Quality Enhancement Research Initiative

1. Quality Enhancement Research Initiative Introduction to Implementation Research: Policy/Practice Goals, Features and Current StatusBrian S. Mittman, PhDDirector, VA Center for Implementation Practiceand Research SupportJuly 14, 2010

2. Why implementation research? Implementation – and implementation research – are critical to: • the success of major policy initiatives in the US and internationally (in healthcare, education, environmental protection, criminal justice, economic competitiveness, etc.) and • achievement of the associated societal goals.

3. Why implementation research (cont.)? Implementation and implementation research are also critical to achievement of the institutional missions of: • health and social service research and research funding programs • professional schools (medicine, nursing, social welfare, education) • regulatory agencies, advocacy organizations and service delivery systems and agencies (including VHA)

4. Outline Part 1: The need for increased implementation and implementation research in health and health care Part 2: Defining and characterizing implementation research Part 3: Implementation research resources; systems engineering

5. The need to accelerate implementation in health:Two streams of policy concern • Stream 1 -- translational roadblocks; implementation gap barriers to rapid, efficient progression of innovations from basic science to clinical application to routine use • Stream 2 -- quality chasm gaps in the quality, safety, equity, efficiency, timeliness and patient-centeredness of health care delivery

6. Stream 1: Translational roadblocksand the Clinical Research Crisis • AAMC Clinical Research Summit: Clinical Research: A National Call to Action(Nov 1999) • IoM Clinical Research Roundtable (2000-2004)

7. Translational roadblocksand inefficiency in health research Basic / Lab Research Clinical Research Improved Health Basic / Lab Research Clinical Research Improved Health Type 2 Translation Type 1 Translation

8. The Implementation Gap(second translational roadblock) • NIH recognition • NIH Roadmap (June 2003+) and CTSA program

9. Investing in discovery/development vs. fidelity

10. Stream 2: The Quality Chasm in healthcare delivery • Institute of Medicine (1999, 2001) • US and international quality measurement studies

11. Key terms and concepts • diffusion • dissemination • implementation • innovation, best practice/evidence-based practice • intervention • implementation program, strategy • quality improvement (QI) • context

12. Implementation research vs.quality improvement research Generally speaking… • implementation research studies processes and strategies for increasing adoption, use of innovative, effective practices and research findings, whereas • quality improvement research studies approaches for addressing quality problems (often – but not always – via implementation of effective, innovative practices) Both fields encompass theory, research, policy and practice in organizational and professional behavior and behavior change

13. Outline Part 1: The need for increased implementation and implementation research in health and health care Part 2: Defining and characterizing implementation research Part 3: Implementation research resources; systems engineering

14. Implementation research definition Implementation research is the scientific study ofmethods to promote the systematic uptake of research findings and other evidence-based practices into routine practice, and, hence, to improve the quality and effectiveness of health services. It includes the study of influences on healthcare professional and organizational behavior. (Eccles/Mittman, 2006)

15. Implementation research goals • Develop reliable strategies for increasing use of evidence-based/effective services to improve outcomes; facilitate widespread adoption (scale-up/spread) of these strategies • Produce generalizable knowledge and increased understanding of implementation processes, barriers, facilitators, strategies • Develop, test and refine implementation theories and hypotheses; methods and measures

16. Expanded research-implementation pipeline: Implementation research and clinical research Health Behavior/Promotion Research Clinical Science Clinical TranslationalPre-ClinicalResearch Improved Health Processes, Outcomes Implemen-tationResearch Effective-ness Studies Basic Science Health Behavior Health Services Basic/Lab Science Health Services Research

17. Research-implementation pipeline:Implementation and pre-implementation studies Efficacy studies Observational studies of implementation Clinical Effectiveness studies Interventional implementation studies Health behavior Implementation gap diagnosis, documentation Health services Practice guidelines

18. Observations on the pipeline model • Research/implementation processes rarely progress in a linear manner • Implementation research can (should) be applied to a broad range of interventions, innovations, effective programs, etc. • Observational studies of (naturally occurring) implementation processes permit maximize policy/practice relevance and value, external validity, ability to study contextual factors

19. Observations on pipeline phases and transitions • Implementation trials should be preceded by adequatepre-implementation research (vs. “empirical treatment” approaches to implementation program design) • Hybrid effectiveness/implementation studies (vs. separate phases … e.g., “hand-off” of guidelines to implementation researchers) permit implementation gap diagnosis, preparation for implementation trials

20. Efficacy studies Clinical Health behavior Health services Research-implementation pipeline:Phased implementation trials Observational studies of implementation Effectiveness studies Interventional implementation studies Implementation gap diagnosis, documentation Practice guidelines Phase 4 “Post-Marketing” Monitoring, Refinement Phase 2 Small-Scale Efficacy Trials Phase 1 Pilot Projects Phase 3 Large-Scale Effectiveness Trials

21. Key features of implementation trials Heterogeneity of settings, interventions Context dependence, weak main effects Process and mechanism (vs. outcome/impact) focus Protocol-driven intervention adaptation; adaptive designs External validity vs. internal validity Cluster randomization Sustainability, scale-up/spread potential, economic evaluation

22. Outline Part 1: The need for increased implementation and implementation research in health and health care Part 2: Defining and characterizing implementation research Part 3: Implementation research resources; systems engineering

23. Implementation research resources Journals: Implementation Science; quality/safety; general medical/HSR/PH-HP Conferences: NIH D/I, KU/KT; SGIM, AcademyHealth, AHA/ACC Training: NIMH IRI, Canada KT, CIPRS Centers: QUERI, KP Colorado, EPOC, CTSAs (limited) University departments: GIM/HSR, Fam Med, Prev Med, Geriatrics, Nursing, SPH (Community Health, Health Services); management, education, public administration Professional Associations: AcademyHealth, SGIM, SBM

24. Implementation research vs. systems engineering An implementation researcher’s perspective on (and questions for) systems engineering research and its relationship to implementation research • Location of systems engineering ideas and research in the pipeline: source of effective practices? source of methods for performing implementation studies? • Alternative conception (modifying or replacing pipeline)? • Other?