Pragmatic Clinical Trials Definition: A clinical trial that is designed to study a health intervention in a real-world setting that is similar or identical to the one in which the intervention will be implemented

CTRP classifies trials with the following characteristics as pragmatic:

• Unit of randomization may be other than an individual participant (e.g., the clinic, the healthcare system, or a neighborhood if a community setting)
• Intervention may be multi-level involving changes to:
  • Participant behavior (e.g., completing a symptom report measures online), and
  • Provider behavior (e.g., receiving the participant’s symptom report and having to act on it)
• Data are often obtained directly from medical records and, are likely collected on a large number of participants
  • Data may be collected during a pre-intervention period and again during a post-intervention period in each clinic that is randomized
  • Participants for whom data are collected in the pre-intervention period may not be the same ones for whom data are collected in the post-intervention period