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      The use of electronic medical records for recruitment in clinical trials: findings from the Lifestyle Intervention for Treatment of Diabetes trial

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          Abstract

          Background

          The use of the electronic medical record (EMR) system in recruitment in clinical trials has the potential for providing a very reliable and cost-effective recruiting methodology which may improve participant recruitment in clinical trials. We examined a recruitment approach centered on the use of the EMR, as well as other traditional methods, in the Lifestyle Intervention for Treatment of Diabetes (LIFT Diabetes) trial.

          Methods

          LIFT Diabetes is a randomized controlled trial designed to investigate the effects of two contrasting interventions on cardiovascular disease risk: a community-based intensive lifestyle program aimed at achieving weight loss and a clinic-based enhanced diabetes self-management program. Eligible participants were overweight/obese (body mass index, BMI ≥25 kg/m 2) patients with type 2 diabetes who were aged 21 years or older. Recruitment strategies included the use of the EMR system (primary), direct referrals, media advertisements, and community screenings.

          Results

          A total of 1102 telephone screens were conducted, resulting in randomization of 260 participants (61.5 % from EMR, mean age 56.3 years, 66.2 % women, 48.1 % non-Hispanic blacks) over a 21-month period, with a yield of 23.6 %. Recruitment yields differed by recruitment method, with referrals having the highest yield (27.5 %). A history of cardiovascular disease was the main health reason for exclusion from the study (16.5 %). An additional 8.9 % were excluded for BMI <25 kg/m 2 (<27 kg/m 2 for insulin users), 5.4 % could not exercise, 5.2 % had an HbA1c >11 %, and 34.9 % were excluded for other non-medical reasons. Exclusion criteria did not appear to differentially affect enrollment in terms of race or ethnicity.

          Conclusions

          Future clinical studies should tailor their recruitment strategies based on the participant demographics of interest. Efficient methods such as using the EMR system and referrals should be prioritized over labor-intensive, low-yielding methods such as community screenings and mass mailings.

          Trial registration

          ClinicalTrials.gov: NCT01806727. Registered on 5 March 2013.

          Electronic supplementary material

          The online version of this article (doi:10.1186/s13063-016-1631-7) contains supplementary material, which is available to authorized users.

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          Most cited references 17

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          AADE7 Self-Care Behaviors.

            (2015)
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            Baseline characteristics of the randomised cohort from the Look AHEAD (Action for Health in Diabetes) study.

            The Look AHEAD (Action for Health in Diabetes) study is a 16-centre randomised clinical trial in overweight and obese individuals with type 2 diabetes, designed to evaluate the long-term effects (up to 11.5 years) of intensive weight loss intervention on the time to incidence of major cardiovascular events. Eligibility requirements are diagnosis of type 2 diabetes (determined by self-report and verification) in individuals aged 4574 years and body mass index (BMI) > 25 kg/m2 (> 27 kg/m2 if currently taking insulin). The intensive lifestyle intervention is designed to achieve and maintain weight loss through decreased caloric intake and increased physical activity. The study is designed to provide 90% probability of detecting an 18% difference in major cardiovascular disease event rates in patients randomised to the intensive lifestyle intervention compared to the control group receiving standard diabetes support and education. The 5,145 participants who were randomised between 2001 and 2004 were 63.3% white, 15.6% African-American, 13.2% Hispanic, 5.0% American Indian and 1.0% Asian-American, which closely paralleled the ethnic distribution of diabetes in the National Health and Nutrition Examination Survey (NHANES) 1999-2000 survey. Their average age at entry was 59+/-6.8 years (mean+/-SD), and 60% were women. There were 31.5% between 4555 years of age, 51.5% were 5665, and 17.0% were 6676 years of age. Some 15.4% of participants were taking insulin at the time of randomisation and 14.0% had a history of cardiovascular disease. More men (21.3%) than women (9.2%) had a history of cardiovascular disease. Few participants (4.4%) were current cigarette smokers, compared to 16.2% in the NHANES 1999-2000 survey. Furthermore, 65.0% of participants had a first-degree relative with diabetes. Overall, BMI averaged 36+/-5.9 kg/m2 at baseline, with 83.6% of the men and 86.1% of women having a BMI > 30 kg/m2 and 17.9% of men and 25.4% of women having a BMI > 40 kg/m2. The Look AHEAD study has successfully randomised a large cohort of participants who have type 2 diabetes with a wide distribution of age, obesity, ethnicity and racial background and will examine the effects of lifestyle intervention on the incidence of major cardiovascular events.
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              The Diabetes Prevention Program: recruitment methods and results.

              The Diabetes Prevention Program (DPP) is a multicenter randomized controlled trial designed to test whether diet and exercise or medication can prevent or delay the onset of type 2 diabetes in persons with impaired glucose tolerance, who are at increased risk of the disease. This paper describes DPP recruitment methods, strategies, performance, and costs. The DPP developed an organizational structure for comprehensive management and continuous monitoring of recruitment efforts. The DPP utilized a variety of recruitment strategies, alone or in combination, and a stepped informed consent procedure leading to randomization. Studywide and clinic-specific recruitment data were monitored, analyzed, and used to modify recruitment approaches. DPP recruitment was completed slightly ahead of schedule, meeting goals for the proportion of women enrolled and nearly meeting goals for the proportion of racial/ethnic minorities. Clinics varied widely in the recruitment strategies they used, and these strategies also varied by participant age, gender, and race/ethnicity. Staff time devoted to recruitment averaged 86.8 hours per week per clinic, with the majority of effort by staff specifically assigned to recruitment. The number of staff hours required to recruit a participant varied by recruitment strategy. Recruitment cost (excluding staff cost) was about 1075 US dollars per randomized participant. The DPP experience offers lessons for those planning similar efforts: (1) a method for ongoing assessment and revision of recruitment strategies is valuable; (2) a range of recruitment strategies may be useful; (3) the most effective methods for recruiting potential subjects may vary according to the gender, age, and race/ethnicity of those individuals; (4) recruitment strategies vary in the amount of staff time required to randomize a participant; and (5) a stepped screening may make it easier to identify and recruit volunteers who understand the requirements of the study.
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                Author and article information

                Contributors
                valeffoe@gmail.com
                jkatula@wakehealth.edu
                jkirk@wakehealth.edu
                cpedley@wakehealth.edu
                lbollhal@wakehealth.edu
                wmbrown@wakehealth.edu
                msavoca@wakehealth.edu
                stedjone@wakehealth.edu
                jbaek@wakehealth.edu
                abertoni@wakehealth.edu
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                13 October 2016
                13 October 2016
                2016
                : 17
                Affiliations
                [1 ]Department of Epidemiology and Prevention, Division of Public Health Sciences, Wake Forest School of Medicine, Medical Center Blvd, Winston-Salem, NC 27127 USA
                [2 ]Department of Medicine, Morehouse School of Medicine, Atlanta, GA USA
                [3 ]Department of Health and Exercise Science, Wake Forest University, Winston-Salem, NC USA
                [4 ]Department of Family and Community Medicine, Wake Forest School of Medicine, Winston-Salem, NC USA
                [5 ]Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, NC USA
                [6 ]Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, NC USA
                [7 ]Department of Medicine, Wake Forest School of Medicine, Winston-Salem, NC USA
                [8 ]Maya Angelou Center for Health Equity, Wake Forest School of Medicine, Winston-Salem, NC USA
                Article
                1631
                10.1186/s13063-016-1631-7
                5062894
                27733193
                © The Author(s). 2016

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/100006545, National Institute on Minority Health and Health Disparities;
                Award ID: P60MD006917
                Award Recipient :
                Categories
                Research
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                © The Author(s) 2016

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