Condition category
Surgery
Date applied
25/03/2018
Date assigned
29/03/2018
Last edited
28/03/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
University Hospitals Birmingham (UHB) carry out over 250 liver transplants per year, and at any one time, there are around 3000 liver patients who need to come to the hospital every 3 or 6 months for routine follow-up appointments with their doctor. The hospital covers a large area, and many transplant patients need to travel long distances to attend their follow-up appointments. The hospital has developed a tool (called myVirtualClinic) to allow patients to have video consultations from their home without needing to travel to the hospital for their follow-up appointment. This study is an evaluation of whether virtual clinics can increase liver transplant patients' satisfaction with their care. Virtual clinics may also save patients and the hospital money.

Who can participate?
Patients aged 18 or over who have had a liver transplant at least 1 year and no more than 5 years before the start of the study

What does the study involve?
Participants are randomly allocated to one of two group. Participants in the virtual clinic group have their follow-up appointments from home via secure video link for 12 months. Participants in the standard care group carry on with the standard arrangements for follow-up and come to the hospital for face-to-face appointments for 12 months as normal. Satisfaction with care is measured to see if patients who have had virtual clinics are more or less satisfied with care compared to those who continued having standard care. Interviews are also carried out with patients, carers/family members and healthcare professionals involved in the study to find out about their thoughts and experiences of the study, and understand whether it would be worth expanding virtual clinics to other clinical areas or to other hospitals.

What are the possible benefits and risks of participating?
There is no direct benefit to patients participating in the study, but the information collected will show how virtual clinics may work if they become part of normal care. If the study shows that virtual clinics are effective, they may be used in the future as part of routine follow-up care for transplant patients or those with other conditions. There are no potential risks associated with participating in the study.

Where is the study run from?
Queen Elizabeth Hospital, Birmingham (UK)

When is the study starting and how long is it expected to run for?
February 2018 to September 2020

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Elaine O'Connell-Francischetto

Trial website

Contact information

Type

Public

Primary contact

Ms Elaine O'Connell-Francischetto

ORCID ID

Contact details

Institute of Applied Health Research
Murray Learning Centre
University of Birmingham
Birmingham
B15 2TT
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Protocol version 1.2

Study information

Scientific title

Virtual clinics versus standard face-to-face appointments for liver transplant patients in routine hospital outpatient care: pragmatic randomised evaluation of myVirtualClinic

Acronym

Study hypothesis

This randomised evaluation randomised evaluation is designed to assess the effectiveness of providing virtual clinics as an alternative to standard face-to-face consultations in delivering routine follow-up care for clinically stable liver transplant patients. The primary aim is to assess whether the option of myVirtualClinic can increase patient satisfaction in the VSQ-9 domains of ‘convenience of location’, ‘getting through to the office by phone’ and ‘length of time waiting’ compared to standard care (face-to-face consultations) for clinically stable liver transplant patients.

Ethics approval

1. NHS Health Research Authority (HRA), 25/09/2017
2. West Midlands Solihull Research Ethics Committee, 24/10/2017, ref: 17/WM/0338
3. University Hospitals Birmingham NHS Foundation Trust, February 2018, ref: RRK6080

Study design

Pragmatic two-armed parallel group statistician-blinded randomised evaluation

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Liver transplantation

Intervention

After giving consent and completing a baseline questionnaire, participating patients (clinically stable patients who received a liver transplant between 1 and 5 years previously) will be randomised in a 1:1 ratio to either the intervention (myVirtualClinic) or control (standard care) arm of the study using the GraphPad online randomisation tool. Patients randomised to the intervention arm of the study will have routine outpatient appointments with their liver consultant from home via secure video link accessed through the patient portal at University Hospitals Birmingham NHS Foundation Trust instead of needing to attend the hospital for a face-to-face appointment. Patients randomised to standard care carry on with the standard arrangements for follow-up and will come to the hospital for face-to-face appointments for 12 months as normal. Satisfaction with care is compared in the two groups to see if patients who have had virtual clinics are more or less satisfied with care compared to those who continued having standard care. Interviews are also carried out with patients, carers/family members and healthcare professionals involved in the study to see what their thoughts and experiences of the study were.

Intervention type

Other

Phase

Drug names

Primary outcome measure

The combined satisfaction score for three domains of the RAND modified Visit-Specific Satisfaction Instrument (VSQ-9) (convenience of location, getting through to the office by phone and length of time waiting). The VSQ-9 asks participants to rate their satisfaction with various aspects of their clinic appointment on a 5-point scale (poor, fair, good, very good, excellent). Scores are then transformed into a 0-100 linear scale where higher scores denote higher levels of satisfaction. VSQ-9 data will be collected at baseline and after every virtual clinic or face-to-face appointment via patient questionnaires. A difference of 10 points between the intervention and control groups in the three selected domains of the VSQ-9 at study end (12 months) will be taken as clinically significant.

Secondary outcome measures

1. Patient reported health-related quality of life measured through EQ-5D-5L patient questionnaires at baseline, 6 months and end of study
2. Patient satisfaction scores in the other six VSQ-9 domains not forming part of the primary outcome measure. Measured through patient questionnaires at baseline, 3 months (if applicable), 6 months, 9 months (if applicable) and 12 months
3. Routinely collected clinical outcomes collected via patient records at study end
4. Number and length of clinical contacts, instances of appointment non-attendance, collected via routinely collected metrics, clinician reporting throughout the study
5. Health service use, collected via patient questionnaires at baseline and end of study
6. Patient costs, collected via patient questionnaires at baseline, 3 months (if applicable), 6 months, 9 months (if applicable), 12 months
7. Secondary care costs, collected via routinely collected data at study end
8. MyVirtualClinic system performance, collected via routinely collected metrics at study end
9. Whether patients in the intervention arm have been able to have clinical tests carried out locally prior to their virtual clinic appointment, collected via clinician-completed case report form after each appointment
10. Patient, carer and clinician experience of the study, collected via semi-structured interviews at the end of the study
11. Questionnaire completion rates, assessed using information on the proportion of questionnaires completed by participating patients at the end of the study
12. Participants' travel requirements, assessed using patient questionnaire at baseline

Overall trial start date

01/02/2018

Overall trial end date

30/09/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Have had a liver transplant at least 1 year and no more than 5 years prior to study baseline
2. Aged 18 or over
3. Considered clinically stable by their consultant
4. Have access to myhealth@QEHB patient portal (or agree to sign up)
5. Able to arrange for clinical testing (blood tests, weight and blood pressure) to be undertaken locally at a GP practice or dialysis centre and the results uploaded to myhealth@QEHB prior to myVirtualClinic appointment
6. Have access to a computing device (e.g. desktop computer or laptop) running an operating system compatible with the virtual clinic software, as well as camera and internet connection
7. Able to consent to participate in the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

180

Participant exclusion criteria

1. Unable to speak and/or read English
2. Unable to comply with study follow-up procedure (completion of electronic questionnaires)
3. Involvement in another research study or clinical trial involving ongoing questionnaire completion

Recruitment start date

12/03/2018

Recruitment end date

31/05/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queen Elizabeth Hospital, Birmingham
Mindelsohn Way, Edgbaston
Birmingham
B152GW
United Kingdom

Sponsor information

Organisation

University of Birmingham

Sponsor details

Edgbaston
Birmingham
B15 2TT
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The protocol is shortly to be submitted for open-access publication and will be publicly available online after publication. Study findings will be presented at academic conferences and published in an open-access high impact peer-reviewed journals within 12 months of the overall trial end date. Study results will also be disseminated to key stakeholders locally. A CLAHRC BITE (Brokering Innovation Through Evidence) will be produced. BITEs are designed to be accessible, bite-sized summaries of findings from published work undertaken by CLAHRC West Midlands. The BITE will be publicly available on the CLAHRC website and will be sent via the my health@QEHB system to all study participants.

IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available as study participants are not being asked to give consent for their data to be used outside of the specific trial for which it is being collected. The study is an evaluation of a new service at a single hospital Trust, and secondary analysis of participant-level data is unlikely to be of wider interest or utility outside of this setting. However, the study findings will be published in an open-access journal, and results for the primary outcome and each of the secondary outcomes will be reported. Study data will be stored electronically on secure, password-protected University of Birmingham servers for 10 years after the conclusion of the study, as required by the University of Birmingham Code of Practice for Research.

Intention to publish date

30/09/2021

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes