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implementation research a synthesis of the literature and Practices and how to do implementation research mplementation of research findings into practice
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Fundamentals of Implementation Research MS-12-55 20122  Sub-Module 1: Defining Implementation Research Objectives  Identify the goal and function of implementation research (IR)  Identify characteristics of IR common to the definitions currently used  Differentiate IR from other forms of research and evaluation activities  Understand the role of implementation research in the implementation process  Differentiate problems that can be solved with IR from problems for which IR would be inappropriate  Identify relevant IR questions Overview  Purpose of IR  Defining characteristics of IR  What IR is and is not  The Implementation Process  IR Problems  IR Questions3  Purpose of Implementation Research Example of tobacco "Implementation science is the study of methods to improve the policy challenges in uptake, implementation, and translation of research findings into routine and common practices (the 'know-do' or 'evidence to IR 4 program' gap).” Tobacco control, cessation, and Implementation research rests on the public health value of prevention are addressed through a applying what we already know to achieve long-term health variety of interventions and policies. benefits that are within reach. A review by Jones et al. suggests that Recently, policy has included about two-thirds of child deaths could be prevented by increased taxation on tobacco interventions that are available today and feasible for products and bans on cigarette smoking in commercial and public implementation in low-income countries at high levels of 5 spaces. population coverage. In their discussion of translational research, 6 Kottke et al. use the term optimizing practice through research. These policies have met with varying This is a good way to think of IR, which addresses challenges at degrees of success, depending on the the intersection of public health research and practice. According to support they have and barriers they Leroy et al., “The main challenge today is to transfer what we face. Unfunded mandates or policies already know into action; deliver the interventions we have in hand that are approved with insufficient funding or enforcement mechanisms are classic IR policy challenges. While the policy or intervention itself has proven efficacious, implementation is failing to realize expected benefits. Somewhere, something in the implementation process or local context is inhibiting success of the policy as written. IR can explore this and address the challenges to improve the effectiveness of the policy on changing tobacco-smoking behaviors. 4 Padian, N. S., C.B. Holmes, S.I. McCoy, R. Lyerla., Bouey, P. D., & Goosby, E. P. (2011). “Implementation science for the US president's emergency plan for AIDS relief (PEPFAR).” Journal of Acquired Immune Deficiency Syndromes 56(3): 199-203. 5 Jones, G., Steketee, R. W., Black, R. E., Bhutta, Z. A., Morris, S. S., & Bellagio. (2003). “How many child deaths can we prevent this year?” Lancet 362 (9377): 65-71. 6 Kottke, T. E., Solberg, L. I., Nelson, A. F., Belcher, D. W., Caplan, W., Green, L. W., et al. (2008). “Optimizing practice through research: A new perspective to solve an old problem.” Annals of Family Medicine 6(5): 459-462 4    7 to those who need them.” As funding makes a departure away from short-term goals and pilot projects, IR works to meet that challenge and move toward long-term goals, sustainability, and scale-up. IR aims to integrate evidence-based interventions and research findings into health policy and practice. So, IR moves results from effectiveness studies and efficacy trials to real- world settings, obtaining information to guide scale-up and sustainability. One example of this is tobacco research and policy. The function of IR includes  Identifying implementation problems that hinder access to interventions, and delivery of services, as well as usability of evidence-based interventions, and their main determinants  Developing and testing practical solutions to these problems that are specific to particular health systems and environments or that address a problem common to a region  Identifying how evidence-based interventions, tools, and services should be modified to achieve sustained health impacts in real-world settings, including low- and middle- income countries  Determining the best way to introduce practical solutions into health systems and facilitating their full-scale implementation, evaluation and modification Examples of IR projects and research questions can be found on page 14 of Implementation Research in TDR: Conceptual and Operational Framework (available at IR studies factors that affect the uptake, adaptation, and adoption of evidence-based health interventions. Even the best interventions have been adapted over time. Whether findings indicate that a program doesn’t fit, it’s only viable with major adaptations, or a few minor adaptations are enough, these are all useful, beneficial findings. Successful IR integrates these findings into practice, improving program implementation. This success often relies on support from stakeholders and policy makers. So, engaging stakeholders early is essential to successful integration of IR findings. Take-home Message IR uses contextual knowledge to study processes to improve practice. It applies research findings and methods to real-world contexts and settings. The outcome of a successful IR project is integration of findings into practice or policy.                                                              7 Leroy, J. L., Habicht, J. P., Pelto, G., & Bertozzi, S. M. (2007). “Current priorities in health research funding and lack of impact on the number of child deaths per year.” American Journal of Public Health 97(2): 219-223.   6  Defining Characteristics of IR There are many accepted definitions of IR, which vary by region and discipline. Different organizations adhere to different definitions. Here are some commonly used definitions: Implementation Research is the scientific study of methods to promote the systematic uptake of research findings and other evidence-based practices into routine practice by developing and evaluating practical solutions to common, critical problems in the implementation of these 89 interventions and, hence, to improve the quality and effectiveness of health services and care. Implementation Research is the scientific study of methods to promote the integration of 10 research findings and evidence-based interventions into health care policy and practice. More definitions are available in Appendix 1.1. For your research, it will be useful to select the definition that best matches your purpose and that of your funding organization. While there are differences between the different definitions, they all share similar, defining characteristics. Common characteristics of IR include: IR Characteristic Application for use  The systematic study of how a specific set of activities integrate an Systematic evidence-based public health intervention within specific settings and how health outcomes vary across communities  Balances relevance with rigor, strictly adhering to norms of scientific inquiry Multidisciplinary  Analysis of biological, social, economic, political, system, and environmental factors that impact implementation  Interdisciplinary collaborations between behavioral and social scientists, clinicians, epidemiologists, statisticians, engineers, business analysts, policy makers, and stakeholders Contextual  It is relevant to local specifics and need  Generates generalizable knowledge that can be applied across contexts  Culture, community Complex  Dynamic and adaptive  Multi-scale: occurs at multiple levels of health care systems and community practices  Analyzes multi-component programs and policies  Non-linear, iterative, evolving 8 Eccles M, Grimshaw J, Walker A, Johnston M, Pitts N. (2005). “Changing the behaviour of healthcare professionals: the use of theory in promoting the uptake of research findings.” J Clin Epidemiol 58:107-112. 9 Eccles, M. P., Hrisos, S., Francis, J. J., Steen, N., Bosch, M., & Johnston, M. (2009). “Can the collective intentions of individual professionals within healthcare teams predict the team's performance: Developing methods and theory.” Implementation Science 4: 24. 10 National Institutes of Health Fogarty International Center. Implementation Science Information and Resources.  7   Addresses complex, important problems (see here)  Includes many variables, introducing unintended consequences Take-home message: The characteristics of IR (systematic, multidisciplinary, contextual, and complex) are paramount to the exact definition. Selecting a specific definition may be determined by the funding organization Knowledge Check Select the best option from the choices listed below. Q: Which of the following characteristics does NOT describe IR? A. Systematic B. Multidisciplinary C. Contextual D. Complex E. Routine8  What IR Is and Is Not IR involves looking at barriers and constraints, identifying potential solutions to those barriers, testing the solutions, and integrating those solutions. IR addresses scale, feasibility, cost- effectiveness, sustainability, health maintenance, acceptability, equity, coverage, access, and compliance of programs and interventions. To review, IR is:  Systematic  Multidisciplinary  Contextual  Complex IR is NOT:  Routine, applied operations research  Basic biomedical research (e.g., discovery of a new gene pathway or etiology research)  Initial or replication of intervention efficacy trials in a top-down controlled setting  Routine program progress reporting It should be noted that monitoring and evaluation (M&E) activities are an important component of IR, but M&E and IR are not the same. IR does not refer to standard program delivery or ‘business as usual’. To better understand the difference between IR and other types of research, we consider the example of zinc deficiency and diarrhea. The research questions are shown below: Epidemiological research: What is the association of zinc deficiency with severity of diarrhea? Clinical efficacy research: What is the effect of zinc as an adjunct for treatment of diarrhea? Program effectiveness research: What is the effect of a program of promoting zinc as an adjunct treatment of diarrhea? Implementation research: How can the barriers to scaling up zinc promotion programs be overcome so that it reaches all children with diarrhea? First, epidemiological research is used to establish an association between zinc and diarrhea. Then, clinical efficacy research examines how well zinc treatment works on the health outcome (diarrhea). Program effectiveness research examines how well a specific intervention or program works in promoting the use of zinc treatment. So far, all of these research questions aim to determine whether or not an effect or association exists between exposure and outcome (in this case, zinc and diarrhea). IR uses findings from previous research in practical applications, examining implementation strategies to scale up the program and treatment coverage. 9  IR should not be confused with operational research or health systems research, though they overlap. It may be helpful to consider these different types of research as a continuum from local and specific to broad. IR links the ends of the spectrum together.  Operational research (OR) focuses on a specific, local, clearly defined setting and context.  Implementation research (IR) starts with a specific setting and applies findings to broader contexts through scale-up and other implementation processes.  Health systems research (HSR) focuses on a broader context, covering many settings under the umbrella of an entire system.10  The following example applies the spectrum of research domains to a male circumcision intervention designed to reduce HIV transmission in Africa: Voluntary Medical Male Circumcision Scale-up in Eastern and Southern Africa With evidence that male circumcision (MC) reduces the risk of HIV transmission in specific settings, countries in Eastern and Southern Africa are working to scale up MC service delivery and coverage. Delivering this evidence-based male circumcision intervention includes opportunities for operations research, implementation research, and health systems research. OR question: Which locations should be targeted for delivering MC services in Eastern Africa? IR question: How can access to MC services among populations who are currently not reached by MC services be improved? HSR question: What has been the impact of the rapid scale-up of MC programs on fragile health Take-home message: IR is not an umbrella term for activities related to program monitoring and evaluation. Rather, IR aims to resolve implementation challenges so that programs may be expanded or optimally implemented across contexts and settings. Knowledge Check Select the best option from the choices listed below. Q: Which of the following research topics fits under the umbrella of Implementation Research? A. Routine monitoring and evaluation activities B. Randomized trials to determine efficacy C. Health systems research questions D. Studies to assess unintended consequences of programs E. Formative research to determine the distribution of a disease in a specific region11  The Implementation Process Because IR has to fit, be embedded, and influence implementation programs, it is imperative to understand the implementation process. Engaging stakeholders, which will be discussed later, is an essential component of implementation and IR. Stakeholder engagement should begin as early as possible, and continue for the duration of the implementation process. Implementation is the use of strategies to adopt, adapt, and integrate evidence-based health interventions and policies, changing practice patterns within specific settings. That is to say that implementation is a specified set of activities and policies designed to be put into practice. Relevant stakeholders will provide valuable input for all of these activities and policies at each stage. IR studies these activities using an iterative, ongoing process (not a one-time event), and can take place at a number of levels: practitioners, agency, or community. Implementation seldom succeeds perfectly when it is first attempted – adaptations are required as more knowledge is gained. IR attempts to understand barriers that inhibit implementation in different environments. Achieving sufficient program fidelity is a frequently encountered challenge in implementation. It is critical to balance fidelity and fit. Fidelity refers to maintaining key components and principles and fit refers to adaptation to local culture. Striking this balance is the art of implementation science. Adaptation to context is important, but remember that whatever is implemented needs to be measured. More on the importance of fidelity is available in Appendix 1.2. The following 11 points on fidelity are relevant to implementation and IR:  Implementation fidelity is the degree to which a program is delivered as intended.  Implementation fidelity affects the credibility and utility of research.  A high level of adherence to an intervention, or its essential components, is not achieved easily. Factors that influence the degree of implementation fidelity include: complexity of intervention, quality of delivery, practitioner training, and participant responsiveness.  By measuring implementation fidelity, one can begin to understand how and why an intervention works, and the extent to which outcomes can be improved. So, implementation fidelity should be evaluated as part of any IR study. Scaling up is one area of IR that addresses equity, sustainability, and health maintenance. It is intended to "increase the coverage of services based on the evidence derived from experimental research, leading to improved health outcomes in the target population". Its primary objective is to deliver "more quality benefits to more people over a wider geographical area more quickly, more equitably and more lastingly." An example of community-based health planning and services scale-up in Ghana is available in Appendix 1.3. 11 Carroll, C., M. Patterson, S. Wood, A. Booth, J. Rick and S. Balain. (2007) “A conceptual framework for implementation fidelity.” Implementation Science 2:40. 12  Not all health interventions should be or can be scaled up. A decision to scale up should consider:  Size of programs, resources needed, and effect size  Evidence available  Potential sustainability judgments  Fit for an intervention and the setting in the general population, and fit for sociocultural context In addition, scaled up interventions should not always last indefinitely. Some interventions have a natural time limit or shelf life. For example, a vaccination program may have limited coverage and require scale-up. Expanding efforts to achieve necessary coverage is appropriate for a specific time period. Once a coverage threshold has been reached, it is not useful or sustainable to continue to run the program at scaled up levels. Then, the program may return to routine maintenance levels. ExpandNet’s detailed framework on scaling up is provided in Appendix 1.4. Challenges frequently occur in the planning and implementation of scaling up, including:  Creating an environment to allow flexibility in the process of scaling up  Mobilizing adequate resources and ensuring that they are in place for implementation  Addressing conflicting orientation, mandates, and capacities of stakeholders  Developing robust health information systems for M&E of the implementation process  Improving institutional capacity and infrastructure to sustain scaling up of program efforts or shift towards health maintenance (e.g., communication, logistics, transportation, supply of medicines and other techniques)  Unintended consequences and externalities  Right-size scaling to sustain scaling up or attain the appropriate level of the intervention Many promising health interventions have had limited impact on the burden of diseases in low- and middle-income countries because implementation problems were not identified and dealt with in a timely manner. For example, the impact of insecticide-treated-nets to reduce malaria was diminished because IR on scaling up did not follow effectiveness trials. It is critical to include IR as an extension of the efficacy study phase when testing a new intervention. 13  Take-home message: IR can improve implementation practice by understanding and systematically addressing barriers to implementation. Some interventions do not render themselves to scale-up. Knowledge Check Select the best option from the choices listed below. Q: IR systematically studies implementation challenges. A teen pregnancy intervention is successful at lowering pregnancy rates, but interpartner violence and abortion complications increase in the program delivery area. What type of implementation challenge does this describe? A. Achieving sufficient program fidelity B. Unintended consequences and externalities C. Improving institutional capacity and infrastructure to sustain scaling up D. Mobilizing adequate resources E. Right-size scaling for sustainability14  Implementation Challenges Much like IR itself, challenges that IR addresses are systematic, multidisciplinary, contextual, and complex. IR seeks to solve the following types of issues and programmatic challenges:  Scale-up  Sustainability and health maintenance  Replication  Program integration  Equitability  Real-life effectiveness, cost-effectiveness, and impact  Efficiency  Unintended consequences Examples of problems that are suitable for IR to address include:  Learning about management, administrative, cultural, social, behavioral, economic and other factors that exist as bottlenecks to effective implementation  Testing new, more effective, efficient approaches to programming (e.g., task shifting)  Identifying and solving program problems in a more timely or equitable manner  Helping policy makers and program managers make evidence-based program decisions  Improving program quality and performance using scientifically valid methods  Helping program staff understand how their programs work and how to improve them These are just a few types of IR problems – they will be discussed further in sub-module 3. It is important to note that all of these problems arise within programs and are directed towards finding action-oriented solutions or improvements that can be applied to future implementation practices. IR problems can be thought of as program embedded – they begin and end in programs. Take-home message: By nature, IR problems are applied and arise from contextual factors within programs that inhibit implementation. 15  Knowledge Check Select the best option from the choices listed below. Q: Implementation research problems are unique from problems in other research domains because they are always: A. Specific B. Related to underserved populations C. Program embedded D. Interdisciplinary E. Based on previous research IR Questions As you conduct your own IR, remember that the question determines the methods, and the purpose determines the framework. IR questions address the design, implementation, and outcomes of programs. IR also asks “Are there unintended consequences?” and “Why is it happening as it is?” The following questions are derived from key bottlenecks facing those who implement programs: Challenge IR Question Scale-up How can coverage and usage of a proven intervention be improved to meet set targets? How can a program be scaled up to broader regions or populations? Sustainability Why do established programs lose effectiveness over time? How can sustainability or health maintenance be achieved? Replication and Why do tested programs exhibit unintended effects when transferred to a robustness new setting or problem? Why don’t tested programs work when transferred to new settings or work in some settings and not others? How can implementation be improved to assure replicability? Program How can multiple interventions be effectively packaged and delivered integration within health systems? How can interventions be delivered to assure integration? Equitability How could program or service delivery be more equitable in settings where financial and human resources are low, or where cultural and social norms affect health-seeking behaviors? 16  What is the impact across issues of race, class, education, gender, age, geography (urban-rural) and other relevant factors? Real-life Are there unintended consequences (positive or negative) of the effectiveness program? Under what conditions does the program work? Is the tool, intervention, or strategy worth it? Is it cost-effective? Does the program achieve the intended public health impact?  Specific examples of HIV-related IR questions that the CDC is working to address are available in Table 1 in Appendix 1.5.  Table 2 in Appendix 1.6 provides examples of questions relevant to different types of IR.  IR questions for a variety of public health challenges are available in Table 3 in Appendix 1.7. Take-home message: IR questions are driven by implementation problems and should be designed for action-oriented research in collaboration with stakeholders. Knowledge Check Select the best option from the choices listed below. Q: Please select the best example of an implementation research question. A. What is the effect of zinc as an adjunct for treatment of diarrhea? B. What is the effect of distributing insecticide-treated nets to prevent malaria in vulnerable populations? C. How can tuberculosis treatment be delivered effectively in rural areas? D. Does a health education program increase access to antiretroviral therapy?17  Sub‐Module 2: Implementation Research Fra m e wo r ks Objectives  Identify essential components common to all frameworks presented  Identify relevant criteria for selecting a framework that relates to their IR Overview  IR Frameworks  Selecting Frameworks18  IR Frameworks There are many frameworks for conducting IR. Depending on the context you work in, some frameworks may be more useful than others. While frameworks vary in some ways, there are common characteristics present in many of them:  Proven effectiveness – an evidence-based intervention with demonstrated effectiveness  Proven efficiency – delivering services at low cost and most sustainably  Context – local determinants of program adoption and impact  Implementation – a plan for implementation, adaptation, innovation, and dissemination  Sustainability – assessed through monitoring, evaluation, and impacts  Stakeholder input – involvement of stakeholders early and throughout the entire process Frameworks are useful for developing research questions, and can guide the way you think about your work and come up with questions. In this introductory course, we will consider the following five frameworks. More information on each framework is available through the hyperlinks. 1. Diffusion of Innovation: This model represents the context within which IR is being conducted. Rogers’ diffusion of innovation theory, developed from naturalistic studies across content areas and countries, is the earliest and most widely applied. It indicates that the rate at which an innovation spreads is a function of the intervention itself and the setting it is implemented in. More information in Appendix 1.8. 2. PEPFAR Implementation Science Framework: This framework is an organizational representation of implementation research. It incorporates monitoring and evaluation, operations research, and impact evaluation. More information in Appendix 1.9. 3. CDC REP Framework: This framework specifies steps needed to maximize fidelity to effective interventions while allowing opportunities for flexibility (i.e., community input) to maximize transferability. More information in Appendix 1.10. 4. ExpandNet Scaling Up Framework: This framework identifies conditions that lead to success, articulates strategic choices that have to be made for successful scaling up, and highlights actions that enhance the potential for success and sustainability. More information in Appendix 1.4. 5. RE-AIM Framework: This is a useful research framework that focuses on external validity, which can improve sustainable adoptions and implementation of effective, generalizable, equitable, evidence-based interventions. More information in Appendix 1.10. We have chosen to introduce these frameworks because they are widely used in IR. Depending on program parameters, you may want to consider a framework beyond this list. Additional frameworks can be found here: • The Community Toolbox - • Consolidated Framework for Implementation Research (CFIR) -  • Promoting Action on Research Implementation in Health Services (PARIHS) Framework - 82.pdf. • Quality Enhancement Research Initiative (QUERI) - • Yano, E.M. (2008) “The role of organizational research in implementing evidence- based practice: QUERI Series.” Implementation Science 3: 29. • Greenhalgh, T., Robert, G., Macfarlane, F., Bate, P., & Kyriakidou, O. (2004). Diffusion of innovations in service organizations: Systematic review and recommendations. The Milbank Quarterly, 82(4), 581-629. • Ward, V, House, A, Hamer, S. Developing a framework for transferring knowledge into action: A thematic analysis of the literature. J Health Serv Res Policy. 2009;14: 156-164. Take-home message: There are differences between the frameworks, but they all retain some common characteristics: an evidence-based intervention with demonstrated effectiveness, guided implementation and innovation, evaluation, sustainability, and stakeholder input. Regardless of which framework you select, adhering to it consistently and maintaining its key components is essential. Knowledge Check Select the best option from the choices listed below. Q: Regardless of which framework you select, it is essential that you: A. Adhere to it consistently and maintain its key components B. Use only the components that benefit your research C. Modify your context to fit every single framework component D. Ignore the context when working within a framework E. Modify the framework to fit your methods20  Selecting Frameworks When selecting which framework to use for your research, your purpose will guide which framework your research will readily fit with. In some cases, a funding agency may endorse a specific framework. Consult the funding announcement for this information when selecting a framework. Remember, frameworks can help guide your IR question and process. Implementation frameworks will emphasize guiding you through phases of implementation, whereas IR frameworks will emphasize steps for evaluation. Regardless of which framework you choose, it is important to follow it closely and consistently. A framework is a tool to help achieve more relevant and meaningful results. Here are some other useful tools to assess implementation challenges. These tools can be used to help select an intervention or choose among alternatives before much time and money are invested. CORRECT Criteria (ExpandNet) Innovations with the “CORRECT” criteria (Correct, Observable, Relevant, Relative advantage, Easy to install and understand, Compatible, Testable) are most likely to be successfully scaled up. For more information, please see Appendix 1.12. Scalability Checklist (Management Systems International) This scalability checklist is an aid for prioritizing alternatives and identifying actions to simplify the scaling-up process. It is not a scorecard to determine what can be scaled up and what can’t. The scalability checklist can guide analysis of relevant issues for scaling up. For more information, please see Appendix 1.13. Evaluability (Robert Wood Johnson Foundation) Evaluability assessments are pre-evaluations that allow for making needed modifications before full-scale implementation. In addition, evaluability assessments in the public health sector aid in developing a research question and identifying a specific purpose, which will in turn influence methods and framework selection. For more information, please see Appendix 1.14. Viability (CDC) In public health, viability is the extent to which a program is viable in the real world. Viability alone does not guarantee an intervention’s efficacy or effectiveness, but in real-world settings, viability is essential to an intervention’s overall success. Regardless of an intervention’s efficacy or effectiveness, that intervention should be practical, suitable to community organizations’ capacity for implementation, and acceptable to clients and implementers, to ensure survival in a community. For more information, please see Appendix 1.15. Considering these issues can prevent future implementation problems. Not all interventions should be scaled up or sustained, and these tools can help you determine whether or not your intervention is a candidate for scaling up or sustaining. 21  Take-home message: Selecting an appropriate framework for IR depends on research purpose, funding parameters, and contextual determinants. Knowledge Check Select the best option from the choices listed below. Q: Which of the following will most likely determine which framework you use? A. Planned methodology B. Timeline and logistics C. Context and culture D. Purpose and funding agency E. Political support and stakeholder preference