NCT Number: NCT07118748
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.
Interested in participating?
Request Info18 year–65 year
Female
Interventional
Not applicable
Pharmacie Lemarquis, Aire-sur-l'Adour, France
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
the control group will apply the delegation protocol alone
Time frame: day 14 after inclusion
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
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
Satisfaction score on a scale from 0 (dissatisfaction) to 10 (total satisfaction)
Time frame: day 14 after inclusion
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
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).
Contact information is provided by the study sponsor or research team.
Pierre POULIZAC
CONTACT
Yves-Marie VINCENT, MD
CONTACT
University Hospital, Bordeaux
Other
Dispensing of Antibiotics in Pharmacies for Cystitis According to a Delegation Protocol, Impact of a Decision Support Tool : a Randomised Cluster Trial. PHARIBO: PHarmacy and Resolved Antibiotherapy for Urinary Tract Infections
Acronym: PHARIBO
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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