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 |
| Protocol serial number | SPON 1044-11 |
| Sponsor | Cardiff University (UK) |
| Funder | BUPA Foundation (UK) |
- 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
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
Scientific
Institute of Primary Care and Public Health
Cardiff University
Neuadd Meirionydd
Heath Park
Cardiff
CF14 4XN
United Kingdom
| wood@cardiff.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Stepped wedge exploratory trial |
| Secondary study design | Non randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Option Grids: easy to use shared decision making tools for disadvantaged groups a stepped wedge exploratory trial |
| Study acronym | TOGA |
| Study objectives | 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(s) | South East Wales LREC, 23/12/2011, ref.: 11/WA/0356 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
The primary outcome is the efficacy of the Option Grid in faciliating Shared Decision Making as measured by observer scores using the OPTION scale. |
| Key secondary outcome measure(s) |
Secondary analysis will explore: |
| Completion date | 01/03/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 72 |
| Key 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. |
| Key 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. |
| Date of first enrolment | 01/09/2012 |
| Date of final enrolment | 01/03/2014 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
CF14 4XN
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2016 | Yes | No | |
| Results article | results | 01/12/2017 | Yes | No | |
| Results article | results | 01/02/2018 | Yes | No | |
| Protocol article | protocol | 07/04/2014 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
23/10/2018: Publication reference added.
