Ruth Carrico PhD RN FSHEA CIC Associate Professor Division of Infectious Diseases University of Louisville Clinical & Translational Research Step by Step from Idea to Publication Planning Your Study: Implementation Studies

Step by Step from Idea to Publication Step by Step from Idea to Publication 4. Performing the Study 4. Performing the Study 5. Analyzing the Data 5. Analyzing the Data 3. Planning the Study 3. Planning the Study 1. Clinical & Translational Research: Definitions 1. Clinical & Translational Research: Definitions 6. Disseminating Study Findings: Scientific Writing 6. Disseminating Study Findings: Scientific Writing 7. Clinical Research: Elements for Success 7. Clinical Research: Elements for Success 2. Developing the Research Question 2. Developing the Research Question Clinical & Translational Research

Objectives Objectives Describe the elements of study design in implementation studies Explore conceptual basis of implementation science and its application to clinical and translational research Clinical & Translational Research

Basic Research Clinical Research Clinical Practice Patient Outcomes Translation T1T2 Clinical & Translational Research Clinical & Translational Research Patients in the universe the universe From Research to Practice: Lost in Translation

Basic Research Clinical Research Clinical Practice Patient Outcomes Translation T1T2 Clinical & Translational Research Clinical & Translational Research Patients in the universe the universe Implementation Research *Demonstration Research *Dissemination Research *Translating Research Into Practice: TRIP From Research to Practice: Lost in Translation

The Science Behind Implementation Studies The Science Behind Implementation Studies A. True Clinical & Translational Research Implementation studies, although newly recognized as important, rely largely on qualitative research and as such are of lesser quality compared to interventional studies B. False

The Science Behind Implementation Studies The Science Behind Implementation Studies The study of effectiveness, efficiency, and equity of health program selection, delivery, and uptake 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 Studies The Science Behind Implementation Studies The idea is to bridge the gap between proven interventions and clinical/community practices in real- world settings The study of effectiveness, efficiency, and equity of health program selection, delivery, and uptake Clinical & Translational Research

The Science Behind Implementation Studies The Science Behind Implementation Studies The overall goal of implementation science is to advance the adoption and integration of evidence- based interventions and change practice patterns The overall goal of implementation science is to advance the adoption and integration of evidence- based interventions and change practice patterns The idea is to bridge the gap between proven interventions and clinical/community practices in real- world settings The study of effectiveness, efficiency, and equity of health program selection, delivery, and uptake Clinical & Translational Research

The Science Behind Implementation Studies The Science Behind Implementation Studies The overall goal of implementation science is to advance the adoption and integration of evidence- based interventions and change practice patterns. The overall goal of implementation science is to advance the adoption and integration of evidence- based interventions and change practice patterns. The idea is to bridge the gap between proven interventions and clinical/community practices in real- world settings. The study of effectiveness, efficiency, and equity of health program selection, delivery, and uptake Implementation science examines all points on the causal pathway from program to impact Implementation science examines all points on the causal pathway from program to impact Clinical & Translational Research

Implementation Research Goals Implementation Research Goals Produce generalizable knowledge and increased understanding of implementation processes, barriers, facilitators, and strategies Produce generalizable knowledge and increased understanding of implementation processes, barriers, facilitators, and strategies Develop reliable strategies for increasing use of evidence-based/effective services to improve outcomes; facilitate widespread adoption of those strategies Develop, test and refine implementation theories and hypotheses as the methods and measures used to accomplish them Develop, test and refine implementation theories and hypotheses as the methods and measures used to accomplish them Clinical & Translational Research

Implementation Research: systematic study of how specific 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 Terminology Terminology D. Schillinger. A Resource Manual for Community-Engaged Research 2010

Clinical & Translational Research Basic Research Clinical Research Clinical Practice T2T1 Guideline Development Meta-analyses Systemic reviews Dissemination research Implementation research NIH: Clinical & Translational Science NIH: Clinical & Translational Science Translation to PatientsTranslation to Practice

Clinical & Translational Research Basic Research Clinical Research Implementation Research T2T1 Changing public health practice to improve “prevention” Changing clinical practice to improve “treatment” Patients in the Universe NIH: Clinical & Translational Science NIH: Clinical & Translational Science

Clinical & Translational Research Components of Implementation Science Components of Implementation Science ImplementationSciences Operations Research Mathematical Modeling Impact Studies Evaluation Cost Effectiveness Analysis

Clinical & Translational Research Basic Research Clinical Research Implementation Research Changing public health practice to improve “prevention” Changing clinical practice to improve “treatment” Patients in the Universe NIH: Clinical & Translational Science NIH: Clinical & Translational Science Population Research T1T2

Clinical & Translational Research Patients in the Universe Population-based Research Implementation Research T1 Basic Research Clinical Research T2 NIH: Clinical & Translational Science NIH: Clinical & Translational Science “Cross-Disciplinary Communication”

Evolution of Attitudes Toward Evidence Evolution of Attitudes Toward Evidence Clinical & Translational Research Optimism Belief in passive perfusion of scientific evidence into practice

Evolution of Attitudes Toward Evidence Evolution of Attitudes Toward Evidence Clinical & Translational Research Innocence Lost and Regained 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 Clinical & Translational Research Industrialization 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 Clinical & Translational Research IT and Systems Engineering It is insufficient to focus on the individual. Rather, the redesign of service delivery systems is necessary. Behavior change.

EVIDENCE PRACTICEHEALTH COMMUNITY Health Care Delivery Systems Providers Patients Public Government Payors Public Health Prof. 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 Research Steps in Implementation Research 4. Tailor or develop interventions to improve performance 5. Implement intervention 3. Review evidence on implementation interventions 1. Identify care gaps and need for change 6. Evaluate the process of implementation 7. Evaluate outcomes of the intervention 2. Identify barriers to consistent use of guidelines Clinical & Translational Research

Performance Intervention Uncontrolled before-after Uncontrolled before-after Performance 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 group Interrupted time series Interrupted time series Intervention (e.g., dissemination of national guideline) Clinical & Translational Research Attempts to detect whether intervention had an effect significantly greater than the underlying trend.

Control group performance Intervention Controlled before-after Controlled before-after Control group performance 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 group performance performance difference

Randomized/cluster-randomized controlled trial Study Subjects Planning The Study None or an alternative intervention Interventional Designs 1. Non-Randomized 2. Randomized Intervention

Types of Implementation Interventions Types of Implementation Interventions 4. Educational outreach visits 5. Use of local opinion leaders 3. Local consensus processes 1. Distribution of educational materials 6. Patient-mediated interventions 7. Audit and feedback 2. Educational meetings Clinical & Translational Research

Types of Implementation Interventions Types of Implementation Interventions 10. Mass media 8. Reminders 9. Marketing Clinical & Translational Research

Types of Implementation Interventions Types of Implementation Interventions 11. Patient/HCP stories and experiences 12. Checklists 10. Mass media 8. Reminders 13. Community engagement 14. Simulation 9. Marketing Clinical & Translational Research

Implementation Research Challenges Develop more sophisticated study designs to address key implementation questions Develop a better understanding of interventions and their mechanisms of action Understand the impact of context of practice on effectiveness Clinical & Translational Research

So What? How do I take credit for making happen what needs to happen How do I make happen what needs to happen Implementation studies represent the basis for understanding the impact of best practices Clinical & Translational Research How do I lead change to ensure that what happens needs to happen; and what needs to happen happens Hope is not a plan. Plan needs to be evidence-based

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 Clinical & Translational Research Pay for Performance and Accountable Care Act Performance Measures apply only to hospitals at this time (2012) B. False

Clinical & Translational Research Value-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 Care 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 Central Line Bundle

Antimicrobial selection, timing, redosing and duration Skin preparation Hair removal Glucose control Temperature control (normothermia) Instrument sterilization Clinical & Translational Research Surgical 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 Ventilator Bundle

The Future of Implementation Research The Future of Implementation Research Theory development (limited empiric evidence) Understand applicability of studies conducted in one setting to another/different context Understand interactions between provider, patient, practice environment and broader system of care Clinical & Translational Research