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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

Legislative Changes- ARCHIVED

CHAPTER SECTIONS

ARCHIVED PAGE

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

Dissemination and Implementation


Section 5


Legislative Changes- 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

Legislation can be an important way both to generate interest in a particular trial and to sustain its impacts.  At the onset of the Strategies and Opportunities to Stop Colorectal Cancer (STOP CRC) in Priority Populations trial, colorectal cancer screening was adopted as an incentive metric for Oregon’s Coordinated Care Organizations (CCOs, the Oregon equivalent of Accountable Care Organizations). This meant that Medicaid Health Plans and CCOs would receive incentives for reaching performance or improvement targets for colorectal cancer screening. The initial performance target was set at 47%, and the improvement target was set at 3%. Over the subsequent years, additional state legislation was passed to reduce patient out-of-pocket costs for colorectal cancer screening. In 2014, passed legislation required that a colonoscopy initiated as a screening procedure be billed as a screening procedure—even when polyps were removed. Legislation passed in 2015 further required payers to cover the cost of a follow-up colonoscopy (with no out-of-pocket costs) among patients who screened positive on fecal testing.

Case Example: STOP CRC

  • STOP CRC improves the rates of colorectal-cancer screening by mailing fecal immunochemical testing kits to patients at Federally Qualified Health Centers. STOP CRC has explored facilitators for use (e.g., making it more user-friendly by using wordless instructions). Clinics also used plan-do-study-act (PDSA) cycles for exploring additional implementation strategies (e.g., improving workflow for printing and mailing kits and enhancements to patient materials).
Strategy Details
Diffusion Electronic health record tools and training videos are available to all health systems affiliated with OCHIN (100+ health systems across 18 states). Study materials (introductory letters, FIT kit inserts, reminder letters) are available on a public website.
Dissemination Publications and presentations (65 presentations at regional and national venues;23 publications to-date). Dr. Coronado offers technical assistance to additional Federally Qualified Health Centers as part of contracts with the Washington State Department of Health and the Oregon Health Authority.
Implementation A toolkit with clinic materials is publically available (www.MailedFIT.org). The toolkit includes procedures and materials needed to conduct STOP CRC. The electronic health record tools, developed in Epic, were adapted for Allscripts.
Sustainability Control clinics were able to implement the mailed interventions in year 2. Partnerships with health plans and direct-mail vendors assist smaller health centers to implement the mailed program. State legislation, described above, expands access to colonoscopy services.

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


Version History

December 5, 2018: Updated sustainability and implementation information for STOP CRC (changes made by K. Staman).

Published August 25, 2017

current section :

Legislative Changes- 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: Legislative Changes- 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/legislative-changes/. Updated December 3, 2025. DOI: 10.28929/076.

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