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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
    • Electronic Health Records–Based Phenotyping
    • Navigating the Unknown
  • Interpretation, Dissemination & Implementation
    • Data Sharing and Embedded Research
    • Collaborating With Health System Partners to Review and Understand Trial Results
    • 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

Early Debriefing

CHAPTER SECTIONS

Collaborating With Health System Partners to Review and Understand Trial Results


Section 4

Early Debriefing

ExpandContributors

Gregory Simon, MD, MPH
Laura Mae Baldwin, MD, MPH
Sebastian Tong, MD, MPH
Carol Vance, PT, PhD

In pragmatic trials, ascertainment or availability of study outcomes is often delayed, leading to a gap of many months between the end of the trial’s clinical activities and analyses of primary outcomes. This hiatus is another opportunity for pragmatic trial teams to debrief with health system partners about their experience with study implementation, especially regarding implementation or delivery of study interventions. Experience of clinical leaders and frontline clinical staff is especially valuable for exploring and understanding the feasibility and acceptability of interventions, heterogeneity in uptake and fidelity, and facilitators and barriers to subsequent implementation. Health system partners can identify changes in the local or national environment (such as regulatory changes, financial incentives, and organizational processes or priorities) during the trial.

Ideally, pragmatic trial teams can interview or debrief representatives from all levels of partner health systems: executive leaders, clinic-level leaders, and frontline staff from various roles or disciplines. Impressions may certainly vary across levels within the same organization. Discovering and exploring heterogeneity of experience is especially informative, since facilitators and barriers may vary across health systems or even within health systems.

Collecting feedback from health system partners may involve a variety of methods (for example, informal interviews, semistructured interviews, and brief surveys) depending on the resources and time available. Regardless of the type of data collected, implementation science frameworks, such as the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework (Glasgow et al 2019) or the Consolidated Framework for Implementation Research (Kirk et al 2016), can be helpful both in identifying questions to be explored and organizing information or responses from health system partners.

Previous Section Next Section

SECTIONS

CHAPTER SECTIONS

sections

  1. Introduction
  2. Early Engagement
  3. Learning Along the Way
  4. Early Debriefing
  5. Collaborative Analysis and Interpretation
  6. Dissemination to Different “Customers”

REFERENCES

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Glasgow RE, Harden SM, Gaglio B, et al. 2019. RE-AIM planning and evaluation framework: Adapting to new science and practice with a 20-year review. Front Public Health. 7:64. doi: 10.3389/fpubh.2019.00064. PMID: 30984733.

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Kirk MA, Kelley C, Yankey N, Birken SA, Abadie B, Damschroder L. 2016. A systematic review of the use of the Consolidated Framework for Implementation Research. Implement Sci. 11:72. doi: 10.1186/s13012-016-0437-z. PMID: 27189233.


Version History

Published November 4, 2026

current section :

Early Debriefing

  1. Introduction
  2. Early Engagement
  3. Learning Along the Way
  4. Early Debriefing
  5. Collaborative Analysis and Interpretation
  6. Dissemination to Different “Customers”

Citation:

Collaborating With Health System Partners to Review and Understand Trial Results: Early Debriefing. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Pragmatic Trials Collaboratory. Available at: https://rethinkingclinicaltrials.org/chapters/dissemination/collaborating-with-health-system-partners-to-review-and-understand-trial-results/early-debriefing/. Updated November 4, 2026.

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