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Varicose Vein Education and Informed coNsent (VVEIN) Study (VVEIN)

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ClinicalTrials.gov Identifier: NCT05261412
Recruitment Status : Recruiting
First Posted : March 2, 2022
Last Update Posted : May 2, 2022
Sponsor:
Collaborator:
EIDO Healthcare
Information provided by (Responsible Party):
Aoife Kiernan, Royal College of Surgeons, Ireland

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.

Condition or disease Intervention/treatment Phase
Varicose Veins Other: Standard Consent Other: Digital health education tool (dHET) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Varicose Vein Education and Informed coNsent (VVEIN) Study: A Randomised Feasibility Study
Actual Study Start Date : April 4, 2022
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Varicose Veins

Arm Intervention/treatment
Active Comparator: Standard Consent (Control)
Standard consent (written patient information leaflet (PIL) + verbal discussion with the responsible surgeon) for EVTA followed by signing of consent.
Other: 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.
Other Name: Paper consent

Experimental: Digital health education tool (dHET)
dHET for EVTA + verbal discussion with the responsible surgeon followed by signing of consent.
Other: 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 Names:
  • Educational tool
  • Multimedia consent




Primary Outcome Measures :
  1. Eligible participants [ Time Frame: Through study completion, an average of 12 months ]
    Number of eligible participants (meeting inclusion criteria)

  2. Recruitment rate [ Time Frame: Through study completion, an average of 12 months ]
    Number of participants consenting to participate

  3. Retention rate [ Time Frame: Through study completion, an average of 12 months ]
    (Number of patients who consent to participation) minus (number of patients who voluntarily withdraw) divided by (number of subjects who enrol)

  4. Acceptability [ Time Frame: Through study completion, an average of 12 months ]
    Number of patients declining to participate, reasons for declining, number of patients withdrawing consent

  5. Adherence to protocol [ Time Frame: Through study completion, an average of 12 months ]
    Number of patients who adhered to assigned intervention protocol, also includes the proportion of complete data for each outcome measure

  6. Barriers to assigned intervention [ Time Frame: Through study completion, an average of 12 months ]
    Number of patients not randomised due to staffing or time constraints (with reason recorded), technology issues with tablet/dHET/link to knowledge quiz/ internet access

  7. Time [ Time Frame: Immediately post intervention ]
    Time (seconds) taken to complete the assigned intervention (and any delays caused as a result)


Secondary Outcome Measures :
  1. Knowledge [ Time Frame: Baseline, immediately after intervention, delayed (two week follow up) ]
    Comprehension test about EVTA using True/False format

  2. Patient Anxiety [ Time Frame: Baseline, immediately after intervention, delayed (two week follow up) ]
    Anxiety measured with short-form State Trait Anxiety Inventory (STAI-6)

  3. Patient Satisfaction [ Time Frame: Immediately after intervention and delayed (two week follow up) ]
    Satisfaction of patients measured with Client satisfaction questionnaire (CSQ-8)

  4. Time spent face to face with surgeon [ Time Frame: Post intervention (day of surgery) ]
    Time spent during verbal discussion of consent with responsible surgeon (measured in seconds)

  5. Questions asked [ Time Frame: Post intervention (day of surgery) ]
    Number of questions asked by patients during consent



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05261412


Contacts
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Contact: Aoife Kiernan, MB BCh BAO 00353 (0)1 402 2100 aoifekiernan21@rcsi.ie
Contact: Denis Harkin 00353 1402 2100 denisharkin@rcsi.ie

Locations
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Ireland
Bon Secours Hospital Recruiting
Dublin, Ireland, D09YN97
Contact: Data protection officer    018065300    DPO@bonsecour.ie   
Sponsors and Collaborators
Royal College of Surgeons, Ireland
EIDO Healthcare
Investigators
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Study Director: Denis Harkin Royal College of Surgeons, Ireland
Principal Investigator: Aoife Kiernan Royal College of Surgeons, Ireland
Publications:
Medical Council, The Guide to Professional Conduct and Ethics for Registered Medical Practitioners [2009] para, 9.2

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Responsible Party: Aoife Kiernan, Research Fellow, Royal College of Surgeons, Ireland
ClinicalTrials.gov Identifier: NCT05261412    
Other Study ID Numbers: RoyalCSI1
First Posted: March 2, 2022    Key Record Dates
Last Update Posted: May 2, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aoife Kiernan, Royal College of Surgeons, Ireland:
Informed consent
Educational tool
Digital Consent
Telemedicine
Knowledge recall
Anxiety
Satisfaction
Additional relevant MeSH terms:
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Varicose Veins
Vascular Diseases
Cardiovascular Diseases