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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03419299
Other study ID # OU 4496
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 2015
Est. completion date July 2017

Study information

Verified date June 2019
Source University of Oklahoma
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 376
Est. completion date July 2017
Est. primary completion date July 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

1. Admitted to the ICU

2. Require Mechanical Ventilation

3. Physician plans to order enteral nutrition for the patient

Exclusion Criteria:

1. Death likely within 24 hours

2. Needing parenteral nutrition

3. Cannot tolerate enteral nutrition for any reason

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Tube Feeding Application
A smart device application was developed and used to help residents determine the best enteral nutrition prescription for patients admitted to the ICU

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Oklahoma

Outcome

Type Measure Description Time frame Safety issue
Primary The primary outcome was improved initiation of EN within 24 hours of admission 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 Total time to initiate EN 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
Secondary Percent of goal calories received prior to discharge from ICU 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
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