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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-65
SponsorUniversity Hospital, Bordeaux

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Share making decision tool

    Other intervention

    the 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 intervention

    the control group will apply the delegation protocol alone

Treatment groups

506 Participants
are divided into 2 treatment groups
Group A: Share making tool decision groupExperimental treatment 1 intervention
Group B: Delegation protocol alone groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Dispensing of antibiotic

Dispensing of antibiotic for acute cystitis without risk of complication on the 14 days following the first visit to the pharmacy.

Time frame
day 14 after inclusion

Secondary outcomes

1

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).

Time frame
day 14 after inclusion
2

Satisfaction scale

Satisfaction score on a scale from 0 (dissatisfaction) to 10 (total satisfaction)

Time frame
day 14 after inclusion
3

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.

Time frame
day 14 after inclusion
4

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).

Time frame
day 14 after inclusion

Other outcomes

Sponsors and contacts

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