The study procedures found below will take you step-by-step through the activities that need to be completed by your ICU research team for The EFFORT Trial.
Use the links below to begin working step-by-step through the activities that need to be completed by your ICU team to obtain local ethics and other approvals and begin enrolling patients. We understand that not all sites participating will have research nurses or experienced research colleagues participating, so we have tried to break this down into small steps to move forward. We have also included numerous study tools and templates that will be helpful to you and you can modify as you see fit.
Click on the "+" in each of the sections below to get more information and to download study documents.
- Getting Started Manual – Section 1
- EFFORT protocol (all sites except UK, see below for UK protocol)
- Authorship policy
- National Coordinator List
- United Kingdom Sites
- UK Protocol
- Participants information sheet (retrospective) and declaration form
- Personal Consultee information sheet and declaration form
- Nominated consultee information sheet and declaration form
- Nominated consultee information phone consent sheet - England and Wales
- Nominated consultee information phone consent sheet - Scotland
This section contains central study and regional contact information, and outlines the authorship policy.
Register your ICU
- Register Your ICU Manual – Section 2
- Site Suitability Checklist
- US Site - Single IRB (Reliance) Process
- Ethics Documents
- A justification for use of waived consent in EFFORT (ppt)
- Registration Form & Instructions
- Register Here!
This section contains information for the ICU to determine its suitability to join the trial and to prepare ethics applications.
Prepare & Promote
This section contains information to help the research staff orient ICU clinical staff to the study. As well, resources to prepare tracking logs and tools for study implementation.
Recruit Participants & Achieving Nutrition Goals
This section provides information regarding how to screen patients for eligibility, obtaining consent (if applicable) and enrolling patients into the study. Also, there is some useful information about how to achieve nutrition goals with different enteral and parenteral nutrition products.
Data Collection & Entry
This section provides detailed information regarding the data to be collected for each patient enrolled in the study. In addition, there is instruction on how to use the electronic system 'REDCap.'
This section provides information regarding the Benchmark reports.