Dispensing of Antibiotics in Pharmacies for Cystitis According to a Delegation Protocol, Impact of a Decision Support Tool. PHARIBO: PHarmacy and Resolved Antibiotherapy for Urinary Tract Infections

University Hospital of Bordeaux

Status: Begins enrollment this month

Conditions: Acute Cystitis

Treatments: Other: Delegation protocol; Other: Share making decision tool

Study type: Interventional

Funder types: Other

Identifiers

NCT07118748

CHUBX 2024/66

Details and patient eligibility

About

The purpose of this trial is to demonstrate that when treating acute cystitis without risk of complication, pharmacists may use share Decision Making tool to help patients to better understand the stakes of taking antibiotics and adapt the management of the delegation protocol.

This will select patients in need of antibiotics and preserve the full-capacities of non-treated one.

Full description

Each year, in France, more than 2.000.000 patients visit for a acute cystitis. The literature shows that acute cystitis without risk of complication cause pyelonephritis only on really rare situation, but french delegation protocols to pharmacist ask for systematic antibiotic therapy as soon as the diagnostic is made with the only goal to lowering symptomatology. Studies shows that some informed women would like not to take antibiotics while others studies show us that pain-killers could be as effective as antibiotics on case of low symptomatology.

This study will compare a group following only the French protocols for delegating acute cystitis to the pharmacist with a group using the same protocol, but supplementing it with a shared decision-making tool to determine whether, after being informed of the benefits and risks of this treatment, patients still wish to receive 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 informations (antibiotic prescription or not, patient socio-demographic criteria). Then patients will be followed by telephone on D14 to know if they've take antibiotics and to obtain the following information: AIA scale, O'Connor Scale, Satisfaction scale, if there has been visit to the emergency room or doctor. Antibiotics delivery on pharmacy will be watch by National assurance number of the included patients

Enrollment: 506 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• woman,
• symptom of acute cystitis without risk of complication,
• affiliated to the french public welfare system,
• 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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506 participants in 2 patient groups

Share making tool decision group

Experimental group

Description:

woman, between 18 and 65 years, coming to a pharmacy randomized in the experimental group for symptom of acute cystitis without risk of complication

Treatment:

Other: Share making decision tool

Delegation protocol alone group

Active Comparator group

Description:

woman, between 18 and 65 years, coming to a pharmacy randomized in the control group for symptom of acute cystitis without risk of complication

Treatment:

Other: Delegation protocol