Varicose Vein Education and Informed coNsent (VVEIN) Study
NCT ID: NCT05261412
Last Updated: 2024-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2022-04-04
2023-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Standard Consent (Control)
Standard consent (written patient information leaflet (PIL) + verbal discussion with the responsible surgeon) for EVTA followed by signing of consent.
Standard Consent
Participants in the control arm will undergo Standard Consent which will consist of paper PIL provided by EIDO healthcare followed by a verbal discussion (standardized by following a checklist of topics to discuss) with the responsible consultant surgeon and signing of the consent form. The time taken to read the PIL (self-recorded by the patient) will be recorded. The time spent with the responsible surgeon will also be recorded, as will the number of questions asked by the participant.
Digital health education tool (dHET)
dHET for EVTA + verbal discussion with the responsible surgeon followed by signing of consent.
Digital health education tool (dHET)
Participants randomized to the intervention dHET will receive the dHET followed by a verbal discussion (as above) and signing of the consent form. The dHET will be delivered on a tablet computer and facilitated by a research assistant who will ensure all technological issues are overcome but will not engage with the participant with regard facilitating better understanding of the content. The digital offering will be interactive; participants will be able to traverse through each section at their own pace with the ability to re-visit sections. It also contains a two-minute narrated animation of the procedure, which can played, rewinded or fast forward. The time spent reading each section of the dHET and time spent watching the animation will be recorded. The time spent with the responsible surgeon will also be recorded, as will the number of questions asked by the participant.
Interventions
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Standard Consent
Participants in the control arm will undergo Standard Consent which will consist of paper PIL provided by EIDO healthcare followed by a verbal discussion (standardized by following a checklist of topics to discuss) with the responsible consultant surgeon and signing of the consent form. The time taken to read the PIL (self-recorded by the patient) will be recorded. The time spent with the responsible surgeon will also be recorded, as will the number of questions asked by the participant.
Digital health education tool (dHET)
Participants randomized to the intervention dHET will receive the dHET followed by a verbal discussion (as above) and signing of the consent form. The dHET will be delivered on a tablet computer and facilitated by a research assistant who will ensure all technological issues are overcome but will not engage with the participant with regard facilitating better understanding of the content. The digital offering will be interactive; participants will be able to traverse through each section at their own pace with the ability to re-visit sections. It also contains a two-minute narrated animation of the procedure, which can played, rewinded or fast forward. The time spent reading each section of the dHET and time spent watching the animation will be recorded. The time spent with the responsible surgeon will also be recorded, as will the number of questions asked by the participant.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* First procedure for superficial venous incompetence
* Full consent
* \>18 years
* Proficient in English
Exclusion Criteria
* Cognitive impairment or unable to consent
18 Years
90 Years
ALL
Yes
Sponsors
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EIDO Healthcare
OTHER
Royal College of Surgeons, Ireland
OTHER
Responsible Party
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Aoife Kiernan
Research Fellow
Principal Investigators
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Denis Harkin
Role: STUDY_DIRECTOR
Royal College of Surgeons, Ireland
Aoife Kiernan
Role: PRINCIPAL_INVESTIGATOR
Royal College of Surgeons, Ireland
Locations
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Bon Secours Hospital
Dublin, , Ireland
Countries
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References
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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.
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.
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.
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.
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.
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.
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/
Medical Council, The Guide to Professional Conduct and Ethics for Registered Medical Practitioners [2009] para, 9.2
Grady C. Enduring and emerging challenges of informed consent. N Engl J Med. 2015 Feb 26;372(9):855-62. doi: 10.1056/NEJMra1411250.
Emanuel EJ, Emanuel LL. Four models of the physician-patient relationship. JAMA. 1992 Apr 22-29;267(16):2221-6. No abstract available.
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.
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.
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.
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.
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.
Kiernan A, Boland F, Moneley D, Doyle F, Harkin DW. Varicose Vein Education and Informed coNsent (VVEIN) study: a randomised controlled pilot feasibility study. Pilot Feasibility Stud. 2023 Jun 22;9(1):104. doi: 10.1186/s40814-023-01336-9.
Other Identifiers
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RoyalCSI1
Identifier Type: -
Identifier Source: org_study_id
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