Peter J Embi
Ohio State University
Project start date: 2010-09-30
Project end date: 2012-09-28
Sponsored Links Excellgen http://Excellgen.com
EVALUATING EHR-BASED, POINT-OF-CARE TRIAL RECRUITMENT ACROSS CLINICAL SETTINGS
Peter J Embi, Assistant Professor Of Medicine
University Of Cincinnati, Sponsored Research Services, Cincinnati, Oh 45221
Grant 3R01LM009533-01A1S1 from National Library Of Medicine
Abstract: Inadequate recruitment of eligible subjects for clinical trials is a major impediment to the advancement of medicine. Use of an EHR-based, point-of-care Clinical Trial Alert (CTA) approach has been shown to significantly improve recruitment in a prior study and shows promise for wider use. However, fundamental gaps in our knowledge regarding determinants of EHR-based, point-of-care trial recruitment and the applicability of the CTA approach in different clinical settings must be addressed before potential benefits can be realized. Our long-term goal is to improve clinical research by leveraging health information technology. The objective of this particular application is to evaluate the CTA approach´s effect on physicians´ rates of subject recruitment across different clinical settings and determine the factors that effect this point-of-care recruitment in HER-equipped environments. Our central hypothesis is that by addressing the factors that influence trial recruitment participation, an EHR-based, point-of-care CTA approach will prove broadly efficacious. Guided by our strong preliminary data, we will test our hypotheses by pursuing two specific aims (1) Determine the impacts on trial recruitment of an EHR-based CTA approach in different clinical settings within and across healthcare systems; (2) Identify the range of stakeholders´ perceived barriers, facilitators, and information needs regarding HER-based, point-of-care recruitment in different clinical settings to inform improvements in the CTA approach. Under the first aim, we will perform a series of randomized cross-over designed interventions to evaluate CTA´s impact on recruitment among primary care and subspecialist physicians across three healthcare systems. Under the second aim, we will conduct interviews and surveys of stakeholders including clinicians, patients and researchers involved in the CTA-driven process to ascertain their perceived barriers, facilitators, and information needs regarding point-of-care recruitment. Finally, we will analyze the findings from both aims to produce a summary report that will inform modifications to the CTA approach and next steps in this line of inquiry. This approach is innovative in that it will apply complementary methodological approaches to answer important questions regarding the utility of clinical trial recruitment using a promising EHR-based approach in a range of healthcare settings and the factors that influence its impact. The proposed research is significant because it is expected to advance our knowledge regarding EHR-facilitated trial recruitment at the point-of care
Keywords: Accounting; Address; Affect; Care, Health; Clinical; Clinical Research; Clinical Study; Clinical Trials; Clinical Trials, Unspecified; Communities; Crossover Design; Data; Designs, Cross-Over; Effectiveness; Electronic Health Record; Engineering; Engineerings; Enrollment; Environment; Evaluation; Funding Agency; Funding Source; General Practitioners; Generalists; Goals; Group Interviews; Health; Health Information System; Health system; Healthcare; Healthcare Systems; Human; Human, General; Individual; Informatics; Intervention; Intervention Strategies; Intervention Studies; Interview; Interviews, Group; Investigators; Knowledge; Lead; Man (Taxonomy); Man, Modern; Medical; Medical Specialities; Medicine; Mission; Modeling; Modification; Patients; Pb element; Physicians; Population; Primary Care; Primary Health Care; Primary Healthcare; Process; Qualitative Methods; Randomized; Recruitment Activity; Relative; Relative (related person); Research; Research Personnel; Researchers; Science; Science of Medicine; Series; Solutions; Specialist; Specialties, Medical; Specialty; Study Subject; Summary Reports; Survey Instrument; Surveys; Systems, Health Care; Testing; Universities; Work; base; biomed informatics; biomedical informatics; clinical investigation; enroll; health information technology; heavy metal Pb; heavy metal lead; improved; innovate; innovation; innovative; interventional strategy; knowledge base; medical specialties; point of care; preference; randomisation; randomization; randomly assigned; recruit; success
Project start date: 2009-09-30
Project end date: 2011-09-29
Budget start date: 30-SEP-2009
Budget end date: 29-SEP-2011
PFA/PA: PA-07-070
3R01LM009533-01A1S1 (2009): $137209
Peter J Embi
Ohio State University
Project start date: 2010-09-30
Project end date: 2011-09-29
Grants awarded to Peter J Embi
EVALUATING EHR-BASED, POINT-OF-CARE TRIAL RECRUITMENT ACROSS CLINICAL SETTINGS
Peter J Embi
University Of Cincinnati, Sponsored Research Services, Cincinnati, Oh 45221
Grant 5R01LM009533-03 from National Library Of Medicine
Abstract: Inadequate recruitment of eligible subjects for clinical trials is a major impediment to the advancement of medicine. Use of an EHR-based, point-of-care Clinical Trial Alert (CTA) approach has been shown to significantly improve recruitment in a prior study and shows promise for wider use. However, fundamental gaps in our knowledge regarding determinants of EHR-based, point-of-care trial recruitment and the applicability of the CTA approach in different clinical settings must be addressed before potential benefits can be realized. Our long-term goal is to improve clinical research by leveraging health information technology. The objective of this particular application is to evaluate the CTA approach´s effect on physicians´ rates of subject recruitment across different clinical settings and determine the factors that effect this point-of-care recruitment in HER-equipped environments. Our central hypothesis is that by addressing the factors that influence trial recruitment participation, an EHR-based, point-of-care CTA approach will prove broadly efficacious. Guided by our strong preliminary data, we will test our hypotheses by pursuing two specific aims (1) Determine the impacts on trial recruitment of an EHR-based CTA approach in different clinical settings within and across healthcare systems; (2) Identify the range of stakeholders´ perceived barriers, facilitators, and information needs regarding HER-based, point-of-care recruitment in different clinical settings to inform improvements in the CTA approach. Under the first aim, we will perform a series of randomized cross-over designed interventions to evaluate CTA´s impact on recruitment among primary care and subspecialist physicians across three healthcare systems. Under the second aim, we will conduct interviews and surveys of stakeholders including clinicians, patients and researchers involved in the CTA-driven process to ascertain their perceived barriers, facilitators, and information needs regarding point-of-care recruitment. Finally, we will analyze the findings from both aims to produce a summary report that will inform modifications to the CTA approach and next steps in this line of inquiry. This approach is innovative in that it will apply complementary methodological approaches to answer important questions regarding the utility of clinical trial recruitment using a promising EHR-based approach in a range of healthcare settings and the factors that influence its impact. The proposed research is significant because it is expected to advance our knowledge regarding EHR-facilitated trial recruitment at the point-of care
Keywords: Accounting; Address; Affect; Care, Health; Clinical; Clinical Research; Clinical Study; Clinical Trials; Clinical Trials, Unspecified; Communities; Crossover Design; Data; Designs, Cross-Over; Effectiveness; Electronic Health Record; Engineering; Engineerings; Enrollment; Environment; Evaluation; Funding Agency; Funding Source; General Practitioners; Generalists; Goals; Group Interviews; Health; Health Information System; Health system; Healthcare; Healthcare Systems; Human; Human, General; Individual; Informatics; Intervention; Intervention Strategies; Intervention Studies; Interview; Investigators; Knowledge; Lead; Man (Taxonomy); Man, Modern; Medical; Medical Specialities; Medicine; Mission; Modeling; Modification; Patients; Pb element; Physicians; Population; Primary Care; Primary Health Care; Primary Healthcare; Process; Qualitative Methods; Randomized; Recruitment Activity; Relative; Relative (related person); Research; Research Personnel; Researchers; Science; Science of Medicine; Series; Solutions; Specialist; Specialties, Medical; Specialty; Study Subject; Summary Reports; Survey Instrument; Surveys; Systems, Health Care; Testing; Universities; Work; base; biomed informatics; biomedical informatics; clinical investigation; enroll; health information technology; heavy metal Pb; heavy metal lead; improved; innovate; innovation; innovative; interventional strategy; knowledge base; medical specialties; point of care; preference; randomisation; randomization; randomly assigned; recruit; success
Project start date: 2008-09-30
Project end date: 2011-09-29
Budget start date: 30-SEP-2010
Budget end date: 29-SEP-2011
PFA/PA: PA-07-070
5R01LM009533-03 (2010): $271974
5R01LM009533-02 (2009): $274625
1R01LM009533-01A1 (2008): $274532
Evaluation Of An EHR-based Clinical Trial Alert System
Peter J Embi, Assistant Processor Of Medicine
Internal Medicineuniversity Of Cincinnati
sponsored Research Services
cincinnati, Oh 45221
Grant 5K22LM008534-03 from National Library Of Medicine IRG: BLR
Abstract: Conducting clinical research is critical to mission of academic health centers and to the progress of medical science. Referral of eligible patients for clinical trials represents the major bottleneck to the successful conduct of such studies with only a small fraction of potentially eligible subjects being referred for possible inclusion in the trials. Physician are essential to the successful recruitment of subjects for many clinical trials, but the pace of current clinical practice makes the identification and referral of eligible patients difficult. New methods of identifying and facilitating physician referral of eligible patients for ongoing clinical trials are sorely needed. In the first phase of our study, we propose to deploy an EHR-based clinical trial alert (CTA) system into the process of clinical care with the aim of enhancing referral of patients to an ongoing clinical trial. We will assess (1) Improvements in physician identification of potentially eligible patients for an ongoing clinical trial in the course of regular clinical practice; (2) Referral and enrollment rates to a clinical trial. Following this, we will apply quantitative and qualitative methods to identify the perceived positive and negative aspects of the approach, identify success factors, and discover areas for improvement. Based on our findings, we will then enhance our CTA approach and deploy it more widely while also applying more rigorous methods for evaluating its effectiveness througout our institution and others. In addition, we will apply qualitative and quantitative methods to elucidate success factors for the use of this technology. The second aim of this application is to provide support for the candidate´s career development. By engaging in the research outlined above, advanced training and coursework beyond the candidate´s Masters level education, participating in national and regional Informatics conferences, and working closely with local and national mentors, the candidate will emerge well prepared for an independent research career
Keywords: automated medical record system, clinical trial, health care referral /consultation, physician, technology /technique development biomedical registry /referral center, health care facility information system, informatics clinical research, human subject
Project start date: 2004-09-30
Project end date: 2008-09-29
5K22LM008534-03 (2006): $135000
5K22LM008534-02 (2005): $135000
1K22LM008534-01 (2004): $135000
Peter J Embi
Ohio State University
Project start date: 2008-09-30
Project end date: 2011-12-31