ISRCTN - ISRCTN94871417: Trial of Option Grid for Arthritis of the knee (TOGA): easy to use shared decision making tools for disadvantaged groups

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 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

Trusts, charities, foundations (both publically funded and privately funded)

Location