- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07246382
Evaluatie van een Aanpasbaar Antibioticumstewardshipprogramma Afgestemd op Franse Verpleeghuizen (ORANEAT)
Evaluatie van een aanpasbaar antibioticabeheerprogramma gebaseerd op een uitgebreide beoordeling van organisaties en houdingen van gezondheidsprofessionals, en afgestemd op de behoeften van Franse verpleeghuizen
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Mélanie BEGUINET
- Telefoonnummer: +333 83 15 34 79
- E-mail: M.BEGUINET@chru-nancy.fr
Studie Contact Back-up
- Naam: Aurélie BOCQUIER
- Telefoonnummer: +33372746292
- E-mail: Aurelie.bocquier@univ-lorraine.fr
Studie Locaties
-
-
-
Nantes, Frankrijk, 44093
- Werving
- CPias PdL (for the Pays de la Loire region)
-
Contact:
- Gabriel BIRGAND
- Telefoonnummer: +332 40 08 39 86
- E-mail: gabriel.birgand@chu-nantes.fr
-
Vandœuvre-lès-Nancy, Frankrijk, 54505
- Werving
- CIC-EC (for the Grand Est region)
-
Contact:
- Nelly AGRINIER
- Telefoonnummer: +333 83 15 34 79
- E-mail: nelly.agrinier@univ-lorraine.fr
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Experimental group
Nursing homes in the experimental group will receive the ORANEAT antibiotic stewardship 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). |
|
Geen tussenkomst: Control group
Nursing homes in the control group will not receive the ORANEAT antibiotic stewardship program ("usual care"). |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Overall antibiotic prescription rate (DDD)
Tijdsspanne: 12 months
|
Overall antibiotic prescription rate expressed in Defined Daily Doses (DDD)/1000 resident-days/month. Measured using data from the Health Insurance reimbursement database. |
12 months
|
|
Overall antibiotic prescription rate (number of prescriptions)
Tijdsspanne: 12 months
|
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. |
12 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Effectiveness of the intervention - broad-spectrum antibiotics
Tijdsspanne: 12 months
|
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. |
12 months
|
|
Effectiveness of the intervention - appropriateness of antibiotic prescriptions
Tijdsspanne: 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. |
12 months
|
|
Safety of the intervention
Tijdsspanne: 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. |
12 months
|
|
Sustainability of the effectiveness
Tijdsspanne: 24 months
|
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. |
24 months
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Context of the intervention - nursing homes' characteristics
Tijdsspanne: 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. |
At inclusion
|
|
Context of the intervention - nursing homes' geographic areas' characteristics
Tijdsspanne: At inclusion
|
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. |
At inclusion
|
|
Adoption of the intervention
Tijdsspanne: 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. |
12 months
|
|
Reach of the target population - contextual diagnosis
Tijdsspanne: 12 months
|
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. |
12 months
|
|
Reach of the target population - antimicrobial stewardship tools/actions
Tijdsspanne: Through the end of the intervention, an average of 12 months
|
Proportion of nurses and assistant nurses attending at least one training session; proportion of referring general practitioners contacted at least once regarding the ORANEAT program by the external or the internal facilitators; number of tools distributed (number of copies provided to the nursing home, for each tool); proportion of nursing homes that developed at least one tool as part of the "tool development" action of the ORANEAT program. Measured using data collected by the research team through ad hoc standardized activity reports. |
Through the end of the intervention, an average of 12 months
|
|
Fidelity of the intervention - antimicrobial stewardship tools
Tijdsspanne: 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. |
Through the end of the intervention, an average of 12 months
|
|
Fidelity of the intervention - categories of antimicrobial stewardship tools
Tijdsspanne: At 3 months, 6 months, 9 months and 12 months
|
Number of categories of the antimicrobial stewardship tools/actions implemented in the nursing home according to the contextual diagnostic tool of the ORANEAT program and their evolution over 12 months. Categories are defined according to the Centers for Disease Control and Prevention (CDC) core elements of antibiotic stewardship for nursing homes. Data collected through the questionnaires of the contextual diagnostic. |
At 3 months, 6 months, 9 months and 12 months
|
|
Dose of intervention - score of exposure to the intervention
Tijdsspanne: Through the end of the intervention, an average of 12 months
|
Score of exposure to each component of the ORANEAT program. This composite measure will capture the intensity of exposition to each component of the program in each nursing home (i.e., the contextual diagnosis, the exposition to the tools/actions, and the implementation strategies). Measured using data collected by the research team through ad hoc standardized activity reports, the questionnaires of the contextual diagnostic and annual activity reports from the local antimicrobial stewardship teams. |
Through the end of the intervention, an average of 12 months
|
|
Dose of intervention - antimicrobial stewardship tools
Tijdsspanne: 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. |
Through the end of the intervention, an average of 12 months
|
|
Dose of intervention - implementation support
Tijdsspanne: Through the end of the intervention, an average of 12 months
|
Number of meetings with the internal and external facilitators held as part of the implementation support of the ORANEAT program (third component of the program). Measured using data collected by the by the research team through ad hoc standardized activity reports. |
Through the end of the intervention, an average of 12 months
|
|
Dose of intervention - time to implement the program
Tijdsspanne: Through the end of the intervention, an average of 12 months
|
Average time (days) between validation of the pack with the internal facilitators and the date when all tools are reported as used. Measured using data collected by the by the research team through ad hoc standardized activity reports. |
Through the end of the intervention, an average of 12 months
|
|
Adaptation of the intervention
Tijdsspanne: 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. |
Through the end of the intervention, an average of 12 months
|
|
Users' experiences of the intervention
Tijdsspanne: 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. |
12 months
|
|
Sustainability of the intervention
Tijdsspanne: 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. |
12 months
|
|
Mechanisms of impact of the intervention - prescriptions of urine cultures
Tijdsspanne: 12 months
|
Number of urine cultures prescribed/1000 resident-days/month. Measured using data from the Health Insurance reimbursement database. |
12 months
|
|
Mechanisms of impact of the intervention - nursing home professionals' knowledge, attitudes, practices and motivation
Tijdsspanne: 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. |
At inclusion, 6 and 12 months
|
|
Costs of the intervention
Tijdsspanne: 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. |
Through the end of the intervention, an average of 12 months
|
|
Context, mechanisms of impact, sustainability, implementation, and transferability of the intervention
Tijdsspanne: 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…). |
Through the end of the intervention, an average of 12 months
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Nelly AGRINIER, Professor, Université de Lorraine, Inserm, INSPIIRE, F-54000 Nancy, France; CHRU-Nancy, Inserm, Université de Lorraine, CIC, Epidémiologie clinique, Nancy, France
Publicaties en nuttige links
Algemene publicaties
- Gonthier D, Ricci L, Buzzi M, Birgand G, Kivits J, Agrinier N. Exploration of interprofessional collaboration for the diagnosis of infections and antibiotic prescription in nursing homes using multiple case study observational research. JAC Antimicrob Resist. 2025 Jan 13;7(1):dlae205. doi: 10.1093/jacamr/dlae205. eCollection 2025 Feb.
- Bocquier A, Erkilic B, Babinet M, Pulcini C, Agrinier N; ORANEAT Study Group. Resident-, prescriber-, and facility-level factors associated with antibiotic use in long-term care facilities: a systematic review of quantitative studies. Antimicrob Resist Infect Control. 2024 Mar 6;13(1):29. doi: 10.1186/s13756-024-01385-6.
- Conlin M, Hamard M, Agrinier N, Birgand G; ORANEAT co-investigators. Assessment of implementation strategies adopted for antimicrobial stewardship interventions in long-term care facilities: a systematic review. Clin Microbiol Infect. 2024 Apr;30(4):431-444. doi: 10.1016/j.cmi.2023.12.020. Epub 2023 Dec 22.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- ANR-20-PAMR-0008
- 21-841 (Andere identificatie: CEEI IRB00003888, IORG0003254)
- 2021/170 (Andere identificatie: French Data Protection Authority)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
IPD Sharing Plan Description: N/A
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .