Validation of the Clinical Decision Support Systems (CDSS) Developed in the EU Horizon PREPARE Project in the Rehabilitative Treatment of Idiopathic Scoliosis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 178
- 试验地点
- 1
- 主要终点
- Changes in clinical decision
研究概览
简要总结
The study aims to validate both the predictive capacity and the clinical usability of the Clinical Decision Support System (CDSS) developed within the PREPARE project (European Union Grant Agreement 101080288 PREPARE HORIZON-HLTH-2022-TOOL-12-01) for the management of idiopathic scoliosis (IS). This will be achieved through simulation-based studies.
详细描述
Study Population:
Three participant groups will be included:
- Patients under 18 years who have undergone rehabilitative treatment for idiopathic scoliosis at ISICO's main center in Milan.
- Parents of the included patients.
- Specialist physicians in rehabilitation involved in scoliosis management at ISICO.
All participants must have adequate cognitive and language abilities to take part in discussions and complete questionnaires.
Sample Size:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Initial visits or follow-up appointments of patients with IS attending the Milan site of ISICO - Italian Scientific Spine Institute for rehabilitative treatment;
- •Age between 10 and 18 years;
- •Informed consent to participate in the study
排除标准
- •Visits not related to the treatment of IS (other spinal conditions);
- •Patients undergoing treatment at other clinics or hospitals.
研究组 & 干预措施
Clinical Impact of the CDSS
The study aims to investigate the potential clinical impact of the CDSS on the prescription of rehabilitative treatment for idiopathic scoliosis (IS). Specifically, it seeks to answer the following question:
Would clinical decisions regarding the treatment of IS have changed if clinicians had access to the information provided by the CDSS to discuss with the patient?
干预措施: CDSS simulation (Other)
Impact of the CDSS on clinicians
Focus grous designed to explore the perspectives, experiences, and perceptions of physicians regarding the use of the CDSS in daily clinical practice.
干预措施: Focus group - clinicians (Other)
Impact of the CDSS on Patients
The main objective is to explore patients' perspectives on the implementation of CDSS. The aim is to understand patients' experiences with CDSS, including their interactions with the system and their perceptions of its usefulness and relevance in the care pathway. The study also seeks to identify factors that influence patients' acceptance and usability of CDSS, such as interface design, clarity of information, and alignment with patients' preferences. Finally, we aim to evaluate the impact of CDSS on patient engagement and their satisfaction with the care experience, including the extent to which CDSS facilitate informed decision-making and communication between patients and healthcare providers.
干预措施: Focus group - patients (Other)
结局指标
主要结局
Changes in clinical decision
时间窗: Throughout study completion, an avarage of 6 months
To assess the impact of the CDSS on clinical decisions, a mixed-methods approach, combining quantitative and qualitative analyses, will be adopted. The primary quantitative outcome measure will be the proportion of clinical cases in which the therapeutic decision changes after exposure to the CDSS, defined as a binary outcome (change vs. no change in treatment plan). Therapeutic decisions made before and after CDSS consultation will be compared within the same case. Differences in paired pre- and post-CDSS therapeutic decisions will be evaluated using McNemar's test, which is appropriate for assessing changes in paired binary outcomes. Qualitative analyses will explore clinicians' rationale for decision changes and their perceptions of CDSS influence.
次要结局
未报告次要终点