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.
None
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)
Parallel
The ORANEAT program
Other interventionThe 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).
Overall antibiotic prescription rate (DDD)
Overall antibiotic prescription rate expressed in Defined Daily Doses (DDD)/1000 resident-days/month. Measured using data from the Health Insurance reimbursement database.
Overall antibiotic prescription rate (number of prescriptions)
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.
Effectiveness of the intervention - broad-spectrum antibiotics
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.
Effectiveness of the intervention - appropriateness of antibiotic prescriptions
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.
Safety of the intervention
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.
Sustainability of the effectiveness
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.
Context of the intervention - nursing homes' characteristics
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.
Context of the intervention - nursing homes' geographic areas' characteristics
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.
Adoption of the intervention
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.
Reach of the target population - contextual diagnosis
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.
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University of Lorraine
Lead sponsor
Sciences Po, Centre de Sociologie des Organisations (CSO), CNRS, Paris, France.
Collaborator
Inserm U1219, Bordeaux Population Health Research Center, Bordeaux, France.
Collaborator
Centre Régional en Antibiothérapie (CRAtb) Grand Est, Nancy, France.
Collaborator
Centre Régional en Antibiothérapie (CRAtb) Pays de la Loire, Nantes, France.
Collaborator
National Research Agency, France
Collaborator
Centre d'appui pour la Prévention des Infections Associées aux Soins (CPias) Pays de la Loire, Nantes, France.
Collaborator
Centre d'appui pour la Prévention des Infections Associées aux Soins (CPias) Grand Est, Nancy, France.
Collaborator
