- Development, Implementation and Assessment of Novel Training in Domain-Based Competencies
- Investigating Teleconsent to Improve Clinical Research Access in Remote Communities
- Measure Development to Accelerate the Translation of Evidence Based Clinical Guidelines into Practice
- Modulation of Gut-Brain Axis Using Fecal Microbiome Transplant Capsules in Cirrhosis
- Open Health Natural Language Processing Collaboratory
- Translating Research Into Practice: A Regional Collaborative to Reduce Disparities in Breast Cancer Care
University of Michigan
Principal Investigators: Vicki L. Ellingrod, Pharm.D., Carolynn Thomas Jones, D.N.P., M.S.P.H., RN, Sarah E. Peyre, Ed.D., and Harry P. Selker, M.D., M.S.P.H.
Grant Number: 1-U01TR002013-01
Collaborating Institutions: Tufts University, University of Rochester, Ohio State University
Critical impediments currently exist regarding how clinical trials are conducted, which include inconsistent (or absent) training as well as passive learning techniques used for developing the clinical research workforce. There exists a critical need to develop, demonstrate and publicly disseminate competency-based training for clinical research personnel involved in executing clinical trials throughout the CTSA Program consortium. This proposal, entitled “Development, Implementation and Assessment of Novel Training in Domain-Based Competencies (DIAMOND),” will develop an online educational portal (DIAMOND portal) for competency-based educational offerings and assessments and demonstrate integration of this curriculum into CTSA Program clinical trial education programs at DIAMOND hubs and partner sites in ways that promote more effective, efficient and safe execution of clinical trials, allowing for dissemination to a broader audience.
Medical University of South Carolina
Principal Investigator: Jihad Obeid, M.D.
Grant Number: 1-R21TR002088-01
Collaborating Institution: University of North Carolina at Chapel Hill
Recruitment and enrollment of eligible research participants into clinical trials is a major challenge in most clinical settings, including informed consent at remote sites. Studies often fail to meet enrollment goals, resulting in costly time extensions, underpowered results and, in some cases, early termination. Informed consent is an essential process involving trained research personnel meeting face-to-face with participants, which can be especially challenging during busy clinic schedules or recruitment at remote locations. An innovative informed consent approach that leverages telemedicine technology (teleconsent) was developed at the Medical University of South Carolina (MUSC). Teleconsent enables research personnel to: 1) meet and discuss the study with a prospective participant virtually using a video feed; 2) share an informed consent document that can be collaboratively filled out by the participant and personnel in real time; and 3) generate an electronically signed informed consent that is available for immediate download or print by both parties. The objective of this proposal is to evaluate teleconsent in real-world environments across two institutions, MUSC and the University of North Carolina at Chapel Hill. This includes the examination of ethical and privacy concerns by stakeholders and the community and identification of barriers to adoption.
Measure Development to Accelerate the Translation of Evidence-Based Clinical Guidelines into Practice
New York University School of Medicine
Principal Investigators: Donna R. Shelley, M.D., M.P.H., and Carolyn A. Berry, Ph.D.
Grant Number: 1-U01TR002008-01
Collaborating Institutions: Albert Einstein College of Medicine, Oregon Health & Science University, Medical University of South Carolina
Half of the U.S. adult population has one or more preventable risk factors for cardiovascular disease (CVD), including high blood pressure and high cholesterol, but only 10 percent of individuals are meeting all of their clinical goals due to suboptimal adoption of guideline-recommended care. This is largely because primary care practices and health care systems are struggling to identify which combination of care structures and processes they need to implement to become high-performing practices. The objective of this proposal is address this translational gap by developing a reliable, valid and pragmatic assessment tool that will identify core features of primary care practices that are related to high performance on CVD-related outcomes.
Virginia Commonwealth University
Principal Investigator: Jasmohan S. Bajaj, M.D.
Grant Number: 1-R21TR002024-01
Collaborating Institution: Medical College of Wisconsin
Cirrhosis and its complication, hepatic encephalopathy (HE), are one of the leading causes of morbidity and mortality in the U.S. HE is associated with gut dysbiosis that is usually treated with antibiotics, prebiotics or probiotics. However, HE often continues to recur and cause readmissions despite this standard of care. Multiple episodes of HE can result in cumulative irreversible brain injury. Therefore, the prevention of recurrent HE is an important unmet need that requires translational intervention. Ultimately the goal of this project is to define oral fecal microbiota transplant as a viable treatment approach for recurrent HE patients. Thw hypothesis is that fecal transplants from a rationally derived donor delivered via capsules are safe and well tolerated in patients with cirrhosis and HE and are associated with significant improvement in gut microbiota composition and mucosal defenses.
Mayo Clinic Rochester
Principal Investigators: Hongfang Liu, Ph.D., Xiaqian Jiang, Ph.D., and Serguei V.S. Pakhomov, Ph.D.
Grant Number: 1-U01TR002062-01
Collaborating Institutions: Columbia University Health Sciences, University of California, San Diego, University of Minnesota, University of Texas
One of the major barriers in leveraging electronic health record (EHR) data for clinical and translational science is the prevalent use of unstructured or semistructured clinical narratives for documenting clinical information. Natural language processing (NLP), which extracts structured information from narratives, has received great attention and has played a critical role in enabling secondary use of EHRs for clinical and translational research. This project aims to address the challenges of using EHRs by extending the existing collaboration among multiple CTSA Program hubs on open health natural language processing to share distributional information of NLP artifacts (i.e., words, n-grams, phrases, sentences, concept mentions, concepts and text segments) acquired from real EHRs across multiple institutions.
Translating Research into Practice: A Regional Collaborative to Reduce Disparities in Breast Cancer Care
Boston Medical Center*
Principal Investigators: Tracy A. Battaglia, M.D., Karen Freund, M.D., M.P.H., Jennifer S. Haas, M.D., M.S.P.H., and Stephanie C. Lemon, Ph.D.
Grant Number: 1-U01TR002070-01
Collaborating Institutions: Tufts University, University of Massachusetts, Harvard Medical School, University of Chicago.
The transfer and application of scientific evidence into everyday practice is necessary to mitigate health disparities, yet roadblocks persist in broad implementation of evidence-based interventions among vulnerable communities experiencing disparities. The Boston Breast Cancer Equity Coalition was formed in 2014 in response to persistent city-wide disparities in breast cancer mortality among minority, low-income women. The Coalition identified three evidence-based strategies known to reduce delays in care that have yet to be deployed into clinical practice due to a lack of implementation strategies. Translating Research into Practice (TRIP) draws upon the principles of community-engaged dissemination and implementation science to systematically facilitate deployment and use of regional patient registries, systematic screening for social barriers to care with a personalized referral plan, and patient navigation services in one integrated model of care to improve the quality and effectiveness of care delivery, in this case for minority and/or low-income women with breast cancer. The four Massachusetts CTSA Program hubs (Boston University, Harvard University, Tufts University and University of Massachusetts) partnered with the Coalition to overcome barriers to widespread implementation and dissemination of evidence-based practices that will improve the delivery of guideline-concordant care to vulnerable women. The main hypothesis of this project is that widespread implementation will eliminate care delivery disparities, and CTSA Program hubs have the translational expertise to overcome barriers to such implementation.
*Note: This U01 was co-funded by NCATS and the NIH Office of Behavioral and Social Sciences Research.