Use of a Share Decision Making Tool in the Care of Acute Cystitis Without Risk of Complication in Primary Care (ARIBO)
Utilisation d'un Outil de décision médicale partagée Dans la Prise en Charge Des Cystites Aigues Sans Risque de Complication en médecine générale : Comparaison de la Consommation d'Antibiotique Entre Deux Groupes randomisés en Cluster.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Each year, more than 2.000.000 patients visit their general practitioners for a acute cystitis. The scientific literature shows that acute cystitis without risk of complication cause complications, such as pyelonephritis, in a very rare cases. However, French guidelines systematically request an antibiotic therapy as soon as the diagnostic is confirmed with the only goal to lowering symptomatology.
Recent studies show that some informed women would like not to take antibiotics and pain-killers could be as effective as antibiotics. Canadian studies assessing share decision making tools in patients with acute respiratory infection have shown that matching antibiotic treatment with the patient values lower such prescription without any impact on clinical outcomes .
Investigators aim to assess a similar strategy in patients with acute cystitis. This study will compare a group following French guidelines versus one using a share decision making tool to determine if, after being informed of the benefice and risk of this treatment, patient still want an antibiotic. Targeting instead of systematic prescription will reduce antibiotic consumption.
After diagnostic of acute cystitis to a woman between 18 and 65 years, investigators check if they filing all study criteria and ask for authorization to add them to the study. Then they'll act following their group instruction, and get information (antibiotic prescription or not, score to the Activity Impairment Assessment (AIA) scale, Score to satisfaction scale). Then patients will be followed by phone contact on day 5, day 14 and day 90 after inclusion to get information on antibiotic use, AIA and satisfaction scores and clinical outcomes, such urinary infection. Data on antibiotics delivery by pharmacy will be obtained through National assurance database.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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-
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Bordeaux, Frankrijk
- CHU de Bordeaux
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- woman
- between 18 and 65 years
- symptom of acute cystitis without risk of complication
- affiliated to the French public welfare system
- with signed consent
Exclusion Criteria:
- anomaly of the urinary canal
- pregnancy
- more than 3 cystitis during the last year
- cancer, immunosuppression
- hemopathy, fever
- back-pain
- severe renal failure
- refuse to give consent and previously participate to the study
- under guardianship
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Share making tool decision
Patient recruited from general practitioner in this group will use a share making tool decision to adapt antibiotherapy
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The experimental group will use the share decision making tool during consultation to adapt antibiotherapy
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Actieve vergelijker: Standard recommandation
Patients recruited from general practitioner will receive the standard medical care
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control group will act as usual in their practice.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
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Use of antibiotic for acute cystitis without risk of complication
Tijdsspanne: Day 14 after inclusion (day 0)
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Day 14 after inclusion (day 0)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Score at the "Activity Impairment Assessment" scale
Tijdsspanne: Day 0, Day 5 and Day14
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Scale from 0 (never) to 4 (always) on several items about usuals activities limitations.
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Day 0, Day 5 and Day14
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Score at the satisfaction scale
Tijdsspanne: Day 0, Day 5, Day14 and Day 90
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Scale from 0 (not satisfied) to 10 (very satisfied) on satisfation about medical care.
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Day 0, Day 5, Day14 and Day 90
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Recurrence of the infection
Tijdsspanne: Between Day 15 and Day 90
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Infection reccurence will be assessed with the number of dispensation of antibiotics between day 15 and day 90.
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Between Day 15 and Day 90
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Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Algemene publicaties
- Guillaume Dumont, Jean-Philippe Joseph, Thomas Ferte, Pierre Poulizac, Marion Kret, Guillaume Conort, Yves-Marie Vincent ; Cystitis: Clinical Findings and Diagnostic Uncertainty in General Practice Results From a Cluster-Randomised Controlled Trial ; International Journal of Clinical Pratice ; March 2026 ; Research Gate : DOI:10.1155/ijcp/6710022
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
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
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CHUBX 2017/48
- 2019-A02354-53 (Andere identificatie: ANSM)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
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