- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02277535
An Email Intervention to Prevent Iatrogenic Malnutrition in the ICU
January 31, 2017 updated by: Daniel Dante Yeh, Massachusetts General Hospital
This is a quality improvement research project evaluating if a targeted feedback email to clinicians impacts their nutrition delivery in the ICU.
Study Overview
Detailed Description
This prospective study looks to determine if a targeted email to clinicians taking care of critically ill patients will allow reduce malnutrition in the Intensive Care Units (ICU).
Four ICUs will be included: medical ICU (MICU), coronary care unit (CCU) and two surgical ICUs.
The investigators will rotate a 2 month period intervention amongst the aforementioned participating ICUs and follow simultaneous cohorts to evaluate the effect of our intervention (email feedback to treating clinicians) on nutrition delivery in the ICU.
After the completion of the intervention, there will be a six-month follow-up of nutritional adequacy to assess the durability of changes in behavior.
Study Type
Interventional
Enrollment (Actual)
197
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinicians taking care of patients admitted to the ICU within the past 48hrs
- Clinicians taking care of patients in whom enteral nutrition is prescribed
Exclusion Criteria:
- Clinicians taking care of patients in whom enteral nutrition is not prescribed.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: E-mail intervention
ICU clinicians caring for patients who have not yet been initiated on nutrition 48 hours after ICU admission will receive a reminder email. ICU clinicians caring for patients who accumulate a caloric deficit greater than 4000 calories or 150 g protein deficit will receive a feedback email |
|
No Intervention: No E-mail intervention
Nutrition status of patients will be assessed but no reminder or feedback emails will be sent
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patients started on nutrition within 72 h of ICU admission
Time Frame: After completing the intervention for each ICU (2 months)
|
The ICU admission date and EN initiation date will be collected in a data base which will later be analyzed to assess the percentange of patients initiated on EN within 72 hours of admission to the ICU.
This will be reported as rates and will be compared amongst intervention and no-intervention arms using Fisher's Exact test or Chi-sq Test
|
After completing the intervention for each ICU (2 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2014
Primary Completion (Actual)
April 1, 2015
Study Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
October 27, 2014
First Submitted That Met QC Criteria
October 28, 2014
First Posted (Estimate)
October 29, 2014
Study Record Updates
Last Update Posted (Estimate)
February 2, 2017
Last Update Submitted That Met QC Criteria
January 31, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014P001702
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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