Computerized recruiting for clinical trials in real time

doi:10.1067/mem.2003.52

Annals of Emergency Medicine

Volume 41, Issue 2, February 2003, Pages 242-246

Presented at the American Pediatric Societies, Baltimore, MD, May 2001.

https://doi.org/10.1067/mem.2003.52 Get rights and content

Abstract

Study objective: Success of prospective studies, particularly in the emergency department, often depends on immediate identification of eligible patients to ensure timely sample collection and initiation of study interventions. We report use of a real-time automated notification system to identify potential patients for a clinical trial at the time of ED registration on the basis of information routinely collected. We hypothesize that the automated notification system improves the rate of investigator notification. Methods: We performed a prospective comparison of the notification rate by the automated notification system compared with that by ED clinicians. Results: In the 11 months before use of the automated notification system, the investigator was notified by ED staff for 56% of 61 potentially eligible patients. During 10 months of using the automated notification system, the investigator was paged by the automated notification system for 84% of 49 potentially eligible patients. Conclusion: The automated notification system improves study investigator notification. Use requires online linked registration, a database, and paging systems. The automated notification system is a potentially valuable tool in the recruitment of patients for clinical trials. [Ann Emerg Med. 2003;41:242-246.]

Introduction

The success of prospective clinical research studies, particularly in the emergency department, often depends on immediate identification of potentially eligible patients to ensure timely collection of critical samples, initiation of study interventions, or both. Large numbers of clinicians not directly involved in research must be aware of active studies, know their eligibility criteria, and take the time either to notify the study investigators or to obtain consent from and enroll patients themselves. Especially in a busy ED, consistent and timely study investigator notification often does not occur. A system that maximizes enrollment without disrupting clinical care in the ED is needed.

Computerized, real-time event-monitoring systems that use alphanumeric pages to notify clinicians have been used in clinical care to assist with triage decisions; identify clinical practice guidelines for which patients might be eligible; provide alerts for physiologic data, laboratory results, and medication order errors; and offer diagnostic decision support and treatment recommendations.1, 2, 3 Computer software has also been developed to improve clinical trial processes, including recruitment, enrollment, randomization, data collection, and analysis.4, 5, 6, 7 In general, these systems have been dependent on entry of patient clinical data generated by a clinician. Particularly in the ED, where patient care often precedes clinical data entry, a point-of-entry patient identification and recruitment system would likely be advantageous, particularly for interventional trials. A computer-to-pager automated notification system (RealTime Recruiting, Atul Butte, MD, Children's Hospital Boston, Boston, MA) has previously been used by us in our ED to identify potential study patients and to notify a study investigator in real time on the basis of critical laboratory values.8, 9 We hypothesized that this software system could be modified to identify potential study participants at the time of registration in the ED. The specific aim of this pilot study was to compare the rate of study investigator pages by the automated notification system with the rate from ED staff for potential study patients for a prospective clinical trial. The clinical trial for which the automated notification system was being used evaluated the use of inhaled nitric oxide in the treatment of acute vaso-occlusive crisis in pediatric patients with sickle cell disease.

Section snippets

Materials and methods

The Children's Hospital Boston ED is an urban, academic tertiary-care center. Thirty attending physicians supervise 15 fellows and approximately 200 rotating residents/students annually. Nursing care is provided by 35 permanent and 15 per diem nurses. Patients with possible sickle cell vaso-occlusive crisis are triaged by a nurse directly to a patient-care room, where they are registered and seen promptly by the emergency physician, who initiates diagnostic evaluation and treatment. There are

Results

In the 11 months before use of the automated notification system, the investigator was paged for 34 (56%) of 61 potentially eligible patients. In the 10 months with use of the automated notification system, the investigator was paged for 41 (84%) of 49 potentially eligible patients, a significant increase in notification rate (χ²=9.77; 95% confidence interval 12% to 44%). The study investigator was paged by the automated notification system within 15 minutes for 86% and within 30 minutes for

Discussion

To our knowledge, this is the first report to describe use of a computerized, real-time recruitment system designed to automatically identify and notify study investigators about potential patients for clinical trials on the basis of information obtained at ED patient registration. The automated notification system significantly improved investigator notification of potential study patients for an actual clinical trial of inhaled nitric oxide for treatment of acute vaso-occlusive crisis in

Acknowledgements

We thank Susan Kurth, PNP, Division of Hematology for making data from her review of ED logs available to us.

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Comparison of Electronic Health Record System Functionalities to support the patient recruitment process in clinical trials
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In the literature on IT-supported patient recruitment a variety of approaches has been described, however only few of them being directly integrated into the patient care documentation process and making direct use of EHR data [9]. Some institutions have implemented stand-alone tools (e.g. [8,21]), others have enhanced their EHR system with small functions supporting particular patient recruitment strategies (e.g. [22,23]). To the best of our knowledge no publication has yet defined a comprehensive set of features, which provides electronic support for the complete patient recruitment process.
Reusing data from electronic health records for clinical and translational research and especially for patient recruitment has been tackled in a broader manner since about a decade. Most projects found in the literature however focus on standalone systems and proprietary implementations at one particular institution often for only one singular trial and no generic evaluation of EHR systems for their applicability to support the patient recruitment process does yet exist. Thus we sought to assess whether the current generation of EHR systems in Germany provides modules/tools, which can readily be applied for IT-supported patient recruitment scenarios.
We first analysed the EHR portfolio implemented at German University Hospitals and then selected 5 sites with five different EHR implementations covering all major commercial systems applied in German University Hospitals. Further, major functionalities required for patient recruitment support have been defined and the five sample EHRs and their standard tools have been compared to the major functionalities.
In our analysis of the site's hospital information system environments (with four commercial EHR systems and one self-developed system) we found that – even though no dedicated module for patient recruitment has been provided – most EHR products comprise generic tools such as workflow engines, querying capabilities, report generators and direct SQL-based database access which can be applied as query modules, screening lists and notification components for patient recruitment support. A major limitation of all current EHR products however is that they provide no dedicated data structures and functionalities for implementing and maintaining a local trial registry.
At the five sites with standard EHR tools the typical functionalities of the patient recruitment process could be mostly implemented. However, no EHR component is yet directly dedicated to support research requirements such as patient recruitment. We recommend for future developments that EHR customers and vendors focus much more on the provision of dedicated patient recruitment modules.
The accuracy and efficiency of electronic screening for recruitment into a clinical trial on COPD
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For latter 2 factors, various authors have discussed issues and strategies to overcome them, although approaching and enrolling patients did not progress markedly in the past decade.1–4 However, identification of eligible patients has improved considerably, especially with use of electronic medical records (EMRs).5–10 These systems generally either notify health care providers at the point of care (Clinical Trial Alerts) or create patient lists on a regular basis (electronic screening or E-screening); most are based on a search for discrete data points, for instance, age or laboratory results.
Participant recruitment is an important process in successful conduct of randomized controlled trials. To facilitate enrollment into a National Institutes of Health–sponsored clinical trial involving patients with chronic obstructive pulmonary disease (COPD), we developed and prospectively validated an automated electronic screening tool based on boolean free-text search of admission notes in electronic medical records. During a 2-week validation period, all patients admitted to prespecified general medical services were screened for eligibility by both the electronic screening tool and a COPD nurse. Group discussion was the gold standard for confirmation of true-positive results. Compared with the gold standard, electronic screening yielded 100% sensitivity, 92% specificity, 100% negative predictive value, and 72% positive predictive value. Compared with traditional manual screening, electronic screening demonstrated time-saving potential of 76%. Thus, the electronic screening tool accurately identifies potential study subjects and improves efficiency of patient accrual for a clinical trial on COPD. This method may be expanded into other institutional and clinical settings.
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The ratio of mean time for the manual versus automated patient per eligible patient identified ranges from 0.8 for Study 5 to 19.4 for Study 1. Automated systems for eligibility screening using health information technology tools present a promising solution to the logistical issues facing CRS in identifying and accruing patients to clinical trials [8,16,20–26]. However to date, these tools lack generalizibility as they a) have utilized a customized system against which the queries are run, and b) rely on pre-screening from a few data sources with limited clinical relevance.
Clinical trials (CT) serve as the media that translates clinical research into standards of care. Low or slow recruitment leads to delays in delivery of new therapies to the public. Determination of eligibility in all patients is one of the most important factors to assure unbiased results from the clinical trials process and represents the first step in addressing the issue of under representation and equal access to clinical trials.
This is a pilot project evaluating the efficiency, flexibility, and generalizibility of an automated clinical trials eligibility screening tool across 5 different clinical trials and clinical trial scenarios.
There was a substantial total savings during the study period in research staff time spent in evaluating patients for eligibility ranging from 165 h to 1329 h. There was a marked enhancement in efficiency with the automated system for all but one study in the pilot. The ratio of mean staff time required per eligible patient identified ranged from 0.8 to 19.4 for the manual versus the automated process.
The results of this study demonstrate that automation offers an opportunity to reduce the burden of the manual processes required for CT eligibility screening and to assure that all patients have an opportunity to be evaluated for participation in clinical trials as appropriate. The automated process greatly reduces the time spent on eligibility screening compared with the traditional manual process by effectively transferring the load of the eligibility assessment process to the computer.
Piloting an automated clinical trial eligibility surveillance and provider alert system based on artificial intelligence and standard data models
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Piloting an Automated Clinical Trial Eligibility Surveillance and Provider Alert System based on Artificial Intelligence and Standard Data Models
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^*: Dr. Weiner is supported by US Food and Drug Administration Orphan Drug grant RD-R-001686 and General Clinical Research Center, National Center for Research Resources, National Institutes of Health grant RR02172. Dr. Butte is supported by National Library of Medicine grant 5T15 LM07092-07.

^**: Nitric oxide for the clinical trial was donated by Pulmonox Medical Corporation.

^*: Dr. Butte is the developer of the RealTime Recruiting software and has filed for a patent.

^*: Address for reprints: Debra L. Weiner, MD, PhD, Division of Emergency Medicine, Children's Hospital, 300 Longwood Avenue, Boston, MA 02115; 617-355-4144, fax 617-731-3279; E-mail [email protected]

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Conducting Clinical ResearchComputerized recruiting for clinical trials in real time*,**,*,*

Abstract

Introduction

Section snippets

Materials and methods

Results

Discussion

Acknowledgements

Ballieres Clin Obstet Gynecol

Comput Biomed Res

Detecting alerts, notifying the physician and offering action items: a comprehensive alerting system

Proc AMIA Symp

Wireless clinical alerts for physiologic, laboratory and medication data

Proc AMIA Symp

Automatic identification of patients eligible for a pneumonia guideline

Proc AMIA Symp

Conducting Clinical Research
Computerized recruiting for clinical trials in real time*,**,,