Advancing Implementation Science:Process & Outcome Conceptual Framework

Enola ProctorGeorge Warren Brown School of Social Work

Washington University in St. Louis

Improving Implementation Research Methods for Behavioral and Social Science MeetingSilver Spring, MD September 20, 2010

Definitions drive conceptual framework

Implementation science=

Scientific study of the process ofmoving new practices into routinecare

Key components for focus in IR

Implementation Research concepts

What? QI’s/ EST’s

Where? Setting (multi-level)

Who? Stakeholders

How? Implementation strategies*

Why? Outcomes:*Implementation outcomesService system outcomesHealth status outcomes

* Strategies & Outcomes = focus of presentation

The “What” (is being implemented?)

Treatment guidelines Evidence-based treatments Empirically supported programs Quality improvement processes that have

been shown effective

Product of nation’s investment of $$ billions in

basic, clinical efficacy, effectiveness and CER

THE “WHERE”“Where”

Real-world care = target of implementation science

Health, behavioral health, and social service delivery systems

Complex organizations

Varying infrastructures

“Who”

Array of providers, with variable training in EBP

Why?

• To what effect?

producing change in usual care

provision of evidence-based treatment

Outcomes:

clinical, service system, implementation

Implementation Outcomes

AcceptabilityAdoption

Appropriateness Feasibility

FidelityI Costs

PenetrationSustainability

-

*IOM Standards of Care

Conceptual Model for Implementation Research

What?

QIsESTs

How?

ImplementationStrategies

Implementation Research Methods

ServiceOutcomes*Efficiency

SafetyEffectiveness

EquityPatient-

centerednessTimeliness

Patient Outcomes

SatisfactionFunction

Health status/symptoms

Proctor et al 2009 Admin. & Pol. in Mental Health Services

Emphasis of conceptual model

• Distinguishes processes from outcomes

• Emphasizes two process technologies:– QI’s/ EST’s

– Implementation strategies

• Outcome distinctions– Implementation outcomes versus service & client

outcomes

– Types of implementation outcomes

Key components for focus in IR: Implementation Strategies

systematic intervention processes to adopt and integrate evidence-based health interventions; impact organizational structure, climate, & culture; and change practice patterns within specific settings, thus enabling the …implementation of effective clinical interventions*

*consistent with NIH PAR-10-0380

Implementation requires strategic interventions

• Won’t happen by admonition, or order

• Requires deliberate and targeted action– Thus need for

empirically tested implementation strategies

Implementation strategies

• Preponderance of descriptive research:

Identifying barriers to implementation

Observations of “usual” care in changing practice (naturalistic spread, implementation)

• Need to derive strategies from theory, from descriptive studies

• Context of implementation demands strategies for multiple levels Policy Organizational Provider Patient/consumer

Taxonomies of implementation strategies

• Leeman et al., 2006, Journal of Advanced Nursing– 14 methods in 5 categories: increasing coordination; raising

awareness; persuasion via interpersonal channels; persuasion via reinforcing belief that behavior will lead to desirable results and increasing behavioral control

• EPOC, Cochrane Collaboration– 4 categories: Professional, financial, organizational, regulatory

• AHRQ critical analysis of QI strategies– 5 categories: Provider, information systems, financial, org

change, patient education & reminders

Organizational implementation strategies:

Examples: • Organizational interventions:

– Revision of professional roles (boundary shifting, expansion of roles)

– Team building, including clinical multidisciplinary teams

– Improving organizational climate and culture*– Electronic data and decision support tools– Co-location of care

• * Glisson, ARC model

Provider/ professional implementation strategies:

Examples: • Provider/ professional interventions:

– Educational materials and meetings– Local consensus processes– Academic detailing (information to providers)– Local opinion leaders– Client-mediated interventions (score feedback to providers)– Audit and feedback (summary of clinical performance)– Reminders– Marketing

• *EPOC, also Gilbody et al, JAMA, 2003

Implementation strategies: 30,000 ft. perspective

Top down versus bottom up

“Package” or “bundled approaches, with overlap

Little empirical evidence for components

Few tests of comparative effectiveness

Research priorities: Implementation Strategies

1) Develop taxonomies of distinct implementation strategies for each level of change

initial “measurement” work = nominal definition, conceptual distinctions, internal consistency within categories

2) Discover “breakthroughs” to the barriers to the delivery of evidence-based health care

3) Shape implementation strategies with use in mind; around stakeholder preferences

4)  Map pathways (non-linear) to uptake and sustainability

 

 

Research Priorities, cont’d.

5) Test the comparative effectiveness of implementation strategies

6) Test relationships between EST’s and Implementation strategies:

Are implementation strategies effective across different EST’s?

Drill down: Core components of implementation strategies, unique contribution (for parsimony)

7) Test generalizability of strategies across settings

Key components for focus in IR: Implementation Outcomes

= the effects of deliberate and purposive actions to implement new treatments, practices, and services

Provides way to conceptualize and measure success of implementation processes

Implementation outcomes

Serve as intermediate outcomes, or proximal reflections of, efforts to change clinical outcomes

Implementation outcomes are distinct from clinical outcomes– Could have an effective intervention, poorly

implemented– Could have an ineffective treatment, successfully

implemented

Implementation Outcomes

AcceptabilityAdoption

AppropriatenessFeasibility

FidelityI Costs

PenetrationSustainability

-

*IOM Standards of Care

Conceptual Model for Implementation Research

What?

QIsESTs

How?

ImplementationStrategies

Implementation Research Methods

ServiceOutcomes*Efficiency

SafetyEffectiveness

EquityPatient-

centerednessTimeliness

Patient Outcomes

SatisfactionFunction

Health status/symptoms

Proctor et al 2008 Admin. & Pol. in Mental Health Services

Implementation outcomes: state of art: 30,000 ft perspective

• Overlapping concepts

• Inconsistent terminology

• Literature: Scattered across health and behavioral health fields

Implementation Outcomes:Research agenda

1) Advancing consistency of terminology

2) Advancing measurement

3) Mapping inter-relationships (non-linear) among implementation outcomes

4) Testing salience to stakeholders

5) Testing salience over implementation process

6) As outcomes for tests of implementation strategies

Key components for focus in IR:Multiple stakeholders

• service consumers • families• providers• administrators• funders• legislators

Multiple stakeholders have different priorities

• Shumway research: – Stakeholder groups value and prioritize

different clinical outcomes• We expect that different stakeholders differ

regarding implementation strategies and outcomes:

• Rationale• Preferences• Priorities

Implementation research is team science

Transdisciplinary: economics, policy, organizational researchers psychologists, social workers, MD’s,

anthropologists,

Convergence of research perspectives: mixed methods treatment researchers service systems researchers research design specialists measurement specialists

Implementation research is transdisciplinary, team science

• Transcends “disease states” and funding streams

• “Field” of D&I must be built– Training needs paramount

– Implementation Research Institute • R25 supported 2 year institute in mental health)

– Dissemination and Implementation Research Cores, providing technical assistance to researchers:

• In research centers• Through CTSA’s

Acknowledgements

Paper Co-authors: Greg Aarons, David Chambers, Charles Glisson, John Landsverk, Brian Mittman Adm. Policy Mental Health (2009) 36:24–34

Funding support: Center for Mental Health Services Research, NIMH

“Advanced” Center with focus on implementation science, 5 P30 MH068579

Institute for Clinical and Translational Science, ICTS 5UL1RR024992

Implementation Research Institute in Mental Health, R25 MH080916 & Veterans Administration Contract

Contact & Disclosure: Enola Proctor

Enola Proctor, Director, CMHSR

314-935-6660

ekp@wustl.edu

iri@brownschool.wustl.edu

No relevant financial interests to disclose