Antibacterial Agents
Conditions
Keywords
Antimicrobial Stewardship, Nursing Homes
Brief summary
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.
Interventions
OTHERThe ORANEAT 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).
Sponsors
Sciences Po, Centre de Sociologie des Organisations (CSO), CNRS, Paris, France.
Inserm U1219, Bordeaux Population Health Research Center, Bordeaux, France.
Centre Régional en Antibiothérapie (CRAtb) Grand Est, Nancy, France.
Centre Régional en Antibiothérapie (CRAtb) Pays de la Loire, Nantes, France.
National Research Agency, France
Centre d'appui pour la Prévention des Infections Associées aux Soins (CPias) Pays de la Loire, Nantes, France.
Centre d'appui pour la Prévention des Infections Associées aux Soins (CPias) Grand Est, Nancy, France.
University of Lorraine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
The statisticians responsible for analyzing data on antibiotic use (using data from the Health Insurance reimbursement database, Système national des données de santé)
Intervention model description
Cluster randomized controlled trial with two parallel arms (ORANEAT program vs. no specific intervention); the cluster being the nursing home.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total antibiotic use (DDD) | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of the intervention | 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. |
| Sustainability of the effectiveness | 24 months | Total antibiotic use expressed in Defined Daily Doses (DDD)/1000 resident-days/month. As part of a sensitivity analysis: Total antibiotic use expressed in number of prescriptions/1000 resident-days/month. Measured using data from the Health Insurance reimbursement database. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Fidelity of the intervention | 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. |
| Dose of intervention | 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. |
| Users' experiences of the intervention | 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. |
| Sustainability of the intervention | 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. |
| Adaptation of the intervention | 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. |
| Mechanisms of impact of the intervention - prescriptions of urine cultures | 12 months | Number of urine cultures prescribed/1000 resident-days/month. Measured using data from the Health Insurance reimbursement database. |
| Mechanisms of impact of the intervention - nursing home professionals' knowledge, attitudes, practices and motivation | 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. |
| Costs of the intervention | 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. |
| Context, mechanisms of impact, sustainability, implementation, and transferability of the intervention | 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…). |
| Mechanisms of impact of the intervention - appropriateness of antibiotic prescriptions | 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. |
| Context of the intervention - Nursing homes' characteristics | 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. |
| Adoption of the intervention | 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. |
| Reach of the target population | Through the end of the intervention, an average of 12 months | Number of copies provided to the nursing home, for each tool (initial number of copies and additional copies requested by the nursing home). Measured using data collected by the research team through ad hoc standardized activity reports. |
Contacts
Primary ContactAmandine OSTERMANN
Backup ContactAurélie BOCQUIER
Outcome results
None listed