Dan D. Matlock, MD, MPH Russell E. Glasgow, PhD

1. Implementation Science: How It Can Complement, Extend, and Challenge How You Do Science (and increase your success) Dan D. Matlock, MD, MPH Russell E. Glasgow, PhD VA Eastern Colorado Geriatric Research Education and Clinical Center, Denver, Colorado Dissemination and Implementation Science Program, and Shared Decision Making Core Adult and Child Consortium for Outcomes Research and Delivery Science

2. Conflicts of Interest • FINANCIAL DISCLOSURE: • Matlock: Grant support from the ACC Foundation, NIH, PCORI, AFAR, the Hartford Foundation, the Colorado Health Foundation • Glasgow: National Institutes of Health (NIH), Agency for Healthcare Research and Quality (AHRQ), and Robert Wood Johnson Foundation (RWJF). • UNLABELED/UNAPPROVED USES DISCLOSURE: • None

3. Need for IS Overview How Different Examples Tools Conclusions • Need for Implementation Science • How is Implementation Science Different? • Examples • Tools and Resources • Conclusions, Discussion; Q & A

4. Need for IS Overview How Different Examples Tools Conclusions • Need for Implementation Science • How is Implementation Science Different? • Examples • Tools and Resources • Conclusions, Discussion; Q & A

5. Need for IS Need for Implementation Science? How Different Examples Tools Conclusions

6. Need for IS How Different Examples Tools Conclusions Bench to Bookshelf

7. Need for IS Need for Implementation Science? How Different Examples Tools Conclusions It takes an average of 17 years before 14% of research findings lead to widespread changes in care. • SLOW • Traditional RCTs are slow and expensive • Rarely produce findings that are easily put into practice

8. Need for IS How Different Examples Tools Conclusions Research to Practice Pipeline Green, LW et al. Diffusion theory and knowledge dissemination…Annu Rev Public Health 2009;30:151-74

9. Need for IS Need for Implementation Science How Different Examples Tools Conclusions “If we want more evidence-based practice, we need more practice-based evidence.” Green LW. Am J Pub Health 2006 Rothwell PM. External validity of randomised controlled trials…Lancet 2005;365:82-93. Traditional RCTs study the effectiveness of treatments delivered to carefully selected populations under ideal conditions. Even when we do implement a tested intervention into everyday clinical practice, we often see a “voltage drop”—a dramatic decrease in effectiveness.

10. Need for IS Science How Different Examples Tools Conclusions • knowledge or a system of knowledge covering general truths or the operation of general laws especially as obtained and tested through scientific method.

11. Need for IS Science How Different Examples Tools Conclusions • knowledge or a system of knowledge covering general truths or the operation of general laws especially as obtained and tested through scientific method.

12. Need for IS Implementation Science How Different Examples Tools Conclusions • Implementation science is the study of methodsto promote the integration of research findings and evidence into healthcare policy and practice. • Dissemination science is the study of methodsof distribution of information and intervention materials to a specific public health or clinical practice audience.

13. Need for IS How Different Examples Tools Conclusions When are you ready to study Implementation Science?

14. Need for IS When are you ready to study D&I? How Different Examples Tools Conclusions Adapted from Figure 11.1 Implementation and dissemination of Prevention Programs (2009)

15. Need for IS Effectiveness/Implementation hybrids How Different Examples Tools Conclusions Curran et al. Medical Care. 2012

16. Need for IS Overview How Different Examples Tools Conclusions • Need for Implementation Science • How is Implementation Science Different? • Examples • Tools and Resources • Conclusions, Discussion; Q & A

17. Need for IS How Different Examples Tools Conclusions “The significant problems we face cannot be solved by the same level of thinking that created them.” A. Einstein

18. Need for IS How Different Examples Tools Conclusions PCTs: Fewer Exclusions Allow for a Broader Subset of Settings, Staff, and Participants Traditional RCT PCT • Eligible population • Eligible population • Exclusions, non-response, etc. • Exclusions, non-response, etc. • Efficacy, among a defined subset • Effectiveness, in a broad subset Figure provided by Gloria Coronado, PhD, Kaiser Permanente Center for Health Research

19. Need for IS How Different Examples Tools Conclusions External Validity/ Pragmatic Criteria— Often Ignored • Participant Representativeness • Setting Representativeness • Context and Setting • Community/Setting Engagement • Adaptation/change • Sustainability • Costs/Feasibility of Tx • Comparison Conditions

20. Need for IS A Different Approach: Pragmatic Research How Different Examples Tools Conclusions Explanatory trial: Specialized experiment in a specialized population Pragmatic trial: Real-world test in a real-world population Pragmatic designs emphasize: • Participation or reach • Adoption by diverse settings • Ease of Implementation • Maintenance Generalizability Maclure, M. (2009). Explaining pragmatic trials to pragmatic policy-makers. Canadian Medical Association Journal, 180(10), 1001-1003.

21. Need for IS Key differences between Traditional Randomized Control Trials (RCT) and Pragmatic Controlled Trials (PCT) How Different Examples Tools Conclusions

22. Need for IS How Different Examples Tools Conclusions

23. Need for IS Other models How Different Examples Tools Conclusions • 91 frameworks: http://dissemination-implementation.org/index.aspx Most Common at NIH: REAIM and DOI Many commonalities across models and theories

24. Need for IS How Different Examples Tools Conclusions Readiness for Translation? RE-AIM • Internal validity perspective • The magnitude of effect as the key indicator of readiness for translation and adheres to the principles of evidence rating for determining efficacy • External validity perspective • Attention to intervention features that can be adopted and delivered broadly, have the ability for sustained and consistent implementationat a reasonable cost, reachlarge numbers of people, especially those who can most benefit, and produce replicable and long-lasting effects Glasgow RE, Vogt TM, Boles SM. Evaluating the Public Health Impact…Am J Public Health, 1999;89:1322-1327

25. Need for IS How Different Examples Tools Conclusions RE-AIM Precision (Personalized) Medicine Questions Determine • What percent and types of patients are Reached; • For whom among them is the intervention Effective, in improving what outcomes, with what unanticipated consequences; • In what percent and types of settings and staff is this approach Adopted; • How consistently are different parts of it Implemented at what cost to different parties; • And how well are the intervention components and their effects Maintained? Pawson R, et al. J Health Serv Res Policy 2005;10(S1)S21-S39. Gaglio B, Glasgow RE. Evaluation approaches…In:Brownson R, Colditz G, Procter E, (Eds). Dissemination and implantation research in health: Translating science to practice. New York: Oxford University Press; 2012. Pages 327-356

26. Need for IS How Different Examples Tools Conclusions

27. Need for IS Why is this important?impact Loss at each RE-AIM step How Different Examples Tools Conclusions Re-aim.org

28. Need for IS Why is this important?impact Loss at each RE-AIM step How Different Examples Tools Conclusions Re-aim.org

29. Need for IS Why is this important?impact Loss at each RE-AIM step How Different Examples Tools Conclusions Re-aim.org

30. Need for IS Why is this important?impact Loss at each RE-AIM step How Different Examples Tools Conclusions Re-aim.org

31. Need for IS Ultimate Impact of a Weight Management Program How Different Examples Tools Conclusions Are they representative? Abildso CG, Zizzi SJ, Reger-Nash B. Prev Chronic Dis 2010 May;7(3):A46

32. Need for IS How Different Examples Tools Conclusions WHAT IS THE MORAL OF THIS STORY?

33. Need for IS How Different Examples Tools Conclusions Comparison of Two Different Types of Programs Glasgow et al. AJPH, September 1999, Vol. 89, No. 9

34. Need for IS Extended CONSORT Diagram How Different Examples Tools Conclusions re-aim.org: https://www.re-aim.hnfe.vt.edu/resources_and_tools/figures_and_tables/consort.pdf

35. Need for IS How Different Examples Tools Conclusions What are unique considerations about this framework? • Intended to facilitate translation of research to practice • Internal and external validity and emphasizes representativeness • Individual and organizational factors • Public health impact depends on all elements (reach x effectiveness, etc) • Resource materials for researchers and community leaders (www.re-aim.org)

36. Need for IS Overview How Different Examples Tools Conclusions • Need for Implementation Science • How is Implementation Science Different? • Examples • Tools and Resources • Conclusions, Discussion; Q & A

37. Need for IS Planned Parenthood Smoking Cessation Example How Different Examples Tools Conclusions • Patient randomized study (n = 1154) in low income Planned Parenthood clinics • Eligible and target population = women smokers coming into clinic for contraception, wellness, or non-pregnancy follow-up • INT= 9-minute tailored video, clinician advice to quit, brief behavioral counseling, follow-up phone calls • Control = Advice to Quit and Stop Smoking brochure Glasgow R et al. A brief smoking cessation intervention. AJPH, 2000, 90: 786-789

38. Need for IS How Different Examples Tools Conclusions Planned Parenthood Smoking Cessation Results • Reach: 99% had smoking identified, 76% of smokers approached participated, no differences on demographics for participants vs. decliners • Effectiveness: 10.2% quit INT vs. 6.9% CON at 6-week follow-up, p<.05 • Adoption: Approached 4 clinics in lowest SES neighborhoods in area (most below 125% poverty level), also most diverse clinics—all participated

39. Need for IS Results (cont.) How Different Examples Tools Conclusions • Implementation: • Excellent (>85%) on all components except phone calls, which were problematic—only 43% successfully contacted • Maintenance: • Individual level: Higher, but NS different levels cessation (18.3 vs. 14.9%, p=.09) in INT condition at 6- month follow-up • Setting level: Not reported

40. Need for IS DECIDE – LVAD trial How Different Examples Tools Conclusions

41. Need for IS DECIDE-LVAD Trial How Different Examples Tools Conclusions Objective: Understand the effectivenessand implementationof a shared decision support intervention for advanced heart failure patients considering DT LVAD.

42. Need for IS DECIDE-LVAD Trial How Different Examples Tools Conclusions Key Considerations: • Desire to evaluate implementation in multiple real-world settings • Specific small population (DT LVAD 25-50 per site/year) • Max 5-6 sites due to budget constraints ($2M) • Randomization needed to assess effectiveness • Intervention involves both patients and clinicians/program

43. Need for IS Study Design Optionsfor DECIDE-LVAD Trial How Different Examples Tools Conclusions • Classic patient-level randomization • Intervention is patient AND program-based; not at individual-level • Diffusion among participants at each site is probable • Clusterrandomization • Concerns about statistical power with only 6 total sites • 3 sites intervention, 3 sites control • Homogeneity of intervention participants and control participants • Stepped wedge cluster randomization . . .

44. Need for IS DECIDE-LVAD Trial How Different Examples Tools Conclusions

45. Need for IS Stepped Wedge Design Ideal When… How Different Examples Tools Conclusions • Diffusion of intervention to control participants is likely • Implementation is a focus • Iterative adjustment possible at each phase • All clusters go through implementation (not half) • Staggered rollout provides logistical, practical, or financial advantages • All sites wish to receive the intervention • Randomization itself can be a reason sites don’t participate

46. Need for IS Evaluation Procedures How Different Examples Tools Conclusions • Reach & Effectiveness: • Patients and caregivers • Surveys: • Baseline • 1 month • 6 months • Adoption, Implementation & Maintenance • Qualitative interviews: • Baseline • Post-intervention implementation • Post-study completion • Checklist of education materials/procedures for each patient

47. Need for IS Implementation Intervention How Different Examples Tools Conclusions • Pre-implementation: • Planning, identifying key people • Implementation visit • 1 hour: Grand rounds presentation (large audience) • 1 hour: Communication Training (heart failure team) • 1 hour: Discuss new process • Already a delivery process “plug and play” • Post-implementation • Ongoing site support • Follow-up visit

48. Need for IS Communication Training How Different Examples Tools Conclusions Four key communication concepts • How to introduce the LVAD • How to frame the options: • How to respond to emotions: • How to provide recommendations “Good” “Bad”

49. Need for IS RE-AIM Summary Points How Different Examples Tools Conclusions • RE-AIM is an outcomes framework that can be used for planning and evaluation • Each dimension is an opportunity for intervention • RE-AIM can be used for efficacy, effectiveness, and implementation science projects • All dimensions can be addressed within a given study (though likely not all intervened upon) • Methods exist to combine and summarize RE-AIM outcomes

50. Need for IS Overview How Different Examples Tools Conclusions • Need for Implementation Science • How is Implementation Science Different? • Examples • Tools and Resources • Conclusions, Discussion; Q & A