A high-volume, low-cost approach to participant screening and enrolment

Experiences from the T4DM diabetes prevention trial

Karen Bracken, Anthony Keech, Wendy Hague, Carolyn Allan, Ann Conway, Mark Daniel, Val Gebski, Mathis Grossmann, David J. Handelsman, Warrick J. Inder, Alicia Jenkins, Robert McLachlan, Kristy P. Robledo, Bronwyn Stuckey, Bu B. Yeap, Gary Wittert

Research output: Contribution to journalArticle

Abstract

Background/aims: Participant recruitment to diabetes prevention randomised controlled trials is challenging and expensive. The T4DM study, a multicentre, Australia-based, Phase IIIb randomised controlled trial of testosterone to prevent Type 2 diabetes in men aged 50–74 years, faced the challenge of screening a large number of prospective participants at a small number of sites, with few staff, and a limited budget for screening activities. This article evaluates a high-volume, low-cost, semi-automated approach to screen and enrol T4DM study participants. Methods: We developed a sequential multi-step screening process: (1) web-based pre-screening, (2) laboratory screening through a network of third-party pathology centres, and (3) final on-site screening, using online data collection, computer-driven eligibility checking, and automated, email-based communication with prospective participants. Phone- and mail-based data collection and communication options were available to participants at their request. The screening process was administered by the central coordinating centre through a central data management system. Results: Screening activities required staffing of approximately 1.6 full-time equivalents over 4 years. Of 19,022 participants pre-screened, 13,108 attended a third-party pathology collection centre for laboratory screening, 1217 received final, on-site screening, and 1007 were randomised. In total, 95% of the participants opted for online pre-screening over phone-based pre-screening. Screening costs, including both direct and staffing costs, totalled AUD1,420,909 (AUD75 per subject screened and AUD1411 per randomised participant). Conclusion: A multi-step, semi-automated screening process with web-based pre-screening facilitated low-cost, high-volume participant enrolment to this large, multicentre randomised controlled trial. Centralisation and automation of screening activities resulted in substantial savings compared to previous, similar studies. Our screening approach could be adapted to other randomised controlled trial settings to minimise the cost of screening large numbers of participants.

Original languageEnglish
Pages (from-to)1-10
Number of pages10
JournalClinical Trials
VolumeOnline
DOIs
Publication statusAccepted/In press - 1 Jan 2019

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Costs and Cost Analysis
Randomized Controlled Trials
Communication
Pathology
Automation
Postal Service
Budgets
Information Systems
Type 2 Diabetes Mellitus
Multicenter Studies
Testosterone

Cite this

Bracken, Karen ; Keech, Anthony ; Hague, Wendy ; Allan, Carolyn ; Conway, Ann ; Daniel, Mark ; Gebski, Val ; Grossmann, Mathis ; Handelsman, David J. ; Inder, Warrick J. ; Jenkins, Alicia ; McLachlan, Robert ; Robledo, Kristy P. ; Stuckey, Bronwyn ; Yeap, Bu B. ; Wittert, Gary. / A high-volume, low-cost approach to participant screening and enrolment : Experiences from the T4DM diabetes prevention trial. In: Clinical Trials. 2019 ; Vol. Online. pp. 1-10.
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title = "A high-volume, low-cost approach to participant screening and enrolment: Experiences from the T4DM diabetes prevention trial",
abstract = "Background/aims: Participant recruitment to diabetes prevention randomised controlled trials is challenging and expensive. The T4DM study, a multicentre, Australia-based, Phase IIIb randomised controlled trial of testosterone to prevent Type 2 diabetes in men aged 50–74 years, faced the challenge of screening a large number of prospective participants at a small number of sites, with few staff, and a limited budget for screening activities. This article evaluates a high-volume, low-cost, semi-automated approach to screen and enrol T4DM study participants. Methods: We developed a sequential multi-step screening process: (1) web-based pre-screening, (2) laboratory screening through a network of third-party pathology centres, and (3) final on-site screening, using online data collection, computer-driven eligibility checking, and automated, email-based communication with prospective participants. Phone- and mail-based data collection and communication options were available to participants at their request. The screening process was administered by the central coordinating centre through a central data management system. Results: Screening activities required staffing of approximately 1.6 full-time equivalents over 4 years. Of 19,022 participants pre-screened, 13,108 attended a third-party pathology collection centre for laboratory screening, 1217 received final, on-site screening, and 1007 were randomised. In total, 95{\%} of the participants opted for online pre-screening over phone-based pre-screening. Screening costs, including both direct and staffing costs, totalled AUD1,420,909 (AUD75 per subject screened and AUD1411 per randomised participant). Conclusion: A multi-step, semi-automated screening process with web-based pre-screening facilitated low-cost, high-volume participant enrolment to this large, multicentre randomised controlled trial. Centralisation and automation of screening activities resulted in substantial savings compared to previous, similar studies. Our screening approach could be adapted to other randomised controlled trial settings to minimise the cost of screening large numbers of participants.",
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author = "Karen Bracken and Anthony Keech and Wendy Hague and Carolyn Allan and Ann Conway and Mark Daniel and Val Gebski and Mathis Grossmann and Handelsman, {David J.} and Inder, {Warrick J.} and Alicia Jenkins and Robert McLachlan and Robledo, {Kristy P.} and Bronwyn Stuckey and Yeap, {Bu B.} and Gary Wittert",
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Bracken, K, Keech, A, Hague, W, Allan, C, Conway, A, Daniel, M, Gebski, V, Grossmann, M, Handelsman, DJ, Inder, WJ, Jenkins, A, McLachlan, R, Robledo, KP, Stuckey, B, Yeap, BB & Wittert, G 2019, 'A high-volume, low-cost approach to participant screening and enrolment: Experiences from the T4DM diabetes prevention trial', Clinical Trials, vol. Online, pp. 1-10. https://doi.org/10.1177/1740774519872999

A high-volume, low-cost approach to participant screening and enrolment : Experiences from the T4DM diabetes prevention trial. / Bracken, Karen; Keech, Anthony; Hague, Wendy; Allan, Carolyn; Conway, Ann; Daniel, Mark; Gebski, Val; Grossmann, Mathis; Handelsman, David J.; Inder, Warrick J.; Jenkins, Alicia; McLachlan, Robert; Robledo, Kristy P.; Stuckey, Bronwyn; Yeap, Bu B.; Wittert, Gary.

In: Clinical Trials, Vol. Online, 01.01.2019, p. 1-10.

Research output: Contribution to journalArticle

TY - JOUR

T1 - A high-volume, low-cost approach to participant screening and enrolment

T2 - Experiences from the T4DM diabetes prevention trial

AU - Bracken, Karen

AU - Keech, Anthony

AU - Hague, Wendy

AU - Allan, Carolyn

AU - Conway, Ann

AU - Daniel, Mark

AU - Gebski, Val

AU - Grossmann, Mathis

AU - Handelsman, David J.

AU - Inder, Warrick J.

AU - Jenkins, Alicia

AU - McLachlan, Robert

AU - Robledo, Kristy P.

AU - Stuckey, Bronwyn

AU - Yeap, Bu B.

AU - Wittert, Gary

PY - 2019/1/1

Y1 - 2019/1/1

N2 - Background/aims: Participant recruitment to diabetes prevention randomised controlled trials is challenging and expensive. The T4DM study, a multicentre, Australia-based, Phase IIIb randomised controlled trial of testosterone to prevent Type 2 diabetes in men aged 50–74 years, faced the challenge of screening a large number of prospective participants at a small number of sites, with few staff, and a limited budget for screening activities. This article evaluates a high-volume, low-cost, semi-automated approach to screen and enrol T4DM study participants. Methods: We developed a sequential multi-step screening process: (1) web-based pre-screening, (2) laboratory screening through a network of third-party pathology centres, and (3) final on-site screening, using online data collection, computer-driven eligibility checking, and automated, email-based communication with prospective participants. Phone- and mail-based data collection and communication options were available to participants at their request. The screening process was administered by the central coordinating centre through a central data management system. Results: Screening activities required staffing of approximately 1.6 full-time equivalents over 4 years. Of 19,022 participants pre-screened, 13,108 attended a third-party pathology collection centre for laboratory screening, 1217 received final, on-site screening, and 1007 were randomised. In total, 95% of the participants opted for online pre-screening over phone-based pre-screening. Screening costs, including both direct and staffing costs, totalled AUD1,420,909 (AUD75 per subject screened and AUD1411 per randomised participant). Conclusion: A multi-step, semi-automated screening process with web-based pre-screening facilitated low-cost, high-volume participant enrolment to this large, multicentre randomised controlled trial. Centralisation and automation of screening activities resulted in substantial savings compared to previous, similar studies. Our screening approach could be adapted to other randomised controlled trial settings to minimise the cost of screening large numbers of participants.

AB - Background/aims: Participant recruitment to diabetes prevention randomised controlled trials is challenging and expensive. The T4DM study, a multicentre, Australia-based, Phase IIIb randomised controlled trial of testosterone to prevent Type 2 diabetes in men aged 50–74 years, faced the challenge of screening a large number of prospective participants at a small number of sites, with few staff, and a limited budget for screening activities. This article evaluates a high-volume, low-cost, semi-automated approach to screen and enrol T4DM study participants. Methods: We developed a sequential multi-step screening process: (1) web-based pre-screening, (2) laboratory screening through a network of third-party pathology centres, and (3) final on-site screening, using online data collection, computer-driven eligibility checking, and automated, email-based communication with prospective participants. Phone- and mail-based data collection and communication options were available to participants at their request. The screening process was administered by the central coordinating centre through a central data management system. Results: Screening activities required staffing of approximately 1.6 full-time equivalents over 4 years. Of 19,022 participants pre-screened, 13,108 attended a third-party pathology collection centre for laboratory screening, 1217 received final, on-site screening, and 1007 were randomised. In total, 95% of the participants opted for online pre-screening over phone-based pre-screening. Screening costs, including both direct and staffing costs, totalled AUD1,420,909 (AUD75 per subject screened and AUD1411 per randomised participant). Conclusion: A multi-step, semi-automated screening process with web-based pre-screening facilitated low-cost, high-volume participant enrolment to this large, multicentre randomised controlled trial. Centralisation and automation of screening activities resulted in substantial savings compared to previous, similar studies. Our screening approach could be adapted to other randomised controlled trial settings to minimise the cost of screening large numbers of participants.

KW - cost

KW - diabetes prevention

KW - men’s health

KW - participant recruitment

KW - Randomised controlled trials

KW - screening and enrolment

KW - men's health

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