Optimization of the Perioperative Pathway Coordinated Through the Collection of Patient-reported Outcome Measures in Patients With Complex Care Needs: An Open-label Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 276
- 主要终点
- The main objective is to evaluate the effectiveness of a perioperative follow-up integrating the patient's perspective based on their perceived health status.
研究概览
简要总结
This research aims to identify, as early as the preoperative phase, groups of patients likely to experience maximum clinical improvement through structured paramedical follow-up based on PROMs. However, the high heterogeneity of the included patients could have masked more pronounced effects in certain subgroups, particularly those at higher risk. Relying on a multicenter approach and a subgroup analysis, our study hypothesizes that certain patient profiles are more likely to significantly benefit from personalized follow-up based on PROMs. The objective is to validate the hypothesis that support through PROMs for patients in complex situations could allow for a more pronounced clinical effect. This follow-up will enable better targeting of interventions from the preoperative phase, optimize the use of healthcare resources, and improve quality, safety, and efficiency of perioperative pathways.
详细描述
The study is an open-label, multicenter, randomized controlled trial comparing two groups:
- A control group receiving the usual conventional follow-up, notably by the surgeon and the attending physician.
- An experimental group receiving, in addition to the usual conventional follow-up, follow-up by dedicated nurses focusing on the patient's perspective regarding their health status (OPTIMISTE follow-up).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •Male or female
- •Adult patient, with no upper age limit
- •Undergoing scheduled or unscheduled surgery in a center participating in the research
- •Presenting a care situation identified as complex, defined by a COMID score > 9
- •Subject affiliated to a social health insurance scheme
- •Subject able to understand the objectives and risks related to the research and to give informed consent, dated and signed
排除标准
- •Inability to administer the mQoR-15f questionnaire (cognitive disorders, language barrier)
- •Inability to provide the subject with informed information (subject in an emergency situation, difficulties in understanding, etc.)
- •Patient who has already received previous follow-up by the OPTIMISTE team
- •Patient enrolled in a therapeutic trial that may affect post-operative recovery quality
- •Subject under legal protection, guardianship or curatorship
- •Pregnant or breastfeeding woman
研究组 & 干预措施
Experimental group
Experimental group In addition to routine follow up by the perioperative team including the surgical team, dedicated nurses will conduct PROMs based patients interviews. These interviews are carried out systematically and in a standardized manner during pre-hospitalization on postoperative days 1, 3, 14, 28 During the interview they will assist the patient with completing the QoR-15 questionnaire, allowing a snapshot of the patient's health status.
If the nurse perceive an alteration of the patient healthstatus based on the interview, the patient may be refered to another healthcare professional (eg : surgeons, anesthesiologist, primary care physician for exemple) Preoperative contact by a nurse practitioner (NP) or registered nurse (RN) specialized in PROMs-based follow-up, and organization of perioperative follow-up on postoperative days 1, 3, 14, and 28.
干预措施: Patient-Reported Outcomes-based perioperative follow-up (QoR-15 focus) (Other)
Control group
follow-up by the perioperative team including the surgical team without the intervention of the dedicated PROMs based interviews team.
Control groupe :
The control group, on the other hand, will receive standard follow-up coordinated by the surgeon and in collaboration with the primary care physician and other community healthcare professionals, without intervention by a nurse practitioner (NP) or registered nurse (RN) and without PROMs-based follow-up.
干预措施: Patient-Reported Outcomes-based perioperative follow-up (QoR-15 focus) (Other)
结局指标
主要结局
The main objective is to evaluate the effectiveness of a perioperative follow-up integrating the patient's perspective based on their perceived health status.
时间窗: Between the baseline consultation and "day 35"
Evolution of a modified version of the French Quality-Of-Recovery 15 score (QoR-15f) between the baseline consultation and postoperative "day 35" (depending on the groups: with or without the OPTISMISTE program). The evoluation is scored from 0 to 150 (A higher score indicates better quality of recovery.)
次要结局
未报告次要终点