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Оценка настраиваемой программы рационального использования антибиотиков, адаптированной для французских домов престарелых (ORANEAT)

30 сентября 2026 г. обновлено: Nelly Agriner, University of Lorraine

Оценка настраиваемой программы управления антибиотиками на основе всесторонней оценки организаций и отношения медицинских работников, адаптированной к потребностям французских домов престарелых

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.

Обзор исследования

Статус

Рекрутинг

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Оцененный)

66

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Контакты исследования

  • Имя: Mélanie BEGUINET
  • Номер телефона: +333 83 15 34 79
  • Электронная почта: M.BEGUINET@chru-nancy.fr

Учебное резервное копирование контактов

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Да

Полы, имеющие право на обучение

Все

Описание

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.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Исследования в области здравоохранения
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Одинокий

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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).

Без вмешательства: Control group

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

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Overall antibiotic prescription rate (DDD)
Временное ограничение: 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)
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Effectiveness of the intervention - broad-spectrum antibiotics
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Другие показатели результатов

Мера результата
Мера Описание
Временное ограничение
Context of the intervention - nursing homes' characteristics
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

14 апреля 2026 г.

Первичное завершение (Оцененный)

14 июля 2027 г.

Завершение исследования (Оцененный)

14 июля 2028 г.

Даты регистрации исследования

Первый отправленный

22 августа 2025 г.

Впервые представлено, что соответствует критериям контроля качества

17 ноября 2025 г.

Первый опубликованный (Действительный)

24 ноября 2025 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

5 октября 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

30 сентября 2026 г.

Последняя проверка

1 сентября 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Другие идентификационные номера исследования

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

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Описание плана IPD

IPD Sharing Plan Description: N/A

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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