the MSQC-COHR collaborative. The REP program uses a blend of formats including didactics, flipped classroom design, and narrative storytelling, the REP will address key barriers to adherence previously identified by surgeons.

REP with facilitation (REP-PLUS) BEHAVIORAL

This intervention is a stepped-up REP plus virtual facilitation. The facilitator will: 1) Initiate implementation and benchmark goals: The facilitator will partner with the identified site champions but be masked to primary and secondary outcomes. Together, the facilitator and site champions will review processes to organizationally embed clinical practice guidelines into practice, assess potential barriers and facilitators to these processes, and set measurable goals for adherence to recommendations; 2) Track adherence and provide feedback: Facilitators will use abstracted MSQC-COHR and site-specific operative data to track adherence to clinical practice guidelines, identify barriers to adherence, provide solutions to identified barriers, re-engage stakeholder groups responsible for unsatisfactory measurements, and continuously promote awareness of the guidelines.

Prepara tus preguntas

Qué evalúan los investigadores

Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.

Medidas principales

Adherence to clinical practice guidelines

Plazo: 12, 24, 36 months

Data will be reviewed from the MSQC-COHR. This is defined as the proportion of persons undergoing abdominal wall hernia that receive guideline concordant hernia care. The study team will define a "responder" as a site that has demonstrated ≥85% adherence to all three clinical practice guidelines.

El registro no indica resultados publicados.

Revisa las tablas completas y sus limitaciones en el registro oficial.

Abrir resultados oficiales ↗

Centros de investigación (1)

El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.

1 centros

University of Michigan and other Michigan Surgical Quality Collaborative sitesAnn Arbor, Michigan, United StatesEstado desconocido
Alexander HallwayCONTACTahallway@umich.edu734-998-2400
Anne Ehlers, MD, MPHPRINCIPAL_INVESTIGATOR
Ver ubicación en el mapa ↗

Equipo y fechas

Patrocinador principal
University of Michigan
Inicio del estudio
2028-06 Estimado
Finalización primaria
2029-06 Estimado
Finalización del estudio
2029-06 Estimado
Primera publicación
6 ago 2025 Real
Última actualización
10 nov 2026 Real

Contactos oficiales del estudio

Alexander HallwayCONTACTahallway@umich.edu734-998-2400
Título oficial del estudio

Population Based Strategies for Standardized Surgical Care

EL PRÓXIMO PASO, CON APOYO HUMANO

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Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.

Consultado: 11 nov 2026 · Última actualización del registro: 10 nov 2026