From a public health perspective guidelines for practice cannot address realities of challenges for health faced in community settings And geographically, from a global health perspective, evidence is not implemented at all, implementation is not assessed for efficacy outcomes, and efforts are lacking in providing real integration into low cost effective strategies
Predisposing, Reinforcing, and Enabling Constructs in Educational/ environmental Diagnosis and Evaluation.
F 1 = facilitation method for transforming weak context and strong evidence into a highly receptive context2. F 2 = facilitation method to manage weak context and weak evidence situation – most challenging and possibly involves issues of safety, basic competence needs to be managed3. F 3 = facilitation method to manage strong context and weak evidence situation – issues of routine and power involved Proposed evaluative approach based upon PARiHS framework. In essence, the setting for a proposed implementation project can be evaluated in terms of the two broad elements of context and evidence, judged as falling somewhere on a weak to strong continuum according to degree of support for implementation. In terms of the four cells you see depicted here, then, you might have a setting with F1: context that is weak in support of implementation, but evidence is strong. This might be a unit with that is not organized for training and learning and it may have low morale, but the practice to be implemented may have strong empirical support that matches clinical experience and patient preferences well. F3: Setting for implementation in which Evidence is weak but Context is strong in support of implementation. This might be a unit with high morale and energizing, enabling leadership, but the practice to be implemented has limited empirical literature support and among clinicians opinions are highly divided on its utility. These two hypothetical scenarios would require different facilitation strategies F1: Might require facilitation strategies aiming to move the weak context elements to strong, e.g., develop training programs and foster collaborative relationships among staff F2: Might require facilitation strategies, such as interventions to develop professional consensus on best practices, or education on recommended best practices in other settings.
Research: Empirical research Weak support for implementation would consist of anecdotes, lore, descriptive studies Strong support RCTs, evidence-based guidelines Clinical: Experiences reflected upon and tested by individuals and groups Weak support for implementation would be conditions with absent or divide expert opinion. Strong support would be consensus across experts. Patient: Weak support for implementation would be conditions in which patient input was not included or patients would be opposed to implementation of the practice Strong support for implementation would be conditions where patient opinion is incorporated into the implementation or where patient preferences otherwise matched the practice to be implemented. Local: audits, local research, pilot projects. Weak support: no local experience or experiences are not consistent with the practice to be implemented Strong support: Local information matches the practice to be implemented.
Culture: Attitudes and beliefs about health care, organizational morale. Weak support for implementation are task driven settings with low moral Strong support for implementation is learning, innovation, and patient-centered approaches are valued Leadership Weak support for implementation are those with poor organizational structure, unclear roles Strong support for implementation possess effective organizational structure, clear roles Evaluation Strong support for implementation is found in settings with routine evaluation and feedback.
Facilitation refers to various strategies used to help change occur within an organization. Broadly classed as practical, problem-solving interventions, and supportive activities aimed at enhancing individuals and teams motivation and ability to implement a practice. Can be many things, but PARiHS emphasizes facilitation as characteristics of a person in the specific role of the Facilitator. Characteristics of facilitator Strong support for implementation is found in a facilitator who elicits respect, is credible, and empathic Role Strong support for implementation occurs when the role of the facilitator is clear and adequate for the implementation project. Style Personal styles characterized by flexibility and consistency give strong support for implementation.
To keep my thinking about the PARiHS framework organized I like to think of the three elements in the following narrative format. Summarizing the model with its three elements.
A Few Implementation Frameworks forHealth Interventions in Global Context Margaret Handley, PhD MPH Associate Professor UCSF Department of Epidemiology and Biostatistics andSFGH Division of General Internal Medicine, Center for Vulnerable Populations April 25, 2012
A Starting Point“Many evidence-based innovations fail toproduce results when transferred tocommunities in the global south, largelybecause their implementation is untested,unsuitable or incomplete” T. Madon et al .2007
Implementation is Challenging“Strategies required to delivergood care in low-incomesettings should recognize thatthis will need to be co-produced throughengagement, often overprolonged periods and as partof a directive but adaptive,participatory, information-rich,and reflective process”-English M et al, 2011
Definitions• A theory is a set of testable propositions that help us to explain and predict phenomena, such as health behaviors. A theory is a tool that allows one toinform and strengthen practical solutions to old and emerging problems in public health.• Planning models or frameworks exist at a macroscopic level; they serve as an organizing framework for an entire health promotion effort aimed at fostering reduction in a given disease. Unlike theories, planning models are not made up of a set of testable propositions. Rather, planning models serve as a blueprint for building and improving intervention programs. Crosby and Noar 2011
Conceptually Organizing Implementation Planning Deciding Where you Are Starting From Affects the Choice of Framework(s) WHAT IS TARGET, CONTEXT, PLATFORMS/TOOLS AVAILABLE? TARGET TARGETTo gain an understanding of Are you starting with placing a problem so as to develop an evidence-based and test an intervention? intervention of knownWhat setting? How many? efficacy into a new setting?How many tools? What setting? How many? How many tools?Behavior change theory,intervention design, logic Some of each? Implementation-focused model of the problem, models in which outcomes logic model of may also include more change>>behavior measures of success of change outcomes- implementation focused implementation models
Foundations• What are implementation “theories” (models, frameworks)?• How and why are they useful?
Why Implementation “Theory” or Frameworks?Theories, models, frameworks provide a systematic method: … for identifying, understanding, operationalizing & evaluating the black box phenomenon = “IMPLEMENTATION”
Selecting a Theory/Model• Multiple theories/models often needed – Impact theories/models • Specify the relationship hypothesized about how implementation activities will contribute to desired behavior change and overcome barriers – Process theories/models • The ‘how’ of implementation (planning, organization and scheduling) 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.
Selecting a Theory/Model cont.• Multiple theories/models often needed --Theories/models that focus on specific settings or contexts (e.g. health systems, community activation) -- Theories/models that incorporate multiple layers or multiple components to select from
Examples: Model focusing on Intervention Development and ImplementationSelect theory of Identify potential Select interventionsplanned behavior strategies for that fit with plannedchange achieving change strategies (based on theory)Assess fit withinitial theoryEvaluate effectiveness Launch intervention Identify interventionof intervention, using identified tools tools that fit bothstrategies, tools and strategies strategy and theory
Example: Model focusing on delivery systems setting Alexander and Hearld 2012
Selected Models for Discussion1. PRECEDE-PROCEDE (mostly the PRECEDE)Predisposing, Reinforcing, and Enabling Constructs inEducational/ environmental Diagnosis and Evaluation2. Consolidated Framework for ImplementationResearch (CFIR)3. Promoting Action on Research Implementationin Heath Research (PARIHS) D
Conceptually Organizing Implementation Planning Deciding Where you Are Starting From Affects the Choice of Framework(s) WHAT IS TARGET, CONTEXT, PLATFORMS/TOOLS AVAILABLE? TARGET TARGETTo gain an understanding of Are you starting with placing a problem so as to develop PRECEDE- PRECEDE- an evidence-based and test an intervention? PROCEDE PROCEDE intervention of knownWhat setting? How many? efficacy into a new setting?How many tools? What setting? How many? How many tools?Behavior change theory,intervention design, logic Some of each? Implementation-focused model of the problem, models in which outcomes logic model of may also include more change>>behavior measures of success of change outcomes- implementation focused implementation models
Selected Models for Discussion1. PRECEDE-PROCEDE- the most widely used planning model for the development and evaluation ofhealth promotion and policy programs in the world. Socio-ecological.•Organizing framework, multi-component, time-sequenced activities that serve as a “blueprint,”systematically guiding program developers•Predisposing=•Reinforcing=•Enabling= (Green & Kreuter, 1991, 2005).
Selected Models for Discussion2. CFIR- Consolidated Framework for Implementation-“A comprehensive practical taxonomy of constructs that have an established evidence base in the literature to enable implementation researchers to see further through the complex array of influences on implementation by bringing together constructs across many different scientific disciplines into a single framework for pragmatic and scientific application” Damschroeder and Hagedorn, 2011
Conceptually Organizing Implementation Planning Deciding Where you Are Starting From Affects the Choice of Framework(s) WHAT IS TARGET, CONTEXT, PLATFORMS/TOOLS AVAILABLE? TARGET TARGETTo gain an understanding of Are you starting with placing a problem so as to develop an evidence-based and test an intervention? intervention of knownWhat setting? How many? efficacy into a new setting?How many tools? What setting? How many? How many tools?Behavior change theory,intervention design, logic Some of each? Implementation-focused model of the problem, models in which outcomes logic model of may also include more change>>behavior Multi-level Multi-level implementation measures of success of change outcomes- implementation frameworks that implementation focused implementation frameworks that models address complex address complex interventions interventions
Consolidated Framework forImplementation Research (CFIR) Outer Setting Inner Setting
Consolidated Framework forImplementation Research (CFIR) Outer Setting Inner Setting
Consolidated Framework for Implementation Research (CFIR)Intervention Outer Setting Intervention (adapted) (unadapted) Adaptable Periphery Core ComponentsAdaptable Periphery Inner Setting Core Components Individuals Involved Process
Application of the CFIR• Consists of 39 individual constructs• Cannot use them all in every study – And not all will apply – A priori assessment of which constructs to include • Modifiable & non-modifiable constructs• Determine levels at which each construct may apply – E.g., teams, departments, clinics, regions22
Selected Models for Discussion3. PARiHS Framework3 Positive influence• major domains – Evidence High – Context – Facilitation Evidence•Continuums of high and High n t io talow values that interrelate c ili Fa Low Contextto influence Highimplementation Negative influence Kitson A, Harvey G, McCormack B. Enabling the implementation of evidence based practice: a conceptual framework. Qual. Health Care
PARiHS-Diagnostic and Evaluation Grid Figure 1 The PARiHS Diagnostic and Evaluative Grid. Evaluating the successful implementation of evidence into practice using the PARiHS framework: theoretical and practical challenges Implement Sci. Implement Sci;3:1-1.
Evidence Sub-elements:Research evidence Weak: Anecdotal evidence, descriptive Strong: RCTs, evidence-based guidelinesClinical experience. Weak: Expert opinion divided Strong: ConsensusPatient preferences and experiences Weak: Patients not involved Strong : Partnership with patientsLocal information
Facilitation Sub-elements:Characteristics (of the facilitator) Weak: Low respect, credibility, empathy Strong: High respect, credibility, empathyRole. Weak: Lack of role clarity Strong: Clear rolesStyle. Weak: Inflexible, sporadic Strong: Flexible, consistent
PARiHS FrameworkSuccessful implementation is most likely to occur when: 1.Scientific evidence is viewed as sound and fitting with professional and patient beliefs. 2.The healthcare context is receptive to implementation in terms of supportive leadership, culture, and evaluative systems. 3.There are appropriate mechanisms in place to facilitate implementation.
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)CIPRS: Stetler &Damschroder TheoreticalFrameworks
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)CIPRS: Stetler &Damschroder TheoreticalFrameworks
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… BUT – Trial & error approach – Reinventing the wheel – Cherry-picking interventions – Retrospectively trying to understand the black boxCIPRS: Stetler & 1. Bhattacharyya O, Reeves S, Garfinkel S, Zwarenstein M. Designing theoretically-informed implementationDamschroder Theoretical interventions: fine in theory, but evidence of effectiveness in practice is needed. Implement Sci 2006;1:5.Frameworks
Why “Theory”: Dual Objectives1. Generalize knowledge about how to implement and sustain interventions – Facilitate systematic accumulation of generalizable knowledge • Across studies • Across settings • Across interventions • …other salient characteristics/factors2. Replicate successful implementation • Help navigate complexity of implementation & sustainability • Tailor essential factors to fit the context From Damschroeder and Stetler 2011
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 – SystemCIPRS: Stetler &Damschroder TheoreticalFrameworks
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 successCIPRS: Stetler & Adapted from: Grol RP, Bosch MC, Hulscher ME, Eccles MP, Wensing M. Planning and studyingDamschroder Theoretical improvement in patient care: the use of theoretical perspectives. Milbank Q. 2007;85(1):93-138.Frameworks
Selecting & Using a Theoretical FrameworkCIPRS:Stetler/Damschroder,Theoretical Frameworks
Uses/Potential Value [PDI*]• Provide a way of thinking about a • Describe relationships among study/project/implementation elements/constructs• Focus the user on what is important to the • Guide development of hypotheses to test issue implementation science• Understand your EB-innovation/ • Identify concepts that may be of recommendation/change importance and need to be statistically• Develop a plan for formative evaluation; controlled or tracked e.g., diagnostic analysis of barriers to and • Help with measurement influences on using targeted best practices • Facilitate interpretation re: influences and and applying an implementation strategy meanings• Select and tailor interventions to promote • Identify boundaries around the the use of evidence [Intervention mapping] project/study• Assist with operational definitions of • Provide a framework for summarizing, intervention element reporting findingsCIPRS: Stetler &Damschroder TheoreticalFrameworks
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,CIPRS: Stetler & 2008]Damschroder TheoreticalFrameworks
“Theoretical” Selection• Origins of the framework• Meaning of the “QUERI” Evaluation: framework • In-depth understanding• Logical consistency • Theory criteria• Generalizability• Parsimony • Overall strengths• Testability • Overall limitations• Usefulness • Missing elements [QUERI PDI Working Group][Grol et al., 2007]CIPRS: Stetler &Damschroder TheoreticalFrameworks
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, relevanceCIPRS: Stetler &Damschroder TheoreticalFrameworks
Project: Theory Selection and Use1. 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?CIPRS: Stetler &Damschroder TheoreticalFrameworks
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?CIPRS: Stetler &Damschroder TheoreticalFrameworks
Project: Theory Selection and Use cont’d2. 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 issue2. Assess “fit” of these various frameworks and make selection/s of one or more, as appropriateCIPRS: Stetler &Damschroder TheoreticalFrameworks
4. Plan your implementation project in context of the selected framework a. 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?)CIPRS: Stetler &Damschroder TheoreticalFrameworks
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.CIPRS: Stetler &Damschroder TheoreticalFrameworks
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 absentCIPRS: Stetler &Damschroder TheoreticalFrameworks