Quality Improvement Research

1. Quality Improvement Research Carolyn Clancy, MD Director Agency for Healthcare Research and Quality Secretary’s Advisory Committee on Human Research Protections (SACHRP) Washington, DC – March 27, 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? 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 Confluence of Research and QI Research QI

7. 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?

8. From T1 to T2 to T3

9. 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 AHRQ Investments in QI Research

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 http://www.ahrq.gov/clinic/epcindex.htm#quality

11. 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 • Multiple interventions (sequential and parallel) • Outcome measure: Incidence-rate ratios for CABSIs 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

12. Northern New England Cardiovascular Disease Study Group • Regional Voluntary Consortium • Maintains registries for CABG, PCI & heart valve replacement • Databases & data collection tools track outcomes and help develop risk-adjusted models

13. The Promise of Quality Improvement Partners in Care (PIC) • National study • 46 primary care practices (public & private) • 181 primary care clinicians • 1,356 depressed patients • Patient outcomes measured over five years Kenneth B. Wells, MD, UCLA Neuropsychiatric Institute & Rand

14. PIC Clinics Were Randomized Kenneth B. Wells, MD, UCLA Neuropsychiatric Institute & Rand

15. Research Designs and Methods for Internal Validity

16. 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

17. 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

18. 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

19. Questions? HTTP://WWW.AHRQ.GOV