Quality Enhancement
Research Initiative
Frameworks for Implementation Science and
Quality Improvement Research
Brian S. Mittman, PhD
Center for Implementation Practice
and Research Support (CIPRS)
U.S. Department of Veterans Affairs
June 29, 2009
Outline
Part 1: Policy foundation and goals:
Clinical Research Crisis, Healthcare Quality Chasm
Part 2: Implementation research and its role in the
health research pipeline
Part 3: Frameworks for developing an integrated
program of implementation research
The need to accelerate implementation:
Two streams of policy concern
• Stream 1 – clinical research translational roadblocks
Significant barriers impede timely progression of innovations
from basic science to clinical application to routine use and
population benefit
• Stream 2 – the healthcare quality chasm
Pervasive gaps exist in the quality, safety, equity, efficiency,
timeliness and patient-centeredness of healthcare
Stream 1: The “Clinical Research Crisis”
and Implementation Gap
• AAMC Clinical Research Summit: Clinical Research: A National
Call to Action (Nov 1999)
• IoM Clinical Research Roundtable (2000-2004)
• NIH Roadmap: New Pathways to Discovery, Research Teams of
the Future, and Reengineering the Clinical Research Enterprise
(June 2003)
• FDA Critical Path initiative: Innovation or Stagnation? -- Challenge
and Opportunity on the Critical Path to New Medical Products
(Mar 2004)
• Similar reports have been issued in the UK, Canadian, elsewhere
Stream 1: Translational roadblocks:
IoM Clinical Research Roundtable
Sung NS, Crowley WF et al., Central challenges facing the
national clinical research enterprise, JAMA 2003.
Translational roadblocks and inefficiency
in health research: simplified depiction
Basic / Lab
Research
Basic / Lab
Research
Clinical
Research
Clinical
Research
Improved
Health
Improved
Health
Stream 2: Healthcare “Quality Chasm”
• IoM National Roundtable on Health Care Quality, “The Urgent
Need to Improve Health Care Quality” (JAMA 1998)
• IoM: To Err is Human (1999), Crossing the Quality Chasm (2001)
• McGlynn et al, “The Quality of Health Care Delivered to Adults in
the United States” (NEJM 2003)
• Commonwealth Fund Commission on a High Performance Health
System (2005-present)
• Additional US and non-US reports
Implementation gaps and the quality chasm
• Stream 1 – clinical research translational roadblocks
• Stream 2 – the healthcare quality chasm
Most healthcare quality gaps result from insufficient
implementation of evidence-based practices
Strategies and programs to accelerate implementation
and to improve quality are similar and generally involve
organizational and professional behavior change
Outline
Part 1: Policy foundation and goals:
Clinical Research Crisis, Healthcare Quality Chasm
Part 2: Implementation research and its role in the
health research pipeline
Part 3: Frameworks for developing an integrated
program of implementation research
“Implementation research in health”
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.
It includes the study of influences on healthcare
professional and organizational behavior.
-- Eccles and Mittman, Implementation Science 2006
Refined research-implementation pipeline:
Implementation research and clinical research
Health Behavior/
Promotion Research
Clinical Science
Clinical
Basic
Science
Translational
Pre-Clinical
Research
Health Behavior
Effective
-ness
Studies
Health Services
Basic/Lab Science
Health Services Research
Implementation
Research
Improved
Health
Processes,
Outcomes
Pipelines, roadmaps and roadblocks:
conceptual, definitional confusion
• Multiple labels
– knowledge translation, translational research
– research utilization, knowledge utilization
– knowledge to action, knowledge exchange
– technology transfer
– T1 vs. T2; translation type 1 vs. type 2 (type 3, 4)
• The label “Implementation research” (“implementation science”)
– aims to facilitate clarity and consensus
– avoid pejorative terminology
Implementation research challenges
• Quantity (“Breakeven point”) and quality
• Planning (individual studies, research programs)
– study goals and objectives
– study content and components
– sequencing of implementation studies relative to other
health-related studies
• Design, conduct and reporting
– research approaches
– study designs and methods
– documentation
Implementation research foundations
and sources of guidance
• Clinical research
• Program evaluation
• Health promotion research (complex behavioral pgms)
• Education, public policy, management research
• Phase models, CONSORT statements, additional
templates for study planning and design
Outline
Part 1: Policy foundation and goals:
Clinical Research Crisis, Healthcare Quality Chasm
Part 2: Implementation research and its role in the
health research pipeline
Part 3: Frameworks for developing an integrated
program of implementation research
Implementation research frameworks
Planning
1. Research-Implementation Pipeline
2. QUERI Six-Step Process
3. 4-Phase Implementation Research Framework
Design, conduct and reporting
4. QUERI Service-Directed Project Template
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
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 outcomes and areas of practice within a
selected condition
Step 2: Identify Evidence-Based Guidelines, Practices
2A. identify evidence-based clinical practice guidelines and
recommendations
2B. identify evidence-based clinical practices, care models
Prioritize recommendations for implementation (based on gap,
importance for outcomes, feasibility of improvement)
Expanded QUERI Six-Step Process
Step 3: Measure and Diagnose Quality/Performance Gaps
3A. measure existing practice patterns and outcomes and identify
variations from evidence-based practices and benchmark
outcomes (quality, outcome and performance gaps)
3B. identify determinants of current practices
3C. diagnose quality gaps
3D. identify barriers and facilitators to improvement
Expanded QUERI Six-Step Process
Step 4: Implement Improvement Programs
4A. identify implementation/quality improvement strategies, programs
and program components or tools (e.g., via literature reviews)
4B. develop implementation/quality improvement strategies, programs,
program components or 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)
Pre-QUERI Steps
Step M: Develop measures, methods and data resources
Step C: Develop clinical evidence (effective practices)
Step E:
Effectiveness studies (including research on
elements of implementation)
Step O: Observational studies of implementation
processes
QUERI Research-Implementation Pipeline
Step 1: select conditions
Step E: effectiveness studies
Step C: clinical research
Step 2: best practices
Step 3: document, diagnose gaps
Clinical Research
Health Behavior Res
Effectiveness
Studies
Health Services Res
Implementation
Research
Practice Guidelines
Step M: methods, data
Steps 4/5/6: implementation program
demonstration/evaluation
Step O: observational studies
of implementation
QUERI Research-Implementation Pipeline
Steps 4/5/6: implementation program
demonstration/evaluation
Clinical Research
Health Behavior Res
Effectiveness
Studies
Health Services Res
Improved
processes,
outcomes
Implementation
Research
Practice Guidelines
Phase 1
Pilot Projects
Phase 2
Small-Scale
Efficacy Trials
Phase 3
Large-Scale
Effectiveness
Trials
Phase 4
“Post-Marketing”
Monitoring,
Refinement
QUERI Four-Phase Implementation
Research Framework
Phase
Study Type
Form of Evaluation
Pre-trial Program
Conceptual design of implementation program and underlying
design (logic) model from theory, prior empirical research
Phase 1 Pilot /
Formative
Pilot test, assess feasibility, formative evaluation and refinement,
develop intervention/evaluation protocols
Phase 2 Efficacy
Small-scale rigorous trial in controlled settings with ongoing
intervention support; emphasis on internal validity
Phase 3 Effectiveness Large-scale rigorous trial under routine conditions in varied
settings; emphasis on external validity
Phase 4 Monitoring
Ongoing monitoring and feedback
Quality Enhancement
Research Initiative
Implementation Science and
Quality Improvement Research:
Methods for Translating Research into Practice
Center for the Study of Healthcare Provider Behavior
Center for Implementation Practice
and Research Support
U.S. Department of Veterans Affairs
June 29, 2009
Workshop Goals
• Define and describe implementation science (IS) and
quality improvement research (QIR)
• Discuss why IS and QIR are important, particularly in
2009
• Present frameworks and methods for planning, designing
and conducting IS and QIR (intervention, evaluation)
• Discuss challenges facing the field and impeding progress
Quality Enhancement
Research Initiative
Implementation Science and
Quality Improvement Research:
Methods for Translating Research into Practice
Center for the Study of Healthcare Provider Behavior
Center for Implementation Practice
and Research Support
U.S. Department of Veterans Affairs
June 29, 2009
Evaluating implementation program effectiveness
Two very different questions
1. Does it work?
Should I use it or not? (formulary decision)
2. How, when, why and where does it work?
How should I use it?
Implementation research challenges
• What is the nature of the desired evidence, knowledge,
insights, understanding (and the associated learning,
skills and abilities)?
• How is this understanding generally produced?
Mechanism- vs. impact-oriented approaches
• Is our current portfolio producing this understanding and
generating this learning? (Are prevailing research
approaches, designs and methods – and projects –
appropriate?)
• Must we rebalance our portfolio? How?