1. WELCOME! Pragmatic Trials Training Workshop 2014

2. Introduction www.ucdenver.edu/implementation Elaine Morrato, DrPH MPH CRISP, Collaborative Scientific Lead CCTSI, Pragmatic Trials & Dissemination/Implementation Unit Colorado School of Public Health

3. The Center for Research in Implementation Science and Prevention (CRISP) is one of three national centers funded by AHRQ that focused on improving clinical preventive services within primary care practice. CRISP has brought together expertise in implementation of preventive services, practice-based research networks (PBRNs) and national authorities in innovative health information technology (HIT). Grant Number 5P01HS021138-03.

4. Training and educating researchers and clinicians in implementation science and pragmatic research is a key objective for CRISP. Grant Number 5P01HS021138-03. Theory & Strategies Tools & Approaches Evaluation & Analysis

5. Suite of Training Workshops Dissemination and Implementation Science Pragmatic Trials mHealth Oct 2013 Sep 2014 Oct 2014 www.ucdenver.edu/implementation/workshops Grant Number 5P01HS021138-03.

6. PRAGMATIC TRIALS A randomized controlled trial to inform decisions about practice & real-world effectiveness

7. “Generally, the explanatory trial focuses towards homogeneity, so that the errors and biases will influence the results as little as possible, whereas the pragmatic trial is a race towards maximal heterogeneity in all aspects, e.g., patients, treatments, clinical settings, etc. In order to overcome the inherited heterogeneity, which leads to dilution of the effect, pragmatic trials must be large enough (to increase power to detect small effects) and simple in their design. Simple trials are easier to plan, perform, and follow up.” Patsopoulos, Dialogues Clin Neurosci (2011)

8. PRagmatic-Explanatory Continuum Indicator Summary (PRECIS-2) A framework for designing and reporting pragmatic trials. https://crs.dundee.ac.uk/precis

9. Polling of our learning community Best describes your affiliation… School of Medicine Colorado School of Public Health College of Nursing School of Pharmacy School of Dental Medicine UCD – Auraria campus CSU Kaiser Permanente Veteran’s Administration Denver Health Colorado Children’s Hospital National Jewish N = 144 pre-registered

10. Level of pragmatic trial knowledge N = 144 pre-registered

11. How plan to use the workshop learning N = 144 pre-registered

12. Pragmatic Trials Workshop Objectives Day 1 Provide an introduction to pragmatic trial strategies and design principles using the PRECIS-2 framework Prepare health researchers to write successful grant proposals Serve as a resource navigator Day 2 Provide in-depth feedback on pragmatic trial projects through peer and expert mentorship

13. Learning BlocksTopicTime Importance of Pragmatic Research Introduction to PRECIS-2 8:10 – 8:30 Case-based learningCase: Immunization Delivery among Preschool Children 8:30 – 8:45 Stakeholder engagementPCORI’s approach / CCTSI resources 8:45 – 9:45 BREAKNetworking 9:45 – 10:00 Study population and setting Eligibility, recruitment, setting, and organization 10:00 – Noon LUNCHPCORI Engagement Awards Noon – 1:15 Research designOutcome, follow-up, analysis 1:15 – 3:15 BREAKNetworking 3:15 – 3:30 Real-world useFlexibility (staff delivery) and flexibility (adherence) 3:30 – 5:00 SummaryRecap key insights and resources 5:00 – 5:30 Agenda

14. 4-Step Learning Modules 1.Overview of the topic area / domain 2.Expert stories of application 3.Q&A panel 4.Case study application

15. Workshop materials. Workbook Open-Access Canvas https://canvas.instructure.com/courses/879942https://canvas.instructure.com/courses/879942.

16. Workshop Faculty and Staff Affiliation Elaine Morrato (Director)CRISP, CCTSI, CSPH Russ GlasgowCRISP, UCD SOM Borsika RabinVA, UCD SOM Chase CameronCRISP, UCD SOM Ellen BowmanCRISP, UCD SOM Dennis GurfinkelCRISP, UCD SOM Jeff ProctorCCTSI, UCD Evaluation Center Megan SnowCOHO/COR, UCD SOM

17. Expert Contributors Affiliation Kim BaileyPCORI Elaine BelanskyCSPH Miriam DickinsonSOM Ed HavranekDenver Health, SOM William HiattCPC Clinical Research, SOM Michael HoVA Allison KempeCRISP, SOM Jerry KrishnanUniversity of Illinois Chicago C. Daniel MullinsUniversity of Maryland Montelle TamezCCTSI