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

NCT ID: NCT04272281

Last Updated: 2022-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 169 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-22
• Study Completion Date: 2022-02-17

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.

Conditions

Cystitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Share making tool decision

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

Group Type: EXPERIMENTAL

medical shared decision

Intervention Type: PROCEDURE

The experimental group will use the share decision making tool during consultation to adapt antibiotherapy

Standard recommandation

Patients recruited from general practitioner will receive the standard medical care

Group Type: ACTIVE_COMPARATOR

Standard medical care

Intervention Type: PROCEDURE

control group will act as usual in their practice.

Interventions

medical shared decision

The experimental group will use the share decision making tool during consultation to adapt antibiotherapy

Intervention Type: PROCEDURE

Standard medical care

control group will act as usual in their practice.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU de Bordeaux

Bordeaux, , France

Countries

France

Other Identifiers

CHUBX 2017/48

Identifier Type: -

Identifier Source: org_study_id