NCT06052917招募中不适用
Impact Study of the Decision Aid DECIdE on the Decisional Conflict of Primary Care Patients About Optional Prescription Drugs.
University Hospital, Clermont-Ferrand4 个研究点 分布在 1 个国家目标入组 288 人开始时间: 2024年5月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 288
- 试验地点
- 4
- 主要终点
- decisional conflict
研究概览
简要总结
The aim of the DECIdE study is to evaluate the effect of a decision aid (the DECIdE tool) for shared decision making concerning optional prescription drugs on the level of uncertainty-certainty or comfort-inconfort (= decisional conflict) experienced by patients, compared with a condition of routine care without the use of a decision aid.
General practitionners and pharmacists will propose to their patients, complaining of a common symptom for which a drug is usually prescribed or dispensed, to discuss this drug and the symptom in order to reach a shared decision on whether to take it or choose another alternative.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients over 18 consulting a general practitioner or community pharmacy
- •Patient complaining of a symptom or requesting a optional prescription drug (clinical situations and medicines pre-defined by expert consensus)
- •First use of DECIdE with the healthcare professional for this situation
- •Agreeing to take part in the study and to sign the written consent form
- •Speaks and understands French
排除标准
- •minor patients
- •Patients under guardianship, curatorship or safeguard of justice
- •Pregnant or breast-feeding women
- •Second use of the DECIdE tool in the same situation / for the same drug
- •Refusal to take part in the study
- •Patient not affiliated to a medical insurance
结局指标
主要结局
decisional conflict
时间窗: Day 1
decisional conflict scale score
次要结局
- Identify for which type of patient DECIdE reduces decisional conflict(day 1)
- effect on health professionals' decisional conflict(day 1)
- medical and economic impact of the choice of drug(day 1)
- effect on decisional conflict categories(day 1)
- effect on the final choose drug(day 1)
研究者
研究点 (4)
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