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Ruth Carrico PhD RN FSHEA CICRuth Carrico PhD RN FSHEA CICAssociate Professor Associate Professor
Division of Infectious Diseases Division of Infectious Diseases
University of Louisville University of Louisville
Clinical & Translational Research Clinical & Translational Research Step by Step from Idea to PublicationStep by Step from Idea to Publication
Planning Your Study: Implementation Planning Your Study: Implementation StudiesStudies
Step by Step from Idea to Publication Step by Step from Idea to Publication Step by Step from Idea to Publication Step by Step from Idea to Publication
4. Performing the Study4. Performing the Study
5. Analyzing the Data5. Analyzing the Data
3. Planning the Study 3. Planning the Study
1. Clinical & Translational Research: Definitions1. Clinical & Translational Research: Definitions
6. Disseminating Study Findings: Scientific Writing 6. Disseminating Study Findings: Scientific Writing
7. Clinical Research: Elements for Success7. Clinical Research: Elements for Success
2. Developing the Research Question 2. Developing the Research Question
Clinical & Translational Research Clinical & Translational Research
ObjectivesObjectives ObjectivesObjectives
Describe the elements of study design in Describe the elements of study design in implementation studiesimplementation studies
Explore conceptual basis of implementation science Explore conceptual basis of implementation science and its application to clinical and translational and its application to clinical and translational researchresearch
Clinical & Translational Research Clinical & Translational Research
Basic Research
ClinicalResearch
ClinicalPractice
PatientOutcomes
Translation Translation
T1 T2
Clinical & Translational Research Clinical & Translational Research
Patients inPatients in the universethe universe
http://nihroadmap.nih.gov/
From Research to Practice: Lost in TranslationFrom Research to Practice: Lost in Translation
Basic Research
ClinicalResearch
ClinicalPractice
PatientOutcomes
Translation Translation
T1 T2
Clinical & Translational Research Clinical & Translational Research
Patients inPatients in the universethe universe
http://nihroadmap.nih.gov/
Implementation Research
*Demonstration Research*Dissemination Research*Translating Research Into Practice: TRIP
From Research to Practice: Lost in TranslationFrom Research to Practice: Lost in Translation
The Science Behind Implementation StudiesThe Science Behind Implementation Studies The Science Behind Implementation StudiesThe Science Behind Implementation Studies
A. True A. True
Clinical & Translational Research Clinical & Translational Research
Implementation studies, although Implementation studies, although newly recognized as important, rely newly recognized as important, rely largely on qualitative research and largely on qualitative research and
as such are of lesser quality as such are of lesser quality compared to interventional studiescompared to interventional studies
B. FalseB. False
The Science Behind Implementation StudiesThe Science Behind Implementation Studies The Science Behind Implementation StudiesThe Science Behind Implementation Studies
The study of effectiveness, efficiency, and equity of The study of effectiveness, efficiency, and equity of health program selection, delivery, and uptakehealth program selection, delivery, and uptake
Clinical & Translational Research Clinical & Translational Research
Clinical & Translational Research Clinical & Translational Research
Research has indicated that provision of a peanut butter sandwich to all patients will result in an improved nutritional status.
The new guideline states that a peanut butter sandwich should be provided daily to all targeted patient populations.
You are responsible for implementation.
Make a peanut butter sandwich for your patient.
Research
Performance Improvement
Teaching
Application
People Skills
Variation in Knowledge and Skills
The Science Behind Implementation StudiesThe Science Behind Implementation Studies The Science Behind Implementation StudiesThe Science Behind Implementation Studies
The idea is to bridge the gap between proven The idea is to bridge the gap between proven interventions and clinical/community practices in real-interventions and clinical/community practices in real-world settingsworld settings
The study of effectiveness, efficiency, and equity of The study of effectiveness, efficiency, and equity of health program selection, delivery, and uptakehealth program selection, delivery, and uptake
Clinical & Translational Research Clinical & Translational Research
The Science Behind Implementation StudiesThe Science Behind Implementation Studies The Science Behind Implementation StudiesThe Science Behind Implementation Studies
The overall goal of implementation science is to The overall goal of implementation science is to advance the adoption and integration of evidence-advance the adoption and integration of evidence-based interventions and change practice patternsbased interventions and change practice patterns
The idea is to bridge the gap between proven The idea is to bridge the gap between proven interventions and clinical/community practices in real-interventions and clinical/community practices in real-world settings world settings
The study of effectiveness, efficiency, and equity of The study of effectiveness, efficiency, and equity of health program selection, delivery, and uptakehealth program selection, delivery, and uptake
Clinical & Translational Research Clinical & Translational Research
The Science Behind Implementation StudiesThe Science Behind Implementation Studies The Science Behind Implementation StudiesThe Science Behind Implementation Studies
The overall goal of implementation science is to The overall goal of implementation science is to advance the adoption and integration of evidence-advance the adoption and integration of evidence-based interventions and change practice patterns.based interventions and change practice patterns.
The idea is to bridge the gap between proven The idea is to bridge the gap between proven interventions and clinical/community practices in real-interventions and clinical/community practices in real-world settings. world settings.
The study of effectiveness, efficiency, and equity of The study of effectiveness, efficiency, and equity of health program selection, delivery, and uptakehealth program selection, delivery, and uptake
Implementation science examines all points on the Implementation science examines all points on the causal pathway from program to impactcausal pathway from program to impact
Clinical & Translational Research Clinical & Translational Research
Implementation Research GoalsImplementation Research Goals Implementation Research GoalsImplementation Research Goals
Produce generalizable knowledge and increased Produce generalizable knowledge and increased understanding of implementation processes, barriers, understanding of implementation processes, barriers, facilitators, and strategiesfacilitators, and strategies
Develop reliable strategies for increasing use of Develop reliable strategies for increasing use of evidence-based/effective services to improve outcomes; evidence-based/effective services to improve outcomes; facilitate widespread adoption of those strategiesfacilitate widespread adoption of those strategies
Develop, test and refine implementation theories and Develop, test and refine implementation theories and hypotheses as the methods and measures used to hypotheses as the methods and measures used to accomplish themaccomplish them
Clinical & Translational Research Clinical & Translational Research
Clinical & Translational Research Clinical & Translational Research
Implementation Research: systematic study of how specific Implementation Research: systematic study of how specific activities and strategies are used to successfully integrate activities and strategies are used to successfully integrate
Implementation: use of strategies to adopt and integrate evidence-based interventions and change practice patterns
Dissemination Research: systematic study of how the distribution can be successful executed
Translation Research: comprised of dissemination, implementation and diffusion research
Dissemination: targeted distribution of information and intervention materials to a specific audience
TerminologyTerminology
D. Schillinger. A Resource Manual for Community-Engaged Research 2010
Clinical & Translational Research Clinical & Translational Research
Basic Research
ClinicalResearch
Clinical Practice
T2T1
Guideline DevelopmentMeta-analyses
Systemic reviews
Dissemination researchImplementation research
NIH: Clinical & Translational ScienceNIH: Clinical & Translational Science
Translation to Patients Translation to Practice
Clinical & Translational Research Clinical & Translational Research
Basic Research
ClinicalResearch
Implementation Research
T2T1
Changing public health practice to improve
“prevention”
Changing clinical practice to improve
“treatment”
Patients in the UniversePatients in the Universe
NIH: Clinical & Translational ScienceNIH: Clinical & Translational Science
Clinical & Translational Research Clinical & Translational Research
Components of Implementation ScienceComponents of Implementation Science
Clinical & Translational Research Clinical & Translational Research
Basic Research
ClinicalResearch Implementation
Research
Changing public health practice to improve
“prevention”
Changing clinical practice to improve
“treatment”
Patients in the UniversePatients in the Universe
NIH: Clinical & Translational ScienceNIH: Clinical & Translational Science
PopulationResearch
T1 T2
Clinical & Translational Research Clinical & Translational Research
Patients in the UniversePatients in the Universe
Population-based Research
Implementation Research
T1
Basic Research
ClinicalResearch
T2
NIH: Clinical & Translational ScienceNIH: Clinical & Translational Science
““Cross-Disciplinary Communication”Cross-Disciplinary Communication”
Evolution of Attitudes Toward Evidence Evolution of Attitudes Toward Evidence Evolution of Attitudes Toward Evidence Evolution of Attitudes Toward Evidence
Clinical & Translational Research Clinical & Translational Research
Belief in passive perfusion of scientific evidence into practice
Evolution of Attitudes Toward Evidence Evolution of Attitudes Toward Evidence Evolution of Attitudes Toward Evidence Evolution of Attitudes Toward Evidence
Clinical & Translational Research Clinical & Translational Research
Demonstration that much of clinical practice not evidence based and even if it were, the magnitude makes it impossible for clinicians to keep up with
Evolution of Attitudes Toward Evidence Evolution of Attitudes Toward Evidence Evolution of Attitudes Toward Evidence Evolution of Attitudes Toward Evidence
Clinical & Translational Research Clinical & Translational Research
Passive dissemination does not work. “Quality Chasm” requires aggressive action including performance measurement and accountability
Evolution of Attitudes Toward Evidence Evolution of Attitudes Toward Evidence Evolution of Attitudes Toward Evidence Evolution of Attitudes Toward Evidence
Clinical & Translational Research Clinical & Translational Research
It is insufficient to focus on the individual. Rather, the redesign of service delivery systems is necessary. Behavior change.
EV
IDE
NC
E
PRACTICE HEALTH
COMMUNITYHealth Care Delivery
Systems
Providers
Patients
Public
GovernmentPayors
Public HealthProf. Societies
Academia
System-Centered Implementation
Strategies
Translating Practice Into Evidence: Community Engagement Strategies
Advocacy & Policy Strategies
Individual-Centered
Implementation Strategies
Introduction to Translating Evidence into Practice:
Theory, Evidence & Design
STAKEHOLDERS
Translating Evidence Into Practice, Policy and Public Health
UCSF Model
Steps in Implementation ResearchSteps in Implementation Research Steps in Implementation ResearchSteps in Implementation Research
4. 4. Tailor or develop interventions to improve performanceTailor or develop interventions to improve performance
5. Implement intervention5. Implement intervention
3. Review evidence on implementation interventions3. Review evidence on implementation interventions
1. Identify care gaps and need for change1. Identify care gaps and need for change
6. Evaluate the process of implementation6. Evaluate the process of implementation
7. Evaluate outcomes of the intervention7. Evaluate outcomes of the intervention
2. Identify barriers to consistent use of guidelines2. Identify barriers to consistent use of guidelines
Clinical & Translational Research Clinical & Translational Research
PerformancePerformance
InterventionIntervention
Uncontrolled before-afterUncontrolled before-after Uncontrolled before-afterUncontrolled before-after
PerformancePerformance
Clinical & Translational Research Clinical & Translational Research
Measures performance before and after the intervention in uncontrolled group. Differences in performance assumed to be due to intervention.
Performance in non-randomized or controlled groupPerformance in non-randomized or controlled group
Interrupted time seriesInterrupted time series Interrupted time seriesInterrupted time series
Intervention (e.g., Intervention (e.g., dissemination ofdissemination of
national guideline)national guideline)
Clinical & Translational Research Clinical & Translational Research
Attempts to detect whether intervention had an effect significantly greater than the underlying trend.
Control groupControl groupperformanceperformance
InterventionIntervention
Controlled before-afterControlled before-after Controlled before-afterControlled before-after
Control group Control group performanceperformance
Clinical & Translational Research Clinical & Translational Research
Measures performance before and after the intervention in controlled population with similar characteristics. Compares post-intervention performance in study and control groups
Study groupStudy groupperformanceperformance
Study groupStudy groupperformanceperformance
difference difference
Randomized/cluster-randomized controlled trialRandomized/cluster-randomized controlled trialRandomized/cluster-randomized controlled trialRandomized/cluster-randomized controlled trial
Study Subjects
Planning The StudyPlanning The Study
None or an alternative intervention
Interventional Designs
1. Non-Randomized
2. Randomized
Intervention
Types of Implementation InterventionsTypes of Implementation Interventions Types of Implementation InterventionsTypes of Implementation Interventions
4. 4. Educational outreach visitsEducational outreach visits
5. Use of local opinion leaders5. Use of local opinion leaders
3. Local consensus processes3. Local consensus processes
1. Distribution of educational materials1. Distribution of educational materials
6. Patient-mediated interventions6. Patient-mediated interventions
7. Audit and feedback7. Audit and feedback
2. Educational meetings2. Educational meetings
Clinical & Translational Research Clinical & Translational Research
Types of Implementation InterventionsTypes of Implementation Interventions Types of Implementation InterventionsTypes of Implementation Interventions
10. Mass media10. Mass media
8. Reminders8. Reminders
9. Marketing9. Marketing
Clinical & Translational Research Clinical & Translational Research
Types of Implementation InterventionsTypes of Implementation Interventions Types of Implementation InterventionsTypes of Implementation Interventions
11. 11. Patient/HCP stories and experiencesPatient/HCP stories and experiences
12. Checklists12. Checklists
10. Mass media10. Mass media
8. Reminders8. Reminders
13. Community engagement13. Community engagement
14. Simulation14. Simulation
9. Marketing9. Marketing
Clinical & Translational Research Clinical & Translational Research
Implementation Research ChallengesImplementation Research ChallengesImplementation Research ChallengesImplementation Research Challenges
Develop more sophisticated study designs to address key Develop more sophisticated study designs to address key implementation questionsimplementation questions
Develop a better understanding of interventions and their Develop a better understanding of interventions and their mechanisms of actionmechanisms of action
Understand the impact of context of practice on Understand the impact of context of practice on effectivenesseffectiveness
Clinical & Translational Research Clinical & Translational Research
So What?So What?So What?So What?
How do I take credit for making happen what needs to How do I take credit for making happen what needs to happenhappen
How do I make happen what needs to happenHow do I make happen what needs to happen
Implementation studies represent the basis for Implementation studies represent the basis for understanding the impact of best practicesunderstanding the impact of best practices
Clinical & Translational Research Clinical & Translational Research
How do I lead change to ensure that what happens needs How do I lead change to ensure that what happens needs to happen; and what needs to happen happensto happen; and what needs to happen happens
Hope is not a plan. Plan needs to be evidence-basedHope is not a plan. Plan needs to be evidence-based
Clinical & Translational Research Clinical & Translational Research
Pay for Reporting
Pay for Performance
Financial reward for practitioners in healthcare facilities for collecting and submitting performance data to a quality measurement program (CMS via NHSN)
Financial reward for scoring well on performance measures
A. True A. True
Clinical & Translational Research Clinical & Translational Research
Pay for Performance and Pay for Performance and Accountable Care Act Performance Accountable Care Act Performance Measures apply only to hospitals at Measures apply only to hospitals at
this time (2012)this time (2012)
B. FalseB. False
Clinical & Translational Research Clinical & Translational Research
Value-Based PurchasingValue-Based PurchasingValue-Based PurchasingValue-Based Purchasing
• Notion that standardized care processes reduce error and help to “perfect” the system by identifying and reducing defect
• Data inconclusive as to degree of bundle adherence and outcomes
• Reporting generally all or none
Clinical & Translational Research Clinical & Translational Research
Care BundlesCare BundlesCare BundlesCare Bundles
• Use of chlorhexidine-alcohol skin preparation– Maximum sterile barriers– Full size body drape
• Complete surgical garb • Insertion site selection• Hand hygiene• Daily evaluation of need• Feedback (performance and outcomes)
Clinical & Translational Research Clinical & Translational Research
Central Line BundleCentral Line BundleCentral Line BundleCentral Line Bundle
• Antimicrobial selection, timing, redosing and duration
• Skin preparation
• Hair removal
• Glucose control
• Temperature control (normothermia)
• Instrument sterilization
Clinical & Translational Research Clinical & Translational Research
Surgical Care BundleSurgical Care BundleSurgical Care BundleSurgical Care Bundle
• Head of bed elevation
• Oral care
• Closed suction
• Care of ventilator
• Hand hygiene
• Sedation vacation
• Rapid extubation/discontinuation of ventilator
Clinical & Translational Research Clinical & Translational Research
Ventilator BundleVentilator BundleVentilator BundleVentilator Bundle
The Future of Implementation ResearchThe Future of Implementation Research The Future of Implementation ResearchThe Future of Implementation Research
Theory development (limited empiric evidence)Theory development (limited empiric evidence)
Understand applicability of studies conducted in one Understand applicability of studies conducted in one setting to another/different contextsetting to another/different context
Understand interactions between provider, patient, Understand interactions between provider, patient, practice environment and broader system of carepractice environment and broader system of care
Clinical & Translational Research Clinical & Translational Research