Plain English Summary
Background and study aims
During consultations surgeons tend to communicate with their patients using verbal explanations for about 10 minutes on average. The consultation experience could be improved with the use of visual models of the joint to explain the disease process and treatment options. Although visual aids are recommended to be used in the consultation and consenting process, there has been little research on how well they work. The aim of this study is to observe the effect of using visual three-dimensional (3D) models of the knee and shoulder joints on patient satisfaction during informed consent.
Who can participate?
Patients aged over 18 who are being consented for either knee or shoulder surgery by a senior attending orthopedic surgeon
What does the study involve?
Participants are randomly allocated to one of two groups. During informed consent patients in the first group are given a verbal explanation and are shown a 3D model of the joint, whilst the second group are given only a verbal explanation with no model. Afterwards, both groups are asked to fill in a questionnaire on their satisfaction with the consultation and are asked a set of questions as to why they were satisfied (or not). The results from the questionnaire and the interview are compared to see whether there was a difference between the groups as a result of the use of the visual model in the clinic.
What are the possible benefits and risks of participating?
Patients who are shown visual models may be more satisfied with the consultations. There are no risks involved in this study.
Where is the study run from?
St Mary's Hospital (UK)
When is the study starting and how long is it expected to run for?
July 2014 to November 2014
Who is funding the study?
Imperial College London (UK)
Who is the main contact?
Dr Kapil Sugand
Trial website
Contact information
Type
Scientific
Primary contact
Dr Kapil Sugand
ORCID ID
http://orcid.org/0000-0003-3185-954X
Contact details
MSk Lab
Imperial College London
Level 7 East
Charing Cross Hospital
Fulham
London
W6 8RF
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Effect of 3-dimensional visual aids on patient satisfaction in orthopedic consent: a single-blinded randomized controlled trial
Acronym
Simulating Trauma & Orthopaedic procedures with Models for Patients (STOMP)
Study hypothesis
There is a difference in patient satisfaction with the use of visual aids during orthopedic consenting as determined by MISS-26 scores.
Ethics approval
Imperial College London Joint Research Compliance Office (JRCO) under NRES Committee East of England committee, 25/07/2013, ref: 13/EE/0191
Study design
Single-blinded single-centre randomized controlled trial
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
Degenerative orthopaedic joint disease
Intervention
52 patients undergoing elective knee or shoulder orthopedic operations were randomized into two groups when undergoing preliminary explanation and consent for their procedures. The intervention group (n=26) was given a verbal explanation and shown a 3D model of the joint whilst the control group (n=26) were given only a verbal explanation with no model.
Allocation was done by prior computerized random number generator using unique hospital numbers of patients. All other identifying data was anonymized and not featured within the study. Both surgeons and patients were masked as to which cohort they were assigned to until the consultation where the consultant was given or not given a visual model to use during the consultation.
After the consultation, patients rated their satisfaction on the validated Medical Interview Satisfaction Scale (MISS-26). Semi-structured interviews were analyzed for thematic analysis to determine key factors influencing patient satisfaction. No follow-up was conducted.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Patient satisfaction, determined by the MISS-26 scores. The responses were collated into behavioral, cognitive, affective and overall scores, measured at the single study visit without follow up.
Secondary outcome measures
Key factors that contributed to patient and surgeon satisfaction, determined through thematic analysis from semi-structured interviews, measured at the single study visit without follow up
Overall trial start date
01/07/2014
Overall trial end date
30/11/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Adult patients (over 18 years of age), being consented for either knee or shoulder surgery by a senior attending orthopedic surgeon
2. Three attending orthopedic surgeons from clinic
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
53
Participant exclusion criteria
1. Pediatric patients
2. Patients undergoing surgery on other joints
3. Attended previous consultations using visual models
4. Those undergoing non-operative management
Recruitment start date
01/07/2014
Recruitment end date
15/11/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St Mary's Hospital
Praed Street
Paddington
London
W2 1NY
United Kingdom
Funders
Funder type
University/education
Funder name
Imperial College London
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Aimed towards publication in a PubMed-indexed journal and international conference presentations.
IPD sharing plan
Dataset will not be made available due to the addition of hospital identification numbers, date of births and possible patient identifying features that have been anonymized to the best of our abilities and in line with the ethics committee guidelines. The data will be held on a departmental computer (where the study was conducted) with access restricted only to research team. The data will be destroyed after publication of paper in a peer-reviewed journal or 5 years from end of study (whichever comes first).
Intention to publish date
28/09/2016
Participant level data
Not expected to be available
Basic results (scientific)
See additional file ISRCTN12323123_BasicResults_21Sep16.pdf
Publication list
Publication citations
Additional files
- ISRCTN12323123_BasicResults_21Sep16.pdf Uploaded 22/06/2018