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, 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

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, 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

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Publisher:: Springer Nature
Publication Type:: Journal Article
Citation:: Trials, 2025, 26, (1), pp. 209
Issue Date:: 2025-06-17

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Field	Value	Language
dc.contributor.author	Vizza, L
dc.contributor.author	Maher, CG
dc.contributor.author	Ivers, R
dc.contributor.author	McLachlan, AJ
dc.contributor.author	Kelly, PJ
dc.contributor.author	Blyth, F
dc.contributor.author	Clare, PJ
dc.contributor.author	Thompson, R
dc.contributor.author	Lung, T
dc.contributor.author	Degenhardt, L
dc.contributor.author	Reid, S
dc.contributor.author	Martin, BC
dc.contributor.author	Wright, M https://orcid.org/0000-0003-2708-4753
dc.contributor.author	Osman, R
dc.contributor.author	French, SD
dc.contributor.author	McCaffery, KJ
dc.contributor.author	Campbell, G
dc.contributor.author	Jenkins, HJ
dc.contributor.author	Mathieson, S
dc.contributor.author	Boogs, M
dc.contributor.author	McMaugh, J
dc.contributor.author	Bennett, C
dc.contributor.author	Stanaway, F
dc.contributor.author	Abdel Shaheed, C
dc.date.accessioned	2025-07-15T06:52:36Z
dc.date.available	2025-04-19
dc.date.available	2025-07-15T06:52:36Z
dc.date.issued	2025-06-17
dc.identifier.citation	Trials, 2025, 26, (1), pp. 209
dc.identifier.issn	1745-6215
dc.identifier.issn	1745-6215
dc.identifier.uri	http://hdl.handle.net/10453/188409
dc.description.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.
dc.format	Electronic
dc.language	eng
dc.publisher	Springer Nature
dc.relation.ispartof	Trials
dc.relation.isbasedon	10.1186/s13063-025-08852-4
dc.rights	info:eu-repo/semantics/openAccess
dc.subject	1102 Cardiorespiratory Medicine and Haematology, 1103 Clinical Sciences
dc.subject.classification	Cardiovascular System & Hematology
dc.subject.classification	General & Internal Medicine
dc.subject.classification	3202 Clinical sciences
dc.subject.classification	4202 Epidemiology
dc.subject.classification	4203 Health services and systems
dc.subject.mesh	Humans
dc.subject.mesh	Low Back Pain
dc.subject.mesh	Motivation
dc.subject.mesh	Randomized Controlled Trials as Topic
dc.subject.mesh	Patient Selection
dc.subject.mesh	Limited English Proficiency
dc.subject.mesh	Australia
dc.subject.mesh	Multicenter Studies as Topic
dc.subject.mesh	Humans
dc.subject.mesh	Low Back Pain
dc.subject.mesh	Motivation
dc.subject.mesh	Patient Selection
dc.subject.mesh	Australia
dc.subject.mesh	Multicenter Studies as Topic
dc.subject.mesh	Randomized Controlled Trials as Topic
dc.subject.mesh	Limited English Proficiency
dc.subject.mesh	Humans
dc.subject.mesh	Low Back Pain
dc.subject.mesh	Motivation
dc.subject.mesh	Randomized Controlled Trials as Topic
dc.subject.mesh	Patient Selection
dc.subject.mesh	Limited English Proficiency
dc.subject.mesh	Australia
dc.subject.mesh	Multicenter Studies as Topic
dc.title	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).
dc.type	Journal Article
utslib.citation.volume	26
utslib.location.activity	England
utslib.for	1102 Cardiorespiratory Medicine and Haematology
utslib.for	1103 Clinical Sciences
pubs.organisational-group	University of Technology Sydney
pubs.organisational-group	University of Technology Sydney/Faculty of Health
pubs.organisational-group	University of Technology Sydney/UTS Groups
pubs.organisational-group	University of Technology Sydney/UTS Groups/Centre for Health Economics Research and Evaluation (CHERE)
utslib.copyright.status	open_access	*
dc.rights.license	This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License (CC BY-NC-ND 4.0). To view a copy of this license, visit https://creativecommons.org/licenses/by-nc-nd/4.0/
dc.date.updated	2025-07-15T06:52:33Z
pubs.issue	1
pubs.publication-status	Published online
pubs.volume	26
utslib.citation.issue	1

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.

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