1. Quality Improvement in Parallel Circuits: WHAT METHODS DOES IMPLEMENTATION RESEARCH EMPLOY? Teresa Damush, Ph.D. Implementation Research Coordinator VA Stroke QUERI Center Research Scientist, HSRD COE, Roudebush VAMC Associate Research Professor, IU School of Medicine

2. Interdisciplinary Research Teams “It Takes a Village”… to conduct implementation research Interdisciplinary – local staff, clinical experts, and implementation researchers ◦ Health Services Research ◦ Clinician researchers – trained HSR ◦ Research Scientists who study organization change, behavior change, communications, education, health economics, informatics…..

3. Implementation Research Employs mixed methods ◦ Quantitative ◦ Qualitative Varies in Scope Invests efforts across the pipeline: ◦ Pre-implementation, ◦ Implementation planning ◦ Active implementation, and ◦ Post-implementation

4. The Classic Six-Step QUERI Process 1. Identify high risk/high burden conditions 2. Identify best practices 3. Define existing practice patterns in VA and variations from best practices 4. Identify (or develop) and implement programs to promote best practices 5. Document outcome and system improvements 6. Document improvements in health related quality of life Health Services Research Implementation Research

5. QUERI CENTER IMPLEMENTATION RESEARCH PIPELINE

6. Evidence Based Practice Gap Evidence Based Practice Gap CLINICAL PRACTICES BEST CURRENT Implementation Research: How can we intervene to fix this gap? PERFORMANCE GAP

7. Know Your Audience: Identify and Utilize Local Leaders and Engage Relevant Stakeholders Solicit “buy in” from a broad audience of those whose work functioning will be effected – bottoms up approach vs top down. Identify the person who staff view as most influential in establishing clinic policy and practice How will the results affect the administration? Get their support in advance

8. Engagement of Targeted Audience Engagement of Targeted Audience PRE-IMPLEMENTATIONSYSTEM REDESIGN/LEAN Engage local front line participants Qualitative methods Assess general context ◦ Setting of EBP ◦ Barriers to change ◦ Facilitators of change “Voice of the Customer” Open ended questions ◦ Assess customer requirements ◦ Expectations ◦ Recommendations for improvement

9. IR Employs Mixed Methods Quantitative ◦ Survey scales – organizational readiness to change ◦ Performance Rates - % screened for depression Qualitative ◦ Semi structured interviews – (users of a tool) ◦ Focus groups (key stakeholder groups) ◦ Ethnographic observations – current state - ED ◦ Communication analyses (i.e., doc-patient)

10. Formative Evaluation PRE-IMPLEMENTATIONSYSTEM REDESIGN/LEAN What is the current state? What is the difference between current and ideal state (EBP)? Operational BARRIERS to implementing EBP? Current State Process Flow Diagram KAPOWEES

11. Implementation Planning Identify applicable theories and previously used implementation strategies (both theory based and pragmatic) Select theory(s) and implementation strategy(s) and provide rationale for use Select implementation intervention based upon evidence and feasibility to address identified gaps in EBP

12. *Based on Rogers’ model of Diffusion of Innovation Titler, M.G. & Everett, L.Q. (2001) Translational Research Model

13. Implementation Planning Locally Tailor ◦ Utilize results from formative evaluation to tailor to the site ◦ Any combination of information or change strategies intended to reach a group based on group/organization characteristics Adapt a Program ◦ Essential Core components ◦ Adaptable components ◦ Adapting a program is when you preserve necessary elements while adding new or changing modifiable elements to make the program relevant for (or fit) the context

14. Identify Implementation Tools Computerized clinical reminder Toolkits Program materials (ASA Stroke Peer Visitor Program)

15. Implementation Efficacy Study Pre Trial Develop New or Refine Targeted Implementation Intervention

16. IMPLEMENTATION TRIAL -Scale Single facility – small scale –Roudebush VA Modest multi-site evaluation (research staff assists internal implementers) – VISN 11 Stroke Collaborative Regional Roll out – broader 10-20 diverse facilities – INSPIRE Stroke Collaborative National level – field implementation with evaluation

17. Study design –Multiple Levels System/Provider and Patient System/provider intervention Site 1 (N = 56) System/provider intervention Site 2 (N = 84) Patient self-management intervention Usual care 28 42 Aim 1: improvement in Post Stroke Depression (PSD) screening during 6 months of post-stroke follow-up (compared to prior screening rates;) Target Providers Aim 2: depression symptoms, HRQL, etc. vs. usual care; TargetPatients

18. IMPLEMENTATION TRIAL Execute implementation strategy(s) and evaluate its progress, uptake and outcomes

19. Clinical Effectiveness Research Implementation Research Hybrid Type I Hybrid Type II Hybrid Type III Hybrid Type I: test clinical intervention, observe/gather information on implementation Hybrid Type II: test clinical intervention, test implementation intervention Hybrid Type III: test implementation intervention, observe/gather information on clinical intervention and outcomes Hybrid Designs: SDP Geoff Curran, 2010

20. Another Look… Hybrid Type I: test clinical intervention, observe/gather information on implementation Hybrid Type II: test clinical intervention, test implementation intervention Hybrid Type III: test implementation intervention, observe/gather information on clinical intervention and outcomes Geoff Curran 2010

21. EVALUATION Formative evaluation - Rigorous assessment of the process designed to identify potential and actual influences on the progress and effectiveness of implementation efforts (Stetler et al, 2006) Fidelity – extent implementation strategy was followed/refined; targeted users used the intervention as designed. Summative evaluation – impact on providers, patients/families, and health care delivery system/organization (effectiveness) Cost – Business Case analysis

22. Developmental Identify determinants of current practice Identify potential barriers / facilitators Assess feasibility of proposed intervention Integrate findings into intervention design and refinement prior to implementation Implementation-Focused Assess discrepancies between implementation plan and execution, exploring issues of fidelity, intensity, exposure Understand and document nature and implications of local adaptation Progress-Focused Monitor impacts and indicators of progress toward project goals Use data to inform need for modifying or refining original strategy Provide positive reinforcement to high performers; negative reinforcement to low performers Interpretive Assess intervention usefulness/value from stakeholder perspective Elicit stakeholder recommendations for further intervention refinements Assess satisfaction with intervention and implementation process Identify additional barriers / facilitators Stages of FE Post- Implementation Pre- Implementation Implementation Stetler et al, JGIM 2006

23. Assess Theoretical Fit Did actual experience fit with selected theory – how and why Under what circumstances did specific implementation activities succeed or fail What were the most important determinants of success? Failure? Why? CFIR: Consolidated Framework for Implementation –comprehensive taxonomy and definitions for constructs that influence implementation success Foundation to compare findings across studies and settings Damschroeder L et al Fostering implementation…Imp Sci 2009: 4(1): p 50.

24. How will we sustain the innovation? AHRQ Decisionmaker’s guide to adopting innovations: Will it work here? 2008 Can we expect the innovation to substitute for any current activities? How much staff time and other resources are needed to sustain? (booster training, training of new staff) How can we keep staff engaged?

25. Provide Clinical Resources to Market and Sustain change Reference Manuals Algorithms Grids or charts Websites Cue cards Pocket guides Posters Toolkits

26. Dissemination: Social Marketing Does not seek to benefit marketer Seeks to benefit target audience and general society Primary focus is on consumer ◦ Focus on what the consumer wants ◦ Seeks a change or call to action rather than to buy the product

27. Targets Patients

28. Targets Providers “Stall Street” News Guidelines posted in work areas

29. Summary Implementation research employs mixed methods and extensive planning and evaluation methodology IR engages front line users of EBP to locally tailor or adapt the implementation intervention IR evaluates both the process and outcomes of the implementation and clinical intervention. For additional info: QUERI Guide to Implementation Research http://www.hsrd.research.va.gov/queri/implementation/ http://www.hsrd.research.va.gov/queri/implementation/ Thank you!