Quality Improvement ResearchQuality Improvement Research

Carolyn Clancy, MDCarolyn Clancy, MD

DirectorDirector

Agency for Healthcare Research and QualityAgency for Healthcare Research and Quality

Secretary’s Advisory Committee on Human Research Protections (SACHRP) Secretary’s Advisory Committee on Human Research Protections (SACHRP)

Washington, DC – March 27, 2008Washington, DC – March 27, 2008

Quality Improvement ResearchQuality Improvement Research

Health System Health System TransformationTransformation

Challenges in QI Challenges in QI ResearchResearch

What We Know So FarWhat We Know So Far

What We Need to Move What We Need to Move ForwardForward

AHRQ’s MissionAHRQ’s Mission

Improve the quality, safety, Improve the quality, safety, efficiency and effectiveness of efficiency and effectiveness of health care for all Americanshealth care for all Americans

The Quality ChallengeThe Quality Challenge

What Is Quality?What Is Quality?

Health carecosts up 6.7%

per year

Health care quality up

2.3%

A Quality DisconnectA Quality Disconnect

The Right Care

For The Right Person

At The Right Time

Health Care Quality and AccessHealth Care Quality and Access

Disparities in health care quality and access Disparities in health care quality and access are staying the same or increasingare staying the same or increasing

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QualityQuality AccessAccess

2007 National Healthcare Disparities Report2007 National Healthcare Disparities Report

The Confluence of The Confluence of Research and QIResearch and QI

ResearchResearch QIQI

The Complexity of QI ResearchThe Complexity of QI Research

Quality Improvement Research is complex Quality Improvement Research is complex

– Not an intervention in the way we understand Not an intervention in the way we understand clinical interventionsclinical interventions

– Can be multi-levelCan be multi-level

– Involves organizational and behavioral changes as Involves organizational and behavioral changes as part of implementationpart of implementation

– Context beyond the “it” is importantContext beyond the “it” is important Quality improvement is local (often single site), but Quality improvement is local (often single site), but

Federal, State, professional policies impactFederal, State, professional policies impact

– QI interventions may change over time and QI interventions may change over time and between sites between sites

– Potential for harm – to whom?Potential for harm – to whom?

From T1 to T2 to T3From T1 to T2 to T3

AHRQ Investments AHRQ Investments in QI Researchin QI Research

Since 1993, AHRQ (often in Since 1993, AHRQ (often in partnership with NIH, VA and partnership with NIH, VA and others) has generated research others) has generated research on topics including:on topics including:– CancerCancer

– DiabetesDiabetes

– AsthmaAsthma

– Health ITHealth IT

– Patient Safety Patient Safety

– Chronic Care ModelChronic Care Model

Using mechanisms ofUsing mechanisms of– GrantsGrants

– ContractsContracts

The Current Evidence BaseThe Current Evidence Base

Diabetes care: Diabetes care: No single strategy more effective than No single strategy more effective than anotheranother

Hypertension care: Hypertension care: All assessed strategies may be All assessed strategies may be beneficial under some circumstances, and in varying beneficial under some circumstances, and in varying combinations.combinations. There may be other useful strategies There may be other useful strategies that have not been studied that have not been studied

Reducing antibiotic prescribing: Reducing antibiotic prescribing: No individual QI No individual QI strategy (or combination of strategies) was more strategy (or combination of strategies) was more effectiveeffective

Reducing healthcare-associated infections: Reducing healthcare-associated infections: studies studies are of suboptimal quality. Some strategies may be are of suboptimal quality. Some strategies may be worth more study.worth more study.

Care Coordination:Care Coordination: Evidence about key intervention Evidence about key intervention components is lackingcomponents is lacking

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

Pronovost StudyPronovost Study

Settings: Volunteer MI hospital Settings: Volunteer MI hospital ICUs for adults (108 intention to ICUs for adults (108 intention to treat)treat)

Primary hypothesis: Rate of Primary hypothesis: Rate of CABSIs would be reduced during CABSIs would be reduced during first 3 months of intervention v first 3 months of intervention v baselinebaseline

Multiple interventions (sequential Multiple interventions (sequential and parallel)and parallel)

Outcome measure: Incidence-Outcome measure: Incidence-rate ratios for CABSIs rate ratios for CABSIs

Pronovost et al., NEJM 355(26); Dec. 28, 2006Pronovost et al., NEJM 355(26); Dec. 28, 2006

Analytic approach: Generalized linear latent and mixed Analytic approach: Generalized linear latent and mixed model with robust variance estimation and random effects model with robust variance estimation and random effects to account for clustering within hospitals and hospitals to account for clustering within hospitals and hospitals within regions, adjusted for hospital teaching status and within regions, adjusted for hospital teaching status and number of bedsnumber of beds

New Yorker, December 2007New Yorker, December 2007

Northern New England Northern New England Cardiovascular Disease Study GroupCardiovascular Disease Study Group

Regional Voluntary ConsortiumRegional Voluntary Consortium– Maintains registries for CABG, PCI & heart Maintains registries for CABG, PCI & heart

valve replacementvalve replacement

– Databases & data collection tools track Databases & data collection tools track outcomes and help develop risk-adjusted outcomes and help develop risk-adjusted modelsmodels

The Promise of Quality ImprovementThe Promise of Quality Improvement

National studyNational study 46 primary care practices 46 primary care practices

(public & private)(public & private) 181 primary care clinicians181 primary care clinicians 1,356 depressed patients1,356 depressed patients Patient outcomes measured Patient outcomes measured

over five yearsover five years

Kenneth B. Wells, MD, UCLA Neuropsychiatric Institute & RandKenneth B. Wells, MD, UCLA Neuropsychiatric Institute & Rand

Partners in Care (PIC)Partners in Care (PIC)

PIC Clinics Were RandomizedPIC Clinics Were Randomized

Kenneth B. Wells, MD, UCLA Neuropsychiatric Institute & RandKenneth B. Wells, MD, UCLA Neuropsychiatric Institute & Rand

Design Design Unit of AnalysisUnit of Analysis Potential for Use Potential for Use Level of difficulty in Level of difficulty in current environmentcurrent environment

Randomized Randomized Controlled Controlled Trial (RCT)Trial (RCT)

Individual patient Individual patient level level

RareRare High High

--applies to few interventions--applies to few interventions

RCTRCT Providers/delivery Providers/delivery systems/policy systems/policy

RareRare HighHigh

--Refusal to be randomized--Refusal to be randomized

Cluster RCTCluster RCT Clinical practices, Clinical practices, States, etc.States, etc.

When more than one When more than one site can be randomized site can be randomized

High High

--single site studies the norm--single site studies the norm

--criteria for randomization --criteria for randomization unknownunknown

Quasi-Quasi-experimentsexperiments

(ITS)(ITS)

AllAll Frequent Frequent HighHigh

--academic acceptance--academic acceptance

--acceptance in practice--acceptance in practice

--funding--funding

QualitativeQualitative All?All? ?? HighHigh

--above, plus cost--above, plus cost

Research Designs and Research Designs and Methods for Internal ValidityMethods for Internal Validity

Some Provisional DefinitionsSome Provisional Definitions

Quality improvement InterventionQuality improvement Intervention– An effort to enhance the extent to which health care is An effort to enhance the extent to which health care is

safe, timely, effective, efficient, equitable, and patient-safe, timely, effective, efficient, equitable, and patient-centered and results in the best possible patient centered and results in the best possible patient outcomes. It can occur at the policy, delivery system, outcomes. It can occur at the policy, delivery system, or clinical microsystems levels (or all of these) and will or clinical microsystems levels (or all of these) and will enhance the way care delivery is structured, organized, enhance the way care delivery is structured, organized, and operationalized to ensure that patients receive and operationalized to ensure that patients receive care based on the best available evidence.care based on the best available evidence.

Implementation researchImplementation research– The scientific study of how specific sets of activities The scientific study of how specific sets of activities

and strategies are used to integrate evidence-based or and strategies are used to integrate evidence-based or evidence-informed policy-, organizational-, or provider-evidence-informed policy-, organizational-, or provider-oriented interventions within specific settings toward a oriented interventions within specific settings toward a goal of improving the quality of health caregoal of improving the quality of health care

What We Need to Move What We Need to Move Forward in QI ResearchForward in QI Research

DefinitionsDefinitions ConstructsConstructs Frameworks Frameworks Methods appropriate to answering QI Methods appropriate to answering QI

questionsquestions Methods for synthesizing resultsMethods for synthesizing results ResourcesResources

– ResearchersResearchers– Research Participants (policymakers, delivery Research Participants (policymakers, delivery

systems, providers)systems, providers)– FundingFunding

ConclusionConclusion

We need researchers and research We need researchers and research participants in order to learnparticipants in order to learn

We need to focus on resolving research We need to focus on resolving research ethics issues to enhance research capacity ethics issues to enhance research capacity

Implementation of effective QI interventions Implementation of effective QI interventions can and should proceed unfetteredcan and should proceed unfettered

QI researchers should understand the QI researchers should understand the flexibility provided by the Common Rule – flexibility provided by the Common Rule – both in terms of allowable exemptions and both in terms of allowable exemptions and waivers of informed consentwaivers of informed consent

Questions?Questions?

HTTP://WWW.AHRQ.GOVHTTP://WWW.AHRQ.GOV