Use of a Share Decision Making Tool in the Care of Acute Cystitis Without Risk of Complication in Primary Care

Study Overview
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Brief Summary
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the aim of this trial is to demonstrate that when caring women with symptoms of acute cystitis without any risk of complication, general practitioner may use share decision making tool to help patients better understand the stakes of taking antibiotics.

Detailed Description
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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.

Official Title
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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.

Conditions
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Cystitis

Intervention / Treatment
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* Procedure: medical shared decision
* Procedure: Standard medical care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Share making tool decision<br>Patient recruited from general practitioner in this group will use a share making tool decision to adapt antibiotherapy | Procedure: medical shared decision<br>* The experimental group will use the share decision making tool during consultation to adapt antibiotherapy<br>|
| Active Comparator: Standard recommandation<br>Patients recruited from general practitioner will receive the standard medical care | Procedure: Standard medical care<br>* control group will act as usual in their practice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of antibiotic for acute cystitis without risk of complication |  | Day 14 after inclusion (day 0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score at the Activity Impairment Assessment scale | Scale from 0 (never) to 4 (always) on several items about usuals activities limitations. | Day 0, Day 5 and Day14 | 
| Score at the satisfaction scale | Scale from 0 (not satisfied) to 10 (very satisfied) on satisfation about medical care. | Day 0, Day 5, Day14 and Day 90 | 
| Recurrence of the infection | Infection reccurence will be assessed with the number of dispensation of antibiotics between day 15 and day 90. | Between Day 15 and Day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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primary health care, share decision making, antibiotics, daily activities