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Quality Enhancement Research Initiative

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Presentation on theme: "Quality Enhancement Research Initiative"— Presentation transcript:

1 Quality Enhancement Research Initiative
Center for the Study of Healthcare Provider Behavior Applying Implementation Science to Enhance the Impact of Health Services Research Brian S. Mittman, PhD Senior Social Scientist VA/UCLA/RAND Center for the Study of Healthcare Provider Behavior June 5, 2007

2 Outline What is implementation science? Definition, scope, goals
Disciplinary foundations: theoretical, methodological How does IS relate to HSR? How can IS enhance HSR? What insights, conclusions and guidance does IS offer? How does one plan, conduct, document and use IS? What is needed to enhance IS (to further enhance HSR)?

3 Implementation science definition
“Implementation research is the scientific study of methods 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 and care.” “This relatively new field includes the study of influences on healthcare professional and organizational behavior.”

4 Implementation science goals
Generate new insights and generalizable knowledge regarding dissemination/implementation processes and strategies – and their outcomes and determinants Apply, test and refine models, theories and hypotheses Improve health-related processes and outcomes within participating settings and groups Develop reliable strategies for improving health-related processes and outcomes in other settings and groups

5 Implementation science and the pipeline IoM Clinical Research Roundtable identified two “translational roadblocks” Crowley WF, et al. Clinical Research in the United States at a Crossroads. JAMA :

6 IoM CRR translational roadblocks
Basic / Lab Research Clinical Research Improved Health Basic / Lab Research Clinical Research Improved Health

7 Revised depiction of health-related research / implementation pipeline
Clinical Translational,Pre-Clinical Research Improved Health Processes, Outcomes Basic Science Implemen- tation Research Health Behavior Health Services

8 Revised depiction of health-related research / implementation pipeline
Health Behavior/ Promotion Research Clinical Science Clinical Translational,Pre-Clinical Research Basic Science Implemen- tation Research Improved Health Processes, Outcomes Health Behavior Health Services Basic/Lab Science Health Services Research

9 Developing, implementing effective practices
Effective (evidence-based) practices are developed via clinical research, health behavior/promotion research, health services research HSR also studies attributes, use and impacts of effective clinical and health behavior/promotion practices Implementation research studies strategies and processes related to adoption/update (dissemination, implementation) of effective practices Not all research findings are suitable for implementation

10 Implementation science subfields, labels
Knowledge utilization Knowledge translation Diffusion research Research utilization Research translation Technology transfer Taking to scale Knowledge brokering Translational research Dissemination/implementation research

11 Implementation science foundations: theory, conceptual frameworks
Psychology, sociology, political science, economics Health psychology, organization/management theory Program evaluation, clinical research

12 Implementation science foundations: research approaches and frameworks
Clinical research: RCT, PCT frameworks Program evaluation: logic models, designs, measurement Health behavior/health promotion research: PBT, etc. Pipeline and phase models: IoM CRR, drug trials, complex interventions CONSORT-like statements, templates, criteria

13 Implementation theories and principles
Organization/management theory vs. psychological theories Systems, structures, policies/procedures, norms vs. attitudes and intentions Management principles and frameworks Multi-level framework (hypothesis) Multi-faceted portfolio addressing all levels Coordinated campaign

14 Implementation research frameworks
QUERI Six-Step Process QUERI 4-phase implementation research framework QUERI Service-Directed Project template: elements for an implementation research “CONSORT extension”

15 QUERI’s mission To enhance the quality, outcomes and efficiency of VA health care by systematically implementing evidence-based clinical guidelines and innovations into routine clinical practice Just a reminder--our mission remains the same. How to operationalize this mission is the focus of our meeting this year. We know that it’s working but need to begin to fill in the details of what we do, what works and what does not. Your active input during this meeting will help put some of the pieces of this amazing puzzle into place.

16 Nine QUERI coordinating centers
Chronic Heart Failure Diabetes HIV/AIDS Ischemic Heart Disease Mental Health Polytrauma Spinal Cord Injury Stroke Substance Use Disorder

17 Framework 1: The Six-Step QUERI Process
Identify high risk/high burden conditions Identify best practices Define existing practice patterns in VA and variations from best practices Identify (or develop) and implement programs to promote best practices Document outcome and system improvements Document improvements in health related quality of life

18 QUERI’s research/implementation pipeline
Step 1 Step M Step 3 Step C Step 2 Steps 4/5/6 Clinical, Health Behavior Research / Guideline Development Implementation Research Improved processes, outcomes Mainstream Health Services Research Clinical evidence (effective practices) Document/diagnose current practices and quality gaps Demonstration / evaluation projects

19 Expanded QUERI Six-Step Process
Step 1: Select Diseases/Conditions/Patient Populations 1A. Identify and prioritize (via a formal ranking procedure) high risk/high burden clinical conditions 1B. Identify high priority clinical practices/outcomes within a selected condition Step 2: Identify Evidence-Based Guidelines/Recommendations 2A. Identify evidence-based clinical practice guidelines 2B. Identify evidence-based clinical recommendations

20 Expanded QUERI Six-Step Process
Step 3: Measure and Diagnose Quality/Performance Gaps 3A. Measure existing practice patterns and outcomes across VHA and identify variations from evidence-based practices (quality, outcome and performance gaps) 3B. Identify determinants of current practices; diagnose quality gaps 3C. Identify barriers and facilitators to improvement (Step 3 activities are performed first in representative sites and then in Step 4/5/6 sites.)

21 Expanded QUERI Six-Step Process
Step 4: Implement Improvement Programs 4A. Identify quality improvement strategies, programs and program components or tools to address quality gaps (e.g., via literature reviews) 4B. Develop or adapt quality improvement strategies, programs, program components or tools (e.g., educational resources, decision support tools) 4C. Implement quality improvement strategies and programs Step 5/6: Evaluate Improvement Programs 5. Assess improvement program feasibility, implementation and impacts on patient, family and system outcomes 6. Assess improvement program impacts on health related quality of life (HRQOL)

22 Expanded QUERI Six-Step Process
Step M: Develop Measures, Methods and Data Resources M1. Develop and/or evaluate patient registries, cohort databases, data warehouses M2. Develop and/or evaluate case-finding or screening tools M3. Develop and/or evaluate structure, process or outcome measures M4. Develop and/or evaluate organizational structure/system, clinical practice, utilization or outcome databases Step C: Develop Clinical Evidence, Effective Practices C1. Develop evidence-based clinical interventions, recommendations (clinical research) C2. Develop evidence-based health promotion/prevention programs (health behavior/health promotion research) C3. Develop evidence-based health services interventions (health services research)

23 QUERI’s research/implementation pipeline
Step 1 Step M Step 3 Step C Step 2 Steps 4/5/6 Clinical, Health Behavior Research / Guideline Development Implementation Research Improved processes, outcomes Mainstream Health Services Research Phase 1 Pilot Projects Phase 2 Small-Scale Demonstrations Phase 3 Regional Demonstrations Phase 4 “National Rollout”

24 Framework 2: QUERI four-phase implementation research framework
Phase Study Type Form of Evaluation Pre-trial Design Conceptual design of implementation program and underlying program (logic) model from theory, prior empirical research Phase 1 Pilot / Pilot test, assess feasibility, formative evaluation and refinement, Formative develop intervention/evaluation protocols Phase 2 Efficacy Small-scale rigorous trial in controlled settings with ongoing intervention support Phase 3 Effectiveness Large-scale rigorous trial under routine conditions in varied settings Phase 4 Monitoring Ongoing monitoring and feedback

25 Framework 3: QUERI Service-Directed Project template
Motivation implementation projects are hybrid research/practice initiatives implementation projects require a unique set of design features, methods, skills and competencies Goal provide guidance in designing, conducting and documenting implementation projects

26 QUERI Service-Directed Project Template
A. Specific aims Implementation aims: short- and long-term (phases) Science aims: theory/models, empirical insights Hypotheses: intervention impacts, influences B. Background and significance Clinical issue: morbidity, mortality, burden Clinical evidence (effective practice): strength, acceptance, implementation gaps (magnitude, potential to close) Implementation processes, knowledge

27 QUERI SDP Template C. Previous studies
Current practices: determinants, barriers and facilitators to change Implementation strategy: theory, empirical evidence base and status (phase)

28 QUERI SDP Template D. Design and methods
Intervention overview (conceptual framework, approach) Intervention details (components, operational details): Legitimacy of evidence Motivation for change, external expectations, pressure Norms (organizational, professional, consumer) Clinician, staff, consumer education and skills Financial, administrative, logistical facilitation Organizational redesign, as needed Tailoring and adaptation Monitoring and refinement

29 QUERI SDP Template D. Design and methods (continued)
Evaluation details Experimental design Usual care condition Randomization protocol Diagnostic analysis: practice determinants; barriers and facilitators to change Formative evaluation: overall plan, details Impact (summative) evaluation: overall plan Process evaluation Project sites, site recruitment Subjects, subject recruitment

30 QUERI SDP Template D. Design and methods (continued)
Evaluation details, impact evaluation Outcomes (clinical practices, patient outcomes, system outcomes): variables, measures, data collection protocols Contextual factors: variables, measures, data collection protocols Analysis plans and methods; interpretation (research, policy, practice)

31 QUERI SDP Template D. Design and methods (continued)
Evaluation details, process evaluation Identify mechanisms of impact and measures: variables, measures, data collection protocols Influences on mechanisms: variables, measures, data collection protocols Analysis plans and methods Evaluation details, other Sustainability (phase 3) Cost (phase 3)

32 QUERI SDP Template D. Design and methods (continued) Management plan
Intervention management plan, team Evaluation management plan, team Staff qualifications: intervention, evaluation

33 Implementation research resources
Northstar, RE-AIM, UK MRC, etc. Phase models, efficacy/effectiveness studies Green/Glasgow external validity criteria Experimental/quasi-experimental designs, cluster RCTs Stetler et al, formative evaluation, process evaluation Economic evaluation CONSORT-like statements, templates Diffusion, dissemination, implementation theories, models Qualitative research methods Publication guidelines (protocols, main and supporting)

34 Key challenges Increase quality and quantity of implementation research Quantity Steve Woolf’s Breakeven Point: greater benefit from investing in enhanced use of existing innovations vs. developing new innovations Negative relationship between QI success and evaluation rigor: temporal trends, QI paradox Quality Modest contribution of QI/implementation research (symptom) Inconsistencies in peer reviews, approaches/methods, legitimacy Lack of academic programs, standards, journals, conferences

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