Plain English Summary
Background and study aims
Option Grids are one-page evidence-based summaries of the available condition-specific treatment options, listing patients frequently asked questions. They are designed to be brief and accessible enough to support better communication between patients and doctors during routine consultations. This study aims to find out whether an Option Grid for osteoarthritis of the knee (OA of the knee) aids in shared decision making (SDM), and to explore the use of Option Grids by patients with language difficulties or poor medical knowledge.
Who can participate?
Patients over the age of 18 with osteoarthritis of the knee referred to a specialist musculoskeletal clinic in Oldham (Pennine MSK Ltd) can participate.
What does the study involve?
We will collect information from two groups of people: one group will be given an Option Grid by their doctor in their appointment; the other group will not be given an Option Grid by their doctor. We will then compare the information we collect from both groups to see if there are any differences.
What are the possible benefits and risks of taking part?
The information we gain from this study may help us provide future patients with osteoarthritis of the knee with better information about the available treatment options. Apart from the time and effort required to take part in the study, we foresee no difficulties or risks to taking part.
Where is the study run from?
The study is being run by researchers in the School of Medicine at Cardiff University, UK.
When is the study starting and how long is it expected to run for?
Recruitment to the study started in September 2013 and is expected to finish in March 2014.
Who is funding the study?
The study is being funded by the Bupa Foundation, UK.
Who is the main contact?
Dr Fiona Wood
wood@cardiff.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Fiona Wood
ORCID ID
Contact details
Institute of Primary Care and Public Health
Cardiff University
Neuadd Meirionydd
Heath Park
Cardiff
CF14 4XN
United Kingdom
-
wood@cardiff.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SPON 1044-11
Study information
Scientific title
Option Grids: easy to use shared decision making tools for disadvantaged groups a stepped wedge exploratory trial
Acronym
TOGA
Study hypothesis
It is hypothesised that levels of shared decision making (as measured by the OPTION tool) will be higher in consultations where an option grid is used by patients and clinicians.
Ethics approval
South East Wales LREC, 23/12/2011, ref.: 11/WA/0356
Study design
Stepped wedge exploratory trial
Primary study design
Interventional
Secondary study design
Non randomised controlled trial
Trial setting
Hospitals
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Osteoarthritis of the knee
Intervention
Six physiotherapists will sequentially join the trial and consult with six patients using usual care procedures. After a period of brief training in using the Option Grid, the same six physiotherapists will consult with six further patients using an Option Grid in the consultation. The primary outcome will be efficacy of the Option Grid in facilitating SDM as measured by observational scores using the OPTION scale. Comparisons will be made between patients who have received the Option Grid and those who received usual care. A Decision Quality Measure (DQM) will assess quality of decision making. The health literacy of patients will be measured using the REALM-R instrument. Consultations will be observed and audio-recorded. Interviews will be conducted with the physiotherapists, patients and any interpreters present to explore their views of using the Option Grid.
There is no randomisation. Patients are sequentially assigned to the next clinician who is either in the pre-intervention or post-intervention stage.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
The primary outcome is the efficacy of the Option Grid in faciliating Shared Decision Making as measured by observer scores using the OPTION scale.
Secondary outcome measures
Secondary analysis will explore:
1. The quality of decision making as measured by the Decision Quality Measure (DQM); treatment decision at 3 months post consultation
2. The extent to which the intervention has reached disadvantaged groups as measured by the literacy of participants utilising the REALM-R instrument and socio-demogrraphic variables
3. A qualitative investigation will explore the acceptability of the option grid to patients and physiotherapists and how these tools are used in consultations where interpreters are present
Overall trial start date
01/09/2012
Overall trial end date
01/03/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients over the age of 18 with osteoarthritis of the knee who are reffered to the Pennine MSK specialist musculoskeletal centre.
Clinicians will be employed by Pennine MSK.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
72
Participant exclusion criteria
There are no specific exclusion criteria. We will only exclude those patient participants who are unable to communicate adequately in English (as judged by their ability to understand the participant information sheet) and where we do not have interpreters or family members available to assist their participation.
Recruitment start date
01/09/2012
Recruitment end date
01/03/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Institute of Primary Care and Public Health
Cardiff
CF14 4XN
United Kingdom
Sponsor information
Organisation
Cardiff University (UK)
Sponsor details
c/o Mrs Kathyrn Prittard-Davies
Research and Commercial Division
30-36 Newport Road
Cardiff
CF24 0DE
United Kingdom
-
DaviesKP2@cardiff.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Hospital/treatment centre
Funder name
BUPA Foundation (UK)
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/24708747