Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04444323 |
| Other study ID # |
GN20HS300 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 10, 2021 |
| Est. completion date |
March 31, 2022 |
Study information
| Verified date |
May 2022 |
| Source |
NHS Greater Glasgow and Clyde |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
It is critical to establish an effective form of telemedicine during the Covid 19 pandemic,
that will allow safe social distancing of clinicians and patients. Canniesburn Regional
Plastic Surgery and Burns Unit serves as the regional plastic, burns and reconstructive
centre for West of Scotland, population 3 million. All face to face clinics have been
cancelled and converted to telephone/telemedicine only consultations. The research will
establish both 2D and 3D telemedicine as normal patient follow up practice during this
period.The project therefore aims to implement a 3D telemedicine system to facilitate patient
follow up and remote physiotherapy, that will act as if the patient is physically 'present'
in the room. Physiotherapy is crucial to patient outcomes after burns contractures, hand
trauma and cancer reconstruction. The 3D telemedicine system will be built by an industrial
partner, with CE marked equipment, specifically to help during the Covid-19 Pandemic.
Description:
1. Background:
Telemedicine is critical during Covid pandemic. A seismic shift in clinical practice has
occurred in the UK, with nearly all medical clinics cancelled or converted to telephone
or telemedicine clinics (Attend Anywhere or Zoom). These fail to adequately substitute
for a face-to-face consultation, with the National Health Service (NHS) needing higher
quality, more clinically effective methods of remote patient interaction. This project
will be the world's first evaluation of a novel, potentially transformative form of 3D
telemedicine, facilitating telepresence as if the patient were in the room. This
state-of-the-art system has been developed by an industrial partner, specifically to
help with remote patient communication during Covid pandemic. This uses an array of 3D
cameras connected to fusion and render servers, allowing reconstruction of a 3D image in
real time. This may give more information about a patient's condition, particularly in
more visual specialties such as Plastic Surgery
The research will fulfil criteria for the European Commission's Model for Assessment of
Telemedicine applications (MAST, Kidholm 2012). This will include participatory design,
and evaluation with a preliminary cohort study, to shape the follow on research. This
will assess clinicians' and patients' perception of system usability, delivery of
therapies, clinical accuracy and interaction. On project completion, fulfilment of MAST
criteria will enable upscaling and lead onto a randomized trial. The study design will
be informed by participatory design prior to the start of the clinical study. This will
include clinical stakeholders (specialist nurses, doctors and physiotherapists), the
digital research team, and patient groups. The focus groups will collate user groups
opinions about the 3D system, functionality, risks, and applicability.
The clinical study will be a feasibility study involving clinician and patient feedback
on 3D telemedicine, and will additionally collect safety, reliability and fidelity data.
The study will be a mixed methods analysis assessing measures of usability,
satisfaction, presence, task load index, and accuracy. Clinicians and patients will
complete questionnaires and undergo a short interview on the use of both forms of
telemedicine. There are no data regarding the use of 3D telemedicine, but this will
leverage study design and validated questionnaires from other similar studies (Buvik
2016). The study will continue as post covid services are being established.
2. Aims
This study will refine and pilot the feasibility of introducing 3D telemedicine into
plastic surgery clinics and gain pilot data on the comparative efficacy and
acceptability compared to face-to-face clinics, from both a patient and clinician
perspective. The feasibility study will then inform the design and size of larger
randomised study to compare 2D and 3D telemedicine.
3. Research Questions Primary
• Understand the feasibility and acceptability of introducing 3D telemedicine into
plastic surgery clinics, in particular assessing safety, reliability and feedback data.
Secondary
- Provide preliminary evidence regarding how 3D telemedicine compares to face-to-face
consultations using clinician and patient assessments
- Assess the appropriate rating scales/instruments to take forward to a RCT
- Provide preliminary objective data to assess the accuracy of 3D telemedicine to
determine clinical measurements (where applicable e.g. angles of contracture in
hand) and outcome scoring scales (where applicable e.g. validated Unilateral Cleft
Score Surgical Outcomes Evaluation Scale - UCLSOE)
- Provide preliminary data for machine learning training to Strathclyde University
- Safety and reliability measures of the system (number of failed and interrupted 3D
telemedicine consultations).
- To assess if clinical outcomes determined by 3D Telemedicine are similar to
face-to-face
4. Study Design
Pre-study protocol optimisation will include data from a patient feedback study and a
clinician feedback study. This will provide feedback for incremental system improvement and
baseline outcome data. This will be followed by a Clinician Cohort Trial.
4A. Patient Feedback Study
Focus groups will co-design the features and functionality of the 3D Telemedicine, and inform
clinical/patient feedback questionnaires. Clinical stakeholders (specialist nurses, doctors
and physiotherapists), the digital research team and patient groups (existing user groups in
breast cancer, sarcoma, cleft, hand surgery and physiotherapy) will be invited to participate
in focus groups. The discussion will explore user groups opinions and ideas about the 3D
system, functions that they would like to see implemented, and scenarios where this may be
advantageous over a standard 2D system, and potential risks, using open ended questions. The
patient group will consist of 40 patients sampled from existing user groups and will include
patients already known to the research team. These patients will be invited to participate in
a feedback study and will be examined by both 3D and 2D Telemedicine by their usual care
clinician, and without any randomisation. They will be then asked to complete a feedback
questionnaire and interview. Patient outcomes assessed will include:
Satisfaction: Visual Analogue Scale 0-100 Mental Effort Rating Scale - single instrument
Likert scale (Paas 1996) System Usability Scale - 10 item industry standard technology scale
Single Item Presence Questionnaire - This will ask patients the question "To which extent did
you feel present in the virtual clinic, as if you were really there?". This is a single item
evaluation of presence validated by Bouchard et al 2004.
Telehealth Usability Questionnaire - 21 item scale - assessment of telemedicine (TUQ,
Parmanto 2016) Semi Structured exit interview - will discuss with participant their views on
the telemedicine system, using "Keep, Lose and Change" feedback prompts to help in
incremental system improvements.
4B. Clinician Feedback Study
A group of 25 clinicians including nurses, doctors and physiotherapists, will be invited to
assess both 3D and 2D Telemedicine systems without randomisation, with a member of the
research team acting as a "patient". They will be then asked to complete a feedback
questionnaire and interview. Clinician outcomes assessed will include:
Satisfaction: Visual Analogue Scale 0-100 Mental Effort Rating Scale - single instrument
Likert scale (Paas 1996) System Usability Scale - 10 item industry standard technology scale
Presence Questionnaire - 29 item scale - assessment of presence in the system/virtual
environment (PQ, Witmer 2005).
Telehealth Usability Questionnaire - 21 item scale - assessment of telemedicine (TUQ,
Parmanto 2016) Semi Structured exit interview - will discuss with participant their views on
the telemedicine system, using "Keep, Lose and Change" feedback prompts to help in
incremental system improvements.
4C. Cohort Study
Patient Identification Patients will be recruited for this study from plastic surgery
clinics, including breast cancer, sarcoma, head & neck reconstruction, flap reconstruction,
limb reconstruction, hand trauma, burns and cleft lip. Clinicians recruited to the study be
from Canniesburn Regional Plastic Surgery and Burns Unit. The wide spectrum of clinical cases
including in this cohort trial will allow increased generalizability of the results.
Inclusion criteria
- Patients 1-95 years old (children will include post-cleft lip repair)
- Patients able to read and understand English
- Patients able to give informed consent
Exclusion criteria
- Patients not meeting the inclusion criteria
- Patients who do not have capacity to consent
- Patients who are registered blind or deaf
Consent The patient information sheets (PIS) will be sent to the patients for their
consideration prior to them attending their clinic appointment. The nurse will then take the
patient into a private telemedicine clinic room to go through the PIS with them and answer
any questions. If the patient wishes to participate, the nurse will provide a consent form
which has some statements to agree to and sign. The patient can keep a copy of the signed
consent form as well as the PIS.
Additional consent will be taken for opting into photo or video recordings. Telemedicine data
may be used in further research, including machine learning. The PIS will make it clear to
the patient that a copy of their identifiable images will be held for research purposes.
The PIS and consent will also explain that the our industrial partner will have access to the
data, system and images (covered by a data processing agreement and 3rd Party Access
agreement) to resolve any image quality, render, fusion, or transmission problems.
Study procedures
All patients will be assessed first face-to-face, and subsequently with 3D telemedicine by a
separate clinician. In addition to the standard consultation, all patients will have the
range of motion of the right and left elbows measured face-to-face with blinded (scales
hidden) goniometers, and on the 3D system with a blinded on-screen goniometer. Patients will
fill in a questionnaire and undertake a short exit interview after completion of
consultations. Clinicians involved in this study will be asked to fill in a clinician consent
form, and will be provided with a clinician information sheet prior to the study. The
clinician fills in a questionnaire on the use of telemedicine for each patient, and undergoes
an exit interview just once at the end of the study. The data for the elbow range of motion
will be stored on computer and the clinician will re-measure at 1 week (patient does not need
to return).
The Clinician telemedicine questionnaire will be filled in once per patient and comprises 71
items from the following rating scales.
Mental Effort Rating Scale - single instrument Likert scale (Paas 1996) University of North
Northway - 5 item - telemedicine questionnaire (UNN, Buvik 2016) System Usability Scale - 10
item industry standard technology scale Presence Questionnaire - 29 item scale - assessment
of presence in the system/virtual environment (PQ, Witmer 2005).
Telehealth Usability Questionnaire - 21 item scale - assessment of telemedicine (TUQ,
Parmanto 2016) NASA task load index (NASA TLX) - 5 item modified scale - an indication of the
ease of performing a task and frustration levels.
Semi Structured exit interview - will discuss with participant their views on the
telemedicine system, what went well, and what can be improved.
The clinician conducting the face-to-face will complete a shortened questionnaire with the
UNN scale only. The patient will fill also fill in a shortened questionnaire with a maximum
of 37 items, including the Mental Effort Rating Scale, Telehealth Usability Questionnaire,
NASA TLX and System Usability Scale.
The telemedicine consultation will include clinical outcome scales (where applicable e.g.
unilateral cleft outcome scoring) recorded as part of normal practice. This will be compared
to actual clinical outcomes taken in clinic on the same day (to provide "ground truth" for
comparison with telemedicine measurements).
Safety and reliability data will be collected throughout the study, incuding:
1. Failed 3D telemedicine visits - failure and interruption, including reasons e.g.
network/ software/ hardware. In event of failure a face to face consultation will still
take place.
2. Image aberration - record of subjective distortion/ noise.
3. Correlation of face-to-face and telemedicine patient outcomes and findings
The 3D system will be permanently set up in a locked clinic room in a non-covid hospital. The
system can be switched to 2D if required.
The 3D telemedicine system will comprise:
- 80/20 aluminium frame support for cameras
- 8 3D cameras
- 2 Patient LED screens
- Fusion and render computers
- At 'receiving' end - standard computer and LED screen
The system will be simple to use - 3D images will be viewed on a screen and can be
manipulated in space, enlarged, and frozen using mouse controls. The research team's
industrial partner will have provided training of clinic staff on how to operate the
equipment and support of the equipment during the data collection activity. Training of the
participating clinicians will take the form of a short introductory session by the research
team at the start of each research clinic. The patient will likewise be shown how to use the
system, but there will be no need for the patient to use any controls or interface.
Follow Up
There is no follow up required - patients are only required to attend an extended clinic
visit and complete the study questionnaires.
