Patient-centered recruitment and retention for a randomized controlled study

Sumedha Chhatre, Ashlie Jefferson, Ratna Cook, Caitlin R Meeker, Ji Hyun Kim, Kayla Marie Hartz, Yu-Ning Wong, Adele Caruso, Diane K Newman, Knashawn H Morales, Ravishankar Jayadevappa, Sumedha Chhatre, Ashlie Jefferson, Ratna Cook, Caitlin R Meeker, Ji Hyun Kim, Kayla Marie Hartz, Yu-Ning Wong, Adele Caruso, Diane K Newman, Knashawn H Morales, Ravishankar Jayadevappa

Abstract

Background: Recruitment and retention strategies for patient-centered outcomes research are evolving and research on the subject is limited. In this work, we present a conceptual model of patient-centered recruitment and retention, and describe the recruitment and retention activities and related challenges in a patient-centered comparative effectiveness trial.

Methods: This is a multicenter, longitudinal randomized controlled trial in localized prostate cancer patients.

Results: We recruited 743 participants from three sites over 15 months period (January 2014 to March 2015), and followed them for 24 months. At site 1, of the 773 eligible participants, 551 (72%) were enrolled. At site 2, 34 participants were eligible and 23 (68%) enrolled. Of the 434 eligible participants at site 3, 169 (39%) enrolled. We observed that strategies related to the concepts of trust (e.g., physician involvement, ensuring protection of information), communication (e.g., brochures and pamphlets in physicians' offices, continued contact during regular clinic visits and calling/emailing assessment), attitude (e.g., emphasizing the altruistic value of research, positive attitude of providers and research staff), and expectations (e.g., full disclosure of study requirements and time commitment, update letters) facilitated successful patient recruitment and retention. A stakeholders' advisory board provided important input for the recruitment and retention activities. Active engagement, reminders at the offices, and personalized update letters helped retention during follow-up. Usefulness of telephone recruitment was site specific and, at one site, the time requirement for telephone recruitment was a challenge.

Conclusions: We have presented multilevel strategies for successful recruitment and retention in a clinical trial using a patient-centered approach. Our strategies were flexible to accommodate site-level requirements. These strategies as well as the challenges can aid recruitment and retention efforts of future large-scale, patient-centered research studies.

Trial registration: Clinicaltrials.gov , ID: NCT02032550 . Registered on 22 November 2013.

Conflict of interest statement

Ethics approval and consent to participate

The study was approved by the Institutional Review Boards of the University of Pennsylvania, Corporal Michael J. Crescenz VAMC, and the Fox Chase Cancer Center.

All participants provided informed consent and HIPAA approval.

Consent for publication

Not applicable

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Conceptual model of patient-centered recruitment and retention
Fig. 2
Fig. 2
Consolidated Standards of Reporting Trials (CONSORT) Diagram

References

    1. Wong AD, Kirby J, Guyatt GH, Moayyedi P, Vora P, You JJ. Randomized controlled trial comparing telephone and mail follow-up for recruitment of participants into a clinical trial of colorectal cancer screening. Trials. 2013;11:14–40.
    1. Bower P, Brueton V, Gamble C, Treweek S, Smith CT, Young B, Williamson P. Interventions to improve recruitment and retention in clinical trials: a survey and workshop to assess current practice and future priorities. Trials. 2014;15(1):399. doi: 10.1186/1745-6215-15-399.
    1. James AS, Daley CM, Engelman K, Greiner KA, Ellerbeck E. Process evaluation of recruitment for a cancer screening trial in primary care. Health Promot Pract. 2011;12(5):696–703. doi: 10.1177/1524839910366402.
    1. Kaplan PC, Nápoles AM, Dohan D, Hwang ES, Melisko M, Nickleach D, Quinn JA, Haas J. Clinical trial discussion, referral, and recruitment: physician, patient, and system factors. Cancer Causes Control. 2013;24:979–988. doi: 10.1007/s10552-013-0173-5.
    1. Sood A, Prasad K, Chhatwani L, Shinozaki E, Cha SS, Loehrer LL, Wahner-Roedler DL. Patients’ attitudes and preferences about participation and recruitment strategies in clinical trials. Mayo Clin Proc. 2009;84(3):243–247. doi: 10.4065/84.3.243.
    1. Turner JR. Recruitment and retention of research subjects. In: Gellman MD, Turner JR, editors. Behavioral Medicine. New York: Springer; 2013.
    1. Nasser N, Grady D, Balke CW. Commentary: improving participant recruitment in clinical and translational research. Acad Med. 2011;86(11):1334–1335. doi: 10.1097/ACM.0b013e3182302831.
    1. Leathem CS, Cupples ME, Byrne MC, O’Malley M, Houlihan A, Murphy AW, Smith SM. Identifying strategies to maximise recruitment and retention of practices and patients in a multicentre randomised controlled trial of an intervention to optimise secondary prevention for coronary heart disease in primary care. BMC Med Res Methodol. 2009;9:40. doi: 10.1186/1471-2288-9-40.
    1. Newington L, Metcalfe A. Factors influencing recruitment to research: qualitative study of the experiences and perceptions of research teams. BMC Med Res Methodol. 2014;14(1):1–5. doi: 10.1186/1471-2288-14-10.
    1. Newington L, Metcalfe A. Researchers’ and clinicians’ perceptions of recruiting participants to clinical research: a thematic meta-synthesis. J Clin Med Res. 2014;6(3):162–172.
    1. Bower P, Wilson S, Mathers N. Short report: how often do UK primary care trials face recruitment delays? Fam Pract. 2007;24(6):601–603. doi: 10.1093/fampra/cmm051.
    1. McDonald AM, Knight RC, Campbell MK, Entwistle VA, Grant AM, Cook JA, Elbourne DR, Francis D, Garcia J, Roberts I, et al. What influences recruitment to randomised controlled trials? A review of trials funded by two UK funding agencies. Trials. 2006;7(1):9–13. doi: 10.1186/1745-6215-7-9.
    1. Advani AS, Atkeson B, Brown CL, Peterson BL, Fish L, Johnson JL, Gockerman JP, Gautier M. Barriers to the participation of African-American patients with cancer in clinical trials: a pilot study. Cancer. 2003;97:1499–1506. doi: 10.1002/cncr.11213.
    1. Ford JG, Howerton MW, Lai GY, Gary TL, Bolen S, Gibbons MC, Tilburt J, Baffi C, Tanpitukpongse TP, Wilson RF, et al. Barriers to recruiting underrepresented populations to cancer clinical trials: a systematic review. Cancer. 2008;112(228–242):228. doi: 10.1002/cncr.23157.
    1. Fitzgibbon ML, Prewitt TE, Blackman LR, Simon P, Luke A, Keys LC, Avellone ME, Singh V. Quantitative assessment of recruitment efforts for prevention trials in two diverse black populations. Prev Med. 1998;27:838–845. doi: 10.1006/pmed.1998.0367.
    1. Lee RE, McGinnis KA, Sallis JF, Castro CM, Chen AH, Hickmann SA. Active vs. passive methods of recruiting ethnic minority women to a health promotion program. Ann Behav Med. 1997;19:378–384. doi: 10.1007/BF02895157.
    1. Rivers D, August EM, Sehovic I, Lee Green B, Quinn GP. A systematic review of the factors influencing African Americans’ participation in cancer clinical trials. Contemp Clin Trials. 2013;35:13–32. doi: 10.1016/j.cct.2013.03.007.
    1. Sully BG, Julious SA, Nicholl J. A reinvestigation of recruitment to randomised, controlled, multicenter trials: a review of trials funded by two UK funding agencies. Trials. 2013;14:166–167. doi: 10.1186/1745-6215-14-166.
    1. DasMahapatra P, Raja P, Gilbert J, Wicks P. Clinical trials from the patient perspective: survey in an online patient community. BMC Health Serv Res. 2017;17:166.
    1. Treweek S, Lockhart P, Pitkethly M, Cook JA, Kjeldstrøm M, Johansen M, Taskila TK, Sullivan FM, Wilson S, Jackson C, et al. Methods to improve recruitment to randomised controlled trials: Cochrane systematic review and meta-analysis. BMJ Open. 2013;3:e002360. doi: 10.1136/bmjopen-2012-002360.
    1. Mullins CD, Abdulhalim AM, Lavallee DC. Continuous patient engagement in comparative effectiveness research. JAMA. 2012;307(15):1587–1588. doi: 10.1001/jama.2012.442.
    1. Mullins CD, Vandigo JE, Zheng J, Wicks P. Patient-centeredness in the design of clinical trials. Value Health. 2014;17(4):471–475. doi: 10.1016/j.jval.2014.02.012.
    1. Patient Centered Outcomes Research Institute (PCORI). About Us. .
    1. Lee DJ, Avulova S, Conwill R, Barocas DA. Patient engagement in the design and execution of urologic oncology research. Urol Oncol. 2017;35(9):552–558. doi: 10.1016/j.urolonc.2017.07.002.
    1. Sofolahan-Oladeinde Y, Mullins CD, Baquet C. Using community-based participatory research in patient-centered outcomes research to address health disparities in under-represented communities. J Comp Eff Res. 2015;4(5):515–523. doi: 10.2217/cer.15.31.
    1. Pearson CR, Duran B, Oetzel J, Margarati M, Villegas M, Lucero J, Wallerstein N. Research for improved health: variability and impact of structural characteristics in federally funded community engaged esearch. Prog Community Health Partnersh. 2015;9(1):17–29. doi: 10.1353/cpr.2015.0010.
    1. Burke JG, Jones J, Yonas M, Guizzetti L, Virata MC, Costlow M, Morton SC, Miller E. PCOR, CER, and CBPR: alphabet soup or complementary fields of health research? Clin Transl Sci. 2013;6(6):493–496. doi: 10.1111/cts.12064.
    1. Menon U, Gentry-Maharaj A, Ryan A, Sharma A, Burnell M, Hallett R, Lewis S, Lopez A, Godfrey K, Oram D, et al. Recruitment to multicentre trials-lessons from UKCTOCS: descriptive study. BMJ Open. 2008;337:a2079.
    1. Mason V, Shaw A, Wiles N, Mulligan J, Peters T, Sharp D, Lewis G. GPs’ experiences of primary care mental health research: a qualitative study of the barriers to recruitment. Fam Pract. 2007;24(518–525):518. doi: 10.1093/fampra/cmm047.
    1. McCann S, Campbell M, Entwistle V. Recruitment to clinical trials: a meta-ethnographic synthesis of studies of reasons for participation. J Health Serv Res Policy. 2013;18(4):233–241. doi: 10.1177/1355819613483126.
    1. Raftery J, Bryant J, Powell J, Kerr C, Hawker S. Payment to healthcare professionals for patient recruitment to trials: systematic review and qualitative study. Health Technol Assess. 2008;12(10):1–28. doi: 10.3310/hta12100.
    1. Cox K. Enhancing cancer clinical trial management: recommendations from a qualitative study of trial participants’ experiences. Psychooncology. 2000;9:314–322. doi: 10.1002/1099-1611(200007/08)9:4<314::AID-PON464>;2-C.
    1. Patient Centered Outcomes Research Institute. PCOR definitions. .
    1. Cox K, McGarry J. Why patients don’t take part in cancer clinical trials: an overview of the literature. Eur J Cancer Care. 2003;12:114–122. doi: 10.1046/j.1365-2354.2003.00396.x.
    1. Jenkins V, Fallowfield L. Reasons for accepting or declining to participate in randomized clinical trials for cancer therapy. Br J Cancer. 2000;82(11):1783–1788. doi: 10.1054/bjoc.2000.1142.
    1. Hurd RC, Kaplan CD, Cook ED, Chilton JA, Lytton JS, Hawk ET. Building trust and diversity in patient-centered oncology clinical trials: an integrated model. Clin Trials. 2017;14(2):170–9.
    1. Stanford PD, Monte DA, Briggs FM, Flynn PM, Tanney M, Ellenberg JH, Clingan KL, Rogers AS. Recruitment and retention of adolescent participants in HIV research: findings from the REACH (Reaching for Excellence in Adolescent Care and Health) project. J Adolesc Health. 2003;32(3):192–203. doi: 10.1016/S1054-139X(02)00392-0.
    1. Chen DT, Miller FG, Rosenstein DL. Clinical research and the physician-patient relationship. Ann Intern Med. 2003;138:669–672. doi: 10.7326/0003-4819-138-8-200304150-00015.
    1. Mainous AG, Smith DW, Geesey ME, Tilley BC. Factors influencing physician referrals of patients to clinical trials. J Natl Med Assoc. 2008;100:1298–1303. doi: 10.1016/S0027-9684(15)31508-X.
    1. Kass NE, Sugarman J, Faden R, Schoch-Spana M. Trust, the fragile foundation of contemporary biomedical research. Hast Cent Rep. 1996;26:25–29. doi: 10.2307/3528467.
    1. Mills EJ, Seely D, Rachlis B, Griffith L, Wu P, Wilson K, Ellis P, Wright JR. Barriers to participation in clinical trials of cancer: a metaanalysis and systematic review of patient-reported factors. Lancet Oncol. 2006;7:141–148. doi: 10.1016/S1470-2045(06)70576-9.
    1. Moorcraft SY, Marriott C, Peckitt C, Cunningham D, Chau I, Starling N, Watkins D, Rao S. Patients’ willingness to participate in clinical trials and their views on aspects of cancer research: results of a prospective patient survey. Trials. 2016;17:17. doi: 10.1186/s13063-015-1105-3.
    1. Northrup TF, Greer TL, Walker R, Rethorst CD, Warden D, Stotts AL, Trivedi MH. An ounce of prevention: a pre-randomization protocol to improve retention in substance use disorder clinical trials. Addict Behav. 2017;64:137–142. doi: 10.1016/j.addbeh.2016.08.040.
    1. Felsen CB, Shaw EK, Ferrante JM, Lacroix LJ, Crabtree BF. Strategies for in-person recruitment: lessons learned from a New Jersey Family Medicine Research Network (NJFMRN) study. J Am Board Fam Med. 2010;23(4):523–533. doi: 10.3122/jabfm.2010.04.090096.
    1. Jayadevappa R, Chhatre S, Gallo JJ, Wittkink M, Morales KH, Malkowicz SB, Lee D, Guzzo T, Caruso A, Van Arsdalen K, et al. Treatment preference and patient centered prostate cancer care: Design and rationale. Contemp Clin Trials. 2015;45:296–301. doi: 10.1016/j.cct.2015.09.024.
    1. Donovan JL, Peters TJ, Noble S, Powell P, Gillatt D, Oliver SE, Lane JA, Neal DE, Hamdy FC. Who can best recruit to randomized trials?: randomized trial comparing surgeons and nurses recruiting patients to a trial of treatments for localized prostate cancer (the ProtecT study) J Clin Epidemiol. 2003;56(7):605–609. doi: 10.1016/S0895-4356(03)00083-0.
    1. Gilbert H, Leurent B, Sutton S, Morris R, Alexis-Garsee C, Nazareth I. Factors predicting recruitment to a UK wide primary care smoking cessation study (the ESCAPE trial) J Fam Pract. 2012;29(1):110–117. doi: 10.1093/fampra/cmr030.
    1. Asch DA, Jedrziewski K, Christiakis NA. Response rates to mail surveys published in medical journals. J Clin Epidemiol. 1997;50:1129–1136. doi: 10.1016/S0895-4356(97)00126-1.
    1. McColl E, Jacoby A, Thomas L, Soutter J, Bamford C. Design and use of questionnaires: a review of best practice applicable to surveys of health service staff and patients. Health Technol Assess. 2001;5:101–102. doi: 10.3310/hta5310.
    1. Moore DL, Tarnai J. Evaluating nonresponse error in mail surveys. New York: Wiley; 2002.
    1. Islam KM, Opoku ST, Apenteng BA, Fetrick A, Ryan J, Copur M, Tolentino A, Vaziri I, Ganti AK. Engaging patients and caregivers in patient-centered outcomes research on advanced stage lung cancer: insights from patients, caregivers, and providers. J Cancer Educ. 2014;29(4):796–801. doi: 10.1007/s13187-014-0657-3.

Source: PubMed

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

3
S'abonner