Introduction

Data Analysis
SECTION 1

Introduction

Contributors

Charles Cannon, MD, PHD,

Carol S. Channing MVP, MD, DDS

Assessing the feasibility of a randomized PCT is a crucial part of the planning phase, serving as a bridge from trial design to conducting the trial—the point when investigators activate sites, randomize participants, and begin data collection. Because PCTs are embedded within healthcare delivery systems and typically use data extracted from electronic health records (EHRs), feasibility assessment may differ from what is done for explanatory clinical trials. Potential differences include the need to establish close partnerships with healthcare system leadership, clinical staff, IT personnel, and others; develop and validate intervention-specific EHR tools; and incorporate the intervention into the clinical workflow as seamlessly as possible to reduce the burden on care providers.

One component of feasibility is assessing the logistics of embedding the trial within the healthcare system. Consider how the study may modify the system’s current workflow. Another component is pilot-testing the key aspects of the study (such as the randomization scheme, intervention specifics, or data collection) to determine if the procedures are well coordinated and able to generate results. The study team should also evaluate the intervention’s flexibility in both delivery and adherence and ensure that the outcomes will be relevant to patients and other decision makers. Pilot-testing will be particularly critical for complex PCT interventions to reduce uncertainties during the implementation phase. The following sections describe feasibility considerations.

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REFERENCES

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Citation:

Introduction: Introduction. In: Rethinking Clinical Trials: A Living Textbook of Pragmatic Clinical Trials. Bethesda, MD: NIH Health Care Systems Research Collaboratory. Available at: https://rethinkingclinicaltrials.org/introduction-2/. Updated March 15, 2017.