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临床试验/NCT07246382
NCT07246382尚未招募不适用

Evaluation of A Customizable Antibiotic Stewardship Program Based on a Comprehensive Assessment of Organizations and Health Professionals' Attitudes, and Tailored to French Nursing Homes' Needs

University of Lorraine0 个研究点目标入组 66 人开始时间: 2025年12月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
66
主要终点
Total antibiotic use (DDD)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

盲法说明

The statisticians responsible for analyzing data on antibiotic use (using data from the Health Insurance reimbursement database, Système national des données de santé)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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)

排除标准

  • •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.

研究组 & 干预措施

Experimental group

Experimental

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

干预措施: The ORANEAT program (Other)

Control group

No Intervention

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

结局指标

主要结局

Total antibiotic use (DDD)

时间窗: 12 months

Total antibiotic use expressed in Defined Daily Doses (DDD)/1000 resident-days/month. Measured using data from the Health Insurance reimbursement database.

Total antibiotic use (Number of prescriptions)

时间窗: 12 months

As part of a sensibility analysis: Total antibiotic use expressed in number of prescriptions/1000 resident-days/month. Measured using data from the Health Insurance reimbursement database.

次要结局

  • Safety of the intervention(12 months)
  • Sustainability of the effectiveness(24 months)

研究者

发起方
University of Lorraine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Nelly Agriner

Professor

University of Lorraine

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