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Living Textbook of
Pragmatic Clinical Trials

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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

Creation of Targeted Tools- ARCHIVED

CHAPTER SECTIONS

ARCHIVED PAGE

Archived on August 7, 2025. Go to the latest version.

Dissemination and Implementation


Section 6


Creation of Targeted Tools- ARCHIVED

Expand Contributors
Douglas Zatzick, MD

Leah Tuzzio, MPH

David Chambers, DPhil

Jerry Suls, PhD

Doyanne Darnell, PhD

Gloria Coronado, PhD

Lynn DeBar, PhD, MPH

 

Beverly Green, MD, MPH

Susan S. Huang, MD, MPH

Jeffrey G. Jarvik, MD, MPH

Edward Septimus, MD, FACP

Gregory Simon, MD, MPH

Miguel Vazquez, MD

Contributing Editor
Karen Staman, MS

To help speed implementation and translation of research findings into practice across the nation, tools, such as online materials, training videos, etc., can be created. Materials developed to train the sites participating in the PCT are good starting places for materials for a broader audience. But again, a health system leader must first recognize the need for the tool, then champion its implementation (pointing to the need to involve these stakeholders in study design).

Case Example: REDUCE MRSA and ABATE Infection Trials

The REDUCE MRSA trial was a large, cluster-randomized pragmatic trial of 43 hospitals (74 adult ICUs) that demonstrated that universal bathing with chlorhexidine and universal nasal decolonization with mupirocin significantly reduced MRSA clinical cultures and all-cause bloodstream infections in adult ICUs.

To support broad implementation and facilitate rapid integration of techniques into routine care in ICUs across the country, investigators made the toolkit with educational materials and documentation widely available (Universal ICU Decolonization: An Enhanced Protocol), offered standardized support, and encouraged local adaptation and collaboration. Septimus et al. note several contributing factors that influenced the success of implementation: “(1) a well-designed toolkit with proven success in a pragmatic clinical trial; (2) a program team, experienced in implementing evidence-based practices, that is responsive to local needs; and (3) an established infrastructure for implementing large quality improvement projects (Septimus et al. 2016)."

The implementation of the REDUCE MRSA trial was informed by Pronovost’s five key components of effective translation of knowledge into practice:

  • A focus on systems rather than the care of individual patients
  • Engagement of local interdisciplinary teams to assume ownership of the improvement project
  • Creation of centralized support for the technical work
  • Encouraging local adaption of the intervention
  • Creating a collaborative culture within the local unit and larger system (Pronovost et al. 2008; Septimus et al. 2016)

Most importantly, the successful and rapid implementation of the toolkit used in REDUCE MRSA demonstrates the ability to rapidly integrate research into clinical care, which is, in essence, the foundation of a learning health system.

The diffusion, dissemination, implementation, and sustainability strategy for REDUCE MRSA is described in the table below.

Strategy Details
Diffusion Publication of key finding in the New England Journal of Medicine in June 2013 (Huang et al. 2013).

Universal decolonization of patients in the ICU using a combination of chlorhexidine (CHG) bathing and intranasal mupirocin significantly reduced methicillin-resistant Staphylococcus aureus (MRSA)–positive clinical cultures by 37% and bloodstream infections from any pathogen by 44%.

Dissemination Within HCS partner: A policy and procedure for universal decolonization for all ICU patients was introduced by the HCS partner (Hospital Corporation of America) to all their hospitals in January 2013, following abstract presentation of trial results at a national meeting.
Implementation Within HCS partner: Nursing prompts from the trial for CHG bathing documentation were modified (removed trial name) and activated across the health system. ICU order sets for mupirocin were made available to all hospitals.

External: Investigators also developed a generalizable toolkit with protocols and instructions for CHG bathing and targeted decolonization for MRSA, and a multistep translation program to implement routine universal decolonization in ICUs.

Sustainability Within HCS partner: Feedback reports of CHG and mupirocin compliance developed and deployed.

External: The toolkit is publically available by the Agency for Healthcare Research and Quality: Universal ICU Decolonization: An Enhanced Protocol.

The Active Bathing to Eliminate Infection (ABATE) Trial is a sister trial of REDUCE MRSA. The goal was to determine if using antiseptic bathing for all patients and nasal ointments for patients harboring methicillin-resistant Staphylococcus aureus (MRSA) reduces multidrug-resistant organisms and bloodstream infections. The setting for this trial was not ICUs, as with the REDUCE MRSA trial, but rather was conducted in non-ICU settings. Because the trial’s results are pending, the team is holding off on implementation outside of the ICU until an answer is known.

 

The diffusion, dissemination, implementation, and sustainability strategy for the ABATE Infection trial is described in the table below.

Strategy Details
Diffusion Presentation and publication of trial results
Dissemination If trial demonstrates value, the health system partner (HCA Healthcare) will create a policy and procedure for universal decolonization in general medical/surgical units for all hospitals in their system following abstract presentation of trial results at a national meeting.
Implementation Investigators will develop a generalizable toolkit with protocols and instructions for CHG bathing and decolonization targeted decolonization for MRSA and a multistep translation program to implement routine universal decolonization and targeted nasal decolonization in non-ICU units. Video of protocol highlighting important instructions is available in the NIH Collaboratory Knowledge Repository.
Sustainability The toolkit will be publicly available. The patient bathing video is available on the NIH Collaboratory website.

Previous Section Next Section

SECTIONS

CHAPTER SECTIONS

sections

  1. Introduction – ARCHIVED
  2. Dissemination and Implementation Frameworks – ARCHIVED
  3. Let It, Help It, Make It Happen – ARCHIVED
  4. Changes to Policy and Guidelines – ARCHIVED
  5. Legislative Changes- ARCHIVED
  6. Creation of Targeted Tools- ARCHIVED
  7. Stepped Wedge Designs- ARCHIVED
  8. Intervention Staffing and Training Flexibility- ARCHIVED
  9. Pragmatic Implementation Process Assessments- ARCHIVED
  10. Partnering With Quality Improvement and Population Health Initiatives- ARCHIVED
  11. Implementation in the Trial Versus in the Real World- ARCHIVED
  12. Additional Resources- ARCHIVED
  13. FAQ- ARCHIVED

Resources

Engaging Stakeholders and Building Partnerships to Ensure a Successful Trial

Living Textbook chapter that describes best practices for engaging stakeholders in PCTs

REFERENCES

back to top

Huang SS, Septimus E, Kleinman K, et al. 2013. Targeted versus universal decolonization to prevent ICU infection. N Engl J Med. 368:2255–2265. doi:10.1056/NEJMoa1207290. PMID: 23718152

Pronovost PJ, Berenholtz SM, Needham DM. 2008. Translating evidence into practice: a model for large scale knowledge translation. BMJ. 337:a1714. doi: 10.1136/bmj.a1714. PMID: 18838424.

back to top

Septimus E, Hickok J, Moody J, et al. 2016. Closing the translation gap: toolkit-based implementation of universal decolonization in adult intensive care units reduces central line-associated bloodstream infections in 95 community hospitals. Clin Infect Dis. 63:172–177. doi:10.1093/cid/ciw282. PMID: 27143669.


Version History

December 5, 2018: Revised the implementation and sustainability information for the ABATE trial as part of the annual update (changes made by K. Staman).

Published August 25, 2017

current section :

Creation of Targeted Tools- ARCHIVED

  1. Introduction – ARCHIVED
  2. Dissemination and Implementation Frameworks – ARCHIVED
  3. Let It, Help It, Make It Happen – ARCHIVED
  4. Changes to Policy and Guidelines – ARCHIVED
  5. Legislative Changes- ARCHIVED
  6. Creation of Targeted Tools- ARCHIVED
  7. Stepped Wedge Designs- ARCHIVED
  8. Intervention Staffing and Training Flexibility- ARCHIVED
  9. Pragmatic Implementation Process Assessments- ARCHIVED
  10. Partnering With Quality Improvement and Population Health Initiatives- ARCHIVED
  11. Implementation in the Trial Versus in the Real World- ARCHIVED
  12. Additional Resources- ARCHIVED
  13. FAQ- ARCHIVED

Citation:

Zatzick D, Tuzzio L, Chambers D, et al. Dissemination and Implementation: Creation of Targeted Tools- ARCHIVED. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Pragmatic Trials Collaboratory. Available at: https://rethinkingclinicaltrials.org/chapters/dissemination/dissemination-implementation-top/creation-of-targeted-tools-2/. Updated December 3, 2025. DOI: 10.28929/077.

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