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Evaluación de un Programa Personalizable de Optimización del Uso de Antibióticos Adaptado a Residencias de Ancianos Francesas (ORANEAT)

30 de septiembre de 2026 actualizado por: Nelly Agriner, University of Lorraine

Evaluación de un Programa Personalizable de Gestión de Antibióticos Basado en una Evaluación Integral de las Actitudes de las Organizaciones y los Profesionales de la Salud, y Adaptado a las Necesidades de las Residencias de Ancianos Francesas

To tackle antimicrobial resistance (AMR), i.e., one of the top 10 global health threats, antimicrobial stewardship (AMS) programs, i.e., coherent sets of actions promoting responsible use of antimicrobials, have been developed. Despite growing evidence about their effectiveness, their implementation remains suboptimal. Qualifying as complex interventions, these programs are prone to interactions with context, potentially compromising their successful transfer to other settings. AMR remains critical in French nursing homes (NHs). AMS programs have proven effective in reducing antimicrobial resistance in hospitals and in NHs. However, the evidence is inconsistent across studies in NHs and mostly based on North American and North European AMS programs and studies, raising concerns about transferability that might occur while implementing such AMS programs in French NHs. For instance, health systems and NH funding and organization vary considerably across countries, resulting in potential key determinants driving antibiotic use in such facilities in some countries that might remain untargeted by AMS programs developed in other countries. In addition, inconsistent effectiveness of AMS programs in NHs might also result from implementation issues, raising concerns about the strategies used to implement such programs. Based on extensive logic models linking psychosocial and organizational determinants driving antibiotic use in NHs of diverse countries, we developed and pilot-tested a customizable AMS program (i.e., the ORANEAT program) suited to French NHs, including three major components: (i) a contextual diagnostic regarding AMS in the targeted NH; (ii) based on the results of the contextual diagnostic, a bundle of tools selected from an AMS-toolkit including actions and tools suited to French NH setting; and (iii) implementation support relying on French structures involved in tackling AMR (i.e., CRAtb and CPias).

This study aims to assess the effectiveness, the sustainability, the implementation, and the transferability of the ORANEAT program in French NHs, using a mixed-method approach (quantitative and qualitative data). A cluster randomized controlled trial with two arms (ORANEAT program vs. no specific intervention) will be conducted; the cluster being the NH. The primary outcome to measure the effectiveness is total antibiotic use expressed in defined daily doses/1000 resident-days/month.

Descripción general del estudio

Estado

Reclutamiento

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

66

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

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

      • Nantes, Francia, 44093
        • Reclutamiento
        • CPias PdL (for the Pays de la Loire region)
        • Contacto:
      • Vandœuvre-lès-Nancy, Francia, 54505
        • Reclutamiento
        • CIC-EC (for the Grand Est region)
        • Contacto:

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

Sí

Géneros elegibles para el estudio

Todos

Descripción

Nursing homes

Inclusion criteria:

• Nursing home located in one of the geographical areas participating in the study in two French regions (i.e., geographical areas covered by experts in antibiotic stewardship and/or in infection prevention and control who agreed to participate in the study)

Exclusion criteria:

  • Nursing home with a pharmacy for internal use
  • Participation to the pilot study
  • Data from the Health Insurance reimbursement database (Système national des données de santé) not available on the study period
  • Refusal of the nursing director to participate in the study (for Arm 1 only)

Residents (Outcomes 1 to 4 and outcome 12)

Inclusion criteria:

• Resident aged 18 or more who had lived in one of the participating nursing homes during the study period.

Exclusion criteria:

/

Healthcare professionals (Outcomes 11, 13 and 15)

Inclusion criteria:

• Healthcare professionals aged 18 or more working in one of the participating nursing homes from Arm 1 (including healthcare professionals who provide services to or collaborate with the nursing home even if they are not on-site, e.g., private general practitioners, community pharmacists, microbiologists, and professionals responsible for the implementation support).

Exclusion criteria:

• Refusal to complete the self-administered questionnaires or to participate in qualitative investigations.

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: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Experimental group

Nursing homes in the experimental group will receive the ORANEAT antibiotic stewardship program.

The ORANEAT multifaceted customizable antibiotic stewardship program includes (i) a contextual diagnostic regarding AMS in the targeted NH; (ii) based on the results of the contextual diagnostic, a bundle of tools selected from an AMS-toolkit including actions and tools suited to French NH setting and covering the main CDC domains of AMS in NHs; and (iii) implementation support relying on French structures involved in tackling AMR (i.e., CRAtb and CPias).

Sin intervención: Control group

Nursing homes in the control group will not receive the ORANEAT antibiotic stewardship program ("usual care").

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall antibiotic prescription rate (DDD)
Periodo de tiempo: 12 months

Overall antibiotic prescription rate expressed in Defined Daily Doses (DDD)/1000 resident-days/month.

Measured using data from the Health Insurance reimbursement database.

12 months
Overall antibiotic prescription rate (number of prescriptions)
Periodo de tiempo: 12 months

As part of a sensitivity analysis:

Overall antibiotic prescription rate expressed in number of prescriptions/1000 resident-days/month.

Measured using data from the Health Insurance reimbursement database.

12 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Effectiveness of the intervention - broad-spectrum antibiotics
Periodo de tiempo: 12 months

Broad-spectrum antibiotic prescription rate expressed in Defined Daily Doses (DDD)/1000 resident-days/month. Broad-spectrum antibiotics include quinolones and 3rd-generation cephalosporins. Measured using data from the Health Insurance reimbursement database.

12 months
Effectiveness of the intervention - appropriateness of antibiotic prescriptions
Periodo de tiempo: 12 months

Proxy indicators reflecting the appropriateness of antibiotic use in nursing homes (Asquier-Khati et al. 2023, doi:10.1093/jacamr/dlad037). These proxy indicators assess the appropriateness of prescriptions for urinary tract infections, seasonal variations in prescriptions, repeated prescriptions of fluoroquinolones, cephalosporins' route of administration, duration of treatment, rate of second-line antibiotics, and co-prescriptions with non-steroidal anti-inflammatory drugs.

12 months
Safety of the intervention
Periodo de tiempo: 12 months

Number of hospital admissions/1000 resident-days and number of deaths/1000 resident-days among nusing home residents.

Measured using data from the Health Insurance reimbursement database.

12 months
Sustainability of the effectiveness
Periodo de tiempo: 24 months

Overall antibiotic prescription rate expressed in Defined Daily Doses (DDD)/1000 resident-days/month.

As part of a sensitivity analysis: Overall antibiotic prescription rate expressed in number of prescriptions/1000 resident-days/month.

Measured using data from the Health Insurance reimbursement database.

24 months

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Context of the intervention - nursing homes' characteristics
Periodo de tiempo: At inclusion

Nursing homes' staff resources (number of coordinating physicians, nurses, assistant nurses and general practitioners).

Measured using data collected by the research team through ad hoc standardized activity reports.

At inclusion
Context of the intervention - nursing homes' geographic areas' characteristics
Periodo de tiempo: At inclusion

Characteristics of the geographic areas of the nursing homes (type of area: rural/semi-urban/urban; access to general practioners in the area according to the Local Potential Accessibility Index, which considers the number of general practioners, their level of activity, the age of the population, and the distance to GPs' offices within the municipality ).

Measured using data from administrative public databases.

At inclusion
Adoption of the intervention
Periodo de tiempo: 12 months

Number of nursing homes included / number of nursing homes invited to participate in the intervention group * 100, by stratum.

Measured using data collected by the research team through ad hoc standardized activity reports.

12 months
Reach of the target population - contextual diagnosis
Periodo de tiempo: 12 months

For each profesionnal category (nursing home coordinating physician or nurse, nurses, assistant nurses and referring general practitioners), participation rate (%) in the contextual diagnostic questionnaire of the ORANEAT program (first component of the program), calculated as as the number of completed questionnaires divided by the total number of professionals in that category x 100.

12 months
Reach of the target population - antimicrobial stewardship tools/actions
Periodo de tiempo: Through the end of the intervention, an average of 12 months

Proportion of nurses and assistant nurses attending at least one training session; proportion of referring general practitioners contacted at least once regarding the ORANEAT program by the external or the internal facilitators; number of tools distributed (number of copies provided to the nursing home, for each tool); proportion of nursing homes that developed at least one tool as part of the "tool development" action of the ORANEAT program.

Measured using data collected by the research team through ad hoc standardized activity reports.

Through the end of the intervention, an average of 12 months
Fidelity of the intervention - antimicrobial stewardship tools
Periodo de tiempo: Through the end of the intervention, an average of 12 months

Number of tools used / number of tools included in the bundle of tools, for each bundle.

Measured using data collected by the by the research team through ad hoc standardized activity reports.

Through the end of the intervention, an average of 12 months
Fidelity of the intervention - categories of antimicrobial stewardship tools
Periodo de tiempo: At 3 months, 6 months, 9 months and 12 months

Number of categories of the antimicrobial stewardship tools/actions implemented in the nursing home according to the contextual diagnostic tool of the ORANEAT program and their evolution over 12 months. Categories are defined according to the Centers for Disease Control and Prevention (CDC) core elements of antibiotic stewardship for nursing homes.

Data collected through the questionnaires of the contextual diagnostic.

At 3 months, 6 months, 9 months and 12 months
Dose of intervention - score of exposure to the intervention
Periodo de tiempo: Through the end of the intervention, an average of 12 months

Score of exposure to each component of the ORANEAT program. This composite measure will capture the intensity of exposition to each component of the program in each nursing home (i.e., the contextual diagnosis, the exposition to the tools/actions, and the implementation strategies).

Measured using data collected by the research team through ad hoc standardized activity reports, the questionnaires of the contextual diagnostic and annual activity reports from the local antimicrobial stewardship teams.

Through the end of the intervention, an average of 12 months
Dose of intervention - antimicrobial stewardship tools
Periodo de tiempo: Through the end of the intervention, an average of 12 months

Number of tools used for each target population. Measured using data collected by the by the research team through ad hoc standardized activity reports.

Through the end of the intervention, an average of 12 months
Dose of intervention - implementation support
Periodo de tiempo: Through the end of the intervention, an average of 12 months

Number of meetings with the internal and external facilitators held as part of the implementation support of the ORANEAT program (third component of the program).

Measured using data collected by the by the research team through ad hoc standardized activity reports.

Through the end of the intervention, an average of 12 months
Dose of intervention - time to implement the program
Periodo de tiempo: Through the end of the intervention, an average of 12 months

Average time (days) between validation of the pack with the internal facilitators and the date when all tools are reported as used.

Measured using data collected by the by the research team through ad hoc standardized activity reports.

Through the end of the intervention, an average of 12 months
Adaptation of the intervention
Periodo de tiempo: Through the end of the intervention, an average of 12 months

Number of tools withdrawn from the bundle of tools or modified (in form and/or content) or added / number of tools initially proposed (for each bundle of tools and overall).

Measured using data collected by the by the research team through ad hoc standardized activity reports.

Through the end of the intervention, an average of 12 months
Users' experiences of the intervention
Periodo de tiempo: 12 months

Users' experiences with the ORANEAT program assessed among coordinating physicians/nurses, nurses, assistant nurses and general practitioners using a questionnaire UREMs (User Reported Experience Measures) adapted from PREMs (Patient Reported Experience Measures) developed by the research team. This questionnaire was designed to measure the users reported experience of the intervention. A score ranging from 0 to 100 will be calculated; higher score means better experience.

12 months
Sustainability of the intervention
Periodo de tiempo: 12 months

Sustainability of the ORANEAT program assessed among coordinating physicians/nurses, nurses, assistant nurses and general practitioners using the NoMAD questionnaire (questionnaire based on the normalization process theory [NPT], measuring the normalization of complex healthcare interventions - Finch et al. 2018 - doi: 10.1186/s12874-018-0591-x). The NoMAD questionnaire includes three general items on the intervention answered on an 11-point Likert scale ranging from 0 to 10, and 20 items representing the four key constructs of NPT: coherence (4 items), cognitive participation (4 items), collective action (7 items), and reflexive monitoring (5 items) answered on a 5-point Likert scale ranging from strongly agree to strongly disagree. Mean scale scores will be calculated for each NoMAD construct as well as for the overall scale (20 items); higher scores mean higher degree of normalization.

12 months
Mechanisms of impact of the intervention - prescriptions of urine cultures
Periodo de tiempo: 12 months

Number of urine cultures prescribed/1000 resident-days/month. Measured using data from the Health Insurance reimbursement database.

12 months
Mechanisms of impact of the intervention - nursing home professionals' knowledge, attitudes, practices and motivation
Periodo de tiempo: At inclusion, 6 and 12 months

Nursing home professionals' (coordinating physicians/nurses, nurses, assistant nurses and general practitioners) knowledge, attitudes, practices and motivation towards AMS. For each component (knowledge, attitudes, practices and motivation), a score ranging from 0 to 100 will be calculated; higher scores means more favorable position towards AMS.

Data collected through the questionnaires of the contextual diagnostic.

At inclusion, 6 and 12 months
Costs of the intervention
Periodo de tiempo: Through the end of the intervention, an average of 12 months

Cost associated with the work provided by the professionals responsible for the implementation support, with printing and sending the ORANEAT program tools to the nursing homes, etc.

Measured using data collected by the by the research team through ad hoc standardized activity reports.

Through the end of the intervention, an average of 12 months
Context, mechanisms of impact, sustainability, implementation, and transferability of the intervention
Periodo de tiempo: Through the end of the intervention, an average of 12 months

Observations, semi-structured interviews, focus groups with professionals involved in the implementation of the ORANEAT program (coordinating physicians/nurses, nurses, assistant nurses, general practitioners, professionals responsible for the implementation support…).

Through the end of the intervention, an average of 12 months

Colaboradores e Investigadores

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

Publicaciones y enlaces útiles

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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)

14 de abril de 2026

Finalización primaria (Estimado)

14 de julio de 2027

Finalización del estudio (Estimado)

14 de julio de 2028

Fechas de registro del estudio

Enviado por primera vez

22 de agosto de 2025

Primero enviado que cumplió con los criterios de control de calidad

17 de noviembre de 2025

Publicado por primera vez (Actual)

24 de noviembre de 2025

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

30 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • ANR-20-PAMR-0008
  • 21-841 (Otro identificador: CEEI IRB00003888, IORG0003254)
  • 2021/170 (Otro identificador: French Data Protection Authority)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

IPD Sharing Plan Description: N/A

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. .

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