NCT07379593

Validation of the Clinical Decision Support Systems (CDSS) Developed in the EU Horizon PREPARE Project in the Rehabilitative Treatment of Idiopathic Scoliosis

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 178 (estimated)
• Sponsor: Istituto Scientifico Italiano Colonna Vertebrale · Academic / Other
• Sex: All
• Age: 10 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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: Part I: Involves the 8 ISICO physicians performing clinical visits. The main outcome measure is the variation in treatment decisions before and after exposure to the CDSS. With α = 0.05, power = 80%, and expected effect size (Cohen's d = 0.3), the minimum required sample size is 175 clinical cases. Parts II-III (Focus Groups): 6-12 patients 6-12 parents 6-10 physicians These group sizes align with qualitative research standards to ensure thematic saturation. Safety Evaluation: Adverse events will be monitored, recorded, and assessed by the Data Safety Monitoring Committee (DSMC). Statistical and Analytical Plan: Quantitative analysis will evaluate: The frequency, nature, and motivations behind changes in treatment plans after using CDSS recommendations. Correlations between CDSS suggestions and clinicians' treatment decisions. Qualitative analysis will interpret data from focus group discussions to identify patterns, trends, and associations between CDSS recommendations, clinical choices, and possible alternative decisions had the CDSS been applied.

Conditions

• Adolescent Idiopathic Scoliosis (AIS)

Interventions

Type	Name	Description
OTHER	CDSS simulation	The intervention planned in this study consists of a simulation, carried out by physicians, of the use of a Clinical Decision Support System (CDSS) designed to support informed decision-making in prescribing rehabilitative treatment for idiopathic scoliosis (IS). Physicians will continue their routine clinical practice and will subsequently be exposed to the CDSS results for the same cases they had previously assessed, after a three-month interval (the typical period between a visit and a follow-up). This delay is intended to minimize recall bias and to ensure that exposure to the CDSS does not retrospectively influence their therapeutic decisions, thereby avoiding any interference with their daily clinical activity. The study will simulate the integration of the CDSS into the clinicians' routine workflow. The CDSS will be developed based on advanced computational models using artificial intelligence, specifically adapted to the rehabilitation context for IS, and created during the f
OTHER	Focus group - clinicians	Focus group aimed at exploring how the implementation of the CDSS has influenced the clinical practice of physicians who previously simulated its integration into their professional activity, as well as their decision-making processes and approaches to patient care.
OTHER	Focus group - patients	Two separate focus groups will be organized: one for patients and one for parents. During the sessions, hypothetical clinical scenarios involving the use of CDSS in their care pathway will be presented. The scenarios will be identical for both groups. Participants will be encouraged to share their opinions, thoughts, and feelings regarding CDSS. Facilitators will guide the discussion, ensuring that all participants have the opportunity to express their views and that diverse perspectives are collected.

Timeline

• Start date: 2025-11-07
• Primary completion: 2027-03-01
• Completion: 2027-05-30
• First posted: 2026-01-30
• Last updated: 2026-01-30

Locations

1 site across 1 country: Italy