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

Cystitis Clinical Trial

— ARIBO  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04272281
• Other study ID #: CHUBX 2017/48
• Status: Completed
• Phase: N/A
• Start date: July 22, 2020
• Est. completion date: February 17, 2022

Study information

• Verified date: March 2022
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: February 17, 2022
• Est. primary completion date: December 3, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cystitis

Intervention

Procedure:
• medical shared decision
The experimental group will use the share decision making tool during consultation to adapt antibiotherapy
• Standard medical care
control group will act as usual in their practice.

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of antibiotic for acute cystitis without risk of complication		Day 14 after inclusion (day 0)
Secondary	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
Secondary	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
Secondary	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