Transferability and Cost-effectiveness of PROSPECT in Surgical Trainees

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2016-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To design, validate and prove cost-effectiveness of a comprehensive endovascular simulation curriculum consisting of cognitive and psychomotor skills training for endovascular management of symptomatic vascular disease in the lower limbs.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Intraoperative Simultaneous Pressure Guided Revascularization Study

NCT03875846

Peripheral Vascular Diseases Blood Pressure Monitoring, Intraoperative +2 more

COMPLETED

Management of Endothelial Dysfunction in Patients With Chronic Venous Insufficiency After Endovenous Surgical Procedure

NCT04180137

Venous Insufficiency of Leg Venous Insufficiency (Chronic)(Peripheral) Endothelial Dysfunction

COMPLETED NA

Venous Pressure Measurement of the Great Saphenous Vein Using Controlled Compression Ultrasound in Healthy Persons and Patients With Chronic Venous Disease as a New Non Invasive Method for Investigation of the Pathophysiology in Primary Varicose Veins

NCT01000909

Chronic Venous Insufficiency

UNKNOWN

Venous Insufficiency and Neuromuscular Stimulation

NCT02137499

Chronic Venous Disease Venous Insufficiency Deep Venous Obstruction

COMPLETED NA

Foot Perfusion Analysis to Predict Limb Salvage

NCT03810469

Critical Limb Ischemia Peripheral Arterial Disease

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The main goal is to design a comprehensive endovascular simulation curriculum consisting of cognitive and psychomotor skills training for endovascular management of symptomatic vascular disease in the lower limbs (Rutherford classification 2-5; stenosis or occlusion in the iliac, superficial femoral and popliteal arteries). The curriculum will consist of E-learning, video-based learning and simulation exercises on the Virtual Reality simulator on which an endovascular procedure will be simulated.

Skills transferability to real life practice will be verified by means of a RCT. In this RCT the investigators will compare the cognitive knowledge and technical performance of curricular trained surgical trainees with conventionally trained trainees during treatment of patients under supervision. The hypothesis states that surgeons trained within the PROSPECT curriculum will show improved technical knowledge of endovascular treatment of atherosclerotic disease in the iliac, superficial femoral and popliteal arteries and will demonstrate increased technical proficiency in the angiosuite in comparison with surgeons who received only conventional training. Subjects will be surgical trainees (N=32). They will be randomized into a three groups: a control group (N=11), a group that only has access to E-learning (N=10) and a PROSPECT group (N=11). Both groups will continue their traditional clinical education and the PROSPECT group will additionally be trained within this endovascular curriculum. The investigators hope that this study may ultimately lead to an improvement in the quality of patient care by standardizing competencies of endovascular operators in training and practice.

Additionally a cost-effectiveness analysis of PROSPECT compared to traditional training modalities will be executed. A successful training program is expected to lead to a shortening of the learning curve, reduction in number of errors during real life procedures and more efficient use of hybrid angio suites. The financial impact of potentially shorter duration of endovascular interventions will be studied and compared to time investment and additional costs associated with stepwise, supervised training using VR simulators.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vascular Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Initially 39 participants were enrolled, 7 excluded because they declined to participate. 32 people were randomized.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PROSPECT

the trainee will study four modules of E-learning (basic endovascular skills module, iliac artery module, superficial femoral artery module and postoperative care module). After studying each module the trainee will complete a Multiple Choice Questionnaire and perform a simple and a complex exercise on the simulator.

Group Type EXPERIMENTAL

additional curriculum (E-learning + simulation)

Intervention Type OTHER

CONTROL

The trainee will continue clinical education without additional curriculum, but will be allowed to study independently.

Group Type NO_INTERVENTION

No interventions assigned to this group

E-LEARNING

the trainee will study four modules of E-learning (basic endovascular skills module, iliac artery module, superficial femoral artery module and postoperative care module). After studying each module the trainee will complete a Multiple Choice Questionnaire, no simulation.

Group Type EXPERIMENTAL

additional E-learning

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

additional curriculum (E-learning + simulation)

Intervention Type OTHER

additional E-learning

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Surgical trainee
* Knowledge and technical skill level evaluated
* Demographics questionnaire and general MCQ test completed
* 2 endovascular simulated exercises completed after familiarization with the simulator