Skip to content

COVID-19 Resources

Access the latest information on COVID-19 for clinical researchers
  • Home
  • About
    • NIH Collaboratory
      • Coordinating Center
      • NIH Collaboratory Trials
      • Core Working Groups
      • Steering Committee
      • Distributed Research Network
      • Our Impact
    • Living Textbook
      • Table of Contents
      • How to Use This Site
  • Resources
    • Data and Resource Sharing
    • Training Resources
    • Tools for Researchers
    • Publications
    • Knowledge Repository
  • Webinar
  • Podcast
  • News
    • News Feed
    • Calendar
    • Subscribe
return to home
Subscribe to Newsletter go to twitter feed go to linkedin go to blue sky feed
Search
NIH Collaboratory
Living Textbook of
Pragmatic Clinical Trials

COVID-19 Resources

Access the latest information on COVID-19 for clinical researchers
home button

Rethinking Clinical Trials

A Living Textbook of Pragmatic Clinical Trials

  • Design
    • What is a Pragmatic Clinical Trial?
    • Decentralized Pragmatic Clinical Trials
    • Developing a Compelling Grant Application
    • Experimental Designs and Randomization Schemes
    • Endpoints and Outcomes
    • Analysis Plan
    • Using Electronic Health Record Data
    • Building Partnerships and Teams to Ensure a Successful Trial
    • Intervention Delivery and Complexity
    • Patient Engagement
  • Data, Tools & Conduct
    • Assessing Feasibility
    • Acquiring Real-World Data
    • Assessing Fitness-for-Use of Real-World Data
    • Study Startup
    • Participant Recruitment
    • Monitoring Intervention Fidelity and Adaptations
    • Patient-Reported Outcomes
    • Clinical Decision Support
    • Mobile Health
    • Electronic Health Records–Based Phenotyping
    • Navigating the Unknown
  • Dissemination & Implementation
    • Data Sharing and Embedded Research
    • Dissemination Approaches for Different Audiences
    • Implementation
    • End-of-Trial Decision-Making
  • Ethics & Regulatory
    • Privacy Considerations
    • Identifying Those Engaged in Research
    • Collateral Findings
    • Consent, Disclosure, and Non-Disclosure
    • Data and Safety Monitoring
    • Ethical Considerations of Data Sharing in Pragmatic Clinical Trials
    • Ethics for AI and ML
    • IRB Responsibilities and Procedures

Introduction

CHAPTER SECTIONS

Implementation


Section 1

Introduction

Expand Contributors

Devon Check, PhD
Hayden B. Bosworth, PhD

Contributing Editor

Karen Staman, MS

The process of implementing research findings into clinical practice is complex, and implementation strategies are needed to promote real change. Implementing evidence-based interventions often requires organizational change at the health system or provider level (Greenhalgh et al. 2004). Implementation science was developed to create specific strategies to promote the uptake of evidence-based practices into clinical care (Bauer et al. 2015).

Implementation science is defined as “the scientific study of methods to promote the systematic uptake of research findings and other evidence based practices into routine practice to improve the quality and effectiveness of health services and care (Eccles and Mittman 2006).”

Geoffrey Curran developed this slide to explain implementation science at its most basic level (Curran 2020):

From Implementation science made too simple: a teaching tool. Curran 2020.

Part of implementation research is to describe gaps in use of “the thing” (an evidence-based practice), including relevant barriers and facilitators that can impact use at the patient, provider, and/or organizational levels.

Dissemination science is related to implementation science, and concerns the spread of information and education about an evidence-based practice (Bauer et al. 2015).  Dissemination is about distributing and sharing information and tools, while implementation tends to focus on more proactive efforts to get that information into practice. The chapter Dissemination Approaches for Different Stakeholders provides more specific guidance on dissemination strategies for different audiences.

Why Is Implementation Research Needed?

When research uncovers new information or new knowledge that will improve the care of patients, the findings may not—or may be slow to—be adopted or “translated” into clinical practice, creating a “translation gap.” These gaps persist because of complex provider-level and system-level barriers to rapid translation (Curran et al. 2012). Typically, clinical trials are intended to test the clinical effectiveness of interventions, or the impact of interventions on health outcomes. Implementation research focuses on how to get effective interventions into practice. Proctor and colleagues (Proctor et al. 2009) identified a set of key outcomes and related questions related to implementation that need to be considered:

  • How feasibly can an intervention be delivered in a particular health system?
  • Can the practitioners deliver the intervention with fidelity?
  • How acceptable is it to the variety of patients, clinicians, and leaders within the health system?
  • What will the adoption (i.e., uptake) be?
  • What are the costs associated with having the intervention integrated into a system of care?
  • How sustainable can it be?

Implementation trials typically compare 2 or more implementation strategies to study their effects on adoption and/or fidelity.

This chapter will describe implementation science, but not quality improvement activities. For more on quality improvement and its intersection with ePCTs, see the Living Textbook section: Differentiating Between RCTs, PCTs, and Quality Improvement Activities.

Next Section

SECTIONS

CHAPTER SECTIONS

sections

  1. Introduction
  2. Factors Influencing Implementation of PCT Results
  3. Incorporating Implementation Research Into PCTs
  4. Implementation Frameworks
  5. How PCTs Prepare for Implementation

Resources

Successful dissemination and implementation of trial interventions involves teamwork with health system partners. For more, see the Living Textbook chapter on Building Partnerships to Ensure a Successful Trial.

An introduction to implementation science for the non-specialist

Review that introduces non-specialist investigators, administrators, and policymakers to the principles and methods of implementation science

Implementation science made too simple: a teaching tool

The article provides a teaching tool to assist scientists and non-scientists to grasp key concepts in implementation science.

REFERENCES

back to top

Bauer MS, Damschroder L, Hagedorn H, Smith J, Kilbourne AM. 2015. An introduction to implementation science for the non-specialist. BMC Psychol. 3:32. doi:10.1186/s40359-015-0089-9. PMID: 26376626

Curran GM. 2020. Implementation science made too simple: a teaching tool. Implement Sci Commun. 1:27. doi:10.1186/s43058-020-00001-z. PMID: 32885186

Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. 2012. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 50:217–226. doi:10.1097/MLR.0b013e3182408812. PMID: 22310560

back to top

Eccles MP, Mittman BS. 2006. Welcome to Implementation Science. Implement Sci. 1. doi:10.1186/1748-5908-1-1.

Greenhalgh T, Robert G, Macfarlane F, Bate P, Kyriakidou O. 2004. Diffusion of innovations in service organizations: systematic review and recommendations. Milbank Q. 82:581–629. doi:10.1111/j.0887-378X.2004.00325.x. PMID:15595944.

Proctor EK, Landsverk J, Aarons G, Chambers D, Glisson C, Mittman B. 2009. Implementation research in mental health services: an emerging science with conceptual, methodological, and training challenges. Admin Policy Ment Health. 36:24–34. doi:10.1007/s10488-008-0197-4. PMID: 19104929


Version History

Published August 7, 2025

current section :

Introduction

  1. Introduction
  2. Factors Influencing Implementation of PCT Results
  3. Incorporating Implementation Research Into PCTs
  4. Implementation Frameworks
  5. How PCTs Prepare for Implementation

Citation:

Implementation: Introduction. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Pragmatic Trials Collaboratory. Available at: https://rethinkingclinicaltrials.org/chapters/dissemination/implementation/implementation-introduction/. Updated August 28, 2025. DOI: 10.28929/274.

Footer Menu

  • How to Use This Site
  • About NIH Collaboratory
  • Enrollment Reporting
  • Grand Rounds
  • Funding Statement
Link to Twitter Link to LinkedIn Link to Blue Sky Link to NIH Collaboratory email

Reference in this Web site to any specific commercial products, process, service, manufacturer, or company does not constitute its endorsement or recommendation by the U.S. Government or National Institutes of Health (NIH). NIH is not responsible for the contents of any “off-site” Web page referenced from this server.

Log in
Privacy Statement
WordPress is a content management system and should not be used to upload any PHI as it is not an environment for which we exercise oversight, meaning you the author are responsible for the content you post. Please use this system accordingly. Site Map