Use of a Share Decision Making Tool in the Care of Acute Cystitis Without Risk of Complication in Primary Care (ARIBO)

March 8, 2022 updated by: University Hospital, Bordeaux

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.

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.

Study Overview

Status

Completed

Conditions

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

Interventional

Enrollment (Actual)

169

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bordeaux, France
        • CHU de Bordeaux

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2020

Primary Completion (Actual)

December 3, 2021

Study Completion (Actual)

February 17, 2022

Study Registration Dates

First Submitted

February 14, 2020

First Submitted That Met QC Criteria

February 14, 2020

First Posted (Actual)

February 17, 2020

Study Record Updates

Last Update Posted (Actual)

March 9, 2022

Last Update Submitted That Met QC Criteria

March 8, 2022

Last Verified

March 1, 2022

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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