Use of a Share Decision Making Tool in the Care of Acute Cystitis Without Risk of Complication in Primary Care (ARIBO)
Primary Purpose
Cystitis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
medical shared decision
Standard medical care
Sponsored by
About this trial
This is an interventional treatment trial for Cystitis focused on measuring primary health care, share decision making, antibiotics, daily activities
Eligibility Criteria
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
Sites / Locations
- CHU de Bordeaux
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Share making tool decision
Standard recommandation
Arm Description
Patient recruited from general practitioner in this group will use a share making tool decision to adapt antibiotherapy
Patients recruited from general practitioner will receive the standard medical care
Outcomes
Primary Outcome Measures
Use of antibiotic for acute cystitis without risk of complication
Secondary Outcome Measures
Score at the "Activity Impairment Assessment" scale
Scale from 0 (never) to 4 (always) on several items about usuals activities limitations.
Score at the satisfaction scale
Scale from 0 (not satisfied) to 10 (very satisfied) on satisfation about medical care.
Recurrence of the infection
Infection reccurence will be assessed with the number of dispensation of antibiotics between day 15 and day 90.
Full Information
NCT ID
NCT04272281
First Posted
February 14, 2020
Last Updated
March 8, 2022
Sponsor
University Hospital, Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT04272281
Brief Title
Use of a Share Decision Making Tool in the Care of Acute Cystitis Without Risk of Complication in Primary Care
Acronym
ARIBO
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
July 22, 2020 (Actual)
Primary Completion Date
December 3, 2021 (Actual)
Study Completion Date
February 17, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
the aim of this trial is to demonstrate that when caring women with symptoms of acute cystitis without any risk of complication, general practitioner may use share decision making tool to help patients better understand the stakes of taking antibiotics.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystitis
Keywords
primary health care, share decision making, antibiotics, daily activities
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
169 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Share making tool decision
Arm Type
Experimental
Arm Description
Patient recruited from general practitioner in this group will use a share making tool decision to adapt antibiotherapy
Arm Title
Standard recommandation
Arm Type
Active Comparator
Arm Description
Patients recruited from general practitioner will receive the standard medical care
Intervention Type
Procedure
Intervention Name(s)
medical shared decision
Intervention Description
The experimental group will use the share decision making tool during consultation to adapt antibiotherapy
Intervention Type
Procedure
Intervention Name(s)
Standard medical care
Intervention Description
control group will act as usual in their practice.
Primary Outcome Measure Information:
Title
Use of antibiotic for acute cystitis without risk of complication
Time Frame
Day 14 after inclusion (day 0)
Secondary Outcome Measure Information:
Title
Score at the "Activity Impairment Assessment" scale
Description
Scale from 0 (never) to 4 (always) on several items about usuals activities limitations.
Time Frame
Day 0, Day 5 and Day14
Title
Score at the satisfaction scale
Description
Scale from 0 (not satisfied) to 10 (very satisfied) on satisfation about medical care.
Time Frame
Day 0, Day 5, Day14 and Day 90
Title
Recurrence of the infection
Description
Infection reccurence will be assessed with the number of dispensation of antibiotics between day 15 and day 90.
Time Frame
Between Day 15 and Day 90
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Use of a Share Decision Making Tool in the Care of Acute Cystitis Without Risk of Complication in Primary Care
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