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Implementation Science Tailored to
Precision Prevention
Graham Colditz, MD, DrPH
April 23, 2018
Department of Surgery
Division of Public Health Sciences
Department of Surgery
Division of Public Health Sciences
Disclosures
• I have no conflict of interests
• Talk – slides at
https://www.slideshare.net/GrahamColditz/IS-tailored-
to-precision-prevention
• Or bitly
Department of Surgery
Division of Public Health Sciences
OUTLINE
• Background
• Current environment of precision medicine
• Gap between evidence and implementation
• Models of implementation
• Considerations
• Future progress – Where are we going?
Department of Surgery
Division of Public Health Sciences
Goal of Implementation Science
Ensure that knowledge and materials produced by health
research actually lead to improved population health:
1. Reaching intended audience
2. Adapted to local circumstances
3. Implemented effectively, safely, equitably, and in a timely manner that
keeps patient at forefront of decision making
Department of Surgery
Division of Public Health Sciences
Key Terms
Precision medicine – uses information about a person’s genes,
environment, and lifestyle to prevent, diagnose, and treat disease
• Allows for more accurate prediction of which treatment and prevention strategies for a
particular disease will work in which groups of people
Precision prevention – tailored approach that considers genetic
variants, mechanisms, and environmental and lifestyle factors to reduce the
risk of disease
• Mainly related to reducing the risk of cancer
Pharmacogenomics – study of how genetic variations influence our
response to medications
Department of Surgery
Division of Public Health Sciences
Key Terms (continued)
Implementation science – study of methods to promote integration of
research findings and evidence into healthcare policy and practice
Dissemination research – scientific study of targeted distribution of
information and intervention materials to a specific public health or clinical
practice audience
• Intent is to understand how best to spread and sustain knowledge and the associated
evidence-based interventions
Implementation research – scientific study of the use of strategies to
adopt and integrate evidence-based health interventions into clinical and
community settings in order to improve patient outcomes and benefit
population health
Department of Surgery
Division of Public Health Sciences
Current Examples of Precision Medicine
Finding the
proper dose of
the proper drug
Department of Surgery
Division of Public Health Sciences
Current Examples of Precision Medicine
Genomics and
cancer
Department of Surgery
Division of Public Health Sciences
Current Examples of Precision Medicine
Regenerative
medicine
Department of Surgery
Division of Public Health Sciences
Current Examples of Precision Medicine
Molecular
profiling of
microbes
Department of Surgery
Division of Public Health Sciences
Current Examples of Precision Medicine
Personalized
diets
Department of Surgery
Division of Public Health Sciences
How is precision medicine/prevention explained to
patients?
Department of Surgery
Division of Public Health Sciences
Model of Precision Medicine (Rebbeck 2014)
Department of Surgery
Division of Public Health Sciences
Model of Precision Medicine (Rebbeck)
BUT, there
is a gap!
Department of Surgery
Division of Public Health Sciences
Gaps Between Evidence and Implementation
Colorectal Cancer Screening
• Goal of US National Colorectal Cancer Roundtable (NCCRT) to increase use of
recommended CRC screening tests to 80% by 2018
However…
• Overall screening among adults age 50 years and older is still around 62.6%
• Varies significantly by state with the highest still only 76% (Massachusetts) and the
lowest at 58% (Wyoming)
• Screening still very low among uninsured (25%) and immigrant populations (34%)
Genomic testing and guided treatment for lung cancer
Lynch syndrome screening in bowel cancer
BRCA testing in ovarian cancer
Department of Surgery
Division of Public Health Sciences
Consider Dissemination and Implementation Earlier
Need an earlier focus on…
• Who’s going to deliver the intervention
• Fit with ultimate patient population (consider context)
• Building on tests of training, support, adherence, mediators and
moderators to high quality delivery
• Hybrid designs
Department of Surgery
Division of Public Health Sciences
Model of Implementation Science
Conceptual model of implementation research (Proctor 2009)
Department of Surgery
Division of Public Health Sciences
Model of Implementation Science
Consolidated Framework for Implementation Research (CFIR)
(Damschroder 2009) – Provides/Considers Context
Department of Surgery
Division of Public Health Sciences
Barriers and Facilitators: Evidence to Implementation
Barriers
• Limited resources (money, staff)
• Time constraints
• Negative attitudes toward change
Facilitators
• Genuine interest from health system decision makers
Department of Surgery
Division of Public Health Sciences
Preliminary Results: Clinic Interviews, Illinois
Major patient level barriers:
• Lack of or insufficient insurance coverage for
colonoscopies
• Lack of transportation to get to/from
appointments
• Resistance to screening, in particular
colonoscopy
• Changing/inconsistent contact information
Department of Surgery
Division of Public Health Sciences
Preliminary Results: Clinic Interviews
Some of the improvements clinics suggested for screening
include:
• Ability to run reports of patients due for screening
• Tracking systems in EMR to better track patients referred for
screening
• Patient education
• Community outreach
• Videos to play in waiting room or patient rooms about CRC
screening
• Improved interfaces/information transfer with EMRs at other
sites (hospitals, etc)
• Traveling colonoscopists who could provide procedures locally
Department of Surgery
Division of Public Health Sciences
Consider Medically Underserved Population
Current focus not on intended population
Challenges:
• Access to internet/email
• Health insurance coverage
• Rural locations
• Health literacy
Department of Surgery
Division of Public Health Sciences
Minority groups have higher
percentage of those with below basic
health literacy
• 41% of Hispanics & 24% of Blacks
• 23% of those age 65-75 & 39% of those over age 75
• 27% of those on Medicare, 30% of those on Medicaid,
28% of those with no insurance
One “dose” does not fit all – Considering Health Literacy
77M adults have basic or below basic health literacy
• Only 12% have proficient health literacy
Department of Surgery
Division of Public Health Sciences
One “dose” does not fit all (continued)
Many studies demonstrate ways to address this
disconnect between health materials and
consumers
• Health insurance decision making
• Cancer treatment decision making
• Understanding genome sequencing preferences and results
• Informed consent language
• Discharge instructions
• Following clinical recommendations
• Postmastectomy Breast Reconstruction decisions
Department of Surgery
Division of Public Health Sciences
How do we move from current examples of precision
prevention like breast and colorectal approaches, to a more
comprehensive precision prevention and treatment approach?
Department of Surgery
Division of Public Health Sciences
Considerations
• Communication and context matter
• Tradeoff – for added measure
• Time for visit – testing and another visit
• Time for comprehension – health literacy – resources for
understanding the more complex “precision prevention
messages”
• Same strategy does not work everywhere (e.g. Victoria
vs. Missouri)
Department of Surgery
Division of Public Health Sciences
Conclusion
There is a paradox
• Costly
• Time-intensive
• Only works for small percentage of patients
• Still not always clear which variant to target
Let’s not exacerbate disparities, but HOW do
we do this?
Department of Surgery
Division of Public Health Sciences
Next Steps
Commonalities across many guidelines poorly
implemented, if at all
Identify when we need new strategies and when we
can adapt existing approaches?
How do we scale up once we have sufficient tool kit
How do we de-implement strategies no longer
supported by new evidence, science, etc.
Department of Surgery
Division of Public Health Sciences
Thank you
Graham Colditz
colditzg@wustl.edu
Department of Surgery
Division of Public Health Sciences
Levels of analysis
System
Academic institutions
Non-academic
institutions
Laboratory
Providers
Doctors
Nurses
Other Staff
IT staff
Laboratory staff
Patients
Patients’ families
ProblemStatement
Howwillweincreaseclinicalutilityofgenomicsequencingfor
underservedandruralpatientsandproviders
Genomic
testing
Interpret
results
Genetic
counseling
Implementation
Strategies
System
ORCHID
Providers
Training
CCT
Other Staff
Training
Patients
Decision making
support
CCT
Implementation
Outcomes
System
Readiness to change
Adoption
Penetration
Providers
Acceptability
Feasibility
Other Staff
Adoption
Patients
Acceptability
Reach
Service Outcomes
Safety
Equity
Patient-centeredness
Timeliness
Client Outcomes
Patients:
Participation
decision (yes/no)
Participants
% consenting to
secondary results
% who do initial
genetic
counseling call
%who access
germline info
%who hold a
follow up genetic
counseling call
NCI Guidelines
Health Equity Impact Assessment
Scoping, Potential impacts, Mitigation, Monitoring
Guideline
characteristics
Guideline
Factors
Individual Health
Professional
Factors
Patient Factors
Professional
interactions
Adapted from Proctor et al. (2011) and Feldstein and Glasgow (2008) and Health Equity Impact Assessment (2012)

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Implementation science tailored to precision prevention

  • 1. Implementation Science Tailored to Precision Prevention Graham Colditz, MD, DrPH April 23, 2018 Department of Surgery Division of Public Health Sciences
  • 2. Department of Surgery Division of Public Health Sciences Disclosures • I have no conflict of interests • Talk – slides at https://www.slideshare.net/GrahamColditz/IS-tailored- to-precision-prevention • Or bitly
  • 3. Department of Surgery Division of Public Health Sciences OUTLINE • Background • Current environment of precision medicine • Gap between evidence and implementation • Models of implementation • Considerations • Future progress – Where are we going?
  • 4. Department of Surgery Division of Public Health Sciences Goal of Implementation Science Ensure that knowledge and materials produced by health research actually lead to improved population health: 1. Reaching intended audience 2. Adapted to local circumstances 3. Implemented effectively, safely, equitably, and in a timely manner that keeps patient at forefront of decision making
  • 5. Department of Surgery Division of Public Health Sciences Key Terms Precision medicine – uses information about a person’s genes, environment, and lifestyle to prevent, diagnose, and treat disease • Allows for more accurate prediction of which treatment and prevention strategies for a particular disease will work in which groups of people Precision prevention – tailored approach that considers genetic variants, mechanisms, and environmental and lifestyle factors to reduce the risk of disease • Mainly related to reducing the risk of cancer Pharmacogenomics – study of how genetic variations influence our response to medications
  • 6. Department of Surgery Division of Public Health Sciences Key Terms (continued) Implementation science – study of methods to promote integration of research findings and evidence into healthcare policy and practice Dissemination research – scientific study of targeted distribution of information and intervention materials to a specific public health or clinical practice audience • Intent is to understand how best to spread and sustain knowledge and the associated evidence-based interventions Implementation research – scientific study of the use of strategies to adopt and integrate evidence-based health interventions into clinical and community settings in order to improve patient outcomes and benefit population health
  • 7. Department of Surgery Division of Public Health Sciences Current Examples of Precision Medicine Finding the proper dose of the proper drug
  • 8. Department of Surgery Division of Public Health Sciences Current Examples of Precision Medicine Genomics and cancer
  • 9. Department of Surgery Division of Public Health Sciences Current Examples of Precision Medicine Regenerative medicine
  • 10. Department of Surgery Division of Public Health Sciences Current Examples of Precision Medicine Molecular profiling of microbes
  • 11. Department of Surgery Division of Public Health Sciences Current Examples of Precision Medicine Personalized diets
  • 12. Department of Surgery Division of Public Health Sciences How is precision medicine/prevention explained to patients?
  • 13. Department of Surgery Division of Public Health Sciences Model of Precision Medicine (Rebbeck 2014)
  • 14. Department of Surgery Division of Public Health Sciences Model of Precision Medicine (Rebbeck) BUT, there is a gap!
  • 15. Department of Surgery Division of Public Health Sciences Gaps Between Evidence and Implementation Colorectal Cancer Screening • Goal of US National Colorectal Cancer Roundtable (NCCRT) to increase use of recommended CRC screening tests to 80% by 2018 However… • Overall screening among adults age 50 years and older is still around 62.6% • Varies significantly by state with the highest still only 76% (Massachusetts) and the lowest at 58% (Wyoming) • Screening still very low among uninsured (25%) and immigrant populations (34%) Genomic testing and guided treatment for lung cancer Lynch syndrome screening in bowel cancer BRCA testing in ovarian cancer
  • 16. Department of Surgery Division of Public Health Sciences Consider Dissemination and Implementation Earlier Need an earlier focus on… • Who’s going to deliver the intervention • Fit with ultimate patient population (consider context) • Building on tests of training, support, adherence, mediators and moderators to high quality delivery • Hybrid designs
  • 17. Department of Surgery Division of Public Health Sciences Model of Implementation Science Conceptual model of implementation research (Proctor 2009)
  • 18. Department of Surgery Division of Public Health Sciences Model of Implementation Science Consolidated Framework for Implementation Research (CFIR) (Damschroder 2009) – Provides/Considers Context
  • 19. Department of Surgery Division of Public Health Sciences Barriers and Facilitators: Evidence to Implementation Barriers • Limited resources (money, staff) • Time constraints • Negative attitudes toward change Facilitators • Genuine interest from health system decision makers
  • 20. Department of Surgery Division of Public Health Sciences Preliminary Results: Clinic Interviews, Illinois Major patient level barriers: • Lack of or insufficient insurance coverage for colonoscopies • Lack of transportation to get to/from appointments • Resistance to screening, in particular colonoscopy • Changing/inconsistent contact information
  • 21. Department of Surgery Division of Public Health Sciences Preliminary Results: Clinic Interviews Some of the improvements clinics suggested for screening include: • Ability to run reports of patients due for screening • Tracking systems in EMR to better track patients referred for screening • Patient education • Community outreach • Videos to play in waiting room or patient rooms about CRC screening • Improved interfaces/information transfer with EMRs at other sites (hospitals, etc) • Traveling colonoscopists who could provide procedures locally
  • 22. Department of Surgery Division of Public Health Sciences Consider Medically Underserved Population Current focus not on intended population Challenges: • Access to internet/email • Health insurance coverage • Rural locations • Health literacy
  • 23. Department of Surgery Division of Public Health Sciences Minority groups have higher percentage of those with below basic health literacy • 41% of Hispanics & 24% of Blacks • 23% of those age 65-75 & 39% of those over age 75 • 27% of those on Medicare, 30% of those on Medicaid, 28% of those with no insurance One “dose” does not fit all – Considering Health Literacy 77M adults have basic or below basic health literacy • Only 12% have proficient health literacy
  • 24. Department of Surgery Division of Public Health Sciences One “dose” does not fit all (continued) Many studies demonstrate ways to address this disconnect between health materials and consumers • Health insurance decision making • Cancer treatment decision making • Understanding genome sequencing preferences and results • Informed consent language • Discharge instructions • Following clinical recommendations • Postmastectomy Breast Reconstruction decisions
  • 25. Department of Surgery Division of Public Health Sciences How do we move from current examples of precision prevention like breast and colorectal approaches, to a more comprehensive precision prevention and treatment approach?
  • 26. Department of Surgery Division of Public Health Sciences Considerations • Communication and context matter • Tradeoff – for added measure • Time for visit – testing and another visit • Time for comprehension – health literacy – resources for understanding the more complex “precision prevention messages” • Same strategy does not work everywhere (e.g. Victoria vs. Missouri)
  • 27. Department of Surgery Division of Public Health Sciences Conclusion There is a paradox • Costly • Time-intensive • Only works for small percentage of patients • Still not always clear which variant to target Let’s not exacerbate disparities, but HOW do we do this?
  • 28. Department of Surgery Division of Public Health Sciences Next Steps Commonalities across many guidelines poorly implemented, if at all Identify when we need new strategies and when we can adapt existing approaches? How do we scale up once we have sufficient tool kit How do we de-implement strategies no longer supported by new evidence, science, etc.
  • 29. Department of Surgery Division of Public Health Sciences Thank you Graham Colditz colditzg@wustl.edu
  • 30. Department of Surgery Division of Public Health Sciences Levels of analysis System Academic institutions Non-academic institutions Laboratory Providers Doctors Nurses Other Staff IT staff Laboratory staff Patients Patients’ families ProblemStatement Howwillweincreaseclinicalutilityofgenomicsequencingfor underservedandruralpatientsandproviders Genomic testing Interpret results Genetic counseling Implementation Strategies System ORCHID Providers Training CCT Other Staff Training Patients Decision making support CCT Implementation Outcomes System Readiness to change Adoption Penetration Providers Acceptability Feasibility Other Staff Adoption Patients Acceptability Reach Service Outcomes Safety Equity Patient-centeredness Timeliness Client Outcomes Patients: Participation decision (yes/no) Participants % consenting to secondary results % who do initial genetic counseling call %who access germline info %who hold a follow up genetic counseling call NCI Guidelines Health Equity Impact Assessment Scoping, Potential impacts, Mitigation, Monitoring Guideline characteristics Guideline Factors Individual Health Professional Factors Patient Factors Professional interactions Adapted from Proctor et al. (2011) and Feldstein and Glasgow (2008) and Health Equity Impact Assessment (2012)