Informatics-Based Tools to Increase Participant Recruitment and - PowerPoint PPT Presentation

Leveraging Community Engagement and Informatics-Based Tools to Increase Participant Recruitment and Retention Patricia Jones DrPH, MPH NCATS Program Director Lead, Common Metric Initiative NIH Collaboratory May 04, 2018

Presentation Outline • Overview of Operational Challenges in Clinical Trials • Trial Innovation Network: Opportunity to Address Challenges in Clinical Trials • Informatics-based tools and resources used to enhance engagement, recruitment, and retention • Engagement, recruitment, and retention methods

NIH Clinical Trials: Operational Challenges NIH Budget – FY 2015 Clinical Trials $3.2 B ~10% $27.1 B NIH Budget Office; Mullard A. Nature Reviews Drug Disc 2016; GAO Report, 2016; Innovation for Healthier Americans, 2015; Hudson KL, Lauer MS, Collins FS. JAMA 2016.

Getting from discoveries to Health Benefit Discoveries → Better Health • Laboratory • Clinic • Community Seamless hand-offs and streamlined multi-site collaborations Impactful implementation and dissemination Clinicians and patients can use data in a smarter way Workforce is prepared to advance translation 4

NCATS’ Response: Opportunities to Address Operational Challenges Trial Innovation Centers (TICs) Recruitment Innovation  Center for Innovative Trials in Children Center (RIC) and Adults  Improving Clinical Trial Principal Investigators: Daniel Education, Recruitment and Benjamin, Jr., M.D., Ph.D. (Duke) / Enrollment at CTSA Hubs Gordon R. Bernard, M.D. (Vanderbilt)  Utah Trial Innovation Center Principal Investigator: Mike J. Dean, Principal Investigators: Paul M.D. A. Harris, Ph.D. / Consuelo H.  Johns Hopkins -Tufts Trial Innovation Wilkins, M.D. Center Principal Investigator: Daniel Hanley, M.D. (Johns Hopkins)

Trial Innovation Network: Mission  Mission: to develop , demonstrate effectiveness of, and disseminate scientific and operational innovations that dramatically increase the efficiency and effectiveness of clinical trials: • Critical to bringing new interventions to patients and communities • Critical to promoting clinical investigation as a career path

Trial Innovation Network: Goals • Create a national platform for clinical trials and studies that focuses on Operational Innovation and Operational Excellence • Operational Innovation – implement and test new approaches to operationalize clinical trials • Operational Excellence – finish studies on time and within budget • Serve as a resource for NIH, industry, and other partners

Trial Innovation Network Study CTSA Institutions Support: NIH ICs Industry Foundations TIN Partners Liaison Teams Participants/ Patients Providers Public Trial Innovation Network Trial Recruitment Innovation Innovation Centers Center (TICs) (RIC)

Unique characteristics of the Trial Innovation Network  Imbeds a scientific hypothesis within the overall science of the individual trial or longitudinal study it supports  All TIN projects have operational, design or statistical hypotheses, such as testing methods to find, enroll and retain special populations or developing new, less- burdensome trial endpoints  Disease agnostic  Only supports multi-center trials at this time

How the TIN innovates the design and execution of clinical trials/studies Data Driven Trial Designs Approaches • Use novel study • Use EHR-based designs Analytics Execution cohort discovery and site selection • Have compelling Limited Exclusive Innovation tools scientific endpoints Secondary Focus • Model recruitment Strategically Use Of on to minimize • Limit trial Designed Data Science amendments Protocols complexity Proactive • Have realistic Recruitment TIC and RIC Reactive budgets Planning Recruitment Collaboration Planning Recruitment Planning • Engage stakeholders in study design (via Community Engagement Studio) • Develop tailored messages and recruitment materials • Evaluate recruitment; modify strategies as needed

The Trial Innovation Network at 18 months 2017 2017-2018 Jul 2016- Jun Investigators 2017 prepared NIH Implemented applications for Feb 2017 Iteratively built harmonized submission; Key Elements of Launched system & Initial studies Network Network refine launched in network; Built TIC, RIC processes as Teams Est. TIN Liaison needed Teams

The TIN at 18 months: developed integrated website for proposal submission https://trialinnovationnetwork.org/

TIN at 18 months: The Recruitment Innovation Center (RIC)  The goal of the RIC is to improve participant enrollment and retention in multi-center clinical trials and studies . • This includes enrolling and retaining diverse populations using customized strategies, and conducting studies on methods to enhance recruitment efficacy and efficiency.  Achieving this goal requires sophisticated informatics-based recruitment tools and novel engagement approaches to accelerate recruitment and retention.

Paul Harris, PhD and Consuelo H. Wilkins, MD, MSCI Vanderbilt University Medical Center

RIC

RIC Vision and Purpose Our goal is to positively impact human health by improving participant enrollment and retention in multi-center clinical trials . Achieving this goal will require sophisticated informatics-based recruitment tools and novel engagement approaches to Trial accelerate recruitment and retention.

Key principles • Respecting CTSA autonomy and diversity • A focus on minority and underserved populations • Making the most of electronic health records • Preserving a disease neutral approach • Focus on cost efficiency • Respecting and returning value to participants • Build on best practice (avoid reinventing the wheel) • Evidence based…. What works? (test bed) • Finite resources – scalability / tools • Home for recruitment experts (across + beyond CTSA)

What are the CTSAs’ recruitment and retention needs and priorities? “Tools” rank high on the list of needs Surveyed all CTSAs in Sept 2016 (83% Tools to support social media response rate) Evaluation of recruitment and… Purpose: landscape review / gather Training in best practices insights on needs and priorities Tools to support EHR use Resources for online presence… We have used the results to: • Prioritize our services Tools to assess participant… • Engage with recruitment specialists Creating or revising… • Build on best practices 0 10 20 30 40 50 60 • Provide practical & meaningful Extremely Very Moderately support Slightly Not at all

Meeting recruitment goals is hit & miss Difficulty Meeting Goals How Often Meeting Goals 45 45 40 40 35 35 30 30 25 25 20 20 15 10 15 5 10 0 5 0 Very Difficult Neutral Easy Very Easy Difficult Recruitment Retention Recruitment Retention

Challenging Recruitment Experiences Specific challenges : • Complicated trial with narrow eligibility criteria • National trial with minority recruitment needs How can RIC support? • Undiagnosed condition (i.e., prediabetes, • Toolkits mild hypertension, depression) • Best Practices • Web-based screening misses large • Educational Webinars population • Better software • Engaging vulnerable population • Standardized • Logistical issues; need pre-trial identification approaches • Evaluation

http://www.trialinnovationnetwork.org

RIC service offerings Starting with Tailored Consults: • Recruitment Plan • Feasibility Analysis • Engagement Studios • Recruitment Materials And Generalized/Scalable Services: • Webinar Series (Dissemination) • Scalable/Generalizable Tools

RIC Consultations Read, Review, Investigate Listen Recommend Act

RIC Team Recommends Existing Tools & Service Offerings Goal: Right methods for the right project at the right time

RIC Team Recommends Existing Tools & Service Offerings RIC Team Listens for Generalizable Problems   Opportunities Goal: Right methods for   Innovation the right project  New at the right time Services

Community Engagement Studios Consultative model of engagement • Expert panel selected based on project • All phases of research • Experts are not research subjects • Researcher prep prior to meeting • Focus on 2-3 main questions • 1.5-2 hour facilitated meeting • Follow-up with detailed notes Joosten, Israel, Williams, Boone, Schlundt, Mouton, Dittus, Bernard, Wilkins. (2015). Community Engagement Studios: A Structured Approach to Obtaining Meaningful Input from Stakeholders to Inform Research. Academic Medicine. 2015 Dec; 90(12): 1646 – 1650.

CES Use Case: MoTrPAC- Dan Cooper, UC Irvine • Convened CE studio with 10 Latinos/Hispanics in Irvine, CA • Identified barriers (time, transportation, biopsy, cost, distrust) • Identified facilitators (community partners, sharing data, altruism) • Recommendations: • Culturally appropriate messaging • Enhance logistics of access • Cross cultural communications • Return of value to the community

TIN Submission By:

TARGET Study – Other Identified Challenges

TARGET Study Participant Brochure: Before & After Review, Recommendations, Feedback, Recommendations, CAB Presentation, Feedback ….