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 Health System Transformation Challenges in QI Research Challenges in QI Research What We Know So Far What We Know So Far What We Need to Move Forward 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? Health care costs up 6.7% per year Health care quality up 2.3% A Quality Disconnect The Right Care For The Right Person At The Right Time

5. Health Care Quality and Access Disparities in health care quality and access are staying the same or increasing n=number of core measures QualityAccess 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 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 Quality improvement is local (often single site), but u 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. AHRQ Investments in QI Research Since 1993, AHRQ (often in partnership with NIH, VA and others) has generated research on topics including: 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 Using mechanisms of – Grants – Contracts

10. The Current Evidence Base Diabetes care: No single strategy more effective than another 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 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 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. 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 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) 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 Primary hypothesis: Rate of CABSIs would be reduced during first 3 months of intervention v baseline Multiple interventions (sequential and parallel) Multiple interventions (sequential and parallel) Outcome measure: Incidence-rate ratios for CABSIs Outcome measure: Incidence-rate ratios for CABSIs Pronovost et al., NEJM 355(26); Dec. 28, 2006 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 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 New Yorker, December 2007

12. Northern New England Cardiovascular Disease Study Group Regional Voluntary Consortium 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 National study National study 46 primary care practices (public & private) 46 primary care practices (public & private) 181 primary care clinicians 181 primary care clinicians 1,356 depressed patients 1,356 depressed patients Patient outcomes measured over five years Patient outcomes measured over five years Kenneth B. Wells, MD, UCLA Neuropsychiatric Institute & Rand Partners in Care (PIC)

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

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

16. Some Provisional Definitions Quality improvement Intervention 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 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 Definitions Constructs Constructs Frameworks Frameworks Methods appropriate to answering QI questions Methods appropriate to answering QI questions Methods for synthesizing results Methods for synthesizing results Resources Resources – Researchers – Research Participants (policymakers, delivery systems, providers) – Funding

18. Conclusion We need researchers and research participants in order to learn We need researchers and research participants in order to learn We need to focus on resolving research ethics issues to enhance research capacity We need to focus on resolving research ethics issues to enhance research capacity Implementation of effective QI interventions can and should proceed unfettered 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 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