1. Advancing Implementation Science: Process & Outcome Conceptual Framework Enola Proctor George Warren Brown School of Social Work Washington University in St. Louis Improving Implementation Research Methods for Behavioral and Social Science Meeting Silver Spring, MD September 20, 2010

2. Definitions drive conceptual framework Implementation science= Scientific study of the process of moving new practices into routine care

3. Key components for focus in IR Implementation Research concepts What?QI’s/ EST’s Where?Setting (multi-level) Who?Stakeholders How?Implementation strategies* Why?Outcomes:* Implementation outcomes Service system outcomes Health status outcomes * Strategies &Outcomes = focus of presentation

4. The “What” (is being implemented?)  Treatment guidelines  Evidence-based treatments  Empirically supported programs  Quality improvement processes that have been shown effective Product of nation’s investment of $$ billions in basic, clinical efficacy, effectiveness and CER

5. THE “WHERE” “Where” Real-world care = target of implementation science Health, behavioral health, and social service delivery systems Complex organizations Varying infrastructures “Who” Array of providers, with variable training in EBP

6. Why? To what effect? producing change in usual care provision of evidence-based treatment Outcomes: clinical, service system, implementation

7. Implementation Outcomes Acceptability Adoption Appropriateness Feasibility Fidelity I Costs Penetration Sustainability - *IOM Standards of Care Conceptual Model for Implementation Research What? QIs ESTs How? Implementation Strategies Implementation Research Methods Service Outcomes* Efficiency Safety Effectiveness Equity Patient- centeredness Timeliness Patient Outcomes Satisfaction Function Health status/ symptoms Proctor et al 2009 Admin. & Pol. in Mental Health Services

8. Emphasis of conceptual model Distinguishes processes from outcomes Emphasizes two process technologies: –QI’s/ EST’s –Implementation strategies Outcome distinctions –Implementation outcomes versus service & client outcomes –Types of implementation outcomes

9. Key components for focus in IR: Implementation Strategies systematic intervention processes to adopt and integrate evidence-based health interventions; impact organizational structure, climate, & culture; and change practice patterns within specific settings, thus enabling the …implementation of effective clinical interventions* * consistent with NIH PAR-10-0380

10. Implementation requires strategic interventions Won’t happen by admonition, or order Requires deliberate and targeted action –Thus need for empirically tested implementation strategies

11. Implementation strategies Preponderance of descriptive research: Identifying barriers to implementation Observations of “usual” care in changing practice (naturalistic spread, implementation) Need to derive strategies from theory, from descriptive studies Context of implementation demands strategies for multiple levels  Policy  Organizational  Provider  Patient/consumer

12. Taxonomies of implementation strategies Leeman et al., 2006, Journal of Advanced Nursing –14 methods in 5 categories: increasing coordination; raising awareness; persuasion via interpersonal channels; persuasion via reinforcing belief that behavior will lead to desirable results and increasing behavioral control EPOC, Cochrane Collaboration –4 categories: Professional, financial, organizational, regulatory AHRQ critical analysis of QI strate gies –5 categories: Provider, information systems, financial, org change, patient education & reminders

13. Organizational implementation strategies: Examples: Organizational interventions: –Revision of professional roles (boundary shifting, expansion of roles) –Team building, including clinical multidisciplinary teams –Improving organizational climate and culture* –Electronic data and decision support tools –Co-location of care * Glisson, ARC model

14. Provider/ professional implementation strategies: Examples: Provider/ professional interventions: –Educational materials and meetings –Local consensus processes –Academic detailing (information to providers) –Local opinion leaders –Client-mediated interventions (score feedback to providers) –Audit and feedback (summary of clinical performance) –Reminders –Marketing *EPOC, also Gilbody et al, JAMA, 2003

15. Implementation strategies: 30,000 ft. perspective Top down versus bottom up “Package” or “bundled approaches, with overlap Little empirical evidence for components Few tests of comparative effectiveness

16. Research priorities: Implementation Strategies 1)Develop taxonomies of distinct implementation strategies for each level of change initial “measurement” work = nominal definition, conceptual distinctions, internal consistency within categories 2)Discover “breakthroughs” to the barriers to the delivery of evidence-based health care 3)Shape implementation strategies with use in mind; around stakeholder preferences 4) Map pathways (non-linear) to uptake and sustainability

17. Research Priorities, cont’d. 5)Test the comparative effectiveness of implementation strategies 6)Test relationships between EST’s and Implementation strategies: Are implementation strategies effective across different EST’s? Drill down: Core components of implementation strategies, unique contribution (for parsimony) 7)Test generalizability of strategies across settings

18. Key components for focus in IR: Implementation Outcomes = the effects of deliberate and purposive actions to implement new treatments, practices, and services Provides way to conceptualize and measure success of implementation processes

19. Implementation outcomes Serve as intermediate outcomes, or proximal reflections of, efforts to change clinical outcomes Implementation outcomes are distinct from clinical outcomes –Could have an effective intervention, poorly implemented –Could have an ineffective treatment, successfully implemented

20. Implementation Outcomes Acceptability Adoption Appropriateness Feasibility Fidelity I Costs Penetration Sustainability - *IOM Standards of Care Conceptual Model for Implementation Research What? QIs ESTs How? Implementation Strategies Implementation Research Methods Service Outcomes* Efficiency Safety Effectiveness Equity Patient- centeredness Timeliness Patient Outcomes Satisfaction Function Health status/ symptoms Proctor et al 2008 Admin. & Pol. in Mental Health Services

21. Implementation outcomes: state of art: 30,000 ft perspective Overlapping concepts Inconsistent terminology Literature: Scattered across health and behavioral health fields

22. Implementation Outcomes: Research agenda 1)Advancing consistency of terminology 2)Advancing measurement 3)Mapping inter-relationships (non-linear) among implementation outcomes 4)Testing salience to stakeholders 5)Testing salience over implementation process 6)As outcomes for tests of implementation strategies

23. Key components for focus in IR: Multiple stakeholders service consumers families providers administrators funders legislators

24. Multiple stakeholders have different priorities Shumway research: –Stakeholder groups value and prioritize different clinical outcomes We expect that different stakeholders differ regarding implementation strategies and outcomes: Rationale Preferences Priorities

25. Implementation research is team science Transdisciplinary:  economics, policy, organizational researchers  psychologists, social workers, MD’s, anthropologists, Convergence of research perspectives:  mixed methods  treatment researchers  service systems researchers  research design specialists  measurement specialists

26. Implementation research is transdisciplinary, team science Transcends “disease states” and funding streams “Field” of D&I must be built –Training needs paramount –Implementation Research Institute R25 supported 2 year institute in mental health) –Dissemination and Implementation Research Cores, providing technical assistance to researchers: In research centers Through CTSA’s

27. Acknowledgements Paper Co-authors: Greg Aarons, David Chambers, Charles Glisson, John Landsverk, Brian Mittman Adm. Policy Mental Health (2009) 36:24–34 Funding support:  Center for Mental Health Services Research, NIMH “Advanced” Center with focus on implementation science, 5 P30 MH068579  Institute for Clinical and Translational Science, ICTS 5UL1RR024992  Implementation Research Institute in Mental Health, R25 MH080916 & Veterans Administration Contract

28. Contact & Disclosure: Enola Proctor Enola Proctor, Director, CMHSR 314-935-6660 ekp@wustl.edu iri@brownschool.wustl.edu No relevant financial interests to disclose