Implementation Science: Bridging Research and Practice

 
Introduction to Implementation Science
 
Geoffrey M. Curran, PhD
Director, Center for Implementation Research
Professor, Departments of Pharmacy Practice and Psychiatry
University of Arkansas for Medical Sciences
Research Health Scientist, Central Arkansas Veterans Healthcare System
HPV vaccine: 99+ % effective
 
Healthy 2020 Goal = 80%
adolescents 15 and under
US recent: 42/29%
AR recent: 34/16%
 
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Goals for today
 
Discuss principles of “implementation science”
What is it?  Why do we need it?  When do we do it?
Discuss 
outcomes
 in implementation research
Adoption/uptake, fidelity to the intervention/practice
Summarize different 
strategies
 to promote better
implementation of evidence-based practices/interventions
The 
interventions
 in this kind of work/research
E.g., education, training, prompting, incentives, mandates…
 
Some definitions…
 
Some definitions…
 
 
Dissemination
:  “targeted spread of information” 
(from the NIH
program announcement for Dissemination & Implementation research)
Passive
 approach, focusing on knowledge transfer
Implementation
:  “An 
effort
 specifically designed to get best
practice findings… into routine and sustained use via
appropriate 
uptake interventions
.”  
(Curran et al., 2012)
Active
 approach, focusing on stimulating behavior change
Implementation SCIENCE
:  “The scientific study of methods to
promote the systematic uptake of research findings and other
evidence-based practices into routine practice, and, hence, to
improve the quality and effectiveness of health services and
care.” 
(Eccles and Mittman, 
Implementation Science
, 2006)
Science of how BEST to implement, create generalizable knowledge
“QI” = more local solutions
 
OK, so, some 
real scientific 
terms now…
 
When I teach about implementation research I often use this very
simple language:
The intervention/practice/innovation is 
THE THING
In 
clinical effectiveness research
, we are looking at whether THE THING
works
Patients get better because of the THE THING
In 
implementation research
, we are trying to figure out how best to help
people/places 
DO THE THING
Implementation 
strategies 
are the 
stuff we do
 
to help people/places DO
THE THING
Main implementation 
outcomes
 are 
how much
 
and 
how well
 
the
people/places DO THE THING
 
Curran, 
Implementation Science Communications
, 2020
 
So, why do we need implementation research?
 
So, why do we need implementation research?
 
Only ~50% of patients in the US receive recommended/EB care
Wide variability across conditions and treatment:
79% of patients receive recommended care for an age-related cataract
11% of patients receive recommended care for alcohol use disorder
20–25% patients get care that is not needed or potentially
harmful
So, we also need to DE-implement…
1.3 million people are injured annually by medication errors
Most chronic conditions have solid, evidence-based guidelines for
treatment, management, and prevention, but rates of conditions
such diabetes continue to rise
 
More… why we need this
 
17 years 
on average 
from “we know this works” to “routine
delivery of it”
We have been citing this same figure for years…
Dissemination ONLY
 of research results, clinical practice
guidelines (usually driven by research findings), etc., don’t seem
to do much on their own to improve practice delivery
Except in some simpler cases…
Implementation of research findings/EBPs is a 
fundamental
challenge for healthcare systems to optimize care
, outcomes and
costs
 
 
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So, when do we do Implementation Research?
(Research “Pipeline”)
 
NOT REALLY this linear…
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What to measure in implementation research?
 
What are the 
outcomes
 we care about then?
 
We are trying to measure changes in the 
delivery of care
Did the place/people implement the intervention?
Did they get started?  Did they start and stop?
Did everyone get it who should have gotten it?
Was the intervention/practice delivered as much as it should have been?
Were all indicated patients approached?  Given intervention/practice?
Did they do it right when the were delivering the intervention?
Did they deliver the intervention as intended… with “fidelity”?
How close did they get?
Do we also look at the “effectiveness” of the intervention?
Among those who got it, did they get better?
Symptoms, functioning
If the field does not have “enough” evidence on THE THING, then yes…
 
Common Measures in Impl Research
 
Adoption
“Counts and amounts”
Raw count of delivery
Rates of delivery
Fidelity
“How well performed”
LOTS of different ways to measure this
Checklist; Expert rating
Sustainability
“Stick with it or dropped it?”
Adoption and Fidelity measures 
over time
If we are doing pilot/early work, then also look at
 
Implementation strategies
 
Implementation Strategies
 
Depending on the characteristics of the practice, context, and
people… 
uptake interventions
 of some kind are usually necessary
to support adoption– we call those 
implementation strategies
There are numerous types of implementation strategies available,
many with research evidence supporting their use across contexts
We will now discuss a taxonomy presented by Powell et al., and
Waltz et al., 2015, 
Implementation Science
They cover 73 strategies…
We’ll hit some highlights (only about 26!)
 
Waltz et al Taxonomy of Impl Strats
 
Train and educate stakeholders
Develop educational materials
Conduct educational meetings
Conduct educational outreach visits (academic detailing)
Personalized 1 on 1 sessions on intervention;
Provide ongoing consultation
In person, telephone, televideo…; usually about implementation progress
Use “train-the-trainer” strategies
More for widespread “roll-outs”; Train local trainers/mentors
Create a learning collaborative
Groupings of learners/practitioners supported by trainers/experts
Over time, experienced users teach new users (self-sustaining)
 
Waltz et al Taxonomy of Impl Strats
 
Provide interactive assistance
Provide clinical supervision
Expert supervision focused on the intervention/practice being adopted
Provide local technical assistance
Needed usually for medical record, dispensing software tools…
Provide facilitation
Interactive problem-solving; recommend and supply additional strategies
Support clinicians
Remind clinicians
Electronic reminders in EMR or dispensing software; or manual
“This patient due for screening…”
Revise professional roles
E.g., expand role of pharmacists
Create new clinical teams
 
Waltz et al Taxonomy of Impl Strats
 
Change infrastructure
Change physical structure and equipment
Need new tech?  Record system?  Adequate space to provide interventions to patients??
Mandate change
Create policies supportive of adoption of intervention/practice; 
Make people…?
Change credentialing/licensing standards
Make way for changing scope of practice, e.g., prescribing privileges to PharmDs
Utilize financial strategies
Place intervention on formulary/”covered” list
Alter incentive/allowance structure
E.g., pay for performance of practice
Penalize for not doing the intervention/practice
Make billing easier
 
Waltz et al Taxonomy of Impl Strats
 
Engage consumers
Prepare patients/consumers to be participants
Educate and prompt them to act; “ask your pharmacist about…”
Intervene with patients/consumers to enhance uptake/adherence
Proactively approach patients; “Let’s talk about your adherence to this medication…”
Use mass media
Spread the word… TV, posters, etc.
Develop stakeholder relationships
Identify and prepare champions
Champion = local an enthusiastic supporter of intervention; driver of change
Inform and use local opinion leaders
Recruit “influential” practitioners to support the implementation
Recruit, designate, and train for leadership
Build a coalition
Make a team that works together on the implementation
 
Waltz et al Taxonomy of Impl Strats
 
Adapt and tailor to context
Promote adaptability of the intervention
Adapt intervention to match local needs, but don’t sway from evidence-based-ness
Tailor implementation strategies
Tailor implementation strategies for local needs too
Use evaluative and iterative strategies
Audit and feedback
Measure and feedback performance of practitioners/sites
Conduct local needs assessment
Before you start; identify barriers/facilitators to change and target strategies
Conduct small cyclical tests of change
Iterate your change process based on data (
Plan/Do/Study/Act
 anyone?)
 
Strategies:  What do we know?
 
Disseminating and Training… not so great on their own
Many work “OK” (5-10% change in adoption)
Reminders, Audit & Feedback, Academic detailing, Facilitation…
No combo offers a guarantee of success
Many studies support the use of multi-component strats
But some do not!
Most multifaceted strategies involve 2 or more of these:
education/training, prompts of some kind, audit and feedback
Highly regarded, only somewhat supported, is the idea that
strategies work better when matched to barriers/needs
identified through diagnostic analysis
 
So many questions to answer…
 
Why don’t the strategies we have now work better?
Which strategies work best under what conditions/contexts?
Which strategies are 
cost-effective
 (in which context…)?
How do we get EBPs to low resource counties and countries?
Rural US?
How best to 
feasibly
 measure fidelity?
How much does fidelity matter to effectiveness outcomes?
De-adoption strategies?
Sustainability?
These are just a few…
 
 
Models, Theories, Frameworks…
 
Yeah, I know…
Determinant
 Frameworks
“…understand or explain influences on implementation.”
Consolidated Framework for Implementation Research 
(CFIR)
Characteristics of the intervention
Complexity, cost, relative advantage…
Outer setting
External policies, guidelines, incentives...
Inner Setting
Organizational culture and climate, readiness for implementation, infrastructure…
Characteristics of Individuals
Knowledge, beliefs, self-efficacy…
Process
Planning, executing, reflecting…
Used a lot to study
barriers/facilitators
 to uptake
Used a lot to help 
select
strategies
 to test
 
OK, few more frameworks, 
that’s it
 
Process models
EPIS
:  Exploration, Preparation, Implementation, Sustainment
Why important:  Helps think about what kinds of strategies you’ll need for
each “step”
Evaluation frameworks
RE-AIM
:  Reach, Effectiveness, Adoption, Implementation,
Maintenance
Proctor framework
:  See above slides…
Why important:  Helps answer the question, “How do I show this strategy
worked or didn’t?”
 
Selected IS Resources on Campus
 
HMPT 6319
: Implementing Change in Clinical Practice Settings
HMPT 9329
: Advanced Topics in Implementation Science
IS Scholars Program
2 year program for clinician scientists
Monthly group consultations
Center for Implementation Research
4
th
 Wednesday at 1pm
 
Question, comments, heckling…
 
Some common designs in implementation research
 
Remember
, these designs are assuming the traditional pipeline
and that it has produced “suitable” EBPs in need of
implementation support
This is not always true, but we’re leave that alone today…
In this summary, I will focus on 
places
 doing the adopting
Easier to talk about places, but many studies focus on 
providers
I won’t provide a detailed overview of the designs, but discuss
some common ones within these categories:
Within-site designs
Between-site designs
 
Within-Site Designs
 
We use these when we want or need to expose all places to the
same thing/strategy
No comparison places; common in “QI” type scenarios or pilot
tests of strategies in development (research scenarios)
VERY COMMON in Community Pharmacy Practice Research
Causal inference difficult, but many real-world uses for these data
“Post-only” design
Simplest
Can be used when we know baseline use of EBP is 
zippo
“Pre-Post” design
Often used when some adoption has been attempted, but it has not achieved the
desired level
 
Between-Site Designs
 
We use these when we want to expose places to 
different
things/strategies
Causal inference improved when places are 
randomized
 to
different exposures (not always possible tho; when not, try to
“balance” places on important measures)
New Strategy vs. “implementation as usual”
Key is to choose 
useful
 “implementation as usual”
Common in healthcare settings = disseminate, plus training, plus a little technical
support
New Strategy 1 vs. New Strategy 2
“Comparative effectiveness trial” of 2 different strategies (or packages of them)
Different 
doses
 of same type of strategy (lo/hi intensity)?  Different types?
“SMART” designs
:  start all with low intensity, then randomized non-responders to
higher intensity strategy
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This content delves into the principles of implementation science, discussing its significance, outcomes in research, and strategies to enhance the adoption of evidence-based practices. It defines key terms like dissemination and implementation, emphasizing the active approach to behavior change. Simplifying the distinction, it highlights the focus of implementation research on facilitating the execution of interventions rather than testing their effectiveness.

  • Implementation Science
  • Research
  • Evidence-Based Practices
  • Dissemination
  • Active Approach

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  1. Introduction to Implementation Science Geoffrey M. Curran, PhD Director, Center for Implementation Research Professor, Departments of Pharmacy Practice and Psychiatry University of Arkansas for Medical Sciences Research Health Scientist, Central Arkansas Veterans Healthcare System

  2. HPV vaccine: 99+ % effective Healthy 2020 Goal = 80% adolescents 15 and under US recent: 42/29% AR recent: 34/16%

  3. Naloxone Naloxone hydrochloride (naloxone) is an opioid antagonist that reverses the potentially fatal respiratory depression caused by opioids Stops overdose 2016: CDC recommendations 2017: Pharmacist standing orders 2018: 1 in 70 high dose prescriptions accompanied by naloxone dispensing

  4. Goals for today Discuss principles of implementation science What is it? Why do we need it? When do we do it? Discuss outcomes in implementation research Adoption/uptake, fidelity to the intervention/practice Summarize different strategies to promote better implementation of evidence-based practices/interventions The interventions in this kind of work/research E.g., education, training, prompting, incentives, mandates

  5. Some definitions

  6. Some definitions Dissemination: targeted spread of information (from the NIH program announcement for Dissemination & Implementation research) Passive approach, focusing on knowledge transfer Implementation: An effort specifically designed to get best practice findings into routine and sustained use via appropriate uptake interventions. (Curran et al., 2012) Active approach, focusing on stimulating behavior change Implementation SCIENCE: The scientific study of methods to promote the systematic uptake of research findings and other evidence-based practices into routine practice, and, hence, to improve the quality and effectiveness of health services and care. (Eccles and Mittman, Implementation Science, 2006) Science of how BEST to implement, create generalizable knowledge QI = more local solutions

  7. OK, so, some real scientific terms now When I teach about implementation research I often use this very simple language: The intervention/practice/innovation is THE THING In clinical effectiveness research, we are looking at whether THE THING works Patients get better because of the THE THING In implementation research, we are trying to figure out how best to help people/places DO THE THING Implementation strategies are the stuff we do to help people/places DO THE THING Main implementation outcomes are how much and how well the people/places DO THE THING Curran, Implementation Science Communications, 2020

  8. So, why do we need implementation research?

  9. So, why do we need implementation research? Only ~50% of patients in the US receive recommended/EB care Wide variability across conditions and treatment: 79% of patients receive recommended care for an age-related cataract 11% of patients receive recommended care for alcohol use disorder 20 25% patients get care that is not needed or potentially harmful So, we also need to DE-implement 1.3 million people are injured annually by medication errors Most chronic conditions have solid, evidence-based guidelines for treatment, management, and prevention, but rates of conditions such diabetes continue to rise

  10. More why we need this 17 years on average from we know this works to routine delivery of it We have been citing this same figure for years Dissemination ONLY of research results, clinical practice guidelines (usually driven by research findings), etc., don t seem to do much on their own to improve practice delivery Except in some simpler cases Implementation of research findings/EBPs is a fundamental challenge for healthcare systems to optimize care, outcomes and costs

  11. So, when do we do Implementation Research? (Research Pipeline ) Effectiveness Research Implementation Research Efficacy Research Improved processes, outcomes Preclinical Research NOT REALLY this linear

  12. What to measure in implementation research?

  13. What are the outcomes we care about then? We are trying to measure changes in the delivery of care Did the place/people implement the intervention? Did they get started? Did they start and stop? Did everyone get it who should have gotten it? Was the intervention/practice delivered as much as it should have been? Were all indicated patients approached? Given intervention/practice? Did they do it right when the were delivering the intervention? Did they deliver the intervention as intended with fidelity ? How close did they get? Do we also look at the effectiveness of the intervention? Among those who got it, did they get better? Symptoms, functioning If the field does not have enough evidence on THE THING, then yes

  14. Common Measures in Impl Research Adoption Counts and amounts Raw count of delivery Rates of delivery Fidelity How well performed LOTS of different ways to measure this Checklist; Expert rating Sustainability Stick with it or dropped it? Adoption and Fidelity measures over time If we are doing pilot/early work, then also look at

  15. Implementation strategies

  16. Implementation Strategies Depending on the characteristics of the practice, context, and people uptake interventions of some kind are usually necessary to support adoption we call those implementation strategies There are numerous types of implementation strategies available, many with research evidence supporting their use across contexts We will now discuss a taxonomy presented by Powell et al., and Waltz et al., 2015, Implementation Science They cover 73 strategies We ll hit some highlights (only about 26!)

  17. Waltz et al Taxonomy of Impl Strats Train and educate stakeholders Develop educational materials Conduct educational meetings Conduct educational outreach visits (academic detailing) Personalized 1 on 1 sessions on intervention; Provide ongoing consultation In person, telephone, televideo ; usually about implementation progress Use train-the-trainer strategies More for widespread roll-outs ; Train local trainers/mentors Create a learning collaborative Groupings of learners/practitioners supported by trainers/experts Over time, experienced users teach new users (self-sustaining)

  18. Waltz et al Taxonomy of Impl Strats Provide interactive assistance Provide clinical supervision Expert supervision focused on the intervention/practice being adopted Provide local technical assistance Needed usually for medical record, dispensing software tools Provide facilitation Interactive problem-solving; recommend and supply additional strategies Support clinicians Remind clinicians Electronic reminders in EMR or dispensing software; or manual This patient due for screening Revise professional roles E.g., expand role of pharmacists Create new clinical teams

  19. Waltz et al Taxonomy of Impl Strats Change infrastructure Change physical structure and equipment Need new tech? Record system? Adequate space to provide interventions to patients?? Mandate change Create policies supportive of adoption of intervention/practice; Make people ? Change credentialing/licensing standards Make way for changing scope of practice, e.g., prescribing privileges to PharmDs Utilize financial strategies Place intervention on formulary/ covered list Alter incentive/allowance structure E.g., pay for performance of practice Penalize for not doing the intervention/practice Make billing easier

  20. Waltz et al Taxonomy of Impl Strats Engage consumers Prepare patients/consumers to be participants Educate and prompt them to act; ask your pharmacist about Intervene with patients/consumers to enhance uptake/adherence Proactively approach patients; Let s talk about your adherence to this medication Use mass media Spread the word TV, posters, etc. Develop stakeholder relationships Identify and prepare champions Champion = local an enthusiastic supporter of intervention; driver of change Inform and use local opinion leaders Recruit influential practitioners to support the implementation Recruit, designate, and train for leadership Build a coalition Make a team that works together on the implementation

  21. Waltz et al Taxonomy of Impl Strats Adapt and tailor to context Promote adaptability of the intervention Adapt intervention to match local needs, but don t sway from evidence-based-ness Tailor implementation strategies Tailor implementation strategies for local needs too Use evaluative and iterative strategies Audit and feedback Measure and feedback performance of practitioners/sites Conduct local needs assessment Before you start; identify barriers/facilitators to change and target strategies Conduct small cyclical tests of change Iterate your change process based on data (Plan/Do/Study/Act anyone?)

  22. Strategies: What do we know? Disseminating and Training not so great on their own Many work OK (5-10% change in adoption) Reminders, Audit & Feedback, Academic detailing, Facilitation No combo offers a guarantee of success Many studies support the use of multi-component strats But some do not! Most multifaceted strategies involve 2 or more of these: education/training, prompts of some kind, audit and feedback Highly regarded, only somewhat supported, is the idea that strategies work better when matched to barriers/needs identified through diagnostic analysis

  23. So many questions to answer Why don t the strategies we have now work better? Which strategies work best under what conditions/contexts? Which strategies are cost-effective (in which context )? How do we get EBPs to low resource counties and countries? Rural US? How best to feasibly measure fidelity? How much does fidelity matter to effectiveness outcomes? De-adoption strategies? Sustainability? These are just a few

  24. Models, Theories, Frameworks Yeah, I know

  25. Determinant Frameworks understand or explain influences on implementation. Consolidated Framework for Implementation Research (CFIR) Characteristics of the intervention Complexity, cost, relative advantage Outer setting External policies, guidelines, incentives... Inner Setting Organizational culture and climate, readiness for implementation, infrastructure Characteristics of Individuals Knowledge, beliefs, self-efficacy Process Planning, executing, reflecting Used a lot to study barriers/facilitators to uptake Used a lot to help select strategies to test

  26. OK, few more frameworks, thats it Process models EPIS: Exploration, Preparation, Implementation, Sustainment Why important: Helps think about what kinds of strategies you ll need for each step Evaluation frameworks RE-AIM: Reach, Effectiveness, Adoption, Implementation, Maintenance Proctor framework: See above slides Why important: Helps answer the question, How do I show this strategy worked or didn t?

  27. Selected IS Resources on Campus HMPT 6319: Implementing Change in Clinical Practice Settings HMPT 9329: Advanced Topics in Implementation Science IS Scholars Program 2 year program for clinician scientists Monthly group consultations Center for Implementation Research 4th Wednesday at 1pm

  28. Question, comments, heckling

  29. Some common designs in implementation research Remember, these designs are assuming the traditional pipeline and that it has produced suitable EBPs in need of implementation support This is not always true, but we re leave that alone today In this summary, I will focus on places doing the adopting Easier to talk about places, but many studies focus on providers I won t provide a detailed overview of the designs, but discuss some common ones within these categories: Within-site designs Between-site designs

  30. Within-Site Designs We use these when we want or need to expose all places to the same thing/strategy No comparison places; common in QI type scenarios or pilot tests of strategies in development (research scenarios) VERY COMMON in Community Pharmacy Practice Research Causal inference difficult, but many real-world uses for these data Post-only design Simplest Can be used when we know baseline use of EBP is zippo Pre-Post design Often used when some adoption has been attempted, but it has not achieved the desired level

  31. Between-Site Designs We use these when we want to expose places to different things/strategies Causal inference improved when places are randomized to different exposures (not always possible tho; when not, try to balance places on important measures) New Strategy vs. implementation as usual Key is to choose useful implementation as usual Common in healthcare settings = disseminate, plus training, plus a little technical support New Strategy 1 vs. New Strategy 2 Comparative effectiveness trial of 2 different strategies (or packages of them) Different doses of same type of strategy (lo/hi intensity)? Different types? SMART designs: start all with low intensity, then randomized non-responders to higher intensity strategy

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