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

The primary aim of this study was to assess the feasibility of introducing a digital health education tool (dHET) for varicose vein surgery.

This randomized, feasibility study allocated 40 patients, into dHET (n = 20) or standard consent (SC) (n = 20) groups. Primary outcomes were related to feasibility. Secondary outcomes were knowledge recall, anxiety, and satisfaction.

Recruitment and retention rates were 100% and 97.5%, respectively. Acceptability was also rated high, confirming feasibility. There was also no evidence of a difference between groups for early knowledge recall (14 [12-17] vs. 14 [11-16]; P = 0.72) or delayed (at 2 weeks) knowledge recall (15 [13-16] vs. 15 [13-16]; P = 0.89). The dHET module took significantly longer to complete compared to SC (13 min [12-18] vs. 9 min [8-12]; P < 0.01). However, the control group asked significantly more questions about the intended procedure (P = 0.03). There was no evidence of a difference between groups for patient anxiety or satisfaction.

This trial shows that the addition of a dHET is feasible and noninferior to SC. Digital consent provides a unique opportunity to promote patient education and autonomy for better shared decision making. It also offers better documentation of the consent process.