- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03419299
Smart Phone Application for Enteral Nutrition
June 10, 2019 updated by: University of Oklahoma
Smart Phone/Device Application to Improve Delivery of Enteral Nutrition in Adult Patients Admitted to the Medical Intensive Care Unit
Internal medicine resident physicians were provided an ipod with the EN application to assist them in choosing EN formulas for patients during their ICU rotation.
The primary outcome was improved initiation of EN within 24 hours of admission.
Secondary outcomes include, time to initiate EN, goal calories reached, infections rates, length of stay, mortality, and concordance with clinical guidelines.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Background: Resident physicians are frequently uncomfortable ordering enteral nutrition (EN) and are unaware of the variety of formulas and supplements available for different disease processes.
Many depend on a clinical dietitian to assist with recommending EN formulas and patient energy requirements which may not be readily available upon patient admission.
This creates a barrier to early initiation of EN and non-compliance with Society of Critical Care Medicine and American Society of Parenteral and Enteral Nutrition clinical guidelines.
Objective: Internal medicine resident physicians were provided an ipod with the EN application to assist them in choosing EN formulas for patients during their ICU rotation.
The primary outcome was improved initiation of EN within 24 hours of admission.
Secondary outcomes include, time to initiate EN, goal calories reached.
Design: This study is a retrospective chart review to evaluate the impact of a smart phone/device application (EN application) to assist resident physicians when ordering EN.
The study is a single center trial conducted at an academic teaching facility.
All patient data was obtained by a retrospective chart review of patients admitted to the intensive care unit (ICU) at The University of Oklahoma Medical Center.
Study Type
Observational
Enrollment (Actual)
376
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 to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Medical ICU patients who can tolerate enteral nutrition
Description
Inclusion Criteria:
- Admitted to the ICU
- Require Mechanical Ventilation
- Physician plans to order enteral nutrition for the patient
Exclusion Criteria:
- Death likely within 24 hours
- Needing parenteral nutrition
- Cannot tolerate enteral nutrition for any reason
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pre- Application
Patients admitted prior to use of tube feeding application
|
|
Post- Application
Patients admitted when tube feeding application was being used.
|
A smart device application was developed and used to help residents determine the best enteral nutrition prescription for patients admitted to the ICU
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The primary outcome was improved initiation of EN within 24 hours of admission
Time Frame: The time frame does involve a change in practice. The change is introduction of a smart app- 12 months prior to the smart device being used in the ICU by residents and 12 months during which the smart application was use by the ICU residents
|
percent of patients with enteral nutrition ordered within 24 hours of admit compared to all patients admitted
|
The time frame does involve a change in practice. The change is introduction of a smart app- 12 months prior to the smart device being used in the ICU by residents and 12 months during which the smart application was use by the ICU residents
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total time to initiate EN
Time Frame: The time frame does involve a change in practice. The change is introduction of a smart app- 12 months prior to the smart device being used in the ICU by residents and 12 months during which the smart application was use by the ICU residents
|
total hours between admit and when enteral nutrition is ordered
|
The time frame does involve a change in practice. The change is introduction of a smart app- 12 months prior to the smart device being used in the ICU by residents and 12 months during which the smart application was use by the ICU residents
|
Percent of goal calories received prior to discharge from ICU
Time Frame: The time frame does involve a change in practice. The change is introduction of a smart app- 12 months prior to the smart device being used in the ICU by residents and 12 months during which the smart application was use by the ICU residents
|
percent of calories received (a percent of the total recommended calories for the patient)
|
The time frame does involve a change in practice. The change is introduction of a smart app- 12 months prior to the smart device being used in the ICU by residents and 12 months during which the smart application was use by the ICU residents
|
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 (Actual)
June 1, 2015
Primary Completion (Actual)
July 1, 2017
Study Completion (Actual)
July 1, 2017
Study Registration Dates
First Submitted
January 13, 2018
First Submitted That Met QC Criteria
January 31, 2018
First Posted (Actual)
February 1, 2018
Study Record Updates
Last Update Posted (Actual)
June 12, 2019
Last Update Submitted That Met QC Criteria
June 10, 2019
Last Verified
June 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OU 4496
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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