AIMS:
There are several barriers to recruiting participants with limited English proficiency into clinical trials, with time constraints being a key barrier. This may cause a low representation of this group in clinical trials, where 1 out of 5 participants are excluded in low back pain trials due to limited English Proficiency. The study within a trial (SWAT) will determine whether providing additional monetary reimbursement to study GPs increases recruitment of patients with limited English proficiency (English understanding ‘not well’ or ‘not well at all’) who speak Arabic, Cantonese, Mandarin or Italian into the main COMFORT trial (Clinical Observation Management and Function Of low back pain Relief Therapies- ACTRN12622001505796).
METHODS:
COMFORT is a cluster randomised controlled trial in general practice. Forty general practices will be randomised in a 1:1 ratio to either i) intervention (educational outreach visits to support GPs to provide opioid stewardship for their patients with low back pain with non-drug strategies including heat wraps and patient education about judicious opioid use) or ii) control (usual care). In the embedded SWAT, the randomisation schedule will also randomly allocate general practices 1:1 to either a) SWAT intervention (additional monetary reimbursement aimed at enhancing recruitment of individuals with limited English proficiency) or b) SWAT control (no additional reimbursement). Study materials are translated to allow the inclusion of people with limited English proficiency. The SWAT primary outcome will be the proportion of participants with limited English proficiency enrolled into the COMFORT trial in the SWAT intervention versus SWAT control. All other aspects of the SWAT (i.e. recruitment, data collection) will follow COMFORT methodology.
CONCLUSION:
This SWAT will ascertain whether additional monetary reimbursement is a suitable method of facilitating greater recruitment of people with limited English proficiency by GPs participating in the COMFORT clinical trial.