Clinical trial NCT05261412: Varicose Vein Education and Informed coNsent (VVEIN) Study
Official title: Varicose Vein Education and Informed coNsent (VVEIN) Study: A Randomised Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Varicose Veins
Keywords: Informed consent
Educational tool
Digital Consent
Telemedicine
Knowledge recall
Anxiety
Satisfaction
Lead sponsor: Royal College of Surgeons, Ireland
Sponsor class: OTHER
Collaborators: name: EIDO Healthcare
First posted: 2022-03-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a prospective, single centre, randomised controlled, feasibility study recruiting patients with varicose veins. Patients will be randomised to receive standard (verbal discussion and written information pamphlet) consent or a digital health education tool (dHET). The primary endpoints will be feasibility and practicality of introducing dHET into a busy day surgery practice, secondary endpoints will included knowledge recall of essential information, patient anxiety, patient satisfaction and the time spent in person with the responsible surgeon and number of questions asked prior to signing the consent document.

Detailed description: Varicose Veins (VV) affect one-third of the adult population and chronic venous disease (CVD) has a negative effect on quality of life (QoL), which can be significantly improved by treatment.\[1-4\] Chronic venous insufficiency (CVI) can be complicated by venous ulceration in over 3% of patients, and chronic treatment with dressings has been estimated to consume 2% of the health budget. Over the last 15 years, minimally invasive endovenous techniques to treat VV have been introduced and are proven to be cost-effective and safe, particularly when performed under a local anaesthetic in an outpatient setting.\[5\] The American Venous Forum, in 2011, and the National Institute for Health and Care Excellence NICE), in 2013, have recommended endovenous thermal ablation (EVTA) techniques, as the first-line treatments for truncal reflux.\[6,7\]

As doctors, there is a legal requirement and duty of care to ensure patients are enabled to make an informed decision about their treatment, including discussion of the benefits, risks and alternative treatments. This is reflected in the Health Service Executive (HSE) National Consent Policy and Irish Medical Council 'Guide to Professional Conduct and Ethics'. \[8\] A patient centered approach to consent has been firmly established in Ireland since 2000, it reinforces that there is a duty to involve patients in decisions about treatments and to engage in a dialogue that offers comprehensible information. This is in keeping with the fundamental ethical principle of autonomy.\[8\]

Interventions to improve information transfer and comprehension in the consent process \[9\], such as standard Patient Information Leaflets (PIL) report mixed results. Information leaflets used during the process of consent have been shown to increase patient factual recall and satisfaction with the consent process and are considered best practice. \[10-15\] However, even well considered PILs, co-designed with patient or client engagement, do not always cover the less common areas of concern or risk which may be material to an individual patient. \[9\] More rigorous approaches are time and cost intensive, and can adversely impact on the efficiency of healthcare delivery, which limits scalability.

Telemedicine has revolutionised the delivery of care to patients in the modern era of computers, tablets, and smartphones and its use has been rapidly expanded.\[16\] Digital platforms are a novel tool to potentially improve dialogue and communication between doctors and patients. Patients in general have high satisfaction ratings for telemedicine, but certain patient-groups may be less likely to engage or benefit from it on account of disability, technological illiteracy or access.\[16\] The use of novel digital technologies can offer a low cost, accessible and tailored solution.

Thus the rationale for this study is to investigate whether it is feasible and acceptable to deliver a digital health education intervention to patients to supplement the consent process.

Eligibility criteria: Inclusion Criteria:

* Deemed suitable for EVTA by treating surgeon
* First procedure for superficial venous incompetence
* Full consent
* \>18 years
* Proficient in English

Exclusion Criteria:

* Redo or second procedure for superficial venous incompetence (in same or opposite leg)
* Cognitive impairment or unable to consent
* Not meeting inclusion criteria

Primary outcomes:
measure: Eligible participants
timeFrame: Through study completion, an average of 12 months
measure: Recruitment rate
timeFrame: Through study completion, an average of 12 months
measure: Retention rate
timeFrame: Through study completion, an average of 12 months
measure: Acceptability
timeFrame: Through study completion, an average of 12 months
measure: Adherence to protocol
timeFrame: Through study completion, an average of 12 months
measure: Barriers to assigned intervention
timeFrame: Through study completion, an average of 12 months
measure: Time
timeFrame: Immediately post intervention
Secondary outcomes:
measure: Knowledge
timeFrame: Baseline, immediately after intervention, delayed (two week follow up)
measure: Patient Anxiety
timeFrame: Baseline, immediately after intervention, delayed (two week follow up)
measure: Patient Satisfaction
timeFrame: Immediately after intervention and delayed (two week follow up)
measure: Time spent face to face with surgeon
timeFrame: Post intervention (day of surgery)
measure: Questions asked
timeFrame: Post intervention (day of surgery)
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Bon Secours Hospital
Study officials:
affiliation: Royal College of Surgeons, Ireland
name: Denis Harkin
role: STUDY_DIRECTOR
affiliation: Royal College of Surgeons, Ireland
name: Aoife Kiernan
role: PRINCIPAL_INVESTIGATOR
References:
citation: Evans CJ, Fowkes FG, Ruckley CV, Lee AJ. Prevalence of varicose veins and chronic venous insufficiency in men and women in the general population: Edinburgh Vein Study. J Epidemiol Community Health. 1999 Mar;53(3):149-53. doi: 10.1136/jech.53.3.149.
citation: Smith JJ, Garratt AM, Guest M, Greenhalgh RM, Davies AH. Evaluating and improving health-related quality of life in patients with varicose veins. J Vasc Surg. 1999 Oct;30(4):710-9. doi: 10.1016/s0741-5214(99)70110-2.
citation: MacKenzie RK, Paisley A, Allan PL, Lee AJ, Ruckley CV, Bradbury AW. The effect of long saphenous vein stripping on quality of life. J Vasc Surg. 2002 Jun;35(6):1197-203. doi: 10.1067/mva.2002.121985.
citation: Biemans AA, Kockaert M, Akkersdijk GP, van den Bos RR, de Maeseneer MG, Cuypers P, Stijnen T, Neumann MH, Nijsten T. Comparing endovenous laser ablation, foam sclerotherapy, and conventional surgery for great saphenous varicose veins. J Vasc Surg. 2013 Sep;58(3):727-34.e1. doi: 10.1016/j.jvs.2012.12.074. Epub 2013 Jun 13.
citation: van den Bos R, Arends L, Kockaert M, Neumann M, Nijsten T. Endovenous therapies of lower extremity varicosities: a meta-analysis. J Vasc Surg. 2009 Jan;49(1):230-9. doi: 10.1016/j.jvs.2008.06.030. Epub 2008 Aug 9.
citation: Gloviczki P, Comerota AJ, Dalsing MC, Eklof BG, Gillespie DL, Gloviczki ML, Lohr JM, McLafferty RB, Meissner MH, Murad MH, Padberg FT, Pappas PJ, Passman MA, Raffetto JD, Vasquez MA, Wakefield TW; Society for Vascular Surgery; American Venous Forum. The care of patients with varicose veins and associated chronic venous diseases: clinical practice guidelines of the Society for Vascular Surgery and the American Venous Forum. J Vasc Surg. 2011 May;53(5 Suppl):2S-48S. doi: 10.1016/j.jvs.2011.01.079.
citation: National Clinical Guideline Centre (UK). Varicose Veins in the Legs: The Diagnosis and Management of Varicose Veins. London: National Institute for Health and Care Excellence (NICE); 2013 Jul. Available from http://www.ncbi.nlm.nih.gov/books/NBK264166/
citation: Medical Council, The Guide to Professional Conduct and Ethics for Registered Medical Practitioners [2009] para, 9.2
citation: Grady C. Enduring and emerging challenges of informed consent. N Engl J Med. 2015 Feb 26;372(9):855-62. doi: 10.1056/NEJMra1411250.
citation: Emanuel EJ, Emanuel LL. Four models of the physician-patient relationship. JAMA. 1992 Apr 22-29;267(16):2221-6. No abstract available.
citation: Gartner FR, Bomhof-Roordink H, Smith IP, Scholl I, Stiggelbout AM, Pieterse AH. The quality of instruments to assess the process of shared decision making: A systematic review. PLoS One. 2018 Feb 15;13(2):e0191747. doi: 10.1371/journal.pone.0191747. eCollection 2018.
citation: Stiggelbout AM, Pieterse AH, De Haes JC. Shared decision making: Concepts, evidence, and practice. Patient Educ Couns. 2015 Oct;98(10):1172-9. doi: 10.1016/j.pec.2015.06.022. Epub 2015 Jul 15.
citation: Couet N, Desroches S, Robitaille H, Vaillancourt H, Leblanc A, Turcotte S, Elwyn G, Legare F. Assessments of the extent to which health-care providers involve patients in decision making: a systematic review of studies using the OPTION instrument. Health Expect. 2015 Aug;18(4):542-61. doi: 10.1111/hex.12054. Epub 2013 Mar 4.
citation: Pascoe GC. Patient satisfaction in primary health care: a literature review and analysis. Eval Program Plann. 1983;6(3-4):185-210. doi: 10.1016/0149-7189(83)90002-2.
citation: Weinstein RS, Lopez AM, Joseph BA, Erps KA, Holcomb M, Barker GP, Krupinski EA. Telemedicine, telehealth, and mobile health applications that work: opportunities and barriers. Am J Med. 2014 Mar;127(3):183-7. doi: 10.1016/j.amjmed.2013.09.032. Epub 2013 Oct 29.