lowe professor and vice chair director, ccts tl1 and kl2 ... overview... · director, ccts tl1 and...
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STRIDE is a research study supported by the National Institutes of Health/National Center for Advancing Translational Sciences under award number U01TR001812. The content is solely the
responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Kenneth Saag, MD, MSc, Stride Co-PI
Lowe Professor and Vice Chair
Director, CCTS TL1 and KL2, and Center of Outcomes Research
University of Alabama at Birmingham
Stephenie Lemon, PhD (STRIDE PI)
Professor of Medicine
Director of the Umass CCTS Community Engagement Section and the
Umass Worcester Prevention Research Center
Jeroan Allison, MD, MSc (STRIDE co-PI)
Professor and Vice Chair of the Umass Department of Quantitative Health
Associate Vice Provost for Health Disparities Research
Paul Harris, PhD (STRIDE co-PI)
Professor of Biomedical Informatics and Research Professor of Biomedical
Engineering at Vanderbilt University
Director of the Vanderbilt Office of Research Informatics
The Goal of STRIDE
To improve racial and ethnic minority recruitment in clinical trials by creating culturally relevant tools and interventions
Critical Challenges in Clinical Trial Recruitment• ~30% clinical trials have issues
reaching enrollment goals1
• ~20% clinical trials do not enroll a single patient1
• >90% all clinical trials do not meet their proposed timelines because of difficulties with enrollment1
• Recruitment time is biggest contributor to trial increased costs2 0
10
20
30
40
50
60
70
80
90
Blacks Latinos Whites
% of US Pop.
% in ClinicalTrials
1Tufts Center for the Study of Drug Development, 2014. 2Hargreaves. Clinical Trials and their Patients: The Rising Costs and how to Stem the Loss. 2016. www.pharmalife.com3 Dorsett T. Diversity in clinical trials is an issue that we can no longer ignore. MedCity News MedCitizens Program. January 2017. http://medcitynews.com/2017/01/diversity-clinical-trials-issue-can-no-longer-ignore/?rf=1
Minority Representation in Clinical Trials3
Clinical Trial Recruitment in a More Diverse Nation
In 2016, African Americans made up just 7% of clinical trial participants according to FDA reports
According to the US Census, for the first time in 2014, more than 50% of children under 5 were minorities in the US
STRIDE Specific Aims
Aim 1: Expand 3 previously developed intervention components: Storytelling for promotion of research literacy; Simulation-based training for improving culturally appropriate recruitment and informed consent; eConsent
Aim 2: Test effectiveness of STRIDE multi-modal intervention to improve participation of African Americans and Latinos in ongoing clinical trials at each of 3 partnering CTSA hubs
Aim 3: Promote widespread translation/dissemination to CTSA hubs, other research institutions and community organizations
STRIDE Intervention Approach
• Comprehensive, multi-component approach
• Aims to provides clinical trial research teams with the training and tools for culturally adapted informed consent
eConsent
Research Assistant Training
Storytelling
STRIDE is a Three CTSA Collaboration
• Intervention pilot testing
• Integrating components
(storytelling, simulation,
eConsent) into existing
clinical trials
• Simulation: training
research assistants to be
culturally aware when
consenting participants
• Storytelling: participant
stories to increase
understanding of clinical
trials
• eConsent
• Community Studios to
provide feedback on
intervention components.
STRIDE Intervention - Community Input on All Components
Community Investigators Community Engagement Studios
Collaboration with Community Campus Partnerships for Health (CCPH)
Fred Jenoure, UMMS
Jackie Simms, VUMC
Clarice Davis, UAB
STRIDE Intervention Steps
Develop with community input
Evaluate in collaboration with ongoing clinical trials
Disseminatethroughout the CTSA program
and Trial Innovation Network
Aim 1 Aim 2 Aim 3
eConsent
Research Assistant Training
Storytelling
• Contains all of traditional elements of
paper consent PLUS
• Culturally relevant videos for commonly
consented research procedures (e.g. LP,
MRI, CT), Avatars, and hover-over
definitions with audio pronunciations
• Deployable in REDCap – scalable and
shareable
• Part 11 compliant
• Example video:
https://www.youtube.com/watch?v=3hldK
0aD99k&feature=youtu.be
STRIDE Intervention eConsent- What is It?
• Editing of first 4 videos – disseminated
via Recruitment Innovation Center
(RIC)
• Final development of part-11 compliant
“virtual lock box” to store signed
consent documents – deployed
nationally via the REDCap Consortium
• Refining “hover and click” feature with
audio pronunciation – deployed
nationally via REDCap Consortium
STRIDE Intervention eConsent- Progress
eConsent
Research Assistant Training
Storytelling
STRIDE Intervention Research Assistant (RA) Training- What is it?
• Simulation-based training
• Modeled after medical school experiential learning using standardized patients
• Training based on previously established core competencies• establishing rapport
• supporting understanding
• responding to emotion
• 2-day intensive training
• Delivered at UMass Medical School
STRIDE Intervention RA Training – What is it?
• Preparatory work (home site)
• Pretest, training and post-test (UMass)• Standardized checklist
• Minimum passing score
• Opportunity to retrain and reassess
• Debriefing (UMass)
• Deliberate practice (home site)
• In situ validation (home site)
STRIDE Intervention RA Training –Progress
• Training protocols-Developed with Community Investigator input
• Evaluation checklists
eConsent
Research Assistant Training
Storytelling
STRIDE Intervention Storytelling - What is it?
• Short, culturally-relevant video stories
• Real participants from past clinical trials
• Describe personal experiences with research and approaches to overcoming barriers
• Ancillary component to eConsent
• Introduce potential participants to goals of clinical trials research
• Clarify what is trial research? during the informed consent process
STRIDE Intervention Storytelling - Progress
• Completed Story Development at UAB and VUMC• 21 personal interviews filmed
• Initiated process of thematic analysis for story preparation
• Example storytelling video: https://vimeo.com/234717195
• Ongoing Interviews at UMass Medical School
STRIDE - Year 2 Plans
• Actively recruiting eligible clinical trials at each collaborating site
• Completing intervention materials• eConsent
• Storytelling videos
• Case simulations for RA training
• Piloting intervention materials at UAB
June/July, 2018STRIDE Intervention
Implementation Begins
STRIDE Intervention Evaluation: Years 3-4 Plans • Quasi-experimental study
design:• Intervention: Integration
into ongoing clinical trials at UAB, UMass and Vanderbilt (n=3 trials)
• Comparison: Usual protocol (n=3 trials)
• Interrupted time-series design
• Assess rate of recruitment of under-represented minorities before and after the STRIDE intervention is introduced
Original inclusion criteria
• RCT
• >75 weeks
• N > 60
• Chronic disease
• New therapy vs. existing
• Drug trial
Revised inclusion criteria
• RCT
• >30 weeks
• N = 30-40
• > minimal risk
• Include as independent study if multi-site trial
RA travel for training
STRIDE timeline
PI receptivity to intervention
IRB modification for STRIDE overlay
Sponsor permission
Available studies
Study Eligibility Modifications
Based on Stakeholder Input
STRIDE Intervention- Future DisseminationGoal: Make STRIDE intervention widely available to the CTSA Network and
beyond
• Planned scientific reports
• STRIDE design
• Three-phase interrupted time-series study design
• CTSA Network Community Engagement-Community of Practice model
• REDCap consortium – dissemination of plugins, data dictionaries,
customizations
• CTSA conferences
• Trial Innovation Network – RIC toolkit, eConsent
• Community Campus Partnerships for Health
STRIDE Summary• Three CTSA collaboration - focused on critical gap in clinical
research
• Utilization of community investigators in all study phases
• Innovations • Consent including e-consent and storytelling• Research assistant training using simulation• Quasi-experimental design to test multi-modal intervention in practice
• Planned dissemination of tested materials across sites in CTSA network and beyond
Potential to improve informed consent process and enhance under-represented minority participation in research
STRIDE TEAM UMASS
• Stephenie Lemon, Ph.D.-PI
• Jeroan Allison, MD, MS-PI
• Karin Valentine Goins, MPH-
Program Manager
• Fred Jenoure-Community
Investigator
• German Chiriboga, MPH-
Storytelling
• Shauna Simpson, MS-Storytelling
• Isabelle Pierre-Louis, MPH-
Storytelling
• Melissa Fischer, MD-Simulation
• Melissa Puliafico, MBA-Simulation
• Hilarie Haley-Simulation
• Carol Bova, Ph.D.-IRB Chair
• Allison Blodgett, Ph.D.-IRB Director
VANDERBILT
• Paul Harris, Ph.D.-PI
• Colleen Lawrence, Ph.D.-Program Manager
• Jackie Simms-Community Investigator
• Daniel Cruz-Community Investigator
• Leah Dunkel, MPH-Project Coordinator
• Tiffany Israel, MSSW-Community Studios
• Yvonne Boyd, MS-IRB
UAB
• Ken Saag, MD, MSc-PI
• Maio Danila, Ph.D.-Co-I
• Liz Rahn-Ph.D.-Program Manager
• Clarice Davis-Community Investigator
• Amancia Alvarado Carrera-Community Investigator
• Josh Melnick-Project Coordinator
• Vanessa Champigny-IRB
CCPH
• Al Richmond, MSW-Consultant