Improving Patients' Adherence to Their Chronic Treatments by Implementing a Simple, Standardized and Redundant Message Delivered by Healthcare Professionals: a Stepped-wedge Multicenter Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,210
- 试验地点
- 18
- 主要终点
- Improvement in therapeutic adherence
研究概览
简要总结
The primary objective in this study is to achieve a 15% 6-month improvement in therapeutic adherence among patients with chronic pathologies, thanks to a simple, standardized and redundant message delivered by healthcare professionals during consultations/interviews Trained healthcare professionals deliver a simple, standardized and redundant 3-point message to patients, based on the levers of action concerning therapeutic adherence. This message is delivered with the aim of modifying the patient's behavior with regard to treatment intake.
详细描述
This project will enable us to adapt or even modify the practices of healthcare professionals, by making management recommendations to improve patients' adherence to treatment during their consultations/interviews, and throughout their entire course of care. This project will increase the benefit/risk ratio of treatments and reduce the waste of healthcare resources.
For patients, their participation by filling in the therapeutic adherence self-questionnaire will enable them to become active players in the management of their treatment.
If the results of our study prove positive, this will lead to a new, optimized organization of patient care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (age ≥ 18 years)
- •Affiliated to the French social security system
- •Followed in hospital for a chronic pathology within a formalized care pathway
- •Having signed a consent form to participate in the study.
排除标准
- •Patients included in the control period.
- •Patients under guardianship.
- •Pregnant or breast-feeding patients.
- •Patients taking part in research on compliance
研究组 & 干预措施
Intervention period
Trained healthcare professionals deliver a simple, standardized and redundant 3-point message to patients, based on the levers of action for therapeutic adherence.
During this period, the message will be delivered to the patient by each of the healthcare professionals involved in his or her hospital care. It will be formalized by a checklist that will enable them to reformulate the 3 points defined as key elements of therapeutic adherence. Each healthcare professional is free to deliver this message at any time during their consultation/interview with the patient. They will be asked to note the date and tick off each point on the checklist.
The intervention period will take place after the control and wash-out periods, and after healthcare professionals have been trained in the intervention.
干预措施: Trained healthcare professionals deliver a simple, standardized and redundant 3-point message to patients, based on the levers of action for therapeutic adherence. (Other)
Control period
The control period is the period before healthcare professionals are trained in the intervention. Patients included during this period will not receive the simple, standardized and redundant message.
结局指标
主要结局
Improvement in therapeutic adherence
时间窗: 6 months
The medication possession ratio (MPR), calculated as the ratio between the sum of treatment days delivered over the period of interest x 100, expressed as a %. In the literature, an MPR ≥ 80% corresponds to good therapeutic adherence.
次要结局
- Improvement in therapeutic adherence(12 months)
- Predictive factors of improved adherence factors predictive of therapeutic adherence(6 months)
- Improvement in therapeutic adherence estimated(12 months)
- Costs of care according to periods (control vs. intervention)(12 months)
- Cost of the intervention(12 months)
- Satisfaction of participating healthcare professionals and reasons for refusal to participate(12 months)