Varicose Vein Education and Informed coNsent (VVEIN) study: A randomized controlled pilot feasibility study

Abstract

ObjectivesThe primary aim of this study was to assess the feasibility of introducing a digital health education tool (dHET) for varicose vein surgery. MethodsThis randomized, feasibility study allocated 40 patients, into digital Health Education Tool (dHET) (n=20) or Standard Consent (SC) (n=20) groups. Primary outcomes related to feasibility. Secondary outcomes were knowledge recall, anxiety, and satisfaction. ResultsRecruitment 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. ConclusionThis trial shows that the addition of a dHET is feasible and non-inferior to standard consent. 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.