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)

Lisa Vizza; Christopher G. Maher; Rowena Ivers; Andrew J. McLachlan; Patrick J. Kelly; Fiona Blyth; Philip James Clare; Rachel Thompson; Thomas Lung; Louisa Degenhardt; Sharon Reid; Bradley C. Martin; Michael Wright; Rawa Osman; Simon D. French; Kirsten J. McCaffery; Gabrielle Campbell; Hazel J. Jenkins; Stephanie Mathieson; Monika Boogs; Jarrod McMaugh; Carol Bennett; Fiona Stanaway; Christina Abdel Shaheed

doi:10.1186/s13063-025-08852-4

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)

Lisa Vizza, Christopher G. Maher, Rowena Ivers, Andrew J. McLachlan, Patrick J. Kelly, Fiona Blyth, Philip James Clare, Rachel Thompson, Thomas Lung, Louisa Degenhardt, Sharon Reid, Bradley C. Martin, Michael Wright, Rawa Osman, Simon D. French, Kirsten J. McCaffery, Gabrielle Campbell, Hazel J. Jenkins, Stephanie Mathieson, Monika BoogsJarrod McMaugh, Carol Bennett, Fiona Stanaway, Christina Abdel Shaheed^*

^*Corresponding author for this work

Department of Chiropractic

Research output: Contribution to journal › Article › peer-review

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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.

Original language	English
Article number	209
Pages (from-to)	1-10
Number of pages	10
Journal	Trials
Volume	26
Issue number	1
DOIs	https://doi.org/10.1186/s13063-025-08852-4
Publication status	Published - 17 Jun 2025

Bibliographical note

Copyright the Author(s) 2025. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

Keywords

Financial incentive
General practice
Limited English proficiency
Low back pain
Randomised trial
Study within a trial (SWAT)

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10.1186/s13063-025-08852-4

Publisher version (open access)Final published version, 1.17 MBLicence: CC BY-NC-ND

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Vizza, L., Maher, C. G., Ivers, R., McLachlan, A. J., Kelly, P. J., Blyth, F., Clare, P. J., Thompson, R., Lung, T., Degenhardt, L., Reid, S., Martin, B. C., Wright, M., Osman, R., French, S. D., McCaffery, K. J., Campbell, G., Jenkins, H. J., Mathieson, S., ... Abdel Shaheed, C. (2025). 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). Trials, 26(1), 1-10. Article 209. https://doi.org/10.1186/s13063-025-08852-4

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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{\textquoteright}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.",

keywords = "Financial incentive, General practice, Limited English proficiency, Low back pain, Randomised trial, Study within a trial (SWAT)",

author = "Lisa Vizza and Maher, \{Christopher G.\} and Rowena Ivers and McLachlan, \{Andrew J.\} and Kelly, \{Patrick J.\} and Fiona Blyth and Clare, \{Philip James\} and Rachel Thompson and Thomas Lung and Louisa Degenhardt and Sharon Reid and Martin, \{Bradley C.\} and Michael Wright and Rawa Osman and French, \{Simon D.\} and McCaffery, \{Kirsten J.\} and Gabrielle Campbell and Jenkins, \{Hazel J.\} and Stephanie Mathieson and Monika Boogs and Jarrod McMaugh and Carol Bennett and Fiona Stanaway and \{Abdel Shaheed\}, Christina",

note = "Copyright the Author(s) 2025. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher. ",

year = "2025",

month = jun,

day = "17",

doi = "10.1186/s13063-025-08852-4",

language = "English",

volume = "26",

pages = "1--10",

journal = "Trials",

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Vizza, L, Maher, CG, Ivers, R, McLachlan, AJ, Kelly, PJ, Blyth, F, Clare, PJ, Thompson, R, Lung, T, Degenhardt, L, Reid, S, Martin, BC, Wright, M, Osman, R, French, SD, McCaffery, KJ, Campbell, G, Jenkins, HJ, Mathieson, S, Boogs, M, McMaugh, J, Bennett, C, Stanaway, F & Abdel Shaheed, C 2025, '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)', Trials, vol. 26, no. 1, 209, pp. 1-10. https://doi.org/10.1186/s13063-025-08852-4

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). / Vizza, Lisa; Maher, Christopher G.; Ivers, Rowena et al.
In: Trials, Vol. 26, No. 1, 209, 17.06.2025, p. 1-10.

Research output: Contribution to journal › Article › peer-review

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T2 - a study protocol for a study within a trial (SWAT)

AU - Vizza, Lisa

AU - Maher, Christopher G.

AU - Ivers, Rowena

AU - McLachlan, Andrew J.

AU - Kelly, Patrick J.

AU - Blyth, Fiona

AU - Clare, Philip James

AU - Thompson, Rachel

AU - Lung, Thomas

AU - Degenhardt, Louisa

AU - Reid, Sharon

AU - Martin, Bradley C.

AU - Wright, Michael

AU - Osman, Rawa

AU - French, Simon D.

AU - McCaffery, Kirsten J.

AU - Campbell, Gabrielle

AU - Jenkins, Hazel J.

AU - Mathieson, Stephanie

AU - Boogs, Monika

AU - McMaugh, Jarrod

AU - Bennett, Carol

AU - Stanaway, Fiona

AU - Abdel Shaheed, Christina

N1 - Copyright the Author(s) 2025. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

PY - 2025/6/17

Y1 - 2025/6/17

N2 - 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.

AB - 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.

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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

Bibliographical note

Keywords

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