scholarly journals A Real-Time Automated Patient Screening System for Clinical Trials Eligibility in an Emergency Department: Design and Evaluation

10.2196/14185 ◽  
2019 ◽  
Vol 7 (3) ◽  
pp. e14185 ◽  
Author(s):  
Yizhao Ni ◽  
Monica Bermudez ◽  
Stephanie Kennebeck ◽  
Stacey Liddy-Hicks ◽  
Judith Dexheimer
Author(s):  
Yizhao Ni ◽  
Monica Bermudez ◽  
Stephanie Kennebeck ◽  
Stacey Liddy-Hicks ◽  
Judith Dexheimer

BACKGROUND One critical hurdle for clinical trial recruitment is the lack of an efficient method for identifying subjects who meet eligibility criteria. Given the large volume of data documented in electronic health records (EHRs), it is labor-intensive for the staff to screen relevant information, particularly within the time frame needed. To facilitate subject identification, we developed a natural language processing (NLP) and machine learning-based system, Automated Clinical Trial Eligibility Screener© (ACTES), which analyzed structured data and unstructured narratives automatically to determine patients' suitability for clinical trial enrollment. In this study, we integrated the ACTES into clinical practice to support real-time patient screening. OBJECTIVE Our objective was to evaluate the ACTES's impact on the institutional workflow prospectively and comprehensively. We hypothesized that compared with the manual screening process, using EHR-based automated screening would improve efficiency of patient identification, streamline patient recruitment workflow, and increase enrollment in clinical trials. METHODS The ACTES was fully integrated into the clinical research coordinator (CRC) workflow in the pediatric emergency department (ED) at Cincinnati Children's Hospital Medical Center. The system continuously analyzed EHR information for current ED patients and recommended potential candidates for clinical trials. Relevant patient eligibility information was presented in real-time on a dashboard available to CRCs to facilitate their recruitment. To assess the system's effectiveness, we performed a multidimensional, prospective evaluation for a 12-month period, including a time-and-motion study, quantitative assessments of enrollment, and post-evaluation usability surveys collected from the CRCs. RESULTS Compared to manual screening, use of ACTES reduced the patient screening time by 34% (P<0.0001). The saved time was redirected to other work-related activities that streamlined teamwork among the CRCs (P <0.05). The quantitative assessments showed that automated screening improved the numbers of subjects screened, approached and enrolled by more than 10%, suggesting the potential of ACTES in streamlining recruitment workflow. The post-evaluation surveys indicated that the system was a good computerized solution with satisfactory usability. CONCLUSIONS By leveraging NLP and machine learning technologies, the ACTES demonstrated good capacity for improving efficiency of patient identification. The quantitative assessments demonstrated the potential of ACTES in streamlining recruitment workflow and improving patient approach and enrollment. The post-evaluation surveys suggested that the system was a good computerized solution with satisfactory usability.


2020 ◽  
Vol 8 (Suppl 3) ◽  
pp. A422-A422
Author(s):  
Ravi Murthy ◽  
Rahul Sheth ◽  
Alda Tam ◽  
Sanjay Gupta ◽  
Vivek Subbiah ◽  
...  

BackgroundImage guided intra-tumor administration of investigational immunotherapeutic agents represents an expanding field of interest. We present a retrospective review of the safety, feasibility & technical nuances of real-time image guidance for injection & biopsy across a spectrum of extracranial solid malignancies utilizing the discipline of Interventional Radiology.MethodsPatients who were enrolled in image guided intratumoral immunotherapy injection (ITITI) clinical trials over a 6 year period (2013–19) at a single tertiary care cancer center were included in this analysis. Malignancy, location, imaging guidance utilized for ITITI & biopsy for injected (adscopal) & non-injected (abscopal) lesions were determined and categorized. Peri-procedural adverse events were noted.Results262 pts (146 female, 61 yrs median) participating in 29 immunotherapeutic clinical trials (TLR & STING agonists, gene therapy, anti CD-40, viral/bacterial/metabolic oncolytics) met study criteria. Malignancies included melanoma 88, sarcoma 32, colorectal 29, breast 23, lung 17, head & neck 15, ovarian 8, neuroendocrine 7, pancreatic adenocarcinoma 6, 3 each (cholangioCA, endometrial, bladder, GI tract), 2 each (RCC, thymicCA, lymphoma, merkel cell, prostate) & others 1 each (CUP, GIST, dermatofibrosarcoma, DSRT, neuroblastoma, thyroid). All 169 & 93 patients received the intended 1371 ITITI in parietal (abdominal/chest wall, extremity, neck, pelvis) or visceral (liver, lung, peritoneum, adrenal) locations respectively; 83 patients received lymph node injections within either location. Imaging guidance was US in 68% of the cohort (US 161, CT+US 19); CT was used in 30% (81) & MRI in 1 patient. Median diameter of the ITITI lesion was 32 mm (8–230 mm). Median volume of the ITITI therapeutic material/session was 2 ml (1–6.9 ml). Lesions were accessed using a coaxial technique. ITITI delivery needles used at operator preference & tailored to lesion characteristics were either a 21G/22G Chiba, 21G Profusion (Cook Medical), 22G Morrison (AprioMed), 25G hypodermic (BD) & 18G Quadrafuse (Rex Medical). 2840 core biopsies (>18G Tru-cut core, Mission, Bard Medical) were performed in 237 patients during 690 procedures; biopsy sessions were often concurrent & of the ITITI site. 137 patients also underwent biopsy of a non-ITITI site (89 parietal location). Dimensions of the non-ITITI lesion were median 10 mm (7–113 mm); US image guidance was used in 97 patients (72%) to obtain a total of 1257, >18G Tru-core samples. 1.3% of injections resulted in SAE (NCI CTC AE >3) and 0.5% of 4097 biopsies developed major complications (SIR Criteria); both categories were manageable.ConclusionsUtilizing real time image guidance, ITITI to the administration of a myriad of investigational immunotherapeutic agents with concomitant biopsy procedures to date are associated with a high technical success rate & favorable safety profile.AcknowledgementsJoshua Hein, Mara Castaneda, Jyotsna Pera, Yunfang Jiang,Shuang Liu, Holly Liu and Anna LuiTrial RegistrationN/AEthics ApprovalThe study was approved by Institution’s Ethics Board, approval number 2020-0536: A retrospective study to determine the safety, feasibility and technical challenges of real-time image guidance for intra-tumor injection and biopsy across multiple solid tumors.Consent2020-0536 Waiver of Informed ConsentReferenceSheth RA, Murthy R, Hong DS, et al. Assessment of image-guided intratumoral delivery of immunotherapeutics in patients with cancer. JAMA Netw Open 2020;3(7):e207911. doi:10.1001/jamanetworkopen.2020.7911


2021 ◽  
Vol 12 (02) ◽  
pp. 293-300
Author(s):  
Kevin S. Naceanceno ◽  
Stacey L. House ◽  
Phillip V. Asaro

Abstract Background Clinical trials performed in our emergency department at Barnes-Jewish Hospital utilize a centralized infrastructure for alerting, screening, and enrollment with rule-based alerts sent to clinical research coordinators. Previously, all alerts were delivered as text messages via dedicated cellular phones. As the number of ongoing clinical trials increased, the volume of alerts grew to an unmanageable level. Therefore, we have changed our primary notification delivery method to study-specific, shared-task worklists integrated with our pre-existing web-based screening documentation system. Objective To evaluate the effects on screening and recruitment workflow of replacing text-message delivery of clinical trial alerts with study-specific shared-task worklists in a high-volume academic emergency department supporting multiple concurrent clinical trials. Methods We analyzed retrospective data on alerting, screening, and enrollment for 10 active clinical trials pre- and postimplementation of shared-task worklists. Results Notifications signaling the presence of potentially eligible subjects for clinical trials were more likely to result in a screen (p < 0.001) with the implementation of shared-task worklists compared with notifications delivered as text messages for 8/10 clinical trials. The change in workflow did not alter the likelihood of a notification resulting in an enrollment (p = 0.473). The Director of Research reported a substantial reduction in the amount of time spent redirecting clinical research coordinator screening activities. Conclusion Shared-task worklists, with the functionalities we have described, offer a viable alternative to delivery of clinical trial alerts via text message directly to clinical research coordinators recruiting for multiple concurrent clinical trials in a high-volume academic emergency department.


Author(s):  
Luis Hernández-Rodríguez ◽  
Fernanda Bellolio ◽  
Daniel Cabrera ◽  
Alicia E. Mattson ◽  
Derek VanMeter ◽  
...  

CJEM ◽  
2017 ◽  
Vol 20 (6) ◽  
pp. 920-928 ◽  
Author(s):  
Danielle K. Kelton ◽  
Adam Szulewski ◽  
Daniel Howes

AbstractObjectivesTo collect and synthesize the literature describing the use of real-time video-based technologies to provide support in the care of patients presenting to emergency departments.Data SourceSix electronic databases were searched, including Medline, CINAHL, Embase, the Cochrane Database, DARE, and PubMed for all publications since the earliest date available in each database to February 2016.Study SelectionSelected articles were full text articles addressing the use of telemedicine to support patient care in pre-hospital or emergency department settings. The search yielded 2976 articles for review with 11 studies eligible for inclusion after application of the inclusion and exclusion criteria. A scoping review of the selected articles was performed to better understand the different systems in place around the world and the current state of evidence supporting telemedicine use in the emergency department.ConclusionsTelemedicine support for emergency department physicians is an application with significant potential but is still lacking evidence supporting improved patient outcomes. Advances in technology, combined with more attractive price-points have resulted in widespread interest and implementation around the world. Applications of this technology that are currently being studied include support for minor treatment centres, patient transfer decision-making, management of acutely ill patients and scheduled teleconsultations.


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