Varicose Vein Education and Informed coNsent (VVEIN) study: a randomised controlled pilot feasibility study

Area of Science:

• Vascular Surgery
• Medical Education
• Informed Consent

Background:

• Informed consent is a legal and ethical requirement in patient care.
• Telemedicine and digital health tools offer new avenues for patient education.
• Superficial venous interventions have high medicolegal claims, necessitating improved consent processes.

Purpose of the Study:

• To assess the feasibility and acceptability of a digital health education tool (dHET) for patients undergoing endovenous thermal ablation (EVTA).
• To explore the potential of digital solutions to enhance patient understanding and satisfaction with the surgical consent process.

Main Methods:

• A prospective, single-centre, randomized controlled feasibility trial.
• Recruitment of 40 patients with chronic venous disease undergoing EVTA.
• Randomization to either standard consent (SC) or the digital health education tool (dHET).

Main Results:

• Feasibility assessed by recruitment and retention rates.
• Acceptability of the dHET evaluated.
• Secondary outcomes include knowledge retention, anxiety, and patient satisfaction.

Conclusions:

• Digital consent solutions may improve and standardize patient communication.
• This approach has the potential to reduce claims associated with inadequate consent and risk disclosure.