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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 169
- 试验地点
- 1
- 主要终点
- Use of antibiotic for acute cystitis without risk of complication
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •between 18 and 65 years
- •symptom of acute cystitis without risk of complication
- •affiliated to the French public welfare system
- •with signed consent
排除标准
- •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
研究组 & 干预措施
Share making tool decision
Patient recruited from general practitioner in this group will use a share making tool decision to adapt antibiotherapy
干预措施: medical shared decision (Procedure)
Standard recommandation
Patients recruited from general practitioner will receive the standard medical care
干预措施: Standard medical care (Procedure)
结局指标
主要结局
Use of antibiotic for acute cystitis without risk of complication
时间窗: Day 14 after inclusion (day 0)
次要结局
- Recurrence of the infection(Between Day 15 and Day 90)
- Score at the "Activity Impairment Assessment" scale(Day 0, Day 5 and Day14)
- Score at the satisfaction scale(Day 0, Day 5, Day14 and Day 90)