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Published in: Trials 1/2019

Open Access 01-12-2019 | Research

Cost analysis and efficacy of recruitment strategies used in a large pragmatic community-based clinical trial targeting low-income seniors: a comparative descriptive analysis

Authors: Sravya Kakumanu, Braden J. Manns, Sophia Tran, Terry Saunders-Smith, Brenda R. Hemmelgarn, Marcello Tonelli, Ross Tsuyuki, Noah Ivers, Danielle Southern, Jeff Bakal, David J. T. Campbell

Published in: Trials | Issue 1/2019

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Abstract

Objective

One of the most challenging parts of running clinical trials is recruiting enough participants. Our objective was to determine which recruitment strategies were effective in reaching specific subgroups.

Study design and setting

We assessed the efficacy and costs of the recruitment strategies used in the Assessing Outcomes of Enhanced Chronic Disease Care Through Patient Education and a Value-based Formulary Study (ACCESS) in Alberta, Canada.

Results

Twenty percent of the study budget ($354,330 CAD) was spent on recruiting 4013 participants, giving an average cost per enrolled of $88 CAD. Pharmacies recruited the most participants (n = 1217), at a cost of $128/enrolled. ”Paid media” had the highest cost ($806/enrolled), whereas ”word of mouth” and ”unpaid media” had the lowest (~$3/enrolled). Participants enrolled from ”seniors outreach” had the lowest baseline quality of life and income, while participants from ”word of mouth” had the lowest educational attainment.

Conclusion

The ”health care providers” strategies were especially successful — at a moderate cost per enrolled. The "media" strategies were less effective, short lasting, and more costly. No strategy was singularly effective in recruiting our targeted groups, emphasizing the importance of utilizing a variety of strategies to reach recruitment goals.

Trial registration

ClinicalTrials.gov, NCT02579655. Registered on 19 October 2015.
Appendix
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Literature
1.
go back to reference Speich B, von Niederhausern B, Schur N, Hemkens LG, Furst T, Bhatnagar N, et al. Systematic review on costs and resource use of randomized clinical trials shows a lack of transparent and comprehensive data. J Clin Epidemiol. 2018;96:1–11.CrossRef Speich B, von Niederhausern B, Schur N, Hemkens LG, Furst T, Bhatnagar N, et al. Systematic review on costs and resource use of randomized clinical trials shows a lack of transparent and comprehensive data. J Clin Epidemiol. 2018;96:1–11.CrossRef
2.
go back to reference Gul RB, Ali PA. Clinical trials: the challenge of recruitment and retention of participants. J Clin Nurs. 2010;19(1–2):227–33.CrossRef Gul RB, Ali PA. Clinical trials: the challenge of recruitment and retention of participants. J Clin Nurs. 2010;19(1–2):227–33.CrossRef
3.
go back to reference Kasenda B, von Elm E, You J, Blumle A, Tomonaga Y, Saccilotto R, et al. Prevalence, characteristics, and publication of discontinued randomized trials. JAMA. 2014;311(10):1045–51.CrossRef Kasenda B, von Elm E, You J, Blumle A, Tomonaga Y, Saccilotto R, et al. Prevalence, characteristics, and publication of discontinued randomized trials. JAMA. 2014;311(10):1045–51.CrossRef
4.
go back to reference McDonald AM, Knight RC, Campbell MK, Entwistle VA, Grant AM, Cook JA, et al. What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies. Trials. 2006;7:9.CrossRef McDonald AM, Knight RC, Campbell MK, Entwistle VA, Grant AM, Cook JA, et al. What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies. Trials. 2006;7:9.CrossRef
5.
go back to reference Charlson ME, Horwitz RI. Applying results of randomised trials to clinical practice: impact of losses before randomisation. Br Med J (Clin Res Ed). 1984;289(6454):1281–4.CrossRef Charlson ME, Horwitz RI. Applying results of randomised trials to clinical practice: impact of losses before randomisation. Br Med J (Clin Res Ed). 1984;289(6454):1281–4.CrossRef
6.
go back to reference Rendell JM, Licht RW. Under-recruitment of patients for clinical trials: an illustrative example of a failed study. Acta Psychiatr Scand. 2007;115(5):337–9.CrossRef Rendell JM, Licht RW. Under-recruitment of patients for clinical trials: an illustrative example of a failed study. Acta Psychiatr Scand. 2007;115(5):337–9.CrossRef
7.
go back to reference Nasser N, Grady D, Balke CW. Commentary: improving participant recruitment in clinical and translational research. Acad Med. 2011;86(11):1334–5.CrossRef Nasser N, Grady D, Balke CW. Commentary: improving participant recruitment in clinical and translational research. Acad Med. 2011;86(11):1334–5.CrossRef
8.
go back to reference Kitterman DR, Cheng SK, Dilts DM, Orwoll ES. The prevalence and economic impact of low-enrolling clinical studies at an academic medical center. Acad Med. 2011;86(11):1360–6.CrossRef Kitterman DR, Cheng SK, Dilts DM, Orwoll ES. The prevalence and economic impact of low-enrolling clinical studies at an academic medical center. Acad Med. 2011;86(11):1360–6.CrossRef
9.
go back to reference Treweek S, Pitkethly M, Cook J, Fraser C, Mitchell E, Sullivan F, et al. Strategies to improve recruitment to randomised trials. Cochrane Database Syst Rev. 2018;2:Mr000013.PubMed Treweek S, Pitkethly M, Cook J, Fraser C, Mitchell E, Sullivan F, et al. Strategies to improve recruitment to randomised trials. Cochrane Database Syst Rev. 2018;2:Mr000013.PubMed
10.
go back to reference Ward E, King M, Lloyd M, Bower P, Friedli K. Conducting randomized trials in general practice: methodological and practical issues. Br J Gen Pract. 1999;49(448):919–22.PubMedPubMedCentral Ward E, King M, Lloyd M, Bower P, Friedli K. Conducting randomized trials in general practice: methodological and practical issues. Br J Gen Pract. 1999;49(448):919–22.PubMedPubMedCentral
11.
go back to reference Yancey AK, Ortega AN, Kumanyika SK. Effective recruitment and retention of minority research participants. Annu Rev Public Health. 2006;27:1–28.CrossRef Yancey AK, Ortega AN, Kumanyika SK. Effective recruitment and retention of minority research participants. Annu Rev Public Health. 2006;27:1–28.CrossRef
12.
go back to reference Tramm R, Daws K, Schadewaldt V. Clinical trial recruitment—a complex intervention? J Clin Nurs. 2013;22(17–18):2436–43.CrossRef Tramm R, Daws K, Schadewaldt V. Clinical trial recruitment—a complex intervention? J Clin Nurs. 2013;22(17–18):2436–43.CrossRef
13.
go back to reference Witham MD, McMurdo ME. How to get older people included in clinical studies. Drugs Aging. 2007;24(3):187–96.CrossRef Witham MD, McMurdo ME. How to get older people included in clinical studies. Drugs Aging. 2007;24(3):187–96.CrossRef
14.
go back to reference Marcus PM, Lenz S, Sammons D, Black W, Garg K. Recruitment methods employed in the National Lung Screening Trial. J Med Screen. 2012;19(2):94–102.CrossRef Marcus PM, Lenz S, Sammons D, Black W, Garg K. Recruitment methods employed in the National Lung Screening Trial. J Med Screen. 2012;19(2):94–102.CrossRef
15.
go back to reference Bjornson-Benson WM, Stibolt TB, Manske KA, Zavela KJ, Youtsey DJ, Buist AS. Monitoring recruitment effectiveness and cost in a clinical trial. Control Clin Trials. 1993;14(2 Suppl):52s–67s.CrossRef Bjornson-Benson WM, Stibolt TB, Manske KA, Zavela KJ, Youtsey DJ, Buist AS. Monitoring recruitment effectiveness and cost in a clinical trial. Control Clin Trials. 1993;14(2 Suppl):52s–67s.CrossRef
16.
go back to reference Bracken K, Hague W, Keech A, Conway A, Handelsman DJ, Grossmann M, et al. Recruitment of men to a multi-centre diabetes prevention trial: an evaluation of traditional and online promotional strategies. Trials. 2019;20(1):366.CrossRef Bracken K, Hague W, Keech A, Conway A, Handelsman DJ, Grossmann M, et al. Recruitment of men to a multi-centre diabetes prevention trial: an evaluation of traditional and online promotional strategies. Trials. 2019;20(1):366.CrossRef
17.
go back to reference Douglas A, Bhopal RS, Bhopal R, Forbes JF, Gill JM, Lawton J, et al. Recruiting South Asians to a lifestyle intervention trial: experiences and lessons from PODOSA (Prevention of Diabetes & Obesity in South Asians). Trials. 2011;12(1):220.CrossRef Douglas A, Bhopal RS, Bhopal R, Forbes JF, Gill JM, Lawton J, et al. Recruiting South Asians to a lifestyle intervention trial: experiences and lessons from PODOSA (Prevention of Diabetes & Obesity in South Asians). Trials. 2011;12(1):220.CrossRef
18.
go back to reference Ranjani H, Weber M, Anjana R, Lakshmi N, Narayan KV, Mohan V. Recruitment challenges in a diabetes prevention trial in a low- and middle-income setting. Diabetes Res Clin Pract. 2015;110(1):51–9.CrossRef Ranjani H, Weber M, Anjana R, Lakshmi N, Narayan KV, Mohan V. Recruitment challenges in a diabetes prevention trial in a low- and middle-income setting. Diabetes Res Clin Pract. 2015;110(1):51–9.CrossRef
19.
go back to reference Kusek JW, Ahrens A, Burrows PK, Clarke HS, Foster HE, Hanson K, et al. Recruitment for a clinical trial of drug treatment for benign prostatic hyperplasia. Urology. 2002;59(1):63–7.CrossRef Kusek JW, Ahrens A, Burrows PK, Clarke HS, Foster HE, Hanson K, et al. Recruitment for a clinical trial of drug treatment for benign prostatic hyperplasia. Urology. 2002;59(1):63–7.CrossRef
20.
go back to reference Kumar N, Crocker T, Smith T, Pow-Sang J, Spiess PE, Egan K, et al. Challenges and potential solutions to meeting accrual goals in a Phase II chemoprevention trial for prostate cancer. Contemp Clin Trials. 2012;33(2):279–85.CrossRef Kumar N, Crocker T, Smith T, Pow-Sang J, Spiess PE, Egan K, et al. Challenges and potential solutions to meeting accrual goals in a Phase II chemoprevention trial for prostate cancer. Contemp Clin Trials. 2012;33(2):279–85.CrossRef
21.
go back to reference Bhar SS, Wiltsey-Stirman S, Zembroski D, Mccray L, Oslin DW, Brown GK, et al. Recruiting older men for geriatric suicide research. Int Psychogeriatr. 2012;25(1):88–95.CrossRef Bhar SS, Wiltsey-Stirman S, Zembroski D, Mccray L, Oslin DW, Brown GK, et al. Recruiting older men for geriatric suicide research. Int Psychogeriatr. 2012;25(1):88–95.CrossRef
22.
go back to reference Chlebowski RT, Menon R, Chaisanguanthum RM, Jackson DM. Prospective evaluation of two recruitment strategies for a randomized controlled cancer prevention trial. Clin Trials. 2010;7(6):744–8.CrossRef Chlebowski RT, Menon R, Chaisanguanthum RM, Jackson DM. Prospective evaluation of two recruitment strategies for a randomized controlled cancer prevention trial. Clin Trials. 2010;7(6):744–8.CrossRef
23.
go back to reference Heiney SP, Adams SA, Drake BF, Bryant LH, Bridges L, Hebert JR. Successful subject recruitment for a prostate cancer behavioral intervention trial. Clin Trials. 2010;7(4):411–7.CrossRef Heiney SP, Adams SA, Drake BF, Bryant LH, Bridges L, Hebert JR. Successful subject recruitment for a prostate cancer behavioral intervention trial. Clin Trials. 2010;7(4):411–7.CrossRef
24.
go back to reference Moinpour CM, Atkinson JO, Thomas SM, Underwood SM, Harvey C, Parzuchowski J, et al. Minority recruitment in the Prostate Cancer Prevention Trial. Ann Epidemiol. 2000;10(8):S85–91.CrossRef Moinpour CM, Atkinson JO, Thomas SM, Underwood SM, Harvey C, Parzuchowski J, et al. Minority recruitment in the Prostate Cancer Prevention Trial. Ann Epidemiol. 2000;10(8):S85–91.CrossRef
25.
go back to reference Fletcher JM, Saunders-Smith T, Manns BJ, Tsuyuki R, Hemmelgarn BR, Tonelli M, Campbell DJ. Pharmacist and patient perspectives on recruitment strategies for randomized controlled trials: a qualitative analysis. Trials. In press. Fletcher JM, Saunders-Smith T, Manns BJ, Tsuyuki R, Hemmelgarn BR, Tonelli M, Campbell DJ. Pharmacist and patient perspectives on recruitment strategies for randomized controlled trials: a qualitative analysis. Trials. In press.
26.
go back to reference Lovato LC, Hill K, Hertert S, Hunninghake DB, Probstfield JL. Recruitment for controlled clinical trials: literature summary and annotated bibliography. Control Clin Trials. 1997;18(4):328–52.CrossRef Lovato LC, Hill K, Hertert S, Hunninghake DB, Probstfield JL. Recruitment for controlled clinical trials: literature summary and annotated bibliography. Control Clin Trials. 1997;18(4):328–52.CrossRef
27.
go back to reference UyBico SJ, Pavel S, Gross CP. Recruiting vulnerable populations into research: a systematic review of recruitment interventions. J Gen Intern Med. 2007;22(6):852–63.CrossRef UyBico SJ, Pavel S, Gross CP. Recruiting vulnerable populations into research: a systematic review of recruitment interventions. J Gen Intern Med. 2007;22(6):852–63.CrossRef
28.
go back to reference Huynh L, Johns B, Liu SH, Vedula SS, Li T, Puhan MA. Cost-effectiveness of health research study participant recruitment strategies: a systematic review. Clin Trials. 2014;11(5):576–83.CrossRef Huynh L, Johns B, Liu SH, Vedula SS, Li T, Puhan MA. Cost-effectiveness of health research study participant recruitment strategies: a systematic review. Clin Trials. 2014;11(5):576–83.CrossRef
29.
go back to reference Mody L, Miller DK, McGloin JM, Freeman M, Marcantonio ER, Magaziner J, et al. Recruitment and retention of older adults in aging research. J Am Geriatr Soc. 2008;56(12):2340–8.CrossRef Mody L, Miller DK, McGloin JM, Freeman M, Marcantonio ER, Magaziner J, et al. Recruitment and retention of older adults in aging research. J Am Geriatr Soc. 2008;56(12):2340–8.CrossRef
30.
go back to reference Campbell DJ, Tonelli M, Hemelgarn B, Mitchell C, Tsuyuki R, Ivers N, et al. Assessing outcomes of enhanced chronic disease care through patient education and a value-based formulary study (ACCESS)—study protocol for a 2×2 factorial randomized trial. Implement Sci. 2016;11(1):131.CrossRef Campbell DJ, Tonelli M, Hemelgarn B, Mitchell C, Tsuyuki R, Ivers N, et al. Assessing outcomes of enhanced chronic disease care through patient education and a value-based formulary study (ACCESS)—study protocol for a 2×2 factorial randomized trial. Implement Sci. 2016;11(1):131.CrossRef
31.
go back to reference Ghali WA, Knudtson ML. Overview of the Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease. On behalf of the APPROACH investigators. Can J Cardiol. 2000;16(10):1225–30.PubMed Ghali WA, Knudtson ML. Overview of the Alberta Provincial Project for Outcome Assessment in Coronary Heart Disease. On behalf of the APPROACH investigators. Can J Cardiol. 2000;16(10):1225–30.PubMed
32.
go back to reference Usadi RS, Diamond MP, Legro RS, Schlaff WD, Hansen KR, Casson P, et al. Recruitment strategies in two reproductive medicine network infertility trials. Contemp Clin Trials. 2015;45(Pt B):196–200.CrossRef Usadi RS, Diamond MP, Legro RS, Schlaff WD, Hansen KR, Casson P, et al. Recruitment strategies in two reproductive medicine network infertility trials. Contemp Clin Trials. 2015;45(Pt B):196–200.CrossRef
33.
go back to reference Krusche A, Rudolf von Rohr I, Muse K, Duggan D, Crane C, Williams JM. An evaluation of the effectiveness of recruitment methods: the staying well after depression randomized controlled trial. Clin Trials. 2014;11(2):141–9.CrossRef Krusche A, Rudolf von Rohr I, Muse K, Duggan D, Crane C, Williams JM. An evaluation of the effectiveness of recruitment methods: the staying well after depression randomized controlled trial. Clin Trials. 2014;11(2):141–9.CrossRef
34.
go back to reference Silagy CA, Campion K, McNeil JJ, Worsam B, Donnan GA, Tonkin AM. Comparison of recruitment strategies for a large-scale clinical trial in the elderly. J Clin Epidemiol. 1991;44(10):1105–14.CrossRef Silagy CA, Campion K, McNeil JJ, Worsam B, Donnan GA, Tonkin AM. Comparison of recruitment strategies for a large-scale clinical trial in the elderly. J Clin Epidemiol. 1991;44(10):1105–14.CrossRef
35.
go back to reference Borland JM, Aiani LM, Norvelle A, Grantham KN, O'Laughlin K, Terranova JI, Fratz KJ, Albers HE. Sex-dependent regulation of social reward by oxytocin receptors in the ventral tegmental area. Neuropsychopharmacology. 2018;8(44):785–92. Borland JM, Aiani LM, Norvelle A, Grantham KN, O'Laughlin K, Terranova JI, Fratz KJ, Albers HE. Sex-dependent regulation of social reward by oxytocin receptors in the ventral tegmental area. Neuropsychopharmacology. 2018;8(44):785–92.
36.
go back to reference Maas AM, Appelman YA. Gender differences in coronary heart disease. Neth Heart J. 2010;18(12):598–602.CrossRef Maas AM, Appelman YA. Gender differences in coronary heart disease. Neth Heart J. 2010;18(12):598–602.CrossRef
Metadata
Title
Cost analysis and efficacy of recruitment strategies used in a large pragmatic community-based clinical trial targeting low-income seniors: a comparative descriptive analysis
Authors
Sravya Kakumanu
Braden J. Manns
Sophia Tran
Terry Saunders-Smith
Brenda R. Hemmelgarn
Marcello Tonelli
Ross Tsuyuki
Noah Ivers
Danielle Southern
Jeff Bakal
David J. T. Campbell
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-019-3652-5

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