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

ABSTRACT: Clinical research coordinators are increasingly tasked with a multitude of complex study activities critical to scientific rigor and participant safety, though more than half report not receiving appropriate training. To determine the reproducibility of an established clinical research workforce orientation program, collaborative partners across Clinical and Translational Science Award institutions seeded core principles and structure from Mayo Clinic's Clinical Research Orientation program within Penn State University and the University of Mississippi Medical Center from 2019 to 2021. Training concepts were established and tied to those domains deemed critical by the Joint Task Force for Clinical Trial Competency for the conduct of clinical research at the highest levels of safety and quality possible. Significant knowledge and confidence gains and high overall program satisfaction were reported across participants and partner sites, despite programs being required to pivot from traditional, in-person formats to entirely virtual platforms as a result of the COVID-19 pandemic. The successful standardization and translation of foundational clinical research training has important efficiency and efficacy implications for research enterprises across the USA.

SUBMITTER: Musshafen LA

PROVIDER: S-EPMC8601790 | biostudies-literature | 2021

REPOSITORIES: biostudies-literature

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

Musshafen Leslie A LA Poger Jennifer M JM Simmons William R WR Hoke Alicia M AM Hanson Laura N LN Bondurant Whitney W WW McCullough Jody R JR Kraschnewski Jennifer L JL

Journal of clinical and translational science 20210913 1

Clinical research coordinators are increasingly tasked with a multitude of complex study activities critical to scientific rigor and participant safety, though more than half report not receiving appropriate training. To determine the reproducibility of an established clinical research workforce orientation program, collaborative partners across Clinical and Translational Science Award institutions seeded core principles and structure from Mayo Clinic's Clinical Research Orientation program with ...[more]

PMID: 34858640

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Project description:IntroductionThe effectiveness of mailed fecal immunochemical test outreach might be enhanced through an organized colorectal cancer screening program, yet published real-world experiences are limited. We synthesized the process of implementing a colorectal cancer screening program that used mailed fecal immunochemical test outreach in a large integrated academic-community practice.MethodsData from a pilot mailed fecal immunochemical test program were shared with healthcare system leadership, which inspired the creation of a cross-institutional organized colorectal cancer screening program. In partnership with a centralized population health team and primary care, we defined (1) the institutional approach to colorectal cancer screening, (2) the target population and method for screening, (3) the team responsible for implementation, (4) the healthcare team responsible for decisions and care, (5) a quality assurance structure, and (6) a method for identifying cancer occurrence.ResultsThe Fred Hutch/UW Medicine Population Health Colorectal Cancer Screening Program began in September 2021. The workflow for mailed fecal immunochemical test outreach included a mailed postcard, a MyChart message from the patient's primary care provider, a fecal immunochemical test kit with a letter signed by the primary care provider and program director, and up to 3 biweekly reminders. Patients without a colonoscopy 3 months after an abnormal fecal immunochemical test result received navigation through the program. In the first program year, we identified 9,719 patients eligible for outreach, and in an intention-to-treat analysis, 32% of patients completed colorectal cancer screening by fecal immunochemical test or colonoscopy.ConclusionsReal-world experiences detailing how to implement organized colorectal cancer screening programs might increase adoption. In our experience, broadly disseminating pilot data, early institutional support, robust data management, and strong cross-departmental relationships were critical to successfully implementing a colorectal cancer screening program that benefits all patients.

Project description:Community engagement and rigorous science are necessary to address health issues. Increasingly, community health organizations are asked to partner in research. To strengthen such community organization-academic partnerships, increase research capacity in community organizations, and facilitate equitable partnered research, the Partners in Education Evaluation and Research (PEER) program was developed. The program implements an 18-month structured research curriculum for one mid-level employee of a health-focused community-based organization with an organizational mentor and a Case Western Reserve University faculty member as partners.The PEER program was developed and guided by a community-academic advisory committee and was designed to impact the research capacity of organizations through didactic modules and partnered research in the experiential phase. Active participation of community organizations and faculty during all phases of the program provided for bidirectional learning and understanding of the challenges of community-engaged health research. The pilot program evaluation used qualitative and quantitative data collection techniques, including experiences of the participants assessed through surveys, formal group and individual interviews, phone calls, and discussions. Statistical analysis of the change in fellows' pre-test and post-test survey scores were conducted using paired sample t tests. The small sample size is recognized by the authors as a limitation of the evaluation methods and would potentially be resolved by including more cohort data as the program progresses. Qualitative data were reviewed by two program staff using content and narrative analysis to identify themes, describe and assess group phenomena and determine program improvements.The objective of PEER is to create equitable partnerships between community organizations and academic partners to further research capacity in said organizations and develop mutually beneficial research partnerships between academia and community organizations.PEER demonstrates a commitment to successfully developing sustainable research capacity growth in community organizations, and improved partnered research with academic institutions.

Project description:BackgroundDuring the Coronavirus disease (COVID-19) pandemic, countries implemented border control and quarantine measures to reduce transmission. The Alberta Border Testing Pilot Program (ABTPP) allowed international travellers entering Alberta to reduce their quarantine period following two negative COVID-19 tests. We evaluated participant experiences with the ABTPP and implementation.MethodWe used a parallel convergent mixed-methods design to explore participant experiences through electronic web-based questionnaires (n = 21,089; n = 13,839) and semi-structured telephone interviews (n = 30). We evaluated implementation through three staff focus groups (n = 11). We analysed questionnaires using descriptive statistics and analysed interviews using inductive and deductive thematic analysis. We deductively coded focus group data using the 2009 Consolidated Framework for Implementation Research (CFIR).ResultsQuestionnaires indicated minimal issues with registration forms (91.7%), symptom reports (95.5%), and COVID-19 testing (95.7%). Most respondents (95.1%) expressed willingness to participate in the ABTPP again. Interviews revealed three themes related to participant experience: program efficiency, clarity of information, and requisite effort. Focus groups identified key implementation facilitators including the single health information system, strong stakeholder partnerships, and good communication across partnerships. Barriers included program complexity, implementation timeline, and evolving external context.DiscussionParticipants reported high satisfaction with the ABTPP. Border testing programs should have high efficiency, require low effort, and use messaging that is clear and consistent. The effective implementation of border testing programs may be facilitated by strong leadership, adaptability, automated components, good communication, and simple technology. Learnings from participants and staff may help improve the implementation of border control programs for future pandemics or other emergencies.ConclusionsThe ABTTP was a novel border control measure during the COVID-19 pandemic. Our evaluation of both participant and staff experiences demonstrated high levels of traveller satisfaction and identified areas for improvement that can inform the development of future border control measures.

Project description:BackgroundScholarly Concentrations programs in U.S. medical schools aim to instill passion for critical thinking and promote careers in academic medicine. The rise of these programs has seen variable goals, structure, and outcomes. Transformation of these programs internationally is in its infancy.MethodsWe describe implementation of the Johns Hopkins School of Medicine Scholarly Concentrations program, offering Basic Science, Clinical Science, Medical Ethics/Healing Arts, History of Medicine, and Public Health/Community Service, at Bezmiâlem Vakif University in Istanbul, Turkey. Over six modules in the preclinical years, students develop a faculty-mentored experience which encourages the acquisition of attitudes and skills for self-directed, lifelong learning and scholarship. This culminates in abstract and project presentation. We report program characteristics (context and logistics) and outcomes (student engagement and experiences).ResultsThe Scholarly Concentrations program at Bezmiâlem began in 2014, with nearly two completed cohorts of students. In comparison to Johns Hopkins, students at Bezmiâlem begin at an earlier age (thus do not have as much prior research experience) and are subsequently evaluated for residency in terms of test scores rather than scholarship and publications, but have a similar level of intellectual curiosity and desire to take ownership of their project. Eighty-two percent of Bezmiâlem students stated the project they pursued was either their own idea or was an idea they formed after meeting with their mentor. Students at Bezmialem were more likely to choose Clinical Science projects (p = 0.009). Only 5% of Bezmiâlem students in end-of-course survey felt dissatisfied with the level of ownership they experienced with their project, a frequency similar to that seen by Johns Hopkins students (2%).ConclusionsScholarly Concentrations programs play an important role in U.S. medical schools, and these programs can be successfully implemented internationally. The Scholarly Concentrations program at Johns Hopkins has been transformed to a program at Bezmiâlem in Istanbul, the first program outside North America or the European Union. When designing these programs, one must consider the context, logistics, student engagement, and outcomes. While long-term outcomes are needed, this can serve as a model for implementation elsewhere.

Dataset Information

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

Publications

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

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