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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

Questions to Consider

CHAPTER SECTIONS

Participant Recruitment


Section 2


Questions to Consider

Expand Contributors

Adeola Jaiyeola, MD, MHSc
Barbara L. Wells, PhD

Contributing Editor
Liz Wing, MA

When planning a trial's recruitment activities, it would be helpful for study teams to consider important questions like the following:

  • Who (individuals or groups) will be the targets of the embedded intervention?
  • What recruitment methods will be needed in the context of the trial’s randomization scheme, inclusion criteria, enrollment goals, and clinical workflow?
  • What recruitment materials and procedures will be developed?
  • How will eligible participants be contacted and enrolled, whether individual participants or clusters of clinics or clinicians?
  • How will the partner health system’s EHR be used for study recruitment, enrollment, intervention delivery, and/or outcome assessment?
  • What barriers to recruitment are anticipated, and how will these challenges be addressed?

The next section elaborates on each of these recruitment considerations as illustrated by a real-life ePCT case study from the NIH Collaboratory Trials.

 

Previous Section Next Section

DISCLAIMER: The views expressed in this chapter are those of the contributors and do not necessarily represent the views of the National Heart, Lung, and Blood Institute; the National Institutes of Health; or the U.S. Department of Health and Human Services.

SECTIONS

CHAPTER SECTIONS

sections

  1. Introduction
  2. Questions to Consider
  3. Case Study: ICD-Pieces™
  4. Payments and Incentives
  5. Recruitment Highlights
  6. Clinician Recruitment Case Study: HERO
  7. Additional Resources


Version History

August 25, 2020: Made nonsubstantive edits as part of annual content update (changes made by L. Wing).

December 18, 2018: Made nonsubstantive edits as part of annual content update (changes made by L. Wing).

Published August 25, 2017

current section :

Questions to Consider

  1. Introduction
  2. Questions to Consider
  3. Case Study: ICD-Pieces™
  4. Payments and Incentives
  5. Recruitment Highlights
  6. Clinician Recruitment Case Study: HERO
  7. Additional Resources

Citation:

Jaiyeola A, Wells BL. Participant Recruitment: Questions to Consider. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Pragmatic Trials Collaboratory. Available at: https://rethinkingclinicaltrials.org/chapters/conduct/recruitment/questions-to-consider/. Updated January 12, 2024. DOI: 10.28929/065.

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