scholarly journals Strengthening the clinical research workforce through a competency-based orientation program: Process outcomes and lessons learned across three academic health institutions

Author(s):  
Leslie A. Musshafen ◽  
Jennifer M. Poger ◽  
William R. Simmons ◽  
Alicia M. Hoke ◽  
Laura N. Hanson ◽  
...  
2017 ◽  
Vol 1 (1) ◽  
pp. 16-25 ◽  
Author(s):  
Nancy A. Calvin-Naylor ◽  
Carolynn Thomas Jones ◽  
Michelle M. Wartak ◽  
Karen Blackwell ◽  
Jonathan M. Davis ◽  
...  

IntroductionTraining for the clinical research workforce does not sufficiently prepare workers for today’s scientific complexity; deficiencies may be ameliorated with training. The Enhancing Clinical Research Professionals’ Training and Qualifications developed competency standards for principal investigators and clinical research coordinators.MethodsClinical and Translational Science Awards representatives refined competency statements. Working groups developed assessments, identified training, and highlighted gaps.ResultsForty-eight competency statements in 8 domains were developed.ConclusionsTraining is primarily investigator focused with few programs for clinical research coordinators. Lack of training is felt in new technologies and data management. There are no standardized assessments of competence.


2019 ◽  
Vol 3 (s1) ◽  
pp. 77-78
Author(s):  
Stephanie A. Freel ◽  
Christine Deeter ◽  
Deborah Hannah ◽  
Marissa Stroo ◽  
Rebecca Brouwer ◽  
...  

OBJECTIVES/SPECIFIC AIMS: 1.Assess changes in clinical research workforce landscape at Duke 2.Optimize and evaluate efficacy of a tier advancement process for clinical research career progression at Duke 3.Implement CRP engagement as a change management mechanism for workforce innovation METHODS/STUDY POPULATION: We evaluated 857 clinical research positions at Duke to understand changes in the workforce (demographics, numbers in each position and tier) since implementing the tier advancement process in 2016. To understand the efficacy of the tier assessment process, data from a subset of this population (n=84) who underwent the advancement process was examined for success rate. Individual employees and their managers were surveyed to understand their perception of the advancement process and identify areas for improvement. We also describe implementation of multiple mechanisms of community engagement to manage expectations around the tier advancement process and to provide opportunities for employees to self-manage their career planning, including portfolio planning and leadership opportunities. RESULTS/ANTICIPATED RESULTS: Whereas the clinical research workforce has grown by 5.5% since tiering began (2016, n=810; 2018 n=857). Nearly 13% of that growth has been in managerial or senior positions (2016, n=111; 2018 n=127). Distributions across job classifications changed only slightly, representing realignment of positions with study-level responsibilities over department-level responsibilities. Notably, clinical research nurses (CRNC & CRNC Sr.) was the only category including tiered and non-tiered positions to drop overall numbers between 2016 (n = 136) and 2018 (n=115), representing a shift in the workforce from research nurses to research coordinators. General demographics (gender, age) remained largely the same. A total of 359 positions have been hired during this time frame, nearly half of which were entry-level positions (175/359): 47 of these positions represent expansion of the workforce. Of 359 new hires since 2016, 271 currently still work in one of the research roles. Of the 84 employees who underwent the tier advancement process, 84% (43/51) succeeded in tier 2 advancement, 70% (14/20) succeeded in tier 3 advancement (CRC, CRNC, and regulatory coordinators), and 77% (10/13) of research program leaders (RPLs) succeeded in achieving tier two, which is the highest tier for this group. Fifty-five employees (65%) and 32 managers responded to a voluntary feedback survey. Overall confidence in the process improved in both groups from 2016 to 2018, most notably with managers. Both groups indicated a 10 hour reduction (employees = 35hr, 2016 and 25hr 2018; managers 25hr, 2016 and 15hr 2018) in time required to complete the tier advancement process. DISCUSSION/SIGNIFICANCE OF IMPACT: The use of objectively-assessed competencies is an important step in the development of a workforce. By 1) maintaining alignment with industry standards for competencies, 2) upholding high standards, and 3) offering a consistent approach to career growth, Duke is working to develop and maintain a workforce that supports high quality research. Since the implementation of standardized job classifications and competency-based tier advancement, the positions have undergone rigorous competency-based needs evaluation. This leads to better matched jobs to study needs as well as increased standardization across the clinical research workforce. We believe that the subtle workforce shifts represent alignment of our positions with the business needs of our clinical research enterprise. Additionally, approximately 15% of our clinical research workforce has taken advantage of the opportunity to advance their own careers. We have made significant improvements in the following tier advancement processes: standardization of assessments, scoring guides, and modes; changes from LMS to a REDCap delivery of the knowledge assessments; streamlined the utilization of electronic documentation; and additional guidance for employees and managers regarding portfolio inclusions. These improvements have increased satisfaction and acceptance with the advancement process and were made possible through strategic communication across the workforce. Regular town hall meetings and focus group feedback sessions have included the clinical research community in discussions of WE-R initiatives and provided a much-needed feedback loop for process improvement and change management. Moreover, inclusion of WE-R discussion in our Research Professional Network events has provided opportunities to discuss career advancement strategies as well as volunteer opportunities to grow and demonstrate leadership competencies.


1980 ◽  
Vol 5 (3) ◽  
pp. 16-20 ◽  
Author(s):  
Dorothy J. del Bueno ◽  
Frances Barker ◽  
Carol Christmyer

2018 ◽  
Vol 27 (01) ◽  
pp. 177-183 ◽  
Author(s):  
Christel Daniel ◽  
Dipak Kalra ◽  

Objectives: To summarize key contributions to current research in the field of Clinical Research Informatics (CRI) and to select best papers published in 2017. Method: A bibliographic search using a combination of MeSH descriptors and free terms on CRI was performed using PubMed, followed by a double-blind review in order to select a list of candidate best papers to be then peer-reviewed by external reviewers. A consensus meeting between the two section editors and the editorial team was organized to finally conclude on the selection of best papers. Results: Among the 741 returned papers published in 2017 in the various areas of CRI, the full review process selected five best papers. The first best paper reports on the implementation of consent management considering patient preferences for the use of de-identified data of electronic health records for research. The second best paper describes an approach using natural language processing to extract symptoms of severe mental illness from clinical text. The authors of the third best paper describe the challenges and lessons learned when leveraging the EHR4CR platform to support patient inclusion in academic studies in the context of an important collaboration between private industry and public health institutions. The fourth best paper describes a method and an interactive tool for case-crossover analyses of electronic medical records for patient safety. The last best paper proposes a new method for bias reduction in association studies using electronic health records data. Conclusions: Research in the CRI field continues to accelerate and to mature, leading to tools and platforms deployed at national or international scales with encouraging results. Beyond securing these new platforms for exploiting large-scale health data, another major challenge is the limitation of biases related to the use of “real-world” data. Controlling these biases is a prerequisite for the development of learning health systems.


2018 ◽  
Vol 27 (5-6) ◽  
pp. e787-e797 ◽  
Author(s):  
Fabio Zucchelli ◽  
Nichola Rumsey ◽  
Kerry Humphries ◽  
Rhiannon Bennett ◽  
Amy Davies ◽  
...  

2019 ◽  
Vol 25 (4) ◽  
pp. 707-737
Author(s):  
Victor Cattani Rentes ◽  
Silvia Inês Dallavalle de Pádua ◽  
Eduardo Barbosa Coelho ◽  
Monica Akissue de Camargo Teixeira Cintra ◽  
Gabriela Gimenez Faustino Ilana ◽  
...  

Purpose This work explores the potential benefits of aligning the strategic planning process with a BPM program in a clinical research center (CRC). The purpose of this paper is to define a process for executing strategic planning oriented towards the promotion of a BPM program. Design/methodology/approach The method applied is action research. This allowed the solution of a practical problem and at the same time the proposition of a new approach to promote BPM in alignment with strategy, which was synthesized in the model presented. Findings The analysis and structuring of the strategic planning process, with the assessment of the as-is situation, were adequate as a preparation step for the first cycle of a BPM program in the CRC. Based on lessons learned along the research project, a model was proposed for the strategic planning process oriented towards promoting BPM. Research limitations/implications The model was conceived from a single application at a CRC, through a cycle of action research. This is one of the limitations of this work. The model was not yet sufficiently tested in other contexts. This represents opportunities for future research. Practical implications The evaluation step in the action research cycle revealed that the organization in focus was satisfied with the results. New management practices in the organizations in focus were implemented as a result of this work. Originality/value Process improvement initiatives are a novelty in the CRC context, and this work may serve as a reference for CRC managers seeking to improve overall performance. The proposed model in this work indicates that a BPM program should start with strategic planning. An initial assessment of the as-is situation of the organization in focus was performed based on the analysis of the undesirable effects in the organization’s management practices, using a technique of the Theory of Constraints. The use of this technique facilitated the identification of solutions to the root causes identified in the assessment. The level of the assessment was deeper in comparison to results obtained with traditional tools used in strategic planning processes. The assessment supports the definition of actions oriented to solving the majority of the management dysfunctions of the organization in focus.


2019 ◽  
Vol 3 (s1) ◽  
pp. 74-75
Author(s):  
Karen W. McCracken ◽  
Peter Mayinger ◽  
Cynthia Morris

OBJECTIVES/SPECIFIC AIMS: The aim of this program is to provide early support to motivated medical students interested in a career as a physician-scientist in a framework of competency-based medical education. The CTSA creates an opportunity to provide clinical research education and protected time for research for medical students in clinical and translational research. METHODS/STUDY POPULATION: This physician-scientist experience offers research opportunities in a wide variety of research disciplines, focused on clinical and translational investigations. The program offers both five-month and one-year blocks of protected research time. The five-month option is integrated into the four- year medical curriculum. The one-year option requires enrollment in an established Master of Clinical Research degree. Both options provide research experience under the mentorship of a physician-scientist. The five-month option aligns with UME competencies categorized under the six ACGME Domains of Competence. The one-year option includes coursework in research design, biostatistics, research ethics, data management, scientific communication, and proposal development within the CTSA-based education program. All students in the program attend a bimonthly journal club and seminar series starting in year one and extending through the research experience. This includes discussion of the importance of mentorship, selecting a residency, scientific writing and presentation, and personal narratives of physician-scientists and their pathways to this career. All students will be followed to determine career outcome. RESULTS/ANTICIPATED RESULTS: Between 2015 and 2018, 67 students entered the program 46% selected the year out, and 56% selected the 5-month option. Students selecting this program constitute about 10% of the medical student population overall. We have had 17 graduates of the program to date. 55% of the cohort is women which parallels the OHSU medical student population. Long-term follow-up of at least 10 years will be needed to determine career outcomes. We assess student productivity by traditional measures of submitted abstracts, manuscripts, and presentations as well as longer term outcomes such as career orientation in medicine such as entry into a research-oriented residency and ultimately into an academic medicine or research. DISCUSSION/SIGNIFICANCE OF IMPACT: The OHSU physician-scientist experience successfully matches medical students with a diverse set of research mentors focused on the CTSA. Although institutional structures determine the variety of specific research opportunities, the integration of physician-scientist training into a CTSA-based training program expands the reach of training programs such as the TL1.


2017 ◽  
Vol 9 (6) ◽  
pp. 724-729 ◽  
Author(s):  
Teresa M. Chan ◽  
Jonathan Sherbino ◽  
Mathew Mercuri

ABSTRACT Background  Competency-based medical education requires frequent assessment to tailor learning experiences to the needs of trainees. In 2012, we implemented the McMaster Modular Assessment Program, which captures shift-based assessments of resident global performance. Objective  We described patterns (ie, trends and sources of variance) in aggregated workplace-based assessment data. Methods  Emergency medicine residents and faculty members from 3 Canadian university-affiliated, urban, tertiary care teaching hospitals participated in this study. During each shift, supervising physicians rated residents' performance using a behaviorally anchored scale that hinged on endorsements for progression. We used a multilevel regression model to examine the relationship between global rating scores and time, adjusting for data clustering by resident and rater. Results  We analyzed data from 23 second-year residents between July 2012 and June 2015, which yielded 1498 unique ratings (65 ± 18.5 per resident) from 82 raters. The model estimated an average score of 5.7 ± 0.6 at baseline, with an increase of 0.005 ± 0.01 for each additional assessment. There was significant variation among residents' starting score (y-intercept) and trajectory (slope). Conclusions  Our model suggests that residents begin at different points and progress at different rates. Meta-raters such as program directors and Clinical Competency Committee members should bear in mind that progression may take time and learning trajectories will be nuanced. Individuals involved in ratings should be aware of sources of noise in the system, including the raters themselves.


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