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

Sponsor
University Hospital, Bordeaux (Other)
Overall Status
Completed
CT.gov ID
NCT04272281
Collaborator
(none)
169
1
2
18.9
8.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: medical shared decision
  • Procedure: Standard medical care
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
169 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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.
Actual Study Start Date :
Jul 22, 2020
Actual Primary Completion Date :
Dec 3, 2021
Actual Study Completion Date :
Feb 17, 2022

Arms and Interventions

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

Procedure: medical shared decision
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

Procedure: Standard medical care
control group will act as usual in their practice.

Outcome Measures

Primary Outcome Measures

  1. Use of antibiotic for acute cystitis without risk of complication [Day 14 after inclusion (day 0)]

Secondary Outcome Measures

  1. Score at the "Activity Impairment Assessment" scale [Day 0, Day 5 and Day14]

    Scale from 0 (never) to 4 (always) on several items about usuals activities limitations.

  2. Score at the satisfaction scale [Day 0, Day 5, Day14 and Day 90]

    Scale from 0 (not satisfied) to 10 (very satisfied) on satisfation about medical care.

  3. Recurrence of the infection [Between Day 15 and Day 90]

    Infection reccurence will be assessed with the number of dispensation of antibiotics between day 15 and day 90.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de Bordeaux Bordeaux France

Sponsors and Collaborators

  • University Hospital, Bordeaux

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT04272281
Other Study ID Numbers:
  • CHUBX 2017/48
First Posted:
Feb 17, 2020
Last Update Posted:
Mar 9, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Bordeaux
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 9, 2022