NCT Number: NCT07246382
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Nursing homes
Inclusion criteria
Exclusion criteria
Residents (Outcomes 1 to 4 and outcome 12)
Inclusion criteria
Exclusion criteria
/
Healthcare professionals (Outcomes 11, 13 and 15)
Inclusion criteria
Exclusion criteria
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).
Time frame: 12 months
Total antibiotic use expressed in Defined Daily Doses (DDD)/1000 resident-days/month.
Measured using data from the Health Insurance reimbursement database.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
Number of urine cultures prescribed/1000 resident-days/month. Measured using data from the Health Insurance reimbursement database.
Time frame: 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.
Time frame: 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.
Time frame: 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…).
Contact information is provided by the study sponsor or research team.
Amandine OSTERMANN
CONTACT
Aurélie BOCQUIER
CONTACT
University of Lorraine
Other
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
Acronym: ORANEAT
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