1. Quality Improvement Research
Carolyn Clancy, MD
Director
Agency for Healthcare Research and Quality
AcademyHealth Annual Research Meeting
Washington, DC – June 9, 2008

2. Quality Improvement Research
Health System Transformation
Challenges in QI Research
What We Know So Far
What We Need to Move Forward

3. AHRQ’s Mission
Improve the quality, safety, efficiency and effectiveness of health care for all Americans

4. The Quality Challenge What Is Quality? A Quality Disconnect The Right
Care
For The
Right Person
At The
Right Time
A Quality Disconnect
Health care
costs up 6.7%
per year
Health care
quality up
2.3%

5. Health Care Quality and Access
Disparities in health care quality and access are staying the same or increasing
Quality
Access
n=number of core measures
2007 National Healthcare Disparities Report

6. The Complexity of QI Research
Quality Improvement Research is complex
Not an intervention in the way we understand clinical interventions
Can be multi-level
Involves organizational and behavioral changes as part of implementation
Context beyond the “it” is important
Quality improvement is local (often single site), but
Federal, State, professional policies impact
QI interventions may change over time and between sites
Potential for harm – to whom?

7. The 3 T’s Road Map to Transforming U.S. Health Care
T indicates translation. T1, T2, and T3 represent the 3 major translational steps in the proposed framework to transform the health care system. The activities in each translational step test the discoveries of prior research activities in progressively broader settings to advance discoveries originating in basic science research through clinical research and eventually to widespread implementation through transformation of health care delivery. Double-headed arrows represent the essential need for feedback loops between and across the parts of the transformation framework.
Source: JAMA, May 21, 2008: D. Dougherty and P.H. Conway, pp The “3T’s Roadmap to Transform U.S. Health Care: The ‘How’ of High-Quality Care.”

8. AHRQ Investments in QI Research
Since 1993, AHRQ (often in partnership with NIH, VA and others) has generated research on topics including:
Cancer
Diabetes
Asthma
Health IT
Patient Safety
Chronic Care Model
Using mechanisms of
Grants
Contracts

9. Pronovost Study
Settings: Volunteer MI hospital ICUs for adults (108 intention to treat)
Primary hypothesis: Rate of CABSIs would be reduced during first 3 months of intervention v baseline
Interventions (sequential and parallel)
Outcome measure: Incidence-rate ratios for CABSIs
Interventions (sequential and parallel)
Designation of team leaders (doc + nurse) partnered with infection control specialists at each hospital
Team instruction in the science of safety
Training/coaching/statewide meetings
Comprehensive unit-based safety programs to improve culture
Daily goals sheet
Intervention to reduce VAP
Reminders of CDC-recommended procedures (including checklist)
Letter to CEOs about stocking chlorhexidine
New Yorker, December 2007
Analytic approach: Generalized linear latent and mixed model with robust variance estimation and random effects to account for clustering within hospitals and hospitals within regions, adjusted for hospital teaching status and number of beds
Pronovost et al., NEJM 355(26); Dec. 28, 2006

10. The Current Evidence Base
Diabetes care: No single strategy more effective than another
Hypertension care: All assessed strategies may be beneficial under some circumstances, and in varying combinations. There may be other useful strategies that have not been studied
Reducing antibiotic prescribing: No individual QI strategy (or combination of strategies) was more effective
Reducing healthcare-associated infections: studies are of suboptimal quality. Some strategies may be worth more study.
Care Coordination: Evidence about key intervention components is lacking

11. What We Need to Move Forward in QI Research
Definitions
Constructs
Frameworks
Methods appropriate to answering QI questions
Methods for synthesizing results
Resources
Researchers
Research Participants (policymakers, delivery systems, providers)
Funding

12. Some Provisional Definitions
Quality improvement Intervention
An effort to enhance the extent to which health care is safe, timely, effective, efficient, equitable, and patient-centered and results in the best possible patient outcomes. It can occur at the policy, delivery system, or clinical microsystems levels (or all of these) and will enhance the way care delivery is structured, organized, and operationalized to ensure that patients receive care based on the best available evidence.
Implementation research
The scientific study of how specific sets of activities and strategies are used to integrate evidence-based or evidence-informed policy-, organizational-, or provider-oriented interventions within specific settings toward a goal of improving the quality of health care
Source: FORTHCOMING AHRQ IMPLEMENTATION FOA

13. An Interlocking Set of Challenges
Concept/Scope of
QI Poorly
Understood
( IRBs,
Funders,
Mainstream
Health
Research
Community,
Healthcare Industry)
Focus On
RCT/
Patient level As
“Gold
Standard”
For Evidence
Lack of
Interest in
Rigorous
Evaluation
Paucity of
Basic
Science on
Context QI
Interventions
Poorly
Defined
(Field)
Limited $
Limited
Publication
Venues
Academic
Interest

14. What Evidence Can We Share?
What can we as researchers and disseminators of funded research findings share about effective quality improvement strategies?
The glass can be considered half-full or half-empty

15. 21st Century Health Care
Improving quality by promoting a culture of safety through Value-Driven Health Care
Information-rich, patient-focused enterprises
Information and evidence transform interactions from reactive to proactive (benefits and harms)
Evidence is continually refined as a by-product of care delivery
21st Century Health Care
Actionable information available – to clinicians AND patients – “just in time”

16. Conclusion
We need researchers and research participants in order to learn
We need to focus on resolving research ethics issues to enhance research capacity
Implementation of effective QI interventions can and should proceed unfettered
QI researchers should understand the flexibility provided by the Common Rule – both in terms of allowable exemptions and waivers of informed consent

17. Questions?

18. Research Designs and Methods for Internal Validity
Unit of Analysis
Potential for Use
Level of difficulty in current environment
Randomized Controlled Trial (RCT)
Individual patient level
Rare
High
--applies to few interventions
RCT
Providers/delivery systems/policy
--Refusal to be randomized
Cluster RCT
Clinical practices, States, etc.
When more than one site can be randomized
--single site studies the norm
--criteria for randomization unknown
Quasi-experiments
(ITS)
All
Frequent
--academic acceptance
--acceptance in practice
--funding
Qualitative
All? ?
--above, plus cost