Personalized Perioperative Care Based on Patient Reported Outcomes Measures: Randomized Controlled Trial Based on the QoR-15
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Evaluate the effectiveness of a perioperative follow-up integrating the patient's point of view in osteoarticular surgery compared to a classic postoperative management
研究概览
简要总结
In the perioperative setting, Patient Reported Outcomes Measures (PROMs) are important for both patients and clinicians.
Reliable PROMs, like the Quality Of Recovery 15 (QoR-15) questionnaire, are available for patients experiencing surgery. These PROMs are significantly used as endoints for clinical interventions assessment. These PROMs may also be considered to monitor and assess patient health status as part of enhanced recovery after surgery pathway.
However data about the efficacy of PROMs-based perioperative clinical follow up are lacking.
The clinical hypothesis is that a PROMs (QoR-15) based perioperative clinical care is more efficient that the usual care non based on the QoR-15.
详细描述
The study is a multicenter randomized controlled trial comparing 2 groups:
- A control group, including the usual conventional follow-up by the surgeon and the attending physician.
- An experimental group including, in addition to the usual conventional follow-up, the follow-up by nurses specialized in the evaluation of the PROMs using the french version of the QoR-15 questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 patient
- •Benefiting from an osteo-articular surgery
- •Subject affiliated to a social health insurance plan
- •Able to understand the objectives and risks of the research and to give a dated and signed informed consent
排除标准
- •Inability to administer the QoR-15f questionnaire (cognitive impairment, language barrier)
- •Subject under court protection
- •Subject under guardianship or curatorship
- •Patient whose rehabilitation will be performed in a secondary hospital
- •Patient having already benefited from a previous follow-up by the OPTIMISTE team
- •Patient included in a therapeutic trial that may impact postoperative quality of recovery.
结局指标
主要结局
Evaluate the effectiveness of a perioperative follow-up integrating the patient's point of view in osteoarticular surgery compared to a classic postoperative management
时间窗: Inclusion (Day 0), Day 1, Day 3, Day 14, Day 28 and Day 35
Evolution of a modified version of the French Quality-Of-Recovery 15 score (QoR-15f) between the intraoperative consultation and D35 postoperative
次要结局
- Evaluate the effectiveness of perioperative monitoring that incorporates the patient's perspective on reducing postoperative opioid use(Day 35)
- Describe postoperative functional recovery after osteoarticular surgery(Inclusion (Day 0), Day 1, Day 3, Day 14, Day 28 and Day 35)
- Evaluate the safety(Inclusion (Day 0), Day 1, Day 3, Day 14, Day 28 and Day 35])
- Describe the consequences of a perioperative follow-up that integrates the patient's point of view on the patient pathway(Day 1, Day 3, Day 14, Day 28 and Day 35)