Implementation Research Theoretical FrameworksCyberSeminar Series 

			4-Part Series:

April 7

April 14

May 5

May 12

Objectives
        - Purpose/potential value and uses 
        - Process for selection and use
        - Nature and underlying rationale of specific frameworks/approaches
        - Evaluation

APRIL
        - April 7:    Foundations

			Cheryl Stetler & Laura Damschroder
        - April 14:  Applying a Framework

			 Phil Ullrich

		       A Mixed-model Approach-Intro

			 Jeffrey Smith

MAY
        - May 5: A Mixed-model Approach-Cont.

			 Jeffrey Smith

		    Applying the CFIR

			Laura Damschroder & Teresa Damush
        - May 12: Respond to Participant Interests/ 

		     Dialogue with Presenters 

			The “Theory” Team

Your Active Participation
        - Track questions & observations
        - General & per framework/approach
        - DISCUSSION/REACTION FORM page 1
        - DISCUSSION/REACTION FORM page 2

Send your suggestions for discussion at the May 12th  session

Send as early as possible to:

cheryl.stetler@comcast.net

Foundations
        - What are implementation “theories”?
        - How and why are they useful?

Foundations Terminology
        - Theory
        - Theoretical/conceptual framework
        - Model

Handout
        - THEORY: “A set of logical constructs that jointly offer answers to the questions ‘why’ and ‘how,’ as in ‘why would someone change their behavior in this way?’ and ‘how could this  behavior/situation/ outcome be changed” (Sales, et al, 2006)
        - THEORETICAL/CONCEPTUAL FRAMEWORK: “...identifies a set of variables and relationships that should be examined in order to explain the phenomena”; “...need not specify the direction of relationships or identify critical hypotheses” (Kitson et al, 2008)

Theory
        - Provides a denser and logically coherent set of relationships
        - Sheds light on causal relationships and seeks to explain the phenomena
        - Offers explanations,  predictions  and thus “control”

Theoretical or Conceptual Framework
        - More specific and concrete than theory
        - Can usually be shown in a diagram/picture 
        - “... could be populated by multiple theories, at multiple levels” (Kitson et al, 2008)

Model
        - Represents a specific situation
        - Narrower in scope
        - More precise in their assumptions – including relationships (Kitson et a, 2008)
        - May be used interchangeably with “framework” (Sales, et al., 2006)

No Commonality... Illustration1!
        - Conceptual models 
        - Theories of change
        - Frameworks

1. Ref: Graham & Tetroe, in press

May have a preference based on your discipline or doctoral program background

Why “Theory”?

Theories, models, frameworks provide a systematic method:

	 ... for identifying, understanding, operationalizing & evaluating the black box phenomenon =

“IMPLEMENTATION”

Why NOT Theory?
        - Just “use common sense”1
        - Using theory doesn’t make it any easier to judge applicability of evidence
        - It isn’t clear how to translate theory reliably to study design
        - So many theories  why should any one of them be given supremacy?
        - BUT:  “Common Sense” alone hasn’t worked so far...
        - Trial & error approach
        - Reinventing the wheel
        - Cherry-picking interventions
        - Retrospectively trying to understand the black box

1. Bhattacharyya O, Reeves S, Garfinkel S, Zwarenstein M. Designing theoretically-informed implementation interventions: fine in theory, but evidence of effectiveness in practice is needed. Implement Sci 2006;1:5.

Why “Theory”:QUERI Dual Objectives

Generalize knowledge about how to implement and sustain interventions
        - Facilitate systematic accumulation of generalizable knowledge

Across studies

Across settings

Across interventions

...other salient characteristics/factors

QUERI Dual Objectives

Replicate successful implementation
        - Help navigate complexity of implementation & sustainability

Tailor essential factors to fit the context

Using Theory for Implementation Planning

Select theory of planned behaviorchange

Assess fit with initial theory

Identify potential strategies for achieving change

Select interventionsthat fit with plannedstrategies (based on theory)

Identify interventiontools that fit bothstrategy and theory

Launch interventionusing identified toolsand strategies

Evaluate effectivenessof intervention,strategies, tools

See references:  Sales et al., 2006

Using Theory for Implementation Planning

Select theory of planned behaviorchange

See references:  Sales et al., 2006

Assess fit with initial theory

Identify potential strategies for achieving change

Select interventionsthat fit with plannedstrategies (based on theory)

Identify interventiontools that fit bothstrategy and theory

Launch interventionusing identified toolsand strategies

Evaluate effectivenessof intervention,strategies, tools

Select theory of planned behaviorchange

Theories

Models

Frameworks

Selecting a Theory - 1
        - Consider Context
        - Study characteristics
        - Professional discipline/perspective
        - Intervention characteristics
        - Inner and outer setting
        - Individuals involved
        - Implementation process
        - Consider Level
        - Individuals
        - Teams
        - Organization
        - System

Selecting a Theory - 2
        - Multiple theories often needed
        - Process theories
        - How implementation should be planned, organized and scheduled
        - Impact theories
        - Hypotheses and assumptions about how implementation activities will facilitate a desired change, as well as the facilitators and barriers for success

Adapted from: Grol RP, Bosch MC, Hulscher ME, Eccles MP, Wensing M. Planning and studying improvement in patient care: the use of theoretical perspectives. Milbank Q. 2007;85(1):93-138.

Theories re:Implementation
        - NOT: Patient care models
        - Self management; e.g., health belief model
        - NOT: Practice delivery models
        - Chronic care model
        - IT support:  clinical reminders
        - Collaborative care models
        - Implementation models
        - Individual adoption/uptake
        - Maintenance for sustained use

TYPES:  Process Theories
        - Aka: Planned Action Theories1
        - Policy level (example)
        - QUERI core 6-step process
        - Study level (examples)
        - Graham & Logan’s Ottawa Model of Research Uptake 2
        - Grol, et al’s model for effective implementation 3
        - Mendel, et al’s Dissemination Framework 4
        - Stetler’s Model of Research Utilization/EBP 5
        - See references: Graham & Tetroe, in press
        - Graham ID, Logan J. Innovations in knowledge transfer and continuity of care. Can. J. Nurs. Res. 2004;36(2):89-103.
        - Grol, et al. 2007
        - Mendel P, Meredith LS, Schoenbaum M, Sherbourne CD, Wells KB. Interventions in organizational and community context: a framework for building evidence on dissemination and implementation in health services research. Adm. Policy Ment. Health 2008;35(1-2):21-37.
        - Stetler C.  Updating the Stetler model of research utilization to facilitate evidence-based practice. Nurs Outlook 2001;49/6, 272-278.

These are steps you should be doing, regardless of implementation. Some are more likely to get into the black box than others...

Ottawa Model ofResearch Use
        - Action-oriented
        - Prescribes 3 main steps
        - Assess
        - Monitor
        - Evaluate

Graham ID, Logan J. Innovations in knowledge transfer and continuity of care. Can. J. Nurs. Res. 2004;36(2):89-103.

Framework of Dissemination in Health Services Intervention Research

Mendel et al, 2008

Crosses into impact theory – not a neat categorization.

2001

Impact Theories - 1
        - Individual-level theories
        - Stage of change
        - Cognitive
        - Educational
        - Motivational

Grol et al, 2007

Individual Level: Stage of Change
        - Stage of change
        - Assumptions about the phases individuals go through to achieve desired behavior change
        - General phases common to all1:
        - Awareness 
        - Insight 
        - Acceptance 
        - Actual Change 
        - Maintenance

Grol et al, 2007

Grol, et al list 11 different models...

Social Cognitive Theory
        - Literature synthesis of SCT to explain clinician behavior
        - Godin G, Belanger-Gravel A, Eccles M, Grimshaw J. Healthcare professionals' intentions and behaviours: A systematic review of studies based on social cognitive theories. Implement Sci 2008;3(1):36.

http://www.cw.utwente.nl/theorieenoverzicht/Theory%20clusters/Health%20Communication/Social_cognitive_theory.doc/

Organizational Setting

Theory of Planned Behavior
        - Motivational theory

Ajzen I. The theory of planned behavior. Organ Behav Hum Decis Process. 1991;50:179-211.

http://people.umass.edu/aizen/tpb.diag.htm l

One variation of SCT  applied to professional/staff change; TPB is most common across 76 studies reviewed in Godin, et al

Grimshaw and Eccles using – esp. independent physicians.

Impact Theories - 2
        - Social context theories
        - Social Marketing
        - Social learning
        - Communication
        - Social network & influence
        - Teamwork
        - Professional development
        - Leadership 

Grol et al, 2007.

Social Network Theory
        - Tailor engagement strategy to social networks

http://www.istheory.yorku.ca/socialnetworktheory.htm

Impact Theories - 3
        - Organizational Context Theories
        - Innovative organizations
        - Quality management
        - Integrated care
        - Complexity
        - Organizational learning
        - Organizational culture
        - Political & Economic Context Theories
        - Reimbursement
        - Contracting

Grol et al, 2007.

Roger’s Theory of Diffusion

Characteristics of the intervention

Organizational characteristics

Environmental context

Adoption decision

Effective implementation

Outcomes

Application to infection prevention practices

Krein SL, Olmsted RN, Hofer TP, Kowalski C, Forman J, Banaszak-Holl J, et al. Translating infection prevention evidence into practice using quantitative and qualitative research. Am. J. Infect. Control 2006;34(8):507-12.

Greenhalgh, et al’s Conceptual Model

PARiHS Framework
        - 3 major domains
        - Evidence
        - Context
        - Facilitation
        - Continuums of high and low values that interrelate to influence implementation

Kitson A, Harvey G, McCormack B. Enabling the implementation of evidence based practice: a conceptual framework. Qual. Health Care 1998;7(3):149-58.

Positive influence

Negative influence

Low

Evidence

High

High

Context

Facilitation

High

Parsimony – vs. Greenhalgh; balance with how much to put in

Footnotes

PRISM: Practical, Robust Implementation and Sustainability Model
        - 4 Domains:
        - Intervention Design
        - Recipients
        - External Environment
        - Implementation & Sustainability Infrastructure

See references: Feldstein & Glasgow, 2008

Implementation Effectiveness Model
        - Quantitative measures of predictors of implementation effectiveness
        - Strength of relationships empirically estimated

Klein KJ, Conn AB, Sorra JS. Implementing computerized technology: An organizational analysis. J Appl Psychol. 2001;86(5):811-824.

Homogeneous constructs reflecting shared values org-wide or distinct groups of targeted users.

CFIRConsolidated Framework for Implementation Research
        - List of 39 constructs that influence implementation
        - No specific relationships defined
        - Reflects theory from multiple disciplines and findings from empirical research

See references: Damschroder et al. Under Review.

Dual QUERI Objectives: Revisited

Generalize knowledge about how to implement and sustain interventions

Replicate successful implementation

Selecting & Using a Theoretical Framework

Uses/Potential Value [PDI*]
        - Provide a way of thinking about a study/project/implementation
        - Focus the user on what is important to the issue
        - Understand your EB-innovation/  recommendation/change 
        - Develop a plan for formative evaluation; e.g., diagnostic analysis of barriers to and influences on using targeted best practices and applying an implementation strategy
        - Select and tailor interventions to promote the use of evidence [Intervention mapping] 
        - Assist with operational definitions of intervention element
        - Describe relationships among elements/constructs
        - Guide development of hypotheses to test implementation science
        - Identify concepts that may be of importance and need to be statistically controlled or tracked
        - Help with measurement
        - Facilitate interpretation re: influences and meanings
        - Identify boundaries around the project/study
        - Provide a framework for summarizing, reporting findings

Specific Selection and Use: QUERI Centers
        - Use:
        - Facilitate strategic planning overall
        - Guide implementation science goals
        - Study, understand, predict causal mechanisms/paths
        - Evaluate chosen framework/s
        - Selection:
        - Open selection; one or multiple
        - “NO NEW THEORIES” [Banff, International Conference, 2008]

“Theoretical” Selection
        - Origins of the framework
        - Meaning of the framework
        - Logical consistency 
        - Generalizability
        - Parsimony
        - Testability
        - Usefulness

[Grol et al., 2007]

“QUERI” Evaluation:

In-depth understanding

Theory criteria

Overall strengths

Overall limitations

Missing elements

[QUERI PDI Working Group]

Specific Selection and Use: QUERI Projects
        - Use:
        - Assessment 
        - Intervention planning
        - Hypothesis generation
        - Evaluation
        - Black box of implementation and progressive/interim outcomes
        - Usefulness of chosen theories
        - Selection:
        - Based on the issue at hand 
        - Apparent relevance of your “broad” center framework
        - Strengths, limitations, relevance

Project: Theory Selection and Use 

1.  Your targeted EBP recommendation: 

a.  Explore others’ relevant experiences and results  (Grey & published literature):

Did they use process/impact theories?  Which and to what effect?

Evidence of WHY and HOW a particular intervention/ strategy did or did not work therein?

Did they use isolated, atheoretical interventions or a multi-faceted strategy?

Evidence of WHY and HOW a particular intervention did or did not work therein?

What related barriers, facilitators, determinants have been identified?

Outside of QUERI?

Prior Center work, including Step 3 activity?

Project: Theory Selection and Use cont’d

b. Understand the nature of your innovation (e.g., per Rogers):

What are its attributes/characteristics?

“Core/peripheral” to the clinician’s sense of their practice

Complex or “simple”

Obvious appeal or the reverse; etc.

What are the potential targets of change?

 Per Level/s:  Individual, team, clinic, organization? [CAVEAT:  “Individuals” work in a context]

Per Stage/focus of change: Awareness, knowledge, skills, self-perception, attitude, behavior, systems, structures, etc.

Given this information, have potentially influential factors been clearly identified?

Project: Theory Selection and Use cont’d

Choose “2” implementation theories to “try” as a “way of thinking” about your particular issue:

Per your general knowledge of their focus and or prior use

Per their strengths, limitations, potential usefulness for your issue

Assess “fit” of these various frameworks and make selection/s of one or more, as appropriate

        - Plan your implementation project in context of the selected framework

Define relevant terms

Conceptually 

Operationally /measurement and/or actions

b.    Develop formative evaluation questions/tools [E.g., if PARIHS-related]

Local diagnostic analysis:  E.g., assess likely barriers 

	(How do stakeholders perceive the attributes of the expected change?)

Implementation-focused:  E.g., actual barriers (To what extent does leadership actually support the new practice or adoption efforts?)

Progress-focused:  E.g., interim staff performance on the new, expected innovation (Relates to designated outcomes or “successful implementation”)

Theoretical/Interpretive: E.g., to what extent did the framework provide an adequate description of results and related influential factors? (Were any significant factors missing?)

4. Plan... cont’d

c.    Select interventions, per theory/theories and in light of:

Expected barriers

Prior studies’ findings

Local diagnostic data

	(Simple example:  Complex E-B delivery system)

Per PARIHS model, consider use of an external facilitator & routine audit/feedback system; based on identified concerns of clinicians regarding strength of the evidence, additionally use social marketing actions/theory; based on prior similar study findings, use other “facilitation” techniques such as clinical reminder. 

d.   Identify “theory-related” hypotheses to be tested

	(Simple example:  Complex E-B delivery system)

Test hypothesis that sites with an external facilitator will be more successful than comparison sites under analogous conditions of limited resources and passive leadership. 

Application Examples
        - April 14: 
        - Applying a Framework

			 Phil Ullrich
        - A Mixed-model Approach-Intro

			 Jeffrey Smith
        - May 5: 
        - A Mixed-model Approach-Cont.

			Jeffrey Smith
        - Applying the CFIR

			Laura Damschroder & Teresa Damush

Challenges of Understanding the Black Box
        - Implementation theories under-studied
        - May be “borrowed”
        - Few have been critically analyzed for strengths/limitations
        - Measurement tools limited
        - Published studies use of theory often unclear or absent

QUERI’s Dual Function
        - Improve practice through scientifically-based implementation
        - Increase understanding of implementation science

Transparent Selection, Use, Evaluation  & Explicit Reporting of THEORETICAL FRAMEWORKS

        - DISCUSSION/REACTION FORM