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Comparison of electronic physician prompts versus waitroom case-finding on clinical trial enrollment.

ABSTRACT: Recruiting patients into clinical research protocols is challenging. Electronic medical record (EMR) systems capable of prompting clinicians may facilitate enrollment.To compare an EMR-based clinician prompt versus a wait-room-based case-finding strategy at enrolling patients into a clinical trial.Cross-sectional comparison of recruitment data from two trials to treat anxiety disorders in primary care. Both studies utilized similar enrollment criteria, intervention strategies, and the same four practice sites and EMR system.Patients referred by their (primary care physicians) PCPs in response to an EMR prompt (recruited 1/2005-10/2006), and patients enrolled by research assistants stationed in practice waiting rooms (7/2000-4/2002).Referral counts, patients' baseline sociodemographic and clinical characteristics.Over a 22-month period, EMR-prompted PCPs referred 794 patients and 176 (22%) met study inclusion criteria and enrolled, compared to 8,095 patients approached by wait room-based recruiters of whom 193 (2.4%) enrolled. Subjects enrolled by EMR-prompted PCPs were more likely to be non-white (23% vs 5%; P < 0.001), male (28% vs 18%; P = 0.03), and have higher anxiety levels than those recruited by wait-room recruiters (P < 0.0001).EMR systems prompting clinicians to refer patients with specific characteristics are an efficient recruitment tool with critical implications for increasing minority participation in clinical research.

SUBMITTER: Rollman BL

PROVIDER: S-EPMC2359503 | biostudies-literature | 2008 Apr

REPOSITORIES: biostudies-literature

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Comparison of electronic physician prompts versus waitroom case-finding on clinical trial enrollment.

Rollman Bruce L BL Fischer Gary S GS Zhu Fang F Belnap Bea Herbeck BH

Journal of general internal medicine 20080401 4

<h4>Background</h4>Recruiting patients into clinical research protocols is challenging. Electronic medical record (EMR) systems capable of prompting clinicians may facilitate enrollment.<h4>Objective</h4>To compare an EMR-based clinician prompt versus a wait-room-based case-finding strategy at enrolling patients into a clinical trial.<h4>Design</h4>Cross-sectional comparison of recruitment data from two trials to treat anxiety disorders in primary care. Both studies utilized similar enrollment c ...[more]

PMID: 18373143

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Project description:Regulations, study design complexity and amounts of collected and shared data in clinical trials render efficient data handling procedures inevitable. Recent research suggests that electronic data capture can be key in this context but evidence is insufficient. This randomized controlled parallel group study tested the hypothesis that time efficiency is superior when electronic (eCRF) instead of paper case report forms (pCRF) are used for data collection. We additionally investigated predictors of time saving effects and data integrity.This study was conducted on top of a clinical weight loss trial performed at a clinical research facility over six months. All study nurses and patients participating in the clinical trial were eligible to participate and randomly allocated to enter cross-sectional data obtained during routine visits either through pCRF or eCRF. A balanced randomization list was generated before enrolment commenced. 90 and 30 records were gathered for the time that 27 patients and 2 study nurses required to report 2025 and 2037 field values, respectively. The primary hypothesis, that eCRF use is faster than pCRF use, was tested by a two-tailed t-test. Analysis of variance and covariance were used to evaluate predictors of entry performance. Data integrity was evaluated by descriptive statistics.All randomized patients were included in the study (eCRF group n =?13, pCRF group n =?14). eCRF, as compared to pCRF, data collection was associated with significant time savings across all conditions (8.29?±?5.15 min vs. 10.54?±?6.98 min, p =?.047). This effect was not defined by participant type, i.e. patients or study nurses (F(1,112) =?.15, p =?.699), CRF length (F(2,112) =?.49, p =?.609) or patient age (Beta?=?.09, p =?.534). Additional 5.16?±?2.83 min per CRF were saved with eCRFs due to data transcription redundancy when patients answered questionnaires directly in eCRFs. Data integrity was superior in the eCRF condition (0 versus 3 data entry errors).This is the first study to prove in direct comparison that using eCRFs instead of pCRFs increases time efficiency of data collection in clinical trials, irrespective of item quantity or patient age, and improves data quality.Clinical Trials NCT02649907 .

Project description:Our purpose was to identify physicians' individual characteristics, attitudes, and organizational contextual factors associated with higher enrollment of patients in cancer clinical trials among physician participants in the National Cancer Institute's Community Clinical Oncology Program (CCOP). We hypothesized that physicians' individual characteristics, such as age, medical specialty, tenure, CCOP organizational factors (i.e. policies and procedures to encourage enrollment), and attitudes toward participating in CCOP would directly determine enrollment. We also hypothesized that physicians' characteristics and CCOP organizational factors would influence physicians' attitudes toward participating in CCOP, which in turn would predict enrollment.We evaluated enrollment in National Cancer Institute-sponsored cancer clinical trials in 2011 among 481 physician participants using Structural Equation Modeling. The data sources include CCOP Annual Progress Reports, two surveys of CCOP administrators and physician participants, and the American Medical Association Masterfile.Physicians with more positive attitudes toward participating in CCOP enrolled more patients than physicians with less positive attitudes. In addition, physicians who practiced in CCOPs that had more supportive policies and practices in place to encourage enrollment (i.e. offered trainings, provided support to screen and enroll patients, gave incentives to enroll patients, instituted minimum accrual expectations) also significantly enrolled more patients. Physician status as CCOP Principal Investigator had a positive direct effect on enrollment, while physician age and non-oncology medical specialty had negative direct effects on enrollment. Neither physicians' characteristics nor CCOP organizational factors indirectly influenced enrollment through an effect on physician attitudes.We examined whether individual physicians' characteristics and attitudes, as well as CCOP organizational factors, influenced patient enrollment in cancer clinical trials among CCOP physicians. Physician attitudes and CCOP organizational factors had positive direct effects, but not indirect effects, on physician enrollment of patients. Our results could be used to develop physician-directed strategies aimed at increasing involvement in clinical research. For example, administrators may want to ensure physicians have access to support staff to help screen and enroll patients or institute minimum accrual expectations. Our results also highlight the importance of recruiting physicians for volunteer clinical research programs whose attitudes and values align with programmatic goals. Given that physician involvement is a key determinant of patient enrollment in clinical trials, these interventions could expand the overall number of patients involved in cancer research. These strategies will be increasingly important as the CCOP network continues to evolve.

Project description:BackgroundUse of a person's name in a text message has been shown to be effective in instigating behaviour change. We evaluated the effectiveness of a personalised text message (including the recipient's name) versus a standardised text message for prompting a response from trial participants to complete and return postal follow-up questionnaires.MethodsUsing a randomised study within a trial (SWAT) embedded within the host GRASP (Getting it Right: Addressing Shoulder Pain) trial, participants who provided a mobile telephone number were randomised (1:1) by a central computer system to receive either (1) a personalised text message which included their name or (2) a standard text message. Text messages were sent by the trial office on the same day as the 6-month GRASP follow-up questionnaire. The primary outcome was questionnaire response rate, defined as the proportion of 6-month GRASP follow-up questionnaires returned by participants. Secondary outcomes included time to response, the proportion of participants sent a reminder follow-up questionnaire, and cost.ResultsBetween March 2017 and May 2019 (recruitment period for GRASP trial), 618 participants were randomised to a personalised (n = 309) or standard (n = 309) text message and all were included in the analysis. The overall questionnaire response rate was 87% (n = 537/618); 90% (n = 277/309) of participants responded in the personalised text message group compared to 84% (n = 260/309) in the standard text message group (relative risk (RR) 1.07; 95% CI 1.00 to 1.13). Participants randomised to receive the personalised text message were more likely to return their initial postal questionnaire than those who received the standard text message (n = 185/309; 60% vs. n = 160/309; 52%) (RR 1.16; 95% CI 1.00 to 1.33); this represents an absolute percentage difference between intervention groups of 8%. Post hoc subgroup analysis showed that males under 65 years were the group most likely to return their initial questionnaire if they received a personalised text message.ConclusionOverall, participants who received a personalised text message were more likely to return their questionnaire than those who received the standard text message.Trial registrationGRASP Trial ISRCTN16539266 ; SWAT Repository ID 35.

Project description:Background: Community-based active case finding (ACF) for tuberculosis (TB) implemented among marginalised and vulnerable populations in 285 districts of India resulted in reduction of diagnosis delay and prevalence of catastrophic costs due to TB diagnosis. We were interested to know whether this translated into improved treatment outcomes. Globally, there is limited published literature from marginalised and vulnerable populations on the independent effect of community-based ACF on treatment outcomes when compared to passive case finding (PCF). Objectives: To determine the relative differences in unfavourable treatment outcomes (death, loss-to-follow-up, failure, not evaluated) of ACF and PCF-diagnosed people. Methods: Cohort study involving record reviews and interviews in 18 randomly selected districts. We enrolled all ACF-diagnosed people with new smear-positive pulmonary TB, registered under the national TB programme between March 2016 and February 2017, and an equal number of randomly selected PCF-diagnosed people in the same settings. We used log binomial models to adjust for confounders. Results: Of 572 enrolled, 275 belonged to the ACF and 297 to the PCF group. The proportion of unfavourable outcomes were 10.2% (95% CI: 7.1%, 14.3%) in the ACF and 12.5% (95% CI: 9.2%, 16.7%) in the PCF group (p = 0.468). The association between ACF and unfavourable outcomes remained non-significant after adjusting for confounders available from records [aRR: 0.83 (95% CI: 0.56, 1.21)]. Due to patient non-availability at their residence, interviews were conducted for 465 (81.3%). In the 465 cohort too, there was no association after adjusting for confounders from records and interviews [aRR: 1.05 (95% CI: 0.62, 1.77)]. Conclusion: We did not find significant differences in the treatment outcomes. Due to the wide CIs, studies with larger sample sizes are urgently required. Studies are required to understand how to translate the benefits of ACF to improved treatment outcomes.

Project description:ObjectivesTo determine whether face-to-face prompting of critical care physicians reduces empirical antibiotic utilization compared to an unprompted electronic checklist embedded within the electronic health record.DesignRandom allocation design.SettingMedical ICU with high-intensity intensivist coverage at a tertiary care urban medical center.PatientsTwo hundred ninety-six critically ill patients treated with at least 1 day of empirical antibiotics.InterventionsFor one medical ICU team, face-to-face prompting of critical care physicians if they did not address empirical antibiotic utilization during a patient's daily rounds. On a separate medical ICU team, attendings and fellows were trained once to complete an electronic health record-embedded checklist daily for each patient, including a question asking whether listed empirical antibiotics could be discontinued.Measurements and main resultsPrompting led to a more than four-fold increase in discontinuing or narrowing of empirical antibiotics compared to use of the electronic checklist. Prompted group patients had a lower proportion of patient-days on which empirical antibiotics were administered compared to electronic checklist group patients (63.1% vs 70.0%, p = 0.002). Mean proportion of antibiotic-days on which empirical antibiotics were used was also lower in the prompted group, although not statistically significant (0.78 [0.27] vs 0.83 [0.27], p = 0.093). Each additional day of empirical antibiotics predicted higher risk-adjusted mortality (odds ratio, 1.14; 95% CI, 1.05-1.23). Risk-adjusted ICU length of stay and hospital mortality were not significantly different between the two groups.ConclusionsFace-to-face prompting was superior to an unprompted electronic health record-based checklist at reducing empirical antibiotic utilization. Sustained culture change may have contributed to the electronic checklist having similar empirical antibiotic utilization to a prompted group in the same medical ICU 2 years prior. Future studies should investigate the integration of an automated prompting mechanism with a more generalizable electronic health record-based checklist.

Dataset Information

Comparison of electronic physician prompts versus waitroom case-finding on clinical trial enrollment.

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Comparison of electronic physician prompts versus waitroom case-finding on clinical trial enrollment.

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