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

Istituto Scientifico Italiano Colonna Vertebrale

Status: Active, not recruiting

Conditions: Adolescent Idiopathic Scoliosis (AIS)

Treatments: Other: Focus group - patients; Other: Focus group - clinicians; Other: CDSS simulation

Study type: Interventional

Funder types: Other

Identifiers

NCT07379593

PREPARE-pros

Details and patient eligibility

About

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.

Full 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.

Enrollment: 178 estimated patients

Sex: All

Ages: 10+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Visits not related to the treatment of IS (other spinal conditions);

Patients undergoing treatment at other clinics or hospitals.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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178 participants in 3 patient groups

Clinical Impact of the CDSS

Experimental group

Description:

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?

Treatment:

Other: CDSS simulation

Impact of the CDSS on clinicians

Other group

Description:

Focus grous designed to explore the perspectives, experiences, and perceptions of physicians regarding the use of the CDSS in daily clinical practice.

Treatment:

Other: Focus group - clinicians

Impact of the CDSS on Patients

Other group

Description:

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.

Treatment:

Other: Focus group - patients