Condition category
Musculoskeletal Diseases
Date applied
18/09/2016
Date assigned
22/06/2018
Last edited
22/06/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Sponsor information

Organisation

Imperial College London

Sponsor details

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

Sponsor type

University/education

Website

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

Editorial Notes

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