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TIARA Module 1 Anne Sales 042019

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Training in Implementation: Actionable Research Approaches (TIARA): Module 1, Definition, Background, & Rationale

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TIARA Module 1 Anne Sales 042019

  1. 1. Implementation science: How can it support health care research? Anne Sales, PhD RN Department of Learning Health Sciences, University of Michigan Center for Clinical Management Research, VA Ann Arbor Healthcare System salesann@umich.edu
  2. 2. Agenda • Motivation– why do we need a science of implementation? • Background and definitions • Brief overview of current approaches in implementation science • How can this help discovery research? • The importance of evidence: how does it relate to innovation?
  3. 3. Why do we need a science of implementation? • General perception that it takes a very long time to get research evidence into practice • Wide variations in practice • From best practices to middle of the road to pretty bad • Patients don’t get the full benefit of costly treatment when treatment is not based on best current evidence
  4. 4. Digging a little deeper into the “17 years” statement • 17 years from when to when? • Starting points vary • “Original research” • First description publication • Clinical research • First ethics/IRB approval • Ending points vary • Drug discovery • First human use • Date to market • First inclusion in a guideline • First specific use • Highly cited publication • Marketing approval • Implementation From Morris et al. 2011
  5. 5. Valleys of death for biomedical science Basic biomed science Clinical research (trials) Clinical practice (implementation) Valley of death 1: Failure to translate to human Valley of death 2: Failure to commercialize/get to trial Valley of death 3: Failure to get into practice Valley of death 4: patient uptake
  6. 6. Factors at play at different translation points • T1/T2 • Lack of efficacy and/or safety • Lack of financial resources • Lack of human resources • Communication • Design of clinical trials • Culture • Lack of incentives in academia • Profit structure • Focus on specific diseases/health problems • Lack of predictive models • IP issues • T3 • Lack of evidence for practice • Routines of practice • Misfit with workflow • Practice inertia • Lack of knowledge about benefit • Lack of knowledge about costs • Beliefs • Attitudes • Skills • Lack of demand for new practice • Societal pressures/inertia
  7. 7. Different solutions at different times • Commercialization (T1-T2) • Shift costs in development to private sector • Handles some of the barriers well • Others may not be fully addressed • Implementation (T3-T4) • Possibly shift costs to health systems/providers • Incomplete implementation poses major challenges • A possible unifying solution • Considering implementability throughout the development process
  8. 8. A very brief history of implementation research • Systematic reviews • Guidelines Evidence- based medicine • Variation studies • Outcomes research Health services research • Theories • Frameworks Psychology and other cognate theories 1950s-1960s Contemporaneous different streams: Diffusion of Innovation, Quality Improvement, Improvement Science 1980s-1990s 2000s forward
  9. 9. Definitions My definition: Implementation science is the science of planned human behavior change under organizational constraints. Implementation is the process of supporting planned human behavior change under organizational constraints. https://grants.nih.gov/grants/guide/pa- files/PAR-18-007.html Provides NIH definitions for both dissemination science and implementation science
  10. 10. Current practices and questions in implementation research • Current ideal practice • Systematic processes for identifying gaps in practice • Systematic search for evidence based practices/programs to address the gaps • Systematic assessment of factors likely to affect whether or not implementation of these evidence based practices/programs is successful • Systematic evaluation of the success of implementation • Evaluation of effectiveness of implementation • Evaluation of effect of using evidence based practices • Research questions • Does the use of systematic methods make implementation more reliable and successful? Is it effective? • Is it cost-effective? • Do we understand the full range of factors affecting implementation? • Do the strategies we have for supporting implementation work as expected?
  11. 11. It all starts with a problem
  12. 12. Steps in moving from problem to solution to implementation
  13. 13. Learning Health Sciences Frameworks and models provide important guidance for doing implementation • Process frameworks • Describing • Guiding the process • Determinant frameworks • Understanding • Explaining what influences implementation • Evaluation frameworks • How well the process worked Nilsen, Implementation Science 2015 http://www.implementationscience.com/content/10/1/53 These are an important codification of knowledge in implementation practice and research
  14. 14. Different kinds of frameworks (Nilsen 2015) • Process frameworks • How to do implementation • Steps to follow • Knowledge to action • Determinants frameworks • Factors that matter in implementing EBPs • Barriers/facilitators • Tailored Implementation for Chronic Diseases • Evaluation frameworks • Did it work? • How did it work? • RE-AIM • Classic theories • Why you would expect something to work • How implementation works– but usually the “building blocks” of implementation • Implementation theories • What to expect given certain kinds of conditions • Why implementation works • http://www.normalizationprocess.org/
  15. 15. Activities at each step Gap or variation analysis Literature review Determinants assessment using framework Map strategies and behavior change techniques to determinants Assemble elements into a coherent implementation intervention Use appropriate levels of analysis and adjust for clustering as appropriate; typically requires mixed methods
  16. 16. Important lessons learned • Knowledge is never enough • Necessary, not sufficient • Many people know what they should do but don’t do it • Most implementation efforts focus on knowledge • Change is costly • Some material cost • Always psychological cost • New practices are seldom implemented as intended • One reason for the variation we see in practice Chambers et al. Implementation Science 2013, 8:117 http://www.implementationscience.com/content/8/1/117
  17. 17. Textbooks are emerging in the field http://www.crispebooks.org/ DisseminationImplementation
  18. 18. ABCDE in ICU Example Intentional and systematic intervention design principles
  19. 19. What is it like to be mechanically ventilated? • Sedated • Immobile • +/- Delirium
  20. 20. • But what could it look like?:
  21. 21. So how do we get • From here • To here?
  22. 22. Back to the stepped approach
  23. 23. Gap: Patients are on mechanical ventilation for a long time • Longer than other comparable units • Long term outcomes are poor • High mortality • Loss of functional status • Long term impairment • In VA, about 5000 veterans are mechanically ventilated each year • Unclear average duration of MV • 37% mortality within a year • Wide variation in volume of MV patients in a year • Not associated with mortality as an outcome • 169 ICUs in VHA • Over 100,000 ventilator days in FY13
  24. 24. What evidence based practices to implement? • ABCDE evidence based bundle for improvement • Spontaneous Awakening trials • Spontaneous Breathing trials • Coordination of these two • Delirium assessment • Early mobilization • Implementing ABCDE requires significant change in practice and culture • Prior efforts in a small number of ICUs have shown positive results • Expensive, multi-faceted intervention approaches • Little assessment of barriers/facilitators prior to launching interventions • Unclear that positive change is sustained after intervention is withdrawn • Requires the full participation of the entire care team
  25. 25. Robust evidence for elements of the ABCDE bundle Vasilevskis EE, Ely EW, Speroff T, Pun BT, Boehm L, Dittus RS. Reducing iatrogenic risks: ICU- acquired delirium and weakness - Crossing the quality chasm. Chest 2010;138:1224-33
  26. 26. Intervening to implement a new practice • Begin by understanding the bundle of behaviors and decisions that constitute that practice • Map it out • Process mapping • Understanding how processes contribute to outcomes • Identify practices that need intervention • Identify influences above the level of the individual • Practice mapping • Mapping out the practices under consideration for intervention • Understand what behaviors make up the practices • Understand decision points
  27. 27. Process map for spontaneous awakening trial (A of ABCDE)
  28. 28. Generating a list of candidate behaviors • These are behaviors that substitute for the behaviors that need to change • Need to ensure that patient is a candidate for spontaneous awakening trial • Talk with team • Get orders from physician • Change sedation level • Work with pharmacist or physician and respiratory therapist to determine appropriate levels and how quickly to decrease current levels of sedation • Assemble a team to support activity and restrain patient if necessary • Ensure the support is available as sedation is decreased • Assess response • Document response • Determine whether to continue on to spontaneous breathing trial or stop SAT
  29. 29. Practices vs. programs vs. guidelines– vs. behavior • Practices are focused on smaller building blocks • Prescribing • Dressing a wound • Assessing a patient • Programs bundle practices together into a more complete “package” • Somewhat like guidelines • May or may not be fully evidence based • Most evidence based programs are tested to some extent • Guidelines summarize many different recommendations focused on a specific area • Often very high level • Recommendations may be at the level of practice • Behavior • Most practices consist of many different behaviors • Behaviors may be done by different people/different roles • Understanding all the behaviors that go into a practice is complex but doable • Role of process mapping • Working out the relationship between guideline recommendations, practices, and behaviors is important to influencing behavior change
  30. 30. Thinking, decisions and behavior • Most decisions are made by individuals • Most behavior is carried out by individuals • We act as individuals • So a majority of the determinants of behavior are individual • Major focus on cognition • What people think • How they think Behavior Think Decide Act
  31. 31. Barrier: Nurses are not sure they have the skills to handle initial attempts at spontaneous awakening • Barriers: Skills, self-efficacy, action planning • Behavior change techniques: • Goal/target specified: behavior or outcome • Monitoring/self-monitoring • Graded tasks • Social processes of encouragement, support • Prompts, triggers, cues
  32. 32. Barrier: Providers are unaware of their actual performance • Don’t know on average how long their patients are mechanically ventilated • Lack of motivation/goals • Behavior change techniques: • Goal/target specification • Contract • Feedback • Rewards and incentives • Persuasive communication • Information about behavior and outcomes
  33. 33. Systematizing design of implementation interventions • Use a variety of methods for assessing presence or absence of relevant determinants • Interviews • Semi-structured interview guides based on the TICD • Observation– depending on the nature of the practices to be implemented, you may be able to observe them being done • Document analysis • Analyze protocols, policies, guidelines, other documents available • Surveys • Generally designed after some interviews • Goal is to have a short survey covering important topics
  34. 34. Designing interventions • Current leading edge in implementation research • Linking barriers to techniques (at individual level) • Linking barriers to strategies (at higher level) • Designing interventions from strategies (broad) and techniques (micro) as indicated
  35. 35. Designing an intervention • Most relevant issues are self-efficacy on the part of nurses, lack of performance awareness by all staff • Intervention could include • Feedback component: Audit with feedback • Ensure that people know what the current status is and what patient outcomes are • Specifying the goal or target for improvement: Goal setting or action planning • Ensuring they know how they are doing in meeting that target • Social processes of encouragement and support • Leadership engagement and coaching: Mandating change
  36. 36. Thinking about implementability • Evidence is paramount • First level of acceptability • Is there strong evidence of effectiveness? • How cumbersome is the new practice? • How much does it interfere with current practice? • Do people believe that it’s better than current practice? • Clear link between innovation/discovery and evidence • Trialing • Credibility • Weight of evidence
  37. 37. Summary • Implementation science is a new field • It has emerged to address problems in the translation pipeline • Located in the T3-T4 “valleys of death” space • There are some similarities to commercialization and other approaches to T2-T2 translation issues • Features include • Systematic approaches to planning and executing implementation of evidence based practices • Research on what works reliably, effectively, replicably • Evidence is a critical component
  38. 38. Available resources (a short list) • Program funding announcement from 17 different NIH institutes and centers: https://grants.nih.gov/grants/guide/pa-files/PAR-18-007.html • NCI resources related to dissemination and implementation of evidence based practices and programs in cancer: https://cancercontrol.cancer.gov/is/ • Science of behavior change from OBSSR at NIH: https://commonfund.nih.gov/behaviorchange • ACCORDS at University of Colorado at Denver: http://www.ucdenver.edu/academics/colleges/medicalschool/programs/ACCORDS/sharedresources/DandI/ Pages/Dissemination%20and%20Implementation.aspx • Ebooks from CRISP at UC Denver: http://www.crispebooks.org/PragmaticTrials/Landing-1627-179R3.html • WHO Guide to Implementation http://www.who.int/gpsc/5may/Guide_to_Implementation.pdf • VA QUERI Guide to Implementation: https://www.queri.research.va.gov/implementation/implementationguide.pdf • Training opportunities online from UCSF: https://accelerate.ucsf.edu/training/ids • Dissemination and implementation research models: http://www.dissemination-implementation.org/ • Implementation Science newsletter: http://news.consortiumforis.org/ • Online, open access journal: https://implementationscience.biomedcentral.com/ • Health Infrastructures and Learning Systems MS and PhD program at University of Michigan: https://medicine.umich.edu/dept/lhs/education/health-infrastructures-learning-systems-hils-msphd
  39. 39. Questions or comments? salesann@umich.edu

Training in Implementation: Actionable Research Approaches (TIARA): Module 1, Definition, Background, & Rationale

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