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How do clinical research coordinators learn Good Clinical Practice? A mixed-methods study of factors that predict uptake of knowledge.

ABSTRACT: BACKGROUND:Good Clinical Practice is an international standard for the design and conduct of clinical trials to ensure ethical and scientific integrity. Recent National Institutes of Health policy mandates Good Clinical Practice training for all investigators and staff involved in National Institutes of Health-funded clinical trials, yet approaches to Good Clinical Practice training vary widely. There are limited data on Good Clinical Practice knowledge among the clinical trial workforce and no evidence regarding effective methods to learn Good Clinical Practice. METHODS:We used an exploratory sequential mixed-methods design. We conducted 18 exploratory qualitative interviews with clinical research coordinators to help inform the development of the quantitative survey. We then administered a validated 32-item, multiple-choice test of Good Clinical Practice knowledge with a survey of work and training experiences to 625 clinical research coordinators at three academic medical centers in the United States. Variables that were significantly associated with Good Clinical Practice knowledge were entered into a multiple regression analysis to identify unique predictors of Good Clinical Practice knowledge. We controlled for verbal-numerical reasoning and learning orientation. RESULTS:During qualitative interviews, clinical research coordinators reported that formal Good Clinical Practice training had value but they simultaneously emphasized the importance of experience, day-to-day practice, and observing colleagues and mentors as essential to supplement formal training. In our quantitative survey, five variables predicted a total of 22% of variance in Good Clinical Practice knowledge scores: years of experience as a clinical research coordinator, working on diverse types of trials, supporting industry-funded trials, being certified in clinical research coordination, and aggregated hours of online and face-to-face training (in that order). CONCLUSION:The duration and richness of experience as a clinical research coordinator were the strongest predictors of Good Clinical Practice knowledge, a finding consistent with our exploratory qualitative interview results. Our findings suggest that formal online and face-to-face training has a minimal influence on Good Clinical Practice knowledge. The type of training-whether online or face to face-does not make a significant difference in Good Clinical Practice knowledge scores. Much of the variance in Good Clinical Practice knowledge remains unexplained, calling for further research in this area.

SUBMITTER: Mozersky JT

PROVIDER: S-EPMC7211112 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundWhile patient and public involvement (PPI) in clinical trials is beneficial and mandated by some funders, formal guidance on how to implement PPI is limited and challenges have been reported. We aimed to investigate how PPI is approached within a UK Clinical Trials Unit (CTU)'s portfolio of randomised controlled trials, perceived barriers to/facilitators of its successful implementation, and perspectives on the CTU's role in PPI.MethodsA mixed-methods study design, involving (1) an online survey of 26 trial managers (TMs) and (2) Interviews with Trial Management Group members and public contributors from 8 case-study trials. Quantitative survey data were summarised using descriptive statistics and interview transcripts analysed thematically. Two public contributors advised throughout and are co-authors.Results(1) 21 TMs completed the survey; (2) 19 in-depth interviews were conducted with public contributors (n=8), TMs (n=5), chief investigators (n=3), PPI coordinators (n=2) and a researcher. 15/21 TMs surveyed reported that a public contributor was on the trial team, and 5 used another PPI method. 12/21 TMs reported that public contributors were paid (range £10-50/h). 5 TMs reported that training was provided for public contributors and few staff members had received any formal PPI training. The most commonly reported tasks undertaken by public contributors were the review of participant-facing materials/study documents and advising on recruitment/retention strategies. Public contributors wanted and valued feedback on changes made due to their input, but it was not always provided. Barriers to successful PPI included recruitment challenges, group dynamics, maintaining professional boundaries, negative attitudes to PPI amongst some researchers, a lack of continuity of trial staff, and the academic environment. Successful PPI required early and explicit planning, sharing of power and ownership of the trial with public contributors, building and maintaining relationships, and joint understanding and clarity about expectations/roles. CTUs have an important role to play in supporting recruitment, signposting and coordinating PPI.ConclusionsWhile highly valuable, PPI in trials is currently variable. PPI representatives are recruited informally, may not be provided with any training and are paid inconsistently across trials. Study findings can help optimise PPI in trials and ensure researchers and public contributors are adequately supported.

Project description:BackgroundVirtual communities of practice (VCoPs) have been used to support innovation and quality in clinical care. The drug mifepristone was introduced in Canada in 2017 for medical abortion. We created a VCoP to support implementation of mifepristone abortion practice across Canada.ObjectiveThe aim of this study was to describe the development and use of the Canadian Abortion Providers Support-Communauté de pratique canadienne sur l'avortement (CAPS-CPCA) VCoP and explore physicians' experience with CAPS-CPCA and their views on its value in supporting implementation.MethodsThis was a mixed methods intrinsic case study of Canadian health care providers' use and physicians' perceptions of the CAPS-CPCA VCoP during the first 2 years of a novel practice. We sampled both physicians who joined the CAPS-CPCA VCoP and those who were interested in providing the novel practice but did not join the VCoP. We designed the VCoP features to address known and discovered barriers to implementation of medication abortion in primary care. Our secure web-based platform allowed asynchronous access to information, practice resources, clinical support, discussion forums, and email notices. We collected data from the platform and through surveys of physician members as well as interviews with physician members and nonmembers. We analyzed descriptive statistics for website metrics, physicians' characteristics and practices, and their use of the VCoP. We used qualitative methods to explore the physicians' experiences and perceptions of the VCoP.ResultsFrom January 1, 2017, to June 30, 2019, a total of 430 physicians representing all provinces and territories in Canada joined the VCoP and 222 (51.6%) completed a baseline survey. Of these 222 respondents, 156 (70.3%) were family physicians, 170 (80.2%) were women, and 78 (35.1%) had no prior abortion experience. In a survey conducted 12 months after baseline, 77.9% (120/154) of the respondents stated that they had provided mifepristone abortion and 33.9% (43/127) said the VCoP had been important or very important. Logging in to the site was burdensome for some, but members valued downloadable resources such as patient information sheets, consent forms, and clinical checklists. They found email announcements helpful for keeping up to date with changing regulations. Few asked clinical questions to the VCoP experts, but physicians felt that this feature was important for isolated or rural providers. Information collected through member polls about health system barriers to implementation was used in the project's knowledge translation activities with policy makers to mitigate these barriers.ConclusionsA VCoP developed to address known and discovered barriers to uptake of a novel medication abortion method engaged physicians from across Canada and supported some, including those with no prior abortion experience, to implement this practice.International registered report identifier (irrid)RR2-10.1136/bmjopen-2018-028443.

Project description:AimTo achieve profession-wide consensus on clinical practice standards for six broad Australian nurse practitioner specialty areas (termed metaspecialties).DesignSequential mixed methods with initial interpretive study (Interpretive Phase) followed by modified three-round Delphi study (Survey Phase).MethodsParticipants from all Australian jurisdictions were recruited. Main eligibility criterion was current endorsement as a nurse practitioner for 12 or more months. Interpretive Phase comprised in-depth interviews of purposeful sample of nurse practitioners to identify clinical care activities and practice processes. Six sets of draft clinical practice standards relevant to six previously identified metaspecialties were developed. Outcome informed Round 1 of Survey Phase (six nested web-based Delphi surveys), with draft standards reviewed profession-wide. Responses comprised scoring using Likert scales to calculate content validity indexes for individual standards with qualitative responses supporting decision-making. For Rounds 2 and 3, participants rated relevancy of original or revised standards after consideration of individual and group feedback. The study was conducted 2014-2017.ResultsInterpretive Phase: Analysis of interview data with 16 nurse practitioners provided 75 draft standards. Survey Phase: 221 nurse practitioners completed Round 1 (20% of then eligible Australian nurse practitioners). Weighted respondent retention was 92%. Seventy-three standards were validated, with final content validity indices of 92-100%. Scale-level indices were 98%, strongly validating metaspecialty taxonomy.ConclusionA research-derived, professionally endorsed suite of nurse practitioner clinical practice standards was developed. This provides a broad clinical learning structure with metaspecialties guiding nurse practitioner student clinical education.ImpactThe clinical practice standards and metaspecialty taxonomy strengthen nurse practitioner clinical education and professional development nationally and internationally. These novel study methods and findings are applicable to advanced specialty roles in other health professions.

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How do clinical research coordinators learn Good Clinical Practice? A mixed-methods study of factors that predict uptake of knowledge.

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