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

April 22, 2024 updated by: Aoife Kiernan, Royal College of Surgeons, Ireland

Varicose Vein Education and Informed coNsent (VVEIN) Study: A Randomised Feasibility Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ireland
      • Dublin, Ireland, D09YN97
        • Bon Secours Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eligible participants
Time Frame: Through study completion, an average of 12 months
Number of eligible participants (meeting inclusion criteria)
Through study completion, an average of 12 months
Recruitment rate
Time Frame: Through study completion, an average of 12 months
Number of participants consenting to participate
Through study completion, an average of 12 months
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)
Through study completion, an average of 12 months
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
Through study completion, an average of 12 months
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
Through study completion, an average of 12 months
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
Through study completion, an average of 12 months
Time
Time Frame: Immediately post intervention
Time (seconds) taken to complete the assigned intervention (and any delays caused as a result)
Immediately post intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Knowledge
Time Frame: Baseline, immediately after intervention, delayed (two week follow up)
Comprehension test about EVTA using True/False format
Baseline, immediately after intervention, delayed (two week follow up)
Patient Anxiety
Time Frame: Baseline, immediately after intervention, delayed (two week follow up)
Anxiety measured with short-form State Trait Anxiety Inventory (STAI-6)
Baseline, immediately after intervention, delayed (two week follow up)
Patient Satisfaction
Time Frame: Immediately after intervention and delayed (two week follow up)
Satisfaction of patients measured with Client satisfaction questionnaire (CSQ-8)
Immediately after intervention and delayed (two week follow up)
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)
Post intervention (day of surgery)
Questions asked
Time Frame: Post intervention (day of surgery)
Number of questions asked by patients during consent
Post intervention (day of surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal College of Surgeons, Ireland

Collaborators

EIDO Healthcare

Investigators

  • Study Director: Denis Harkin, Royal College of Surgeons, Ireland
  • Principal Investigator: Aoife Kiernan, Royal College of Surgeons, Ireland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 4, 2022

Primary Completion (Actual)

July 1, 2023

Study Completion (Actual)

July 31, 2023

Study Registration Dates

First Submitted

February 9, 2022

First Submitted That Met QC Criteria

February 18, 2022

First Posted (Actual)

March 2, 2022

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RoyalCSI1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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