Varicose Vein Education and Informed coNsent (VVEIN) Study: A Randomized Controlled Pilot Feasibility Study

Area of Science:

• Vascular Surgery
• Digital Health
• Patient Education

Background:

• Assessing the feasibility of a digital health education tool (dHET) for varicose vein surgery.
• Evaluating patient education and consent processes in surgical settings.

Purpose of the Study:

• To determine the feasibility of implementing a dHET for varicose vein surgery.
• To compare patient knowledge, anxiety, and satisfaction between dHET and standard consent (SC).

Main Methods:

• A randomized feasibility study involving 40 patients, divided into dHET (n=20) and SC (n=20) groups.
• Primary outcomes focused on feasibility metrics (recruitment, retention, acceptability).
• Secondary outcomes included knowledge recall, anxiety, and satisfaction levels.

Main Results:

• High recruitment (100%) and retention (97.5%) rates confirmed feasibility.
• No significant differences in early or delayed knowledge recall between groups.
• The dHET group spent more time completing the module, while the SC group asked more procedural questions. No differences in anxiety or satisfaction were observed.

Conclusions:

• The dHET is a feasible and non-inferior alternative to standard consent for varicose vein surgery.
• Digital consent enhances patient education, autonomy, and shared decision-making.
• dHET offers improved documentation of the consent process.