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NIH Collaboratory
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

Additional Resources

CHAPTER SECTIONS

Assessing Feasibility


Section 8


Additional Resources

Expand Contributors

Lynn L. DeBar, PhD, MPH
Jeffrey G. Jarvik, MD, MPH
Leah Tuzzio, MPH
Miguel A. Vazquez, MD

Contributing Editor
Liz Wing, MA

Resource Description
ePCT training resources
Topic 7: Pilot and Feasibility Testing (PDF) (Wendy Weber, ND, PhD, MPH)

 

Topic 7: Case Study Webinar: Pilot-testing Interventions in Pragmatic Trials (Video) (Greg Simon, MD, MPH)

These are a slide deck and video webinar from the 2018 ePCT Training Workshop specifically related to pilot testing and feasibility. Other ePCT training resources are also available.
White papers and guidance
Considerations for Training Front-Line Staff and Clinicians on Pragmatic Clinical Trial Procedures This document helps PCT study teams plan training for study procedures that involve front-line clinicians and staff. The content was developed by drawing on trial-specific experience from the NIH Collaboratory Trials. The document describes how training for PCTs will differ from training conducted for typical research studies, and includes a list of specific considerations, real-world examples, a checklist for PCT training design, and links to additional resources.
Lessons Learned from the NIH Health Care Systems Research Collaboratory Trials This document presents problems and solutions for PCT initiation and implementation based on trial-specific experience from the NIH Collaboratory Trials. For each NIH Collaboratory Trial, problems and solutions are listed as they pertain to building partnerships, defining clinically important questions, assessing feasibility, involving interest holders in study design, developing study workflows, and considering potential Institutional Review Board (IRB), regulatory and biostatistical issues.
Online training
Center for Research Implementation Science and Prevention (CRISP) Pragmatic Trials Workshop Handbook (PDF) An online course and resources for researchers to learn about conducting pragmatic clinical trials.
Journal articles
Readiness assessment for pragmatic trials (RAPT) RAPT is a framework that study teams can use in the pilot phase to assess the readiness of their embedded intervention before advancing to the full implementation phase. RAPT delineates 9 readiness criteria to evaluate from low to high readiness for an intervention.
Communication is the key to success in pragmatic clinical trials in Practice-based Research Networks (PBRNs) Effective communication is the foundation of feasibility and fidelity in practice-based pragmatic research studies. Doing a study with practices spread over several states requires long-distance communication strategies, including e-mails, faxes, telephone calls, conference calls, and texting. Developing and ensuring comfort with distance communications requires additional time and use of different talents and expertise than those required for face-to-face communication. This discussion is based on extensive experience of 2 groups who have worked collaboratively on several large, federally funded, pragmatic trials in a practice-based research network.
Trials without tribulations: minimizing the burden of pragmatic research on healthcare systems Pragmatic clinical trials are increasingly common because they have the potential to yield findings that are directly translatable to real-world healthcare settings. Pragmatic clinical trials need to integrate research into the clinical workflow without placing an undue burden on the delivery system. This requires a research partnership between investigators and healthcare system representatives.
A guide to research partnerships for pragmatic clinical trials A successful pragmatic clinical trial starts with a strong partnership between researcher and healthcare system, goes through a rigorous objective evaluation of the ability of the partner healthcare system to participate, and ends with evidence about sustainable ways to improve care, as well as a long term scientific relationship.

Previous Section

SECTIONS

CHAPTER SECTIONS

sections

  1. Introduction
  2. Developing the Trial Documentation
  3. Establishing Close Partnerships With Participating Healthcare System Leaders and Staff
  4. Delineating the Roles of All Interest Holders to Determine Training Needs
  5. Pilot Testing
  6. Feasibility Assessment Scenarios From the NIH Collaboratory Trials
  7. Spotlight on NIH Collaboratory Trials
  8. Additional Resources


Version History

August 27, 2020: Added a link to the RAPT resource as part of annual content update (changes made by L. Wing).

December 11, 2018: Added new resource to table as part of annual content update (changes made by L. Wing).

Published August 25, 2017

current section :

Additional Resources

  1. Introduction
  2. Developing the Trial Documentation
  3. Establishing Close Partnerships With Participating Healthcare System Leaders and Staff
  4. Delineating the Roles of All Interest Holders to Determine Training Needs
  5. Pilot Testing
  6. Feasibility Assessment Scenarios From the NIH Collaboratory Trials
  7. Spotlight on NIH Collaboratory Trials
  8. Additional Resources

Citation:

DeBar LL, Jarvik JG, Tuzzio L, Vazquez MA. Assessing Feasibility: Additional Resources. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Pragmatic Trials Collaboratory. Available at: https://rethinkingclinicaltrials.org/chapters/conduct/assessing-feasibility/additional-resources/. Updated December 3, 2025. DOI: 10.28929/060.

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