Evaluating the effect of incentives on recruiting people with low back pain with limited English proficiency as part of the COMFORT cluster randomised controlled trial: a study protocol for a study within a trial (SWAT)

Abstract Background Previous research has reported that Australians with limited English proficiency are less likely to be included in clinical trials due to language, literacy, and cultural factors. In the pain field, participants with limited English proficiency are three times more likely to be excluded from research, whereas in low back pain trials, 1 in 5 participants are excluded. This low representation can limit the generalisability of research findings to Australia’s diverse population, and strategies are required to facilitate the inclusion of participants with limited English proficiency in clinical trials. This study within a trial (SWAT) embedded within a registered cluster randomised trial (ACTRN12622001505796) will evaluate a strategy to improve recruitment of participants with limited English proficiency who speak Arabic, Cantonese, Mandarin or Italian. These were chosen as they are the top non-English languages spoken at home in Australia. Methods This SWAT will evaluate the effect of per-participant monetary incentive to facilitate the recruitment of participants with limited English proficiency (in Arabic, Chinese and Italian communities) from participating general practices enrolled in the COMFORT trial. In brief, the COMFORT trial will randomise general practices 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 this embedded SWAT, the randomisation schedule will also randomly allocate general practices 1:1 to either (a) SWAT intervention (monetary incentive aimed at enhancing recruitment of individuals with limited English proficiency) or (b) SWAT control (no additional incentive). 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. Data collection, analyses and general study procedures will follow the COMFORT protocol. Discussion This SWAT will determine whether a per-participant monetary incentive facilitates greater recruitment of people with limited English proficiency who speak Arabic, Cantonese, Mandarin or Italian by participating GPs. Trial registration The trial has been registered via SWAT222 Christina Abdel Shaheed (2023 NOV 14 1147).pdf.