Trial of Option Grid for Arthritis of the knee (TOGA): easy to use shared decision making tools for disadvantaged groups

ISRCTN ISRCTN94871417
DOI https://doi.org/10.1186/ISRCTN94871417
Secondary identifying numbers SPON 1044-11
Submission date
12/03/2014
Registration date
21/03/2014
Last edited
23/10/2018
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
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

Contact information

Dr Fiona Wood
Scientific

Institute of Primary Care and Public Health
Cardiff University
Neuadd Meirionydd
Heath Park
Cardiff
CF14 4XN
United Kingdom

Email wood@cardiff.ac.uk

Study information

Study designStepped wedge exploratory trial
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Hospital
Study typeOther
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleOption Grids: easy to use shared decision making tools for disadvantaged groups – a stepped wedge exploratory trial
Study acronymTOGA
Study objectivesIt 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(s)South East Wales LREC, 23/12/2011, ref.: 11/WA/0356
Health condition(s) or problem(s) studiedOsteoarthritis of the knee
InterventionSix 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 typeOther
Primary outcome measureThe 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 measuresSecondary 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 study start date01/09/2012
Completion date01/03/2014

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants72
Key inclusion criteriaPatients 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.
Key exclusion criteriaThere 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.
Date of first enrolment01/09/2012
Date of final enrolment01/03/2014

Locations

Countries of recruitment

  • United Kingdom
  • Wales

Study participating centre

Institute of Primary Care and Public Health
Cardiff
CF14 4XN
United Kingdom

Sponsor information

Cardiff University (UK)
University/education

c/o Mrs Kathyrn Prittard-Davies
Research and Commercial Division
30-36 Newport Road
Cardiff
CF24 0DE
Wales
United Kingdom

Email DaviesKP2@cardiff.ac.uk
ROR logo "ROR" https://ror.org/03kk7td41

Funders

Funder type

Hospital/treatment centre

BUPA Foundation (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 07/04/2014 Yes No
Results article results 01/04/2016 Yes No
Results article results 01/12/2017 Yes No
Results article results 01/02/2018 Yes No

Editorial Notes

23/10/2018: Publication reference added.