Evaluation of a Customizable Antibiotic Stewardship Program Tailored to French Nursing Homes

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Lorraine

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • The ORANEAT program

    Other intervention

    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).

Treatment groups

66 Participants
are divided into 2 treatment groups
Group A: Experimental groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Total antibiotic use (DDD)

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
2

Total antibiotic use (Number of prescriptions)

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

Secondary outcomes

1

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.

Time frame
12 months
2

Sustainability of the effectiveness

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
24 months

Other outcomes

1

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.

Time frame
At inclusion
2

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.

Time frame
12 months
3

Reach of the target population

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
4

Fidelity of the intervention

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

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

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