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

University Hospital of Bordeaux

Status: Completed

Conditions: Cystitis

Treatments: Procedure: medical shared decision; Procedure: Standard medical care

Study type: Interventional

Funder types: Other

Identifiers

NCT04272281

CHUBX 2017/48

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 169 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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169 participants in 2 patient groups

Share making tool decision

Experimental group

Description:

Patient recruited from general practitioner in this group will use a share making tool decision to adapt antibiotherapy

Treatment:

Procedure: medical shared decision

Standard recommandation

Active Comparator group

Description:

Patients recruited from general practitioner will receive the standard medical care

Treatment:

Procedure: Standard medical care