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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.

ABSTRACT: 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.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/m2) 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.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/m2 (<27 kg/m2 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.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.ClinicalTrials.gov: NCT01806727 . Registered on 5 March 2013.

SUBMITTER: Effoe VS

PROVIDER: S-EPMC5062894 | biostudies-literature | 2016 Oct

REPOSITORIES: biostudies-literature

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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.

Effoe Valery S VS Katula Jeffrey A JA Kirk Julienne K JK Pedley Carolyn F CF Bollhalter Linda Y LY Brown W Mark WM Savoca Margaret R MR Jones Stedman T ST Baek Janet J Bertoni Alain G AG

Trials 20161013 1

<h4>Background</h4>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.<h4>Methods</h4>LIFT Diabetes is a randomized controlled t ...[more]

PMID: 27733193

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Project description:BackgroundEHR phenotyping offers the ability to rapidly assemble a precisely defined cohort of patients prescreened for eligibility to participate in health-related research. Even so, stakeholders in the process must still contend with the practical and ethical challenges associated with research recruitment. Patient perspectives on these matters are particularly important given that the success of research recruitment depends on patients' willingness to participate.MethodsWe conducted 15 focus groups (n =?110 participants) in four counties in diverse regions of the southeastern US: Appalachia, the Mississippi Delta, and the Piedmont area of North Carolina. Based on a hypothetical study of a behavioral intervention for type 2 diabetes, we asked about the acceptability and appropriateness of direct investigator versus physician-mediated contact with patients for research recruitment, and whether patients should be asked to opt in or opt out of further contact in response to recruitment letters.ResultsFor initial contact, nearly all participants said it would be acceptable for researchers to contact patients directly and three-fourths said that it would be acceptable for researchers to contact patients through their physicians. When we asked which would be most appropriate, a substantial majority chose direct contact. Themes that arose in the discussion included trust and transparency, decision-making power, the effect on research, and the effect on patient care. For response expectations, the vast majority of participants said both opt-in and opt-out would be acceptable-typically finding neither especially problematic and noting that both afford patients the opportunity to make their own decisions.ConclusionsExternal validity relies heavily on researchers' success enrolling eligible patients and failure to reach accrual targets is a costly and common barrier to advancing scientific knowledge. Our results suggest that patients recognize multiple advantages and disadvantages of different research recruitment strategies and place value on the implications not just for themselves, but also for researchers and healthcare providers. Our findings, including rich qualitative detail, contribute to the body of empirical and ethical literature on improving research recruitment and suggest specific ways forward as well as important areas for future research.

Project description:BackgroundThe electronic health record (EHR) contains a wealth of clinical data that may be used to streamline the identification of potential clinical trial participants. However, there is little empirical information on site-level facilitators of and barriers to optimal use of EHR systems with respect to trial recruitment.MethodsWe conducted qualitative focus groups and quantitative surveys as part of the EHR Ancillary Study, which is being conducted alongside the multicenter, global, Harmony Outcomes Trial comparing albiglutide to standard care for the prevention of cardiovascular events in type 2 diabetes. Subject matter experts used findings from focus groups to draft a 20-question survey examining the use of the EHR for participant identification, common site recruitment strategies, and variation in perceived barriers to optimal use of the EHR. The final survey was fielded with 446 site investigators actively enrolling participants in the main trial.ResultsNearly two-thirds of respondents were study coordinators (63.2%), 23.1% were principal investigators, and 13.7% held other research roles. Approximately half of the respondents reported using the EHR to find potential trial participants. Of these, 79.4% reported using EHR searches in conjunction with other recruitment methods, including reviewing of upcoming clinic schedules (75.3%) and contacting past trial participants (71.2%). Important barriers to optimal use of the EHR included the lack of availability of certain research-focused EHR modules and limitations on the ability to contact patients cared for by other providers. Of survey respondents who did not use the EHR to find potential participants, one-quarter reported that the EHR was not accessible in their country; this finding varied from 2.6% of respondents in North America to 50% of respondents in the Asia Pacific.ConclusionsWhile EHR screening was commonly used for recruitment in a cardiovascular outcomes trial, important technical, governance, and regulatory barriers persist. Multifaceted, scalable, and customizable strategies are needed to support the optimal use of the EHR for trial participant identification.Trial registrationClinicalTrials.gov NCT02465515. Registered on 8 June 2015.

Project description:BACKGROUND AND AIMS:Screening for substance use disorder (SUD) in general medical settings may be particularly important in patients with comorbid health conditions exacerbated by SUD. This study evaluated whether SUD is associated with type 2 diabetes mellitus (T2DM) complications in patients with co-occurring T2DM and hypertension. DESIGN:Analysis of a limited data set obtained through IBM Watson Health Explorys, a platform integrating data from electronic health records. Matched controls were defined for each of five SUDs: tobacco use disorder (TUD), opioid use disorder (OUD), cocaine use disorder, cannabis use disorder (CUD) and alcohol use disorder (AUD) using Mahalanobis distance within propensity score calipers. SETTING:All patients were seen in the MetroHealth System (Cleveland, OH, USA) and had diagnosis codes for T2DM and hypertension. PARTICIPANTS:SUD group participants had a diagnosis of abuse/dependence for the substance of interest. Controls for each SUD group had no diagnosis code related to the SUD of interest and were selected to match the SUD patients on demographics, residential zip code median income and body mass index. Total sample sizes for each SUD-control comparison ranged from 1160 for CUD to 22?128 for TUD. MEASUREMENTS:Outcome was diagnosis (yes/no) of four T2DM complications (cerebrovascular accident, diabetic neuropathy, diabetic renal disease, myocardial infarction) and all-cause mortality. FINDINGS:Logistic regressions revealed that SUD was significantly associated with greater risk of cerebrovascular accident [TUD odds ratio (OR) = 1.79, OUD-OR = 1.94, cocaine use disorder OR = 2.67], diabetic neuropathy [TUD-adjusted OR (aOR) = 1.47, cocaine use disorder-aOR = 1.35, AUD-aOR = 1.27], diabetic renal disease (TUD-aOR = 1.25, OUD-OR = 1.34), myocardial infarction (TUD-OR = 1.96, OUD-OR = 2.01, cocaine use disorder-OR = 2.68, CUD-OR = 2.48, AUD-OR = 1.42) and mortality (TUD-OR = 1.15, cocaine use disorder-OR = 1.61, CUD-OR = 1.49, AUD-OR = 1.35). CONCLUSIONS:Among patients in Ohio USA with both type 2 diabetes mellitus (T2DM) and hypertension, those with substance use disorders appear to have greater risk for T2DM complications and all-cause mortality.

Project description:BackgroundIn South Korea, most graduated medical students undertake a 1-year internship before beginning residency and specialization. Interns usually work in a tertiary hospital and rotate between different, randomly assigned departments to be exposed to different medical specialties. Their jobs are mostly simple and repetitive but are still essential for the patient care process. However, owing to the lack of experience and overwhelming workload, interns at tertiary hospitals in South Korea are usually inefficient, often delaying the entire clinical process. Health care providers have widely adopted mobile electronic medical records (mEMRs) as they have been shown to improve workflow efficiency.ObjectiveThis study investigates the association between the frequency of mEMR usage and the clinical task completion interval time among interns in a tertiary hospital.MethodsThis mixed methods study was conducted at the Samsung Medical Center, Seoul, South Korea. Interns who worked at the Samsung Medical Center from March 2018 to February 2019 were included. The hospital electronic medical record (EMR) system known as DARWIN (Data Analysis and Research Window for Integrated kNowledge) was launched with PC and mobile. Both versions are actively used in hospitals by personnel in various positions. We collected the log data from the mEMR server and the intern clinical task time-series data from the EMR server. Interns can manage the process of identifying patients, assigning the clinical task, finishing the requested clinical intern tasks, etc, through the use of the mEMR system. We compared the clinical task completion interval among 4 groups of interns divided by the mEMR frequency quantile. Then, System Usability Score (SUS) questionnaires and semistructured interviews were conducted.ResultsThe regular mEMR users were defined as those who logged in more than once a day on average and used the mEMR until the level after login. Among a total of 87 interns, 84 used the mEMR to verify the requested clinical tasks. The most frequently used item was "Intern task list." Analysis of the 4 intern groups revealed an inverse relationship between the median time of the task completion interval and the frequency of mEMR use. Correlation analysis showed that the intern task completion time interval had a significant inverse relationship with the individual frequency of mEMR usage (coefficient=-0.27; 95% CI -0.46 to -0.04; P=.02). In the additional survey, the mean SUS value was 81.67, which supported the results of the data analysis.ConclusionsOur findings suggest that frequent mEMR use is associated with improved work efficiency in hospital interns with good usability of the mEMR. Such finding supports the idea that the use of mEMR improves the effectiveness and workflow efficiency of interns working in hospitals and, more generally, in the context of health care.

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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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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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