Implementation Science Frameworks

Section

Toolkit Home Brief Orientation Key Language and Concepts Key Literature Community and Partner Engagement Reflectivity in Research Practice Implementation Science Frameworks Measurement and Evaluation Data Collection and Analysis Implementation Trials

Section lead: Kelly Aschbrenner, PhD

This section is designed to help investigators consider how to frame an equity-focused approach to implementation research, whether the goal is to study determinants (What are barriers and facilitators?), process (How will we implement?), or outcomes (Did it work?). It contains a review of implementation determinants, processes, and outcomes with examples of how equity has been integrated into related implementation frameworks.

Implementation Context

Implementation context is the set of circumstances or factors (i.e., determinants) that help explain why EBI implementation was or was not successful.1 Within implementation science, determinant frameworks help implementation researchers identify factors that influence implementation outcomes by guiding data collection, analysis, and interpretation of barriers and facilitators to implementation efforts.2 Organizational support, financial resources, social relationships and support, leadership, and organizational culture and climate are among the most common dimensions of contextual determinants.3

Integrating health equity into determinant frameworks can bring greater attention to understanding how upstream determinants (e.g., reliable transportation, stable housing, economic stability) independently influence, or interact with, other contextual dimensions to shape implementation outcomes.4

Consolidated Framework for Implementation Research

The intervention, or thing being implemented (such as a clinical treatment or educational program) has an adaptable periphery and core components. When unadapted, the intervention is less integrated with the inner setting, and is more integrated once adapted. The outer setting (such as a hospital system) encompasses the inner setting (such as a specific hospital), which includes the associated individuals. All of these domains or levels affect the development and implementation process.
Figure 1. Consolidated Framework for Implementation Research

The Consolidated Framework for Implementation Research (CFIR), developed over a decade ago,5 is one of the most widely used determinant frameworks for studying context within implementation science.6 The original CFIR is a comprehensive, empirically based multi-level determinant framework that organizes 39 constructs across five domains (intervention, outer setting, inner setting, individual, and processes), all of which interact to influence intervention and implementation effectiveness.5 Recommendations for applying CFIR in implementation research have included:

  1. justifying the selection of specific CFIR constructs among the 39 described in the framework;
  2. integrating CFIR constructs throughout the research process (e.g., study design, data collection, and analysis); and
  3. appropriately using CFIR given the phase of implementation research (e.g., pre-implementation needs assessment, post-implementation linking determinants to implementation outcomes).6

As a generalized framework designed to be a repository of standardized implementation-related constructs, health equity was not an explicit focus of the original CFIR.5 However, recommendations in the recently updated CFIR 2.0 (Figure 2) include centering equity as a determinant and an outcome. Specific recommendations include:

  1. sharing power with members of historically excluded groups in implementation and evaluation; and
  2. integrating equity focused theories (e.g., equity, justice and discrimination) with CFIR to evaluate implementation outcomes.8
CFIR implementation determinants include antecedent assessments such as acceptability, appropriateness, feasibility, and implementation climate and readiness, as well as both the anticipated and actual implementation outcomes and indicators of success or failure. These lead to innovation determinants, which include innovation outcomes, indicators of success or failure, and impact on key constituents. Innovation deliverers, innovation recipients, and key decision-makers all play a role in equitable population impact. Combined implementation and innovation outcomes lead to adoption, implementation, and sustainment.
Figure 2. CFIR Outcomes Addendum Diagram

Example: Integrating Health Equity into CFIR. Allen and colleagues9 used an analytic approach known as the Public Health Critical Race Praxis10 to adapt the original CFIR to identify the ways that structural racism interacts with intervention implementation and uptake of equity-oriented school-based interventions in a hybrid effectiveness-implementation trial at 10 schools across one urban school district. The researchers conducted secondary analysis of qualitative longitudinal data including observational field notes, youth and parent reflections, and semi-structured interviews with community-academic researchers and school-based partners. The researchers found that adapting CFIR with a health equity lens that explicitly considered how structural racism influenced CFIR outcomes enabled them to identify barriers to implementation uptake not previously recognized using standard race-neutral definitions.

Integrated-Promoting Action on Research Implementation in Health Services

The original Promoting Action on Research Implementation in Health Services (PARIHS) is a conceptual framework designed to help explain why the implementation of evidence into practice is or is not successful.11,12 As a determinant framework, it specifies determinants that act as barriers and facilitators influencing implementation outcomes. The original PARIHS framework proposed that successful implementation (SI) of evidence into practice was a function of the quality and type of evidence (E), the characteristics of the setting or context (C), and the way in which the evidence was introduced or facilitated (F) into practice.11 The Integrated-Promoting Action on Research Implementation in Health Services (i-PARIHS)12 is a revised version of the original PARIHS framework that positions facilitation as the active ingredient (i.e., how component) of implementation.

Facilitation helps implementers navigate complex change processes and contextual challenges encountered during implementation. The i-PARIHS framework focuses on different layers of context, differentiating between inner context at the local and organizational level and outer context at wider system and policy levels. As specified in i-PARIHS,3 implementation context includes the following:

  • Local level: Formal and informal leadership support, culture, past experience of innovation and change, mechanisms for embedding change, and evaluation and feedback
  • Organizational level: Organizational priorities, senior leadership and management support, culture, structure and systems, history of innovation and change, absorptive capacity, and learning networks
  • External health-system level: Policy drivers and priorities, incentives and mandates, regulatory frameworks, environmental (in)stability, inter-organizational networks and relationships

Example: Integrating Health Equity into i-PARIHS. To fill a gap in determinant frameworks that explicitly incorporate health equity factors, Woodward and colleagues integrated and modified two frameworks—one from implementation science (i-PARIHS)13 and one from health care disparities research (Health Care Disparities Framework)14—to develop the Health Equity Implementation Framework (Figure 3).15 The Health Equity Framework helps to identify factors relevant to both implementation and disparities in health care. The Health Equity Framework is designed to help implementation researchers identify barriers and facilitators at all levels, including the patient, provider (recipients), patient-provider interaction (clinical encounter), characteristics of treatment (innovation), and health care system (inner and outer context). The framework focuses on societal influences when assessing all other factors because of the impact society can have on health care disparities. Implementation facilitation is adapted to address factors relevant to both implementation and disparities in health care. Since the original Health Equity Framework was published, Woodward and colleagues have published additional guidance describing specific steps to integrate health equity into implementation frameworks.16

A graphic representing the societal factors, such as economies, physical structures, and sociopolitical forces, that influence the overarching context of the outer and inner settings, which is where the clinical encounter occurs. The consideration of these overlapping factors facilitates successful implementation and improvements in health equity.
Figure 3. The Health Equity Implementation Framework

Theoretical Domains Framework

The Theoretical Domains Framework (TDF) is a determinant framework designed to help investigators understand barriers and facilitators to behavior change required by health professionals, patients, and organizations to implement new practices and/or change existing practies.17,18 The TDF was developed by behavioral scientists and implementation researchers who identified theories relevant to implementation and grouped constructs from these theories into domains. The overarching goal was to make theories more accessible to those working in implementation.

The TDF synthesizes theories of behavior and behavior change clustered into the following 12 domains:

1) knowledge
2) skills
3) social/professional role and identity
4) beliefs about capabilities
5) optimism
6) beliefs about consequences
7) reinforcement
8) intentions
9) goals
10) memory, attention and decision processes
11) environmental context and resources
12) social influences18

Atkins and colleagues published practical guidance for those who wish to apply the TDF to assess implementation problems and support intervention design (Figure 4).19 The guide addresses methodological considerations for using the TDF, including selecting and specifying a target behavior, selecting study design, deciding the sampling strategy, developing an interview schedule, and collecting and analyzing data.

TDF domains pair with sources of behavior. Physical capability pairs with the domain of physical skills. Psychological capability pairs with the domains of knowledge, cognitive and interpersonal skills, memory, attention and decision processes, and behavioral regulation. Automatic motivation pairs with the domain of reinforcement and emotion. Reflective motivation pairs with the domains of social/professional role and identity, beliefs about capabilities, optimism, intentions, goals, and beliefs about consequences. Social opportunity pairs with the domain of social influences. And physical opportunity pairs with the domain of environmental context and resources.
Figure 4. Theoretical Domains Framework

Example: Integrating Health Equity into the TDF. Etherington and colleagues20 led a subgroup of an interdisciplinary Frameworks Committee to enhance the TDF with an intersectional lens through a modified delphi approach. The authors explain that intersectionality, which accounts for the interface between social identity factors (e.g., age, gender) and structures of power (e.g., ageism, sexism), offers a novel approach to understanding how context shapes individual decision-making and behavior. Through the expert-consensus approach, the team developed a tool for applying an intersectionality lens alongside the TDF that includes considerations and prompts designed to assist users to reflect on how individual identities and structures of power may play a role in barriers and facilitators to behavior change and subsequent intervention implementation.

Implementation Process

Implementation process models provide a structure for describing and/or guiding the process of translating evidence into practice,21 and in this way they provide a roadmap for implementation. Implementation process models break down implementation into a series of phases or stages prior to and throughout implementation.22

Different process models are best suited for different implementation situations. Process models for designing for implementation include Implementation Mapping23 and Knowledge-to-Action24. Process models for implementation, spread, and scale include the Quality Implementation Framework25 and the Exploration, Preparation, Implementation, and Sustainment (EPIS) model.26 Process models are often adapted when applied to a new context, and process models can be informed by integrating other models or frameworks (e.g., explore contextual domains in more depth).

Example: Integrating Health Equity into the Dynamic Adaptation Framework. Aschbrenner and colleagues26 developed a Stakeholder and Equity Data-Driven Implementation (SEDDI) process to advance equitable implementation and sustainment of evidence-interventions. SEDDI was modeled on elements of the Dynamic Adaptation Process (DAP),27 a data-informed, collaborative, stakeholder-engaged approach to guiding adaptations to improve the fit of an EBI in a new context. DAP elements applied to SEDDI included a pre-implementation assessment of system, organization, provider, and client characteristics to identify potential barriers and enablers to promoting equitable outreach, access and use of the EBI; using results from the assessment to inform the selection of health equity targets; planning adaptations needed in the service context to address gaps and how such adaptations will be accomplished; and rapidly implementing and evaluating adaptations and making ongoing refinements as needed.

In the pilot study, community health centers used data to identify gaps in outreach and completion of colorectal cancer screening with respect to race/ethnicity, gender, age and language. Adaptations to improve access and use of the paired screening intervention included cultural, linguistic, and health literacy tailoring. SEDDI was acceptable and feasible to implement. Community health center teams reported that facilitation and review of data was helpful in identifying and prioritizing gaps. The research team is conducting additional human-centered design of SEDDI to improve usability of rapid cycle testing components.

Implementation Outcomes

Implementation outcomes have been defined as the effects of deliberate and purposive actions to implement new treatments, practices, and services. They are distinct from, but related to, health outcomes.28 Implementation outcomes include acceptability, reach, adoption, appropriateness, feasibility, fidelity, and implementation cost, penetration and sustainability. RE-AIM is one of the most frequently used frameworks for planning and evaluation in implementation research.28 RE-AIM addresses five individual and setting-level outcomes important to program impact and sustainability: Reach, Effectiveness, Adoption, Implementation, and Maintenance. Shelton and colleagues29 have extended the RE-AIM Framework to integrate sustainability with a focus on addressing dynamic context and promoting health equity. Specifically, the extended RE-AIM framework was developed to guide planning, measurement/evaluation, and adaptations focused on enhancing sustainability.

In applying the RE-AIM extension, the authors recommended consideration of:

  1. extension of “maintenance” within RE-AIM to include recent conceptualizations of dynamic, longer-term intervention sustainability and “evolvability” across the life cycle of EBIs, including adaptation and potential de-implementation in light of changing and evolving evidence, contexts, and population needs;
  2. iterative application of RE-AIM assessments to guide adaptations and enhance long-term sustainability;
  3. explicit consideration of equity and cost as fundamental, driving forces that need to be addressed across RE-AIM dimensions to enhance sustainability; and
  4. use or integration of RE-AIM with other existing frameworks that address key contextual factors and examine multi-level determinants of sustainability, including health-equity-focused determinant frameworks.

The article on the RE-AIM extension includes testable hypotheses and detailed research questions to inform future empirical research in these areas. The article also includes example qualitative questions and evaluation metrics to help explicitly track equity considerations within each of the RE-AIM domains (see table 1 in article), including when and where along the translational continuum health inequities were exacerbated or reduced, or when and where implementation, reach, adoption or other implementation indicators were inequitable.

Example: Integrating Health Equity into RE-AIM. Glasgow and colleagues30 applied the original RE-AIM framework to focus the design, evaluation, and reporting of an intervention targeting an at-risk population. The study was conducted in the context of a randomized, pragmatic weight loss and hypertension self-management intervention. RE-AIM was used to both plan and evaluate the “Be Fit Be Well” program for urban community health center patients. The authors describe the health disparities implications for each of the five key RE-AIM dimensions and assess how “Be Fit Be Well” addressed these issues.

For example, the researchers designed the intervention to decrease commonly found burdens of transportation, time, and access to services by delivering content by phone and internet (reach). To allow for maintenance, the researchers planned to make the website and resources available after the study ended and to address social-environmental determinants of obesity. The study provides an example of how the RE-AIM model can be used to design and evaluate pragmatic trials intended for populations disproportionately experiencing social and health inequities.

References

Consolidated Framework for Implementation Research

  1. McDonald KM. Considering context in quality improvement interventions and implementation: Concepts, frameworks, and application. Acad Pediatr. 2013;13(6 Suppl):S45-S53. doi:10.1016/j.acap.2013.04.013
  2. Nilsen P. Making sense of implementation theories, models and frameworks. Implement Sci. 2015;10(1):53. doi:10.1186/s13012-015-0242-0
  3. Nilsen P, Bernhardsson S. Context matters in implementation science: A scoping review of determinant frameworks that describe contextual determinants for implementation outcomes. BMC Health Serv Res. 2019;19(1):189. doi:10.1186/s12913-019-4015-3
  4. Brownson RC, Kumanyika SK, Kreuter MW, Haire-Joshu D. Implementation science should give higher priority to health equity. Implement Sci. 2021;16(1):28. doi:10.1186/s13012-021-01097-0
  5. Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering implementation of health services research findings into practice: A consolidated framework for advancing implementation science. Implement Sci. 2009;4(1):50. doi:10.1186/1748-5908-4-50
  6. Kirk MA, Kelley C, Yankey N, Birken SA, Abadie B, Damschroder L. A systematic review of the use of the Consolidated Framework for Implementation Research. Implement Sci. 2016;11(1):72. doi:10.1186/s13012-016-0437-z
  7. Damschroder LJ, Reardon CM, Opra Widerquist MA, Lowery J. Conceptualizing outcomes for use with the Consolidated Framework for Implementation Research (CFIR): The CFIR outcomes addendum. Implement Sci. 2022;17(1):7. doi:10.1186/s13012-021-01181-5
  8. Damschroder L, Reardon CM, Widerquist MA, et al. The updated Consolidated Framework for Implementation Research: CFIR 2.0, 27 April 2022, PREPRINT (Version 1). doi:10.1186/s13012-022-01245-0
  9. Allen M, Wilhelm A, Ortega LE, Pergament S, Bates N, Cunningham, B. Applying a race(ism)-conscious adaptation of the CFIR framework to understand implementation of a school-based equity-oriented intervention. Ethn Dis. 2021;31(Suppl 1):375–388. doi:10.18865/ed.31.S1.375
  10. Ford CL, Airhihenbuwa CO. Critical race theory, race equity, and public health: Toward antiracism praxis. Am J Public Health. 2010;100(S1):S30-S35. doi10.2105/ajph.2009.171058

Integrated-Promoting Action on Research Implementation in Health Services

  1. Kitson A, Harvey G, McCormack B. Enabling the implementation of evidence based practice: A conceptual framework. Qual Health Care. 1998;7(3):149-158. doi:10.1136/qshc.7.3.149
  2. Bergström A, Ehrenberg A, Eldh AC, et al. The use of the PARIHS framework in implementation research and practice—A citation analysis of the literature. Implement Sci. 2020;15(1):68. doi:10.1186/s13012-020-01003-0
  3. Harvey G, Kitson A. PARIHS revisited: From heuristic to integrated framework for the successful implementation of knowledge into practice. Implement Sci. 2015;11. doi:10.1186/s13012-016-0398-2.
  4. Kilbourne AM, Switzer G, Hyman K, Crowley-Matoka M, Fine MJ. Advancing health disparities research within the health care system: A conceptual framework. Am J Public Health. 2006;96:2113-2121. doi:10.2105/AJPH.2005.077628
  5. Woodward EN, Matthieu MM, Uchendu US, Rogal S, Kirchner JE. The health equity implementation framework: Proposal and preliminary study of hepatitis C virus treatment. Implement Sci. 2019;14:26. doi:10.1186/s13012-019-0861-y
  6. Woodward EN, Singh RS, Ndebele-Ngwenya P. A more practical guide to incorporating health equity domains in implementation determinant frameworks. Implement Sci Comm. 2021;2:61. doi:10.1186/s43058-021-00146-5

Theoretical Domains Framework

  1. Michie S, Johnston M, Abraham C, Lawton R, Parker D, Walker A. Making psychological theory useful for implementing evidence-based practice: A consensus approach. Qual Saf Health Care. 2005;14:26-33. doi:10.1136/qshc.2004.011155
  2. Cane J, O’Connor D, Michie S. Validation of the theoretical domains framework for use in behaviour change and implementation research. Implement Sci. 2012;7:37. doi:10.1186/1748-5908-7-37
  3. Atkins L, Francis J, Islam R, et al. A guide to using the Theoretical Domains Framework of behaviour change to investigate implementation problems. Implement Sci. 2017;12(1):77. doi:10.1186/s13012-017-0605-9
  4. Etherington N, Rodrigues IB, Giangregorio L, et al. Applying an intersectionality lens to the theoretical domains framework: A tool for thinking about how intersecting social identities and structures of power influence behaviour. BMC Med Res Method. 2020;20:169. doi:10.1186/s12874-020-01056-1

Implementation Process Models

  1. Nilsen P. Making sense of implementation theories, models and frameworks. Implement Sci. 2015;10(1):53. doi:10.1186/s13012-015-0242-0
  2. Moullin JC, Dickson KS, Stadnick NA, et al. Ten recommendations for using implementation frameworks in research and practice. Implement Sci Commun. 2020;1(1):42. doi:10.1186/s43058-020-00023-7
  3. Fernandez ME, ten Hoor GA, van Lieshout S, et al. Implementation mapping: Using intervention mapping to develop implementation strategies. Front Public Health. 2019;7:158. doi:10.3389/fpubh.2019.00158
  4. Graham ID, Logan J, Harrison MB, et al. Lost in knowledge translation: Time for a map? J Contin Educ Health Prof. 2006;26(1):13-24. doi:10.1002/chp.47
  5. Meyers DC, Durlak JA, Wandersman A. The quality implementation framework: A synthesis of critical steps in the implementation process. Am J Community Psychol. 2012;50(3-4):462-480. doi:10.1007/s10464-012-9522-x
  6. Aschbrenner KA, Kruse G, Emmons KM, et al. Stakeholder and equity data-driven implementation: A mixed methods pilot feasibility study. Prev Sci. 2022:1-11. doi:10.1007/s11121-022-01442-9
  7. Aarons GA, Green AE, Palinkas LA, et al. Dynamic adaptation process to implement an evidence-based child maltreatment intervention. Implement Sci. 2012;7(1):32. doi:10.1186/1748-5908-7-32

RE-AIM

  1. Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: The RE-AIM framework. Am J Public Health. 1999;89:1322-1327. doi:10.2105/AJPH.89.9.1322
  2. Shelton RC, Chambers DA, Glasgow RE. An extension of RE-AIM to enhance sustainability: Addressing dynamic context and promoting health equity over time. Front Public Health. 2020;8:134. doi:10.3389/fpubh.2020.00134
  3. Glasgow RE, Askew S, Purcell P, et al. Use of RE-AIM to address health inequities: Application in a low-income community health center-based weight loss and hypertension self-management program. Transl Behav Med. 2013;3(2): 200-210. doi:10.1007/s13142-013-0201-8