Do visual models improve patient satisfaction in orthopedic consenting? A single-blinded randomized controlled trial

ISRCTN ISRCTN12323123
DOI https://doi.org/10.1186/ISRCTN12323123
Secondary identifying numbers N/A
Submission date
18/09/2016
Registration date
22/06/2018
Last edited
22/06/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Kapil Sugand
Scientific

MSk Lab, Imperial College London
Level 7 East
Charing Cross Hospital
Fulham
London
W6 8RF
United Kingdom

ORCiD logoORCID ID 0000-0003-3185-954X

Study information

Study designSingle-blinded single-centre randomized controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeOther
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleEffect of 3-dimensional visual aids on patient satisfaction in orthopedic consent: a single-blinded randomized controlled trial
Study acronymSimulating Trauma & Orthopaedic procedures with Models for Patients (STOMP)
Study objectivesThere is a difference in patient satisfaction with the use of visual aids during orthopedic consenting as determined by MISS-26 scores.
Ethics approval(s)Imperial College London Joint Research Compliance Office (JRCO) under NRES Committee East of England committee, 25/07/2013, ref: 13/EE/0191
Health condition(s) or problem(s) studiedDegenerative orthopaedic joint disease
Intervention52 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 typeBehavioural
Primary outcome measurePatient 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 measuresKey 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 study start date01/07/2014
Completion date30/11/2014

Eligibility

Participant type(s)Mixed
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants53
Key inclusion criteria1. 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
Key exclusion criteria1. Pediatric patients
2. Patients undergoing surgery on other joints
3. Attended previous consultations using visual models
4. Those undergoing non-operative management
Date of first enrolment01/07/2014
Date of final enrolment15/11/2014

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

St Mary's Hospital
Praed Street
Paddington
London
W2 1NY
United Kingdom

Sponsor information

Imperial College London
University/education

Sir Alexander Fleming building
South Kensington
London
SW7 2AZ
England
United Kingdom

ROR logo "ROR" https://ror.org/041kmwe10

Funders

Funder type

University/education

Imperial College London

No information available

Results and Publications

Intention to publish date28/09/2016
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planAimed towards publication in a PubMed-indexed journal and international conference presentations.
IPD sharing planDataset 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).

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Basic results 21/09/2016 22/06/2018 No No
HRA research summary 28/06/2023 No No

Additional files

ISRCTN12323123_BasicResults_21Sep16.pdf
Uploaded 22/06/2018

Editorial Notes

22/06/2018: The basic results of this trial have been uploaded as an additional file.