Recruitment of veterans from primary care into a physical activity randomized controlled trial: the experience of the VA-STRIDE study

Marquis S Hawkins, Linda J Hough, Marie A Berger, Maria K Mor, Ann R Steenkiste, Shasha Gao, Roslyn A Stone, Kelly H Burkitt, Bess H Marcus, Joseph T Ciccolo, Andrea M Kriska, Deborah T Klinvex, Mary A Sevick, Marquis S Hawkins, Linda J Hough, Marie A Berger, Maria K Mor, Ann R Steenkiste, Shasha Gao, Roslyn A Stone, Kelly H Burkitt, Bess H Marcus, Joseph T Ciccolo, Andrea M Kriska, Deborah T Klinvex, Mary A Sevick

Abstract

Background: Much of the existing literature on physical activity (PA) interventions involves physically inactive individuals recruited from community settings rather than clinical practice settings. Recruitment of patients into interventions in clinical practice settings is difficult due to limited time available in the clinic, identification of appropriate personnel to efficiently conduct the process, and time-consuming methods of recruitment. The purpose of this report is to describe the approach used to identify and recruit veterans from the Veterans Affairs (VA) Pittsburgh Healthcare System Primary Care Clinic into a randomized controlled PA study.

Methods: A sampling frame of veterans was developed using the VA electronic medical record. During regularly scheduled clinic appointments, primary care providers (PCPs) screened identified patients for safety to engage in moderate-intensity PA and willingness to discuss the study with research staff members. Research staff determined eligibility with a subsequent telephone screening call and scheduled a research study appointment, at which time signed informed consent and baseline measurements were obtained.

Results: Of the 3,482 veterans in the sampling frame who were scheduled for a primary care appointment during the study period, 1,990 (57.2%) were seen in the clinic and screened by the PCP; moderate-intensity PA was deemed safe for 1,293 (37.1%), 871 (25.0%) agreed to be contacted for further screening, 334 (9.6%) were eligible for the study, and 232 (6.7%) enrolled.

Conclusions: Using a semiautomated screening approach that combined an electronically-derived sampling frame with paper and pencil prescreening by PCPs and research staff, VA-STRIDE was able to recruit 1 in 15 veterans in the sampling frame. Using this approach, a high proportion of potentially eligible veterans were screened by their PCPs.

Trial registration: Clinical trials.gov identifier: NCT00731094.

Figures

Figure 1
Figure 1
Results of VA-STRIDE screening and enrollment activities between 1 June 2010 and 31 April 2012.

References

    1. Schiller JS, Lucas JW, Ward BW, Peregoy JA. Summary health statistics for U.S. adults: National Health Interview Survey, 2010: national center for health statistics. Vital Health Stat. 2012;10:252.
    1. Center for Disease Control and Prevention. Summary health statistics for US adults: national health interview survey 2011. .
    1. Potter MB, Vu JD, Croughan-Minihane M. Weight management: what patients want from their primary care physicians. J Fam Pract. 2001;50:513–518.
    1. Embi PJ, Jain A, Clark J, Bizjack S, Hornung R, Harris CM. Effect of a clinical trial alert system on physician participation in trial recruitment. Arch Intern Med. 2005;165:2272–2277. doi: 10.1001/archinte.165.19.2272.
    1. Siminoff LA, Zhang A, Colabianchi N, Sturm CM, Shen Q. Factors that predict the referral of breast cancer patients onto clinical trials by their surgeons and medical oncologists. J Clin Oncol. 2000;18:1203–1211.
    1. Margitić S, Sevick MA, Miller M, Albright C, Banton J, Callahan K, Garcia M, Gibbons L, Levine BJ, Anderson R, Ettinger W. Challenges faced in recruiting patients from primary care practices into a physical activity intervention trial: activity counseling trial research group. Prev Med. 1999;4:277–286.
    1. Charlson ME, Horwitz RI. Applying results of randomized trials to clinical practice: impact of losses before randomisation. Br Med J (Clin Res Ed) 1984;269:1281–1284.
    1. Grundmeier RW, Swietlik M, Bell LM. Research subject enrollment by primary care pediatricians using an electronic health record. AMIA Annu Symp Proc. 2007, Oct;11:289–293.
    1. McGregor J, Brooks C, Chalasani P, Chukwuma J, Hutchings H, Lyons RA, Lloyd K. The Health Informatics Trial Enhancement project (HITE): Using routinely collected primary care data to identify potential participants for a depression trial. Trials. 2010;11:39. doi: 10.1186/1745-6215-11-39.
    1. Stuardi T, Cox H, Torgerson DJ. Database recruitment: a solution to poor recruitment in randomized trials? Fam Pract. 2011;28:329–333. doi: 10.1093/fampra/cmq108.
    1. Heinemann S, Thuring S, Wedeken S, Schafer T, Scheidt-Nave C, Ketterer M, Himmel W. A clinical trial alert tool to recruit large patient samples and assess selection bias in general practice research. BMC Res Methodol. 2011;11:16. doi: 10.1186/1471-2288-11-16.
    1. Embi PJ, Leonard AC. Evaluating alert fatigue over time to HER-based clinical trial alerts: findings from a randomized controlled study. J Am Med Inform Assoc. 2012;19:e145–e148. doi: 10.1136/amiajnl-2011-000743.
    1. Klemenc-Ketis Z, Bulc M, Kersnik J. Attitudes of Slovenian family practice patients toward changing unhealthy lifestyle and the role of family physicians: cross-sectional study. Croat Med J. 2011;52:205–211. doi: 10.3325/cmj.2011.52.205.
    1. Embi PJ, Jain A, Harris CM. Physicians’ perceptions of an electronic health record-based clinical trial alert approach to subject recruitment: a survey. BMC Med Inform Decis Mak. 2008;8:13. doi: 10.1186/1472-6947-8-13.

Source: PubMed

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

3
Sottoscrivi