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NCT Number: NCT07379593

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Adolescent Idiopathic Scoliosis (AIS)

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ISICO - Italian Scientific Spine Institute

Milan, Italy, 20100

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CDSS simulation

Other

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

Focus group - clinicians

Other

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.

Focus group - patients

Other

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.

Primary outcomes

  1. Changes in clinical decision

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Istituto Scientifico Italiano Colonna Vertebrale

Other

Registry information

Acronym: PREPARE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 30, 2026
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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