Ruth Carrico PhD RN FSHEA CIC Associate Professor Division of Infectious Diseases

1. Clinical & Translational Research Step by Step from Idea to PublicationPlanning Your Study: Implementation Studies Ruth Carrico PhD RN FSHEA CIC Associate Professor Division of Infectious Diseases University of Louisville

2. Clinical & Translational Research Step by Step from Idea to Publication 1. Clinical & Translational Research: Definitions 2. Developing the Research Question 3. Planning the Study 4. Performing the Study 5. Analyzing the Data 6. Disseminating Study Findings: Scientific Writing 7. Clinical Research: Elements for Success

3. Clinical & Translational Research Objectives Describe the elements of study design in implementation studies Explore conceptual basis of implementation science and its application to clinical and translational research

4. Clinical & Translational Research From Research to Practice: Lost in Translation Patients in the universe Translation Translation Clinical Research Clinical Practice Patient Outcomes Basic Research T1 T2 http://nihroadmap.nih.gov/

5. Clinical & Translational Research From Research to Practice: Lost in Translation Patients in the universe Translation Translation Clinical Research Clinical Practice Patient Outcomes Basic Research T1 T2 *Demonstration Research *Dissemination Research *Translating Research Into Practice: TRIP Implementation Research http://nihroadmap.nih.gov/

6. Clinical & Translational Research The Science Behind Implementation Studies Implementation studies, although newly recognized as important, rely largely on qualitative research and as such are of lesser quality compared to interventional studies A. True B. False

7. Clinical & Translational Research The Science Behind Implementation Studies The study of effectiveness, efficiency, and equity of health program selection, delivery, and uptake

8. Clinical & Translational Research

9. Clinical & Translational Research Research has indicated that provision of a peanut butter sandwich to all patients will result in an improved nutritional status. The new guideline states that a peanut butter sandwich should be provided daily to all targeted patient populations. You are responsible for implementation. Make a peanut butter sandwich for your patient.

10. Variation in Knowledge and Skills Performance Improvement Teaching Research Application People Skills

11. Clinical & Translational Research The Science Behind Implementation Studies The study of effectiveness, efficiency, and equity of health program selection, delivery, and uptake The idea is to bridge the gap between proven interventions and clinical/community practices in real-world settings

12. Clinical & Translational Research The Science Behind Implementation Studies The study of effectiveness, efficiency, and equity of health program selection, delivery, and uptake The idea is to bridge the gap between proven interventions and clinical/community practices in real-world settings The overall goal of implementation science is to advance the adoption and integration of evidence-based interventions and change practice patterns

13. Clinical & Translational Research The Science Behind Implementation Studies The study of effectiveness, efficiency, and equity of health program selection, delivery, and uptake The idea is to bridge the gap between proven interventions and clinical/community practices in real-world settings. The overall goal of implementation science is to advance the adoption and integration of evidence-based interventions and change practice patterns. Implementation science examines all points on the causal pathway from program to impact

14. Clinical & Translational Research Implementation Research Goals Develop reliable strategies for increasing use of evidence-based/effective services to improve outcomes; facilitate widespread adoption of those strategies Produce generalizable knowledge and increased understanding of implementation processes, barriers, facilitators, and strategies Develop, test and refine implementation theories and hypotheses as the methods and measures used to accomplish them

15. Clinical & Translational Research Terminology Translation Research: comprised of dissemination, implementation and diffusion research Dissemination: targeted distribution of information and intervention materials to a specific audience Dissemination Research: systematic study of how the distribution can be successful executed Implementation: use of strategies to adopt and integrate evidence-based interventions and change practice patterns Implementation Research: systematic study of how specific activities and strategies are used to successfully integrate D. Schillinger. A Resource Manual for Community-Engaged Research 2010

16. Clinical & Translational Research NIH: Clinical & Translational Science Basic Research Clinical Research Clinical Practice T1 T2 Translation to Patients Translation to Practice Guideline Development Meta-analyses Systemic reviews Dissemination research Implementation research

17. Clinical & Translational Research NIH: Clinical & Translational Science Basic Research Clinical Research Implementation Research T1 T2 Patients in the Universe Changing public health practice to improve “prevention” Changing clinical practice to improve “treatment”

18. Clinical & Translational Research Components of Implementation Science

19. Clinical & Translational Research NIH: Clinical & Translational Science Clinical Research Basic Research Implementation Research T1 T2 Population Research Patients in the Universe Changing public health practice to improve “prevention” Changing clinical practice to improve “treatment”

20. Clinical & Translational Research NIH: Clinical & Translational Science “Cross-Disciplinary Communication” Basic Research Clinical Research T1 Implementation Research Population-based Research T2 Patients in the Universe

21. Clinical & Translational Research Evolution of Attitudes Toward Evidence Belief in passive perfusion of scientific evidence into practice

22. Clinical & Translational Research Evolution of Attitudes Toward Evidence Demonstration that much of clinical practice not evidence based and even if it were, the magnitude makes it impossible for clinicians to keep up with

23. Clinical & Translational Research Evolution of Attitudes Toward Evidence Passive dissemination does not work. “Quality Chasm” requires aggressive action including performance measurement and accountability

24. Clinical & Translational Research Evolution of Attitudes Toward Evidence It is insufficient to focus on the individual. Rather, the redesign of service delivery systems is necessary. Behavior change.

25. Translating Evidence Into Practice, Policy and Public Health Advocacy & Policy Strategies STAKEHOLDERS System-Centered Implementation Strategies Government Payors Public Health Prof. Societies Academia Introduction to Translating Evidence into Practice: Theory, Evidence & Design EVIDENCE COMMUNITY Health Care Delivery Systems Providers Patients Public Individual-Centered Implementation Strategies Translating Practice Into Evidence: Community Engagement Strategies PRACTICE HEALTH UCSF Model

26. Clinical & Translational Research Steps in Implementation Research 1. Identify care gaps and need for change 2. Identify barriers to consistent use of guidelines 3. Review evidence on implementation interventions 4. Tailor or develop interventions to improve performance 5. Implement intervention 6. Evaluate the process of implementation 7. Evaluate outcomes of the intervention

27. Clinical & Translational Research Uncontrolled before-after Performance Performance Intervention Measures performance before and after the intervention in uncontrolled group. Differences in performance assumed to be due to intervention.

28. Clinical & Translational Research Interrupted time series Performance in non-randomized or controlled group Intervention (e.g., dissemination of national guideline) Attempts to detect whether intervention had an effect significantly greater than the underlying trend.

29. Clinical & Translational Research Controlled before-after Control group performance Control group performance difference difference Intervention Study group performance Study group performance Measures performance before and after the intervention in controlled population with similar characteristics. Compares post-intervention performance in study and control groups

30. Planning The Study Randomized/cluster-randomized controlled trial Intervention Interventional Designs Study Subjects 1. Non-Randomized 2. Randomized None or an alternative intervention

31. Clinical & Translational Research Types of Implementation Interventions 1. Distribution of educational materials 2. Educational meetings 3. Local consensus processes 4. Educational outreach visits 5. Use of local opinion leaders 6. Patient-mediated interventions 7. Audit and feedback

32. Clinical & Translational Research Types of Implementation Interventions 8. Reminders 9. Marketing 10. Mass media

33. Clinical & Translational Research Types of Implementation Interventions 8. Reminders 9. Marketing 10. Mass media 11. Patient/HCP stories and experiences 12. Checklists 13. Community engagement 14. Simulation

34. Clinical & Translational Research Implementation Research Challenges Understand the impact of context of practice on effectiveness Develop a better understanding of interventions and their mechanisms of action Develop more sophisticated study designs to address key implementation questions

35. Clinical & Translational Research So What? Implementation studies represent the basis for understanding the impact of best practices How do I make happen what needs to happen How do I take credit for making happen what needs to happen How do I lead change to ensure that what happens needs to happen; and what needs to happen happens Hope is not a plan. Plan needs to be evidence-based

36. Clinical & Translational Research Pay for Performance Pay for Reporting Financial reward for practitioners in healthcare facilities for collecting and submitting performance data to a quality measurement program (CMS via NHSN) Financial reward for scoring well on performance measures

37. Clinical & Translational Research Pay for Performance and Accountable Care Act Performance Measures apply only to hospitals at this time (2012) A. True B. False

38. Clinical & Translational Research Value-Based Purchasing

39. Clinical & Translational Research Care Bundles • Notion that standardized care processes reduce error and help to “perfect” the system by identifying and reducing defect • Data inconclusive as to degree of bundle adherence and outcomes • Reporting generally all or none

40. Clinical & Translational Research Central Line Bundle • Use of chlorhexidine-alcohol skin preparation • Maximum sterile barriers • Full size body drape • Complete surgical garb • Insertion site selection • Hand hygiene • Daily evaluation of need • Feedback (performance and outcomes)

41. Clinical & Translational Research Surgical Care Bundle • Antimicrobial selection, timing, redosing and duration • Skin preparation • Hair removal • Glucose control • Temperature control (normothermia) • Instrument sterilization

42. Clinical & Translational Research Ventilator Bundle • Head of bed elevation • Oral care • Closed suction • Care of ventilator • Hand hygiene • Sedation vacation • Rapid extubation/discontinuation of ventilator

43. Clinical & Translational Research The Future of Implementation Research Understand interactions between provider, patient, practice environment and broader system of care Understand applicability of studies conducted in one setting to another/different context Theory development (limited empiric evidence)