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Pragmatic Clinical Trial Study Design


Description

This learning path will help you gain insights and practical tools for designing a pragmatic clinical trial. Each of its three main sections should take you approximately 15 minutes to complete. Throughout you will hear advice through expert videos, check your knowledge with a series of brief application questions, and receive a downloadable reference that you can use as you plan a study.


Continuing Education Credits
In support of improving patient care, the Duke University Health System Department of Clinical Education and Professional Development is accredited by the American Nurses Credentialing Center (ANCC), the Accreditation Council for Pharmacy Education (ACPE), and the Accreditation Council for Continuing Medical Education (ACCME), to provide continuing education for the health care team.




Physician Credit: Duke University Health System Department of Clinical Education and Professional Development designates this Pragmatic Clinical Trial Study Design learning path activity for a maximum of .75 AMA PRA Category 1 CreditTM. Physicians should claim only credit commensurate with the extent of their participation in the activity.
Nurse Credit: Duke University Health System Department of Clinical Education and Professional Development designates this Pragmatic Clinical Trial Study Design learning path activity for up to .75 credit hour for nurses. Nurses should claim only credit commensurate with the extent of their participation in this activity


***If you haven't enrolled already, simply click "get this course" and then "sign up" to create an account in our learning management system. You will be asked to verify your account via email.***


***Please note: if you receive a "This account is inactive" message after attempting to log in, please send a message to nih-collaboratory@duke.edu to request reactivation.***


Content
  • Introduction
  • Thanks to our expert
  • Before you begin...
  • What is the best study design for my pragmatic trial?
  • TOPIC 1: PCT vs. Explanatory Design
  • Should you be using a pragmatic clinical trial and what’s the best study design?
  • How do PCTs differ from traditional clinical trials?
  • How do you design trials that are fit for purpose?
  • How do I determine if a PCT design the best choice for my research question? 
  • Checkpoint 1: Explanatory or Pragmatic Study Design
  • Topic 2: PCT Randomization
  • What type of randomization? Individual or clusters?
  • What are the reasons to randomize clusters instead of individuals?
  • What is an example of how to choose a study design?
  • Types of randomized trials
  • Checkpoint 2: Cluster or Individual Randomization
  • Topic 3: Choosing a CRT design
  • If I know I will use a CRT, how do I choose the best design for my research?
  • What are the types of CRT designs?
  • How do you choose between a parallel and a stepped-wedge design?
  • Checkpoint 3: Parallel or Stepped-Wedge Design
  • Wrap-up
  • How much did you learn?
  • Tell us what you think
Completion rules
  • You must complete the units "Thanks to our expert, Checkpoint 1: Explanatory or Pragmatic Study Design, Types of randomized trials, Checkpoint 2: Cluster or Individual Randomization, How do you choose between a parallel and a stepped-wedge design?, Checkpoint 3: Parallel or Stepped-Wedge Design, Tell us what you think"
  • Leads to a certificate with a duration: 3 years