Journal of Clinical and Translational Science - Latest issue

Nurses are critical to the research enterprise. However all nurses are not prepared to participate as members of the research team since education and training in clinical research nursing and nurse-specific Good Clinical Practice are not consistently included in nursing curricula. The lack of nurse education and training in clinical research and Good Clinical Practice leaves research participants vulnerable with a nursing workforce that is not prepared to balance fidelity to protocol and patient quality care and safety.

A collaborative network of nurses within Clinical and Translational Science Awards and beyond was established to address this education and training need. Over a 2-year period, using expert opinion, Delphi methods, and measures of validity and reliability the team constructed curriculum and knowledge test items.

A pilot modular electronic curriculum, including knowledge pretest and post-tests, in clinical research nursing and nurse-specific Good Clinical Practice competencies was developed.

As the scope and setting of clinical research changes, it is likely that all practicing nurses, regardless of their practice setting or specialty, will care for patients on research protocol, making all nurses, in essence, clinical research nurses. The curriculum developed by this protocol will address that workforce education and training need.

The Institute of Medicine recommended the advance of innovation and entrepreneurship training programs within the Clinical & Translational Science Award (CTSA) program; however, there remains a gap in adoption by CTSA institutes. The University of Michigan’s Michigan Institute for Clinical & Health Research and Fast Forward Medical Innovation (FFMI) partnered to develop a pilot program designed to teach CTSA hubs how to implement innovation and entrepreneurship programs at their home institutions.

The program provided a 2-day onsite training experience combined with observation of an ongoing course focused on providing biomedical innovation, commercialization and entrepreneurial training to a medical academician audience (FFMI fastPACE).

All 9 participating CTSA institutes reported a greater connection to biomedical research commercialization resources. Six launched their own version of the FFMI fastPACE course or modified existing programs. Two reported greater collaboration with their technology transfer offices.

The FFMI fastPACE course and training program may be suitable for CTSA hubs looking to enhance innovation and entrepreneurship within their institutions and across their innovation ecosystems.

The Rockefeller Clinical Scholars (KL2) program began in 1976 and transitioned into a 3-year Master’s degree program in 2006 when Rockefeller joined the National Institute of Health Clinical and Translational Science Award program. The program consists of ∼15 trainees supported by the Clinical and Translational Science Award KL2 award and University funds. It is designed to provide an optimal environment for junior translational investigators to develop team science and leadership skills by designing and performing a human subjects protocol under the supervision of a distinguished senior investigator mentor and a team of content expert educators. This is complemented by a tutorial focused on important translational skills.

Since 2006, 40 Clinical Scholars have graduated from the programs and gone on to careers in academia (72%), government service (5%), industry (15%), and private medical practice (3%); 2 (5%) remain in training programs; 39/40 remain in translational research careers with 23 National Institute of Health awards totaling $23 million, foundation and philanthropic support of $20.3 million, and foreign government and foundation support of $6 million. They have made wide ranging scientific discoveries and have endeavored to translate those discoveries into improved human health.

The Rockefeller Clinical Scholars (KL2) program provides one model for translational science training.

This paper reports on the baseline stage of a qualitative evaluation of the application of the Innovative Scorecard (ISC) to the Clinical and Translational Science Award (CTSA) at the University of Texas Medical Branch (UTMB) at Galveston. The ISC is adopted from the established Balanced Scorecard system for strategic planning and performance management. In formulating the evaluation, we focused on the organizational identity literature.

The initial evaluation consisted of a series of semi-structured interviews with 22 participants of the ISC Boot Camp conducted in July 2015.

The logic of grounded theory pointed to the clustering of perceptions of the ISC around respondents’ occupational locations at UTMB. Administrators anticipate the expansion of planning activities to include a wider range of participants under the current CTSA award period (2015–2020) than under our first CTSA approval period (2009–2014). A common viewpoint among the senior scientists was that the scientific value of their work will continue to speak for itself without requiring the language of business. Junior scientists looked forward to the ISC’s emphasis on increasingly horizontal leadership that will give them more access to and more control over their work and resources. Postdocs and senior staff welcomed increased involvement in the total research process at UTMB.

The report concludes with strategies for future follow-up.

Clinical and Translational Science Awards (CTSAs) and Practice-Based Research Networks (PBRNs) have complementary missions. We replicated a 2008 survey of CTSA-PBRN leaders to understand how organizational relationships have evolved.

We surveyed 60 CTSA community engagement (CE) Directors and 135 PBRN Directors and analyzed data using between and within-group comparisons.

In total, 43% of CTSA CE Directors (26/60) and 42% of PBRN Directors (57/135) responded. Quantitative responses revealed growing alignment between CTSA/PBRN perceptions, with a few areas of discordance. CE Directors noted declining financial support for PBRNs. PBRN Directors identified greater CTSA effectiveness in PBRN engagement, consultation, and collaborative grant submissions. Qualitative data revealed divergent experiences across CTSA/PBRN programs.

Relationships between CTSAs and PBRNs are maturing; for some that means strengthening and for others a growing vulnerability. Findings suggest a mutual opportunity for PBRNs and CTSAs around applied research. Studies to characterize exemplar CTSA-PBRN collaborations are needed.

Community engagement (CE) has become more prevalent among academic health centers (AHCs), with significant diversity in practices and language. The array of approaches to CE contributes to confusion among practitioners.

We have reviewed multiple models of CE utilized by AHCs, Clinical and Translational Science Awards, and higher education institutions overall. Taking these models into consideration, we propose a comprehensive model of CE that encompasses a broader spectrum of activities and programs.

The CE Components Practical Model includes 5 components: Community Outreach and Service, Education, Clinical Care, Research, and Policy and Advocacy. The components are supported by the foundational elements within administrative functions and infrastructure.

This model will accomplish the following: (1) reduce confusion about CE; (2) provide a broader understanding of CE; and (3) increase the ability of CE practitioners to interact with each other through this common reference and engage in advancing CE scholarship.

In order to fully participate in informed consent, patients must understand what it is that they are agreeing, or not agreeing, to. In most cases, patients look to their clinicians to help develop the appropriate understanding required to give informed consent. Often the quality of the information available as well as the delivery methods are not optimal.

Using a visual aid as an adjunct to risk communication in a stressful setting as the Emergency Department has a clear potential in facilitating the communication process. To support more accurate and consistent presentation of risk, we formed a team with implementation scientists, patient education specialists, nurses, physicians, and professional designers to transform the information available into a 6th grade reading level visual aid tool. We applied a DMAIC (Define, Measure, Analyze, Improve and Control) process to design the tool. We measured and analyzed its effectiveness through feedback from providers, patients, and caregivers. This cycle happened 3 times until we reached the final version of the visual aid.

We utilized a DMAIC methodology as well as modified Delphi method to create and refine a visual aid tool. Several rounds of end-user feedback along with DMAIC allowed us to create a tool that was consistently better with each round of development, analysis and feedback. After arriving at the final version of the tool, we surveyed physicians in our Emergency Department. We measured the difficulty to understand the information, whether doctors think the visual aid will help patients to understand the data, and the appropriateness of the tool’s length and the amount of information in it.

We believe that our experience can be replicated by other researchers and clinicians in the endeavor of translating the evidence into clinical practice. An effort should be made to fully translate research findings until the end of the research to practice continuum in order to better translate knowledge into a useful and useable form for informed consent decisions in busy clinical practice.