1. Varicose Vein Education and Informed coNsent (VVEIN) Study: A Randomized Controlled Pilot Feasibility Study.
- Author
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Kiernan A, Boland F, Naughton P, Moneley D, Doyle F, and Harkin DW
- Subjects
- Humans, Pilot Projects, Female, Male, Middle Aged, Adult, Aged, Time Factors, Anxiety prevention & control, Anxiety psychology, Anxiety etiology, Mental Recall, Treatment Outcome, Computer-Assisted Instruction, Feasibility Studies, Informed Consent, Patient Education as Topic, Varicose Veins surgery, Health Knowledge, Attitudes, Practice, Patient Satisfaction, Vascular Surgical Procedures education
- Abstract
Background: The primary aim of this study was to assess the feasibility of introducing a digital health education tool (dHET) for varicose vein surgery., Methods: 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., Results: 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., Conclusions: 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., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)
- Published
- 2024
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