- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04272281
Use of a Share Decision Making Tool in the Care of Acute Cystitis Without Risk of Complication in Primary Care (ARIBO)
Utilisation d'un Outil de décision médicale partagée Dans la Prise en Charge Des Cystites Aigues Sans Risque de Complication en médecine générale : Comparaison de la Consommation d'Antibiotique Entre Deux Groupes randomisés en Cluster.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bordeaux, France
- CHU de Bordeaux
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Share making tool decision
Patient recruited from general practitioner in this group will use a share making tool decision to adapt antibiotherapy
|
The experimental group will use the share decision making tool during consultation to adapt antibiotherapy
|
Active Comparator: Standard recommandation
Patients recruited from general practitioner will receive the standard medical care
|
control group will act as usual in their practice.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Use of antibiotic for acute cystitis without risk of complication
Time Frame: Day 14 after inclusion (day 0)
|
Day 14 after inclusion (day 0)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Score at the "Activity Impairment Assessment" scale
Time Frame: Day 0, Day 5 and Day14
|
Scale from 0 (never) to 4 (always) on several items about usuals activities limitations.
|
Day 0, Day 5 and Day14
|
Score at the satisfaction scale
Time Frame: Day 0, Day 5, Day14 and Day 90
|
Scale from 0 (not satisfied) to 10 (very satisfied) on satisfation about medical care.
|
Day 0, Day 5, Day14 and Day 90
|
Recurrence of the infection
Time Frame: Between Day 15 and Day 90
|
Infection reccurence will be assessed with the number of dispensation of antibiotics between day 15 and day 90.
|
Between Day 15 and Day 90
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX 2017/48
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cystitis
-
Asan Medical CenterCompletedChronic Interstitial CystitisKorea, Republic of
-
St. Louis UniversityTerminated
-
St. Louis UniversityCompletedInterstitial Cystitis
-
Northwell HealthWithdrawnInterstitial CystitisUnited States
-
CAMC Health SystemCompletedInterstitial CystitisUnited States
-
UroGen Pharma Ltd.CompletedInterstitial Cystitis | ICIsrael
-
Teva Branded Pharmaceutical Products R&D, Inc.Withdrawn
-
St. Louis UniversityCompletedInterstitial CystitisUnited States
-
TriHealth Inc.CompletedInterstitial CystitisUnited States
Clinical Trials on medical shared decision
-
M.D. Anderson Cancer CenterMerck Sharp & Dohme LLCRecruiting
-
The University of Texas Health Science Center,...TerminatedPregnancy Related | Elective InductionUnited States
-
Nemours Children's ClinicPatient-Centered Outcomes Research InstituteCompleted
-
Taipei Medical University Shuang Ho HospitalCompleted
-
Weill Medical College of Cornell UniversityNational Institute of Mental Health (NIMH)Completed
-
Shalvata Mental Health CenterUnknownShared Decision Making With PatientsIsrael
-
Umeå UniversityUnknownPsychosis | Participation, Patient | Psychiatric HospitalizationSweden
-
AstraZenecaBrigham Women's HealthCompletedDiabetes Mellitus Type 2United States
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedLung Diseases | Asthma
-
Yokohama City UniversityCompleted