Clinical trial NCT04272281: Use of a Share Decision Making Tool in the Care of Acute Cystitis Without Risk of Complication in Primary Care
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystitis
Keywords: primary health care
share decision making
antibiotics
daily activities
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2020-02-17
Enrollment: 169
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Use of antibiotic for acute cystitis without risk of complication
timeFrame: Day 14 after inclusion (day 0)
Secondary outcomes:
measure: Score at the "Activity Impairment Assessment" scale
timeFrame: Day 0, Day 5 and Day14
measure: Score at the satisfaction scale
timeFrame: Day 0, Day 5, Day14 and Day 90
measure: Recurrence of the infection
timeFrame: Between Day 15 and Day 90
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux
Study officials:
References: