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Community Health Workers and Promotoras (CHW/Ps) are valued for their role in helping to engage community members in research. CHW/Ps have traditionally received variable training in research fundamentals, including importance and promotion of research rigor to establish consistency in the methods used over time. Research best practices training exists for research professionals, but no standard training is provided as part of the CHW/P job role. To develop this CHW/P research best practices training, our team engaged English- and Spanish-speaking CHW/Ps to watch an early version of an online module and to examine perceptions of the relevance of such a training and optimal delivery methods.
Six virtual focus group discussions were conducted (three in English and three in Spanish) across different US geographic regions with currently employed CHW/Ps.
Forty CHW/Ps participated (95% female, mean age 44 years, 58% identifying as Hispanic/Latino). Four themes emerged: relevance of training, benefits of providing a certificate of completion, flexible training delivery modalities, and peer-led training.
With participation from representatives of the intended learner group of CHW/Ps, our team found that CHW/Ps valued learning about research best practices. They perceived culturally- and linguistically appropriate health research training to be highly relevant to their role, particularly for communicating key information to community members about their participation in health research. Additionally, participants provided input on effective dissemination of the training including the benefit of having proof of course completion, involvement of peer trainers, and value of providing the option to participate in online training.
The African American population of Buffalo, New York experiences striking race-based health disparities due to adverse social determinants of health. A team of community leaders and university faculty determined that a community dialogue was needed to focus research and advocacy on the root causes of these disparities. In response, we organized the annual Igniting Hope conference series that has become the premier conference on health disparities in the region. The series, now supported by an R13 conference grant from NCATS, has been held four times (2018–2021) and has attracted community members, community leaders, university faculty, and trainees. The agenda includes talks by national leaders and breakout/working groups that led to a new state law that has reduced disproportionate traffic-ticketing and drivers' license suspensions in Black neighborhoods; mitigation of the disproportionate COVID-19 fatalities in Black communities; and the launching of a university-supported institute. We describe the key elements of success for a conference series designed by a community–university partnership to catalyze initiatives that are having an impact on social determinants of health in Buffalo.
Parents of children with eczema or psoriasis experience high levels of parenting stress, which can negatively impact their child’s mental and physical health.
We aimed to investigate the effectiveness, feasibility and acceptability of a mindful parenting intervention for parents of children with eczema or psoriasis.
Seven parents of children (4–12 years old) with eczema or psoriasis took part in an 8-week mindful parenting group intervention. A single-case experimental design was adopted, whereby parents completed daily idiographic measures of parenting stress related to their child’s skin condition. Parents also completed standardised questionnaires measuring their parenting stress, depression, anxiety and quality of life, and children completed a quality of life measure, at four time points: baseline, pre-intervention, post-intervention and 6-week follow-up. Parents provided qualitative feedback after the intervention.
All parents completed the intervention and showed improvements in idiographic measures of parenting stress from baseline to follow-up. Improvements in parenting stress were larger at follow-up than post-intervention, suggesting the benefits of intervention continue beyond the intervention. Six of seven parent–child dyads showed improvement in at least one of the wellbeing measures, from pre-intervention to post-intervention or follow-up. Feasibility was demonstrated through good participant retention, adherence to home practice, and treatment fidelity. Acceptability was demonstrated through positive parent evaluations of the intervention.
Mindful parenting can be an effective, feasible and acceptable intervention for parents of children with eczema or psoriasis. Future studies should attempt to replicate the findings through randomised controlled trials.
OBJECTIVES/GOALS: The objective of this evaluation is to evaluate the long-term impact of the PORT program on the clinical and translational research careers of the participating research staff. The impact of the program is best demonstrated through measures of the scientific contributions of the participants as well as their professional advancement over time. METHODS/STUDY POPULATION: The PORT program participants were tracked through the collection of instructional and public records, including the collection of their subsequent grant and publications. The clinical and translational research careers of the participants was also assessed, using a measure adapted from the operational guidelines for NCATS’ Research Careers Common Metric. A survey was administered to part participants and interviews conducted with participants from the past cohorts. RESULTS/ANTICIPATED RESULTS: The evaluation results demonstrate the PORT program participants made substantial contributions to the advancement of clinical and translational research, particularly through their publication of hundreds of scientific works. In addition, the evaluation results reveal that the program had short-, intermediate- and long-term impact on their research careers, thereby contributing to the advancement of the health research workforce at the University of Michigan for well over a decade. Specific participant cases highlight how individuals utilized their experience and training to advance research agendas and their long-term careers at the institution. These findings can inform the development, implementation and evaluation of similar programs throughout the CTSA consortium and beyond. DISCUSSION/SIGNIFICANCE: Most evaluations of research training and award programs for clinical and translational research staff do not evaluate the long-term impact of CTSA support on the research careers of the participants. The findings of this evaluation can help inform the development of new and more effective workforce development initiatives with long-term impact.
OBJECTIVES/GOALS: Researchers include community health workers and promotoras (CHW/Ps) on research teams to increase community engagement; however, no formal training on research best practices exists for this group. Study objectives were to examine perceived relevance of a new culturally and linguistically appropriate CHW/P training and optimal delivery modes. METHODS/STUDY POPULATION: We conducted six focus groups (FGs), three each in English and Spanish, at three study sites, University of Florida, University of Michigan, and University of California Davis from February to August 2021. The CHWs/Ps were purposively selected to include diverse age, race/ethnicity, educational level, and work experience. Separate FGs were conducted for CHWs/Ps in English and Spanish as appropriate. All FGs were audio recorded, translated to English from Spanish, transcribed and analyzed using RADaR (Rigorous and Accelerated Data Reduction) technique. RESULTS/ANTICIPATED RESULTS: Forty CHWs/Ps (95% women, mean age 45) participated, with the majority (58%) identifying as Hispanic/Latino. Of the sample, most identified as White (50%) or Black (25%). The proposed training was mentioned as relevant and would help them to be confident, comfortable, knowledgeable and effective in the community. Online training, though advantageous due to its flexibility also reportedly had barriers such as internet access, computer availability and technological know-how of CHWs/Ps. A hybrid training approach, online plus peer-led, was recommended due to the importance of personal guidance by an experienced CHW/P’ especially for a newly recruited CHW/P. DISCUSSION/SIGNIFICANCE: Findings indicated that a culturally and linguistically appropriate CHW/P training that is flexible and easily accessible in its mode of delivery is relevant and useful. In-person guidance to a new CHW/P was reported as an important training component. Poster will include the detailed quotes on relevance, usefulness, and mode of delivery of training.
Prescribing of medicines in primary care in Wales has been exceptional in 2020 due to COVID-19 and the associated changes to the delivery of health services. The changes are likely to have harmful, albeit unintended, consequences, including disruption of pharmacy stock management; unpredictable changes in prescribing; and interruption to patients’ supply of medicines and reduced medication adherence. Changes in prescribing are unlikely to be distributed evenly across the country or population. Therefore, this study aimed to identify changes in GP prescribing compared with previous years, the variation of these changes, and factors related to the variation in changes, to identify patient subgroups for whom the impact is disproportionate.
We identified medicines of interest where concerns around prescribing have been raised and, for each of these medicines, retrieved monthly prescribing data for each GP practice in Wales (N = 492). We then linked these data with other publicly available data (for example, practice size, indices of multiple deprivation, disease prevalence).
We developed a novel approach to measure the impact of COVID-19 on GP prescribing. We compared observed with expected prescribing volume projected via time series modelling and differences were related to patient and practice characteristics using general estimating equations.
There was evidence of stockpiling of medicines during March 2020 (for example, oral-contraceptives and oral-anticoagulants with 11.6 and 18.5 percent increases from March 2019), followed by a short-term reduction in prescribing for oral-contraceptives (a reduction of 12.9 percent), but not oral-anticoagulants (an increase of 6.5 percent). However, GP level data show considerable deviation from the national trend for several GPs, which may be due to health and socio-demographic factors.
COVID-19 has had a major impact on primary care prescribing in Wales. The distribution of changes in prescribing will not be even across the country or the population. Identification of systematic variation in impacts on prescribing could identify geographical areas or patients in need of additional support to ensure uninterrupted and appropriate access to medicines.
OBJECTIVES/GOALS: Although their 5-year survival >90%, young patients with HL face tradeoffs between near-term disease control and risk of treatment-related adverse effects decades later, so we seek to understand what patients and clinicians value in HL treatment decisions. METHODS/STUDY POPULATION: Leveraging our access to large cohorts of physicians, HL patients/survivors, and caregivers, we will use adaptive choice-based conjoint analysis (ACBC) to elicit treatment preferences when offered scenarios that incorporate tradeoffs, e.g., would a patient rather live 20 years with 10% risk of second malignancy or live 40 years with 30% of second malignancy. To reduce survey fatigue, prior choice responses limit subsequent scenarios. Through ACBC, we will identify variations in preferences and the importance of disease outcomes, treatment characteristics, and late effects for HL by respondent type. RESULTS/ANTICIPATED RESULTS: The goal is a final sample of 200 physicians and 200 patients/caregivers. We will collect demographics from physicians (age, type of physician, years practicing, type of practice, gender, and geography) and patients/caregivers (age at diagnosis, time since treatment, race, gender, smoker, education). We will ask questions about values of disease outcomes, late effects (second cancers, cardiac disease, chronic fatigue and neuropathy), and treatment characteristics (uncertainty of late effects, salvageability). Results will include utilities about participants views on disease-control and late effects. We anticipate participants to value disease control over late effects. DISCUSSION/SIGNIFICANCE OF IMPACT: Our study will elicit how physicians and patients/caregivers value treatment tradeoffs for HL. In an era of multiple treatment choices with varying short- and long-term benefits and harms, identifying values and preferences become critical for patient-centered treatment decisions.
Although several initiatives have produced core competency domains for training the translational science workforce, training resources to help clinical research professionals advance these skills reside primarily within local departments or institutions. The Development, Implementation, and AssessMent of Novel Training in Domain (DIAMOND) project was designed to make this training more readily and publicly available. DIAMOND includes a digital portal to catalog publicly available educational resources and an ePortfolio to document professional development. DIAMOND is a nationally crowdsourced, federated, online catalog providing a platform for practitioners to find and share training and assessment materials. Contributors can share their own educational materials using a simple intake form that creates an electronic record; the portal enables users to browse or search this catalog of digital records and access the resources. Since September 2018, the portal has been visited more than 5,700 times and received over 280 contributions from professionals. The portal facilitates opportunities to connect and collaborate regarding future applications of these resources. Consequently, growing the collection and increasing numbers of both contributors and users remains a priority. Results from a small subset of users indicated over half accomplished their purpose for visiting the site, while qualitative results showed that users identified several benefits and helpful features of the ePortfolio.
The 11th revision to the WHO International Classification of Diseases (ICD-11) identified complex post-traumatic stress disorder (CPTSD) as a new condition. There is a pressing need to identify effective CPTSD interventions.
We conducted a systematic review and meta-analysis of randomised controlled trials (RCTs) of psychological interventions for post-traumatic stress disorder (PTSD), where participants were likely to have clinically significant baseline levels of one or more CPTSD symptom clusters (affect dysregulation, negative self-concept and/or disturbed relationships). We searched MEDLINE, PsycINFO, EMBASE and PILOTS databases (January 2018), and examined study and outcome quality.
Fifty-one RCTs met inclusion criteria. Cognitive behavioural therapy (CBT), exposure alone (EA) and eye movement desensitisation and reprocessing (EMDR) were superior to usual care for PTSD symptoms, with effects ranging from g = −0.90 (CBT; k = 27, 95% CI −1.11 to −0.68; moderate quality) to g = −1.26 (EMDR; k = 4, 95% CI −2.01 to −0.51; low quality). CBT and EA each had moderate–large or large effects on negative self-concept, but only one trial of EMDR provided useable data. CBT, EA and EMDR each had moderate or moderate–large effects on disturbed relationships. Few RCTs reported affect dysregulation data. The benefits of all interventions were smaller when compared with non-specific interventions (e.g. befriending). Multivariate meta-regression suggested childhood-onset trauma was associated with a poorer outcome.
The development of effective interventions for CPTSD can build upon the success of PTSD interventions. Further research should assess the benefits of flexibility in intervention selection, sequencing and delivery, based on clinical need and patient preferences.
Hearing loss is highly prevalent in older adults and can pose challenges for neuropsychologists, as assessment and intervention procedures often involve orally presented information which must be accurately heard. This project examined the hearing status of 20 clients (mean age = 71 years) in a hospital-based outpatient neuropsychology clinic, and explored whether information about hearing loss informed neuropsychologists’ clinical practice. A research assistant administered a brief hearing screening test to each participant. Four treating neuropsychologists were asked to comment on their client’s hearing status before and after being shown their client’s hearing screen test results. Screening revealed that the majority of participants had at least mild hearing loss, and that the neuropsychologists were relatively accurate (60%) at estimating their clients’ hearing status. Neuropsychologists used information about a client’s hearing status to make recommendations that clients pursue audiologic services, and to educate clients and family members about hearing loss and communication.
OBJECTIVES/SPECIFIC AIMS: (1) To discuss key differences of behavioral clinical trials from trials involving drugs, devices, and biologics and (2) to discuss NIH efforts to provide a study protocol template for use by investigators conducting behavioral clinical trials. METHODS/STUDY POPULATION: A working group was convened by NIH to refine the commonly used protocol template required for investigators conducting Phase 2 or 3 NIH-funded clinical trials. The committee met by phone regularly for 4 months to review, discuss, and refine each section of the template as needed to include aspects relevant to behavioral trials. RESULTS/ANTICIPATED RESULTS: The behavioral trial protocol template draft has been created and is being further modified by feedback from the research community. DISCUSSION/SIGNIFICANCE OF IMPACT: Use of the NIH behavioral trial protocol template is expected to enhance the quality of any behavioral study, because the template and supporting materials were developed with the unique aspects of behavioral research in mind.
OBJECTIVES/SPECIFIC AIMS: To evaluate the NIH-sponsored Best Practices for Social and Behavioral Research e-learning course. METHODS/STUDY POPULATION: Four universities partnered in a pilot study to evaluate this new course. Outcomes from 294 participants completing the course included efficient progress through the training, perceived relevance of the course to current work, level of engagement with the course material, intent to work differently as a result of the course, and downloading digital resources. RESULTS/ANTICIPATED RESULTS: Participants rated the course as relevant and engaging (6.4 and 5.8 on a 7-point Likert scale) and 96% of respondents said they would recommend the course to colleagues. Qualitative analysis of participant testimonials suggested that most respondents had a readiness to change in the way they worked as a result of the course. Overall, results suggest participants completed the course efficiently, perceived outcomes positively and worked differently after the training. DISCUSSION/SIGNIFICANCE OF IMPACT: These results will inform new guidelines for future participants (e.g., average time to complete, expectations for knowledge checks in the training). Future studies should include larger samples and closer coordination and communication between study sites.
The Best Practices in Social and Behavioral Research Course was developed to provide instruction on good clinical practice for social and behavioral trials. This study evaluated the new course.
Participants across 4 universities took the course (n=294) and were sent surveys following course completion and 2 months later. Outcomes included relevance, how engaging the course was, and working differently because of the course. Open-ended questions were posed to understand how work was impacted.
Participants rated the course as relevant and engaging (6.4 and 5.8/7 points) and reported working differently (4.7/7 points). Participants with less experience in social and behavioral trials were most likely to report working differently 2 months later.
The course was perceived as relevant and engaging. Participants described actions taken to improve rigor in implementing trials. Future studies with a larger sample and additional participating sites are recommended.
OBJECTIVES/SPECIFIC AIMS: Existing GCP training is geared primarily towards researchers conducting drug, device, or biologic clinical trials, and largely ignores the unique needs of researchers conducting social and behavioral clinical trials. The purpose of this project was to develop a comprehensive, relevant, interactive, and easy to administer GCP eLearning course for social and behavioral researchers. METHODS/STUDY POPULATION: As part of the ECRPTQ project funded by the National Center for Advancing Translational Sciences (NCATS), a Social and Behavioral Work Group of ~30 experienced social and behavioral investigators and study coordinators was formed to develop GCP training for social and behavioral researchers. Existing GCP training programs were reviewed to identify relevant content that should be included as well as gaps specific to social and behavioral clinical trials where new content would need to be developed. In total, 9 specific modules—Introduction, Research Protocol, Roles and Responsibilities, Informed Consent Communication, Confidentiality/Privacy, Recruitment/Retention, Participant Safety/Adverse Event Reporting, Quality Control/Assurance, and Research Misconduct—were identified by the work group and the content was mapped to competency domains defined by the ECRPTQ project, as well as International Council for Harmonisation (ICH) GCP principles. Several investigators and study coordinators were identified as content experts for each module topic. Working with an instructional designer, these experts defined learning objectives and outlined content relevant for both study coordinators and investigators for inclusion in the modules. The curriculum was developed using Articulate Storyline that is SCORM 1.2 compliant making the course usable to the widest audience. The course was designed to be administered on laptop or desktop computers and is accessible for individuals with hearing or viewing impairments. To maximize learning, instructional designers used creative treatments including: narration to guide learners or offer tips; short video scenarios to introduce topics; interactive activities, such as drag and drop games and “click to learn more information”; knowledge checks with feedback; resources, including downloadable job aids; end of module quizzes, and documentation of course completion. The full curriculum takes 2–4 hours to complete, with individual modules taking 30 minutes to complete. RESULTS/ANTICIPATED RESULTS: Pilot testing to evaluate the effectiveness of the eLearning course is underway at 5 sites: University of Michigan, Boston University, University of Rochester, University of Florida, and SUNY Buffalo. DISCUSSION/SIGNIFICANCE OF IMPACT: This eLearning course provides relevant, comprehensive GCP training specifically for social and behavioral researchers. Unlike existing GCP training that is geared towards drug and device researchers, this course includes scenarios and examples that are relevant to social and behavioral researchers. The engaging, interactive nature of this course is designed to improve learning and retention, resulting in improved job performance. In addition, the modules are designed for both investigators and clinical research coordinators, thus eliminating the need for different training modules for different study team members.
OBJECTIVES/SPECIFIC AIMS: To conduct a preliminary evaluation of the Social and Behavioral Research Best Practices Course. METHODS/STUDY POPULATION: Learners are sampled from 5 institutions: University of Michigan, University of Rochester, University of Florida, Boston University, and University of Buffalo. Learners who take the course and consent to be in the study receive a web link to a survey immediately after course completion and at 2–3 months follow up. In addition to demographic information, learners will report their perceptions of usefulness and relevance of the course to their job, their satisfaction with the course and associated job aids, and at follow-up, if and how the course impacted their work. Additional information will be collected from the learning management systems which host the course at each institution. The data collected will include the number of participants who take the course, the number who complete, how many times the course was attempted, and pass rates. RESULTS/ANTICIPATED RESULTS: We anticipate that several hundred learners will take the course by the end of our project. Of learners who agree to participate in the survey, we anticipate that they will find the course useful and relevant to social and behavioral clinical trials and will be satisfied with the course. Information including suggestions about missing content, items or content that were not extremely clear, or any other comments will be collected to iterate and expand the course. DISCUSSION/SIGNIFICANCE OF IMPACT: This course was developed to fill a gap in training in good clinical practice for social and behavioral research. An evaluation of how the training provided in the course impacts the jobs of learners is needed both to ensure that the most relevant information is included in the course as well as to identify ways that the training may contribute to the quality and safety of social and behavioral clinical trials.
This article discusses the process of defining competencies and development
of a best practices training course for investigators and clinical research
coordinators who conduct social and behavioral research.
The first project phase established recommendations for training in Good
Clinical Practice (GCP) and was done in conjunction with representatives
from 62 Clinical and Translational Science Award (CTSA) hubs. Diversity in
behavioral clinical trials and differences in regulation of behavioral
trials compared with clinical trials involving drugs, devices, or biologics
necessitated a separate Social and Behavioral Work Group. This group worked
with CTSA representatives to tailor competencies and fundamental GCP
principles into best practices for social and behavioral research.
Although concepts underlying GCP were deemed similar across all clinical
trials, not all areas were equally applicable and the ways in which GCP
would be enacted differ for behavioral trials. It was determined that
suitable training in best practices for social and behavioral research was
Based on the training need, an e-learning course for best practices is
available to all CTSA sites. Each institution is able to track outcomes for
its employees to help achieve standardized competency-based best practices
for social and behavioral investigators and staff.
Training 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.
Clinical and Translational Science Awards representatives refined competency statements. Working groups developed assessments, identified training, and highlighted gaps.
Forty-eight competency statements in 8 domains were developed.
Training 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.
The translation of discoveries to drugs, devices, and behavioral interventions requires well-prepared study teams. Execution of clinical trials remains suboptimal due to varied quality in design, execution, analysis, and reporting. A critical impediment is inconsistent, or even absent, competency-based training for clinical trial personnel.
In 2014, the National Center for Advancing Translational Science (NCATS) funded the project, Enhancing Clinical Research Professionals’ Training and Qualifications (ECRPTQ), aimed at addressing this deficit. The goal was to ensure all personnel are competent to execute clinical trials. A phased structure was utilized.
This paper focuses on training recommendations in Good Clinical Practice (GCP). Leveraging input from all Clinical and Translational Science Award hubs, the following was recommended to NCATS: all investigators and study coordinators executing a clinical trial should understand GCP principles and undergo training every 3 years, with the training method meeting the minimum criteria identified by the International Conference on Harmonisation GCP.
We anticipate that industry sponsors will acknowledge such training, eliminating redundant training requests. We proposed metrics to be tracked that required further study. A separate task force was composed to define recommendations for metrics to be reported to NCATS.
Recent archaeological investigations at Pueblo Bonito in Chaco Canyon reveal that residents constructed a large diversion channel during the eleventh century A.D. as dramatic growth resulted in the expansion of the building onto the main valley floor. Sediments in the diversion channel reflect repeated episodes of flooding, rather than slow moving water typically found in irrigation canals, and archaeobotanical data indicate deposition during late summer or early fall. Although an agricultural function is possible, the channel may have been built primarily to divert floodwaters away from Pueblo Bonito while providing a nearby water source for construction and domestic use. The diversion channel was destroyed by the entrenchment of the “Bonito paleo-channel” in the late A.D. 1000s, and then buried by a combination of cultural debris and valley flooding. Although the canyon stream system changed throughout the occupation of Pueblo Bonito, there is no evidence that the formation of a deep natural channel in the floodplain had any negative effect on the growth of the great house
To compare the accuracy of surveillance of severe sepsis using electronic health record clinical data vs claims and to compare incidence and mortality trends using both methods.
We created an electronic health record–based surveillance definition for severe sepsis using clinical indicators of infection (blood culture and antibiotic orders) and concurrent organ dysfunction (vasopressors, mechanical ventilation, and/or abnormal laboratory values). We reviewed 1,000 randomly selected medical charts to characterize the definition’s accuracy and stability over time compared with a claims-based definition requiring infection and organ dysfunction codes. We compared incidence and mortality trends from 2003–2012 using both methods.
Two US academic hospitals.
The electronic health record–based clinical surveillance definition had stable and high sensitivity over time (77% in 2003–2009 vs 80% in 2012, P=.58) whereas the sensitivity of claims increased (52% in 2003–2009 vs 67% in 2012, P=.02). Positive predictive values for claims and clinical surveillance definitions were comparable (55% vs 53%, P=.65) and stable over time. From 2003 to 2012, severe sepsis incidence imputed from claims rose by 72% (95% CI, 57%–88%) and absolute mortality declined by 5.4% (95% CI, 4.6%–6.7%). In contrast, incidence using the clinical surveillance definition increased by 7.7% (95% CI, −1.1% to 17%) and mortality declined by 1.7% (95% CI, 1.1%–2.3%).
Sepsis surveillance using clinical data is more sensitive and more stable over time compared with claims and can be done electronically. This may enable more reliable estimates of sepsis burden and trends.
Infect. Control Hosp. Epidemiol. 2016;37(2):163–171