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

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. 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. 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. 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. 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. 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. 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. 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. 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. 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. It all starts with a problem

12. Steps in moving from problem
to solution to implementation

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. 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. 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. 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. Textbooks are emerging in the field
http://www.crispebooks.org/
DisseminationImplementation

18. ABCDE in ICU Example
Intentional and systematic intervention design principles

19. What is it like to be mechanically ventilated?
• Sedated
• Immobile
• +/- Delirium

20. • But what could it look like?:

21. So how do we get
• From here • To here?

22. Back to the stepped approach

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. 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. 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. 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. Process map for spontaneous awakening trial
(A of ABCDE)

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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. Questions or comments?
salesann@umich.edu