About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
woman,
symptom of acute cystitis without risk of complication,
affiliated to the french public welfare system,
signed consent.
Disqualifiers
anomaly of the urinary canal,
pregnancy, more than 3 cystitis during the last year,
cancer,
immunosuppression,
Trial design
Parallel
Treatments tested in this trial
Share making decision tool
Other interventionthe experimental group will apply the delegation protocol, but if the protocol recommends antibiotic therapy, the researchers will propose a shared decision using a specific tool to determine with the patient whether to deliver the antibiotic
Delegation protocol
Other interventionthe control group will apply the delegation protocol alone
Treatment groups
Trial outcomes
Primary outcomes
Dispensing of antibiotic
Dispensing of antibiotic for acute cystitis without risk of complication on the 14 days following the first visit to the pharmacy.
Secondary outcomes
Activity Impairment Assessment(AIA) scale
5-item ranging from 0 (no impact) to 4 (constant impact). It has no sub-dimensions and allows for an overall assessment (sum of the scores for each item) ranging from 0 (no discomfort/no incapacity) to 20 (total discomfort/ total incapacity).
Satisfaction scale
Satisfaction score on a scale from 0 (dissatisfaction) to 10 (total satisfaction)
O'Connor scale
16-item scale rated from 1 to 5. Each score is converted to a base of 100 (1=0, 5=100). The total average of the items out of 100 determines: \< 25: Low conflict - the person is probably ready to make a decision. 25-37.5: Moderate conflict - some discomfort may still exist. ≥ 37.5: High conflict - the person probably needs help deciding.
Medical consultation
Consultations with a doctor or at the emergency room for urinary tract infection and/or possible complications among patients diagnosed with uncomplicated cystitis within two weeks of visiting the pharmacy (telephone survey at two weeks).
Sponsors and contacts
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