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

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

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

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%

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

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?

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. 2319-2321. The “3T’s Roadmap to Transform U.S. Health Care: The ‘How’ of High-Quality Care.”

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

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

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

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

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

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

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

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”

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

Questions? HTTP://WWW.AHRQ.GOV

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