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| Name | Class |
|---|---|
| University of Strathclyde | OTHER |
| Glasgow Royal Infirmary | OTHER |
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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. The investigators serve as the regional plastic, burns and reconstructive centre for the West of Scotland, population 3 million. All face to face clinics have been cancelled and converted to telephone/telemedicine only consultations. The investigators will establish both 2D and 3D telemedicine as normal patient follow up practice during this period.
The aim is 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.
This study forms a follow on study to the investigator's pilot study (based on clinical feedback only)
During Covid pandemic the Canniesburn Plastic Surgery Unit has stopped face to face clinics. The investigators therefore aim to assess current telemedicine options from a clinician viewpoint.
Why is the 3D telemedicine study important during Covid 19?
Method Randomised Controlled Trial. Single blinded (participants blinded - unaware of type of telemedicine, clinicians unblinded - aware of type of telemedicine)
Study setting and Participants:
The study will review clinician's assessments of telemedicine and clinical assessment of patients using telemedicine. These will consist of the plastic surgery patients selected from general plastic surgery clinic including patients with breast reconstruction, sarcoma, limb reconstruction, head & neck reconstruction, flap reconstruction, hand trauma and cleft lip, and will be known to the research team. The assessment is of the telemedicine system by the clinician only. There will be two sites, the 'remote' site where the patient attends, and the 'central' site where the clinician reviews the patient. Remote site will be at West Glasgow Ambulatory Care Hospital (Covid free site) and the central location will be Glasgow Royal Infirmary.
Outcomes The investigators aim to answer the question "How does 3D telemedicine compare to 2D telemedicine?"
Primary outcomes:
Mental Effort Rating Scale, University Hospital of North Norway (UNN) scales, Telehealth Usability Questionnaire (TUQ)
Secondary outcomes:
Subjective feedback with transcribing, coding and thematic analysis. Measurements (where applicable e.g. angles of contracture in hand) Outcome scoring scales (where applicable e.g. validated Unilateral Cleft Score Surgical Outcomes Evaluation Scale - UCLSOE).
Study Methods:
Sample Size The pilot/feasibility study will generate data for sample size calculation. No data exist for sample size calculations of 3D versus 2D telemedicine.
Randomisation Block randomisation. Patient randomised to 2D or 3D telemedicine first.
Patient assessment with Telemedicine The patient is examined with the randomly allocated type of telemedicine and the duration of consultation recorded. The telemedicine room is the same for both 2D and 3D telemedicine, and uses the same equipment. After the consultation the patient does not require further participation
Clinician Feedback The clinician fills in a questionnaire assessment of the type of telemedicine used.
Clinician records measurements where applicable Clinician records outcome scoring scales where applicable
Primary outcomes UNN questionnaire Mental Effort Rating Scale
Secondary outcomes Telehealth Usability Questionnaire Subjective interview Patient measurements (where applicable) Patient outcome scales (where applicable)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3D telemedicine | Active Comparator | 3D telemedicine system |
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| 2D telemedicine | Placebo Comparator | 2D telemedicine system (standard care) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D Telemedicine | Other | Telemedicine using 3D broadcast to clinician |
|
| Measure | Description | Time Frame |
|---|---|---|
| University Hospitals of North Northway questionnaire | University Hospitals of North Northway questionnaire. Outcome scale with a sum score 1 to 5 Higher score is worse | Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient) |
| Mental effort rating scale | Scale 1 to 9 Higher score is worse | Single time point at day 1(Clinician assesses telemedicine system once after seeing patient) |
| Measure | Description | Time Frame |
|---|---|---|
| Telehealth Usability Questionnaire | Telehealth Usability Questionnaire. 21 domains, each with scale 1 to 7. Higher is better. | Single time point at day 1 (Clinician assesses telemedicine system once after seeing patient) |
| Subjective feedback interview |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Steven Lo, FRCS Plast | Contact | 01412114475 | steven.lo@nhs.net | |
| David McGill, FRCS Plast | Contact | 01412114000 | david.mcgill@ggc.scot.nhs.uk |
| Name | Affiliation | Role |
|---|---|---|
| Steven Lo, FRCS Plast | NHS Greater Glasgow and Clyde Clinical Research and Development Central Office | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Canniesburn Regional Plastic Surgery and Burns Unit | Glasgow | Scotland | G4 0SF | United Kingdom |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Randomised controlled trial
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Patient will be blinded to form of telemedicine. Clinician will not be blinded
| 2D Telemedicine | Other | Standard care with 2D telemedicine |
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Clinician Subjective feedback. This is an interview performed by a psychologist and will be transcribed, coded and thematically analysed. There is no statistical analysis or outcome scale involved. |
| Once at study completion, an average of 18 months. |