ClinicalTrials.gg
CompletedNCT03419299Updated Jun 12, 2019

Smart Phone Application for Enteral Nutrition

An observational study in Nutritional and Metabolic Diseases, sponsored by University of Oklahoma. Completed. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2019-06-12.

Sponsored by University of Oklahoma · Observational

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Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
376
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Nutritional and Metabolic Diseases
03

In context

Nutritional and Metabolic Diseases

72 studies on the registry are indexed under Nutritional and Metabolic Diseases; 20 are open to participants now.

This study's enrollment of 376 is above the median of 338 across 18 observational studies indexed under Nutritional and Metabolic Diseases.

Browse Nutritional and Metabolic Diseases studies →

Lead sponsor

University of Oklahoma is the lead sponsor of 432 studies on the registry; 100 are open to participants now.

Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Medical ICU patients who can tolerate enteral nutrition

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Admitted to the ICU
  2. Require Mechanical Ventilation
  3. Physician plans to order enteral nutrition for the patient

Exclusion criteria

Exclusion Criteria:

  1. Death likely within 24 hours
  2. Needing parenteral nutrition
  3. Cannot tolerate enteral nutrition for any reason
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
376 participants (actual)
Patient registry
No

Groups and cohorts

  • Pre- Application

    Patients admitted prior to use of tube feeding application

  • Post- Application

    Patients admitted when tube feeding application was being used.

    Other: Tube Feeding Application

Interventions

  • OtherTube 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

06

What researchers measure

Primary outcomes

  1. 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

    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

Secondary outcomes

  1. Total time to initiate EN

    total hours between admit and when enteral nutrition is ordered

    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

  2. Percent of goal calories received prior to discharge from ICU

    percent of calories received (a percent of the total recommended calories for the patient)

    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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2015 to primary completion in Jul 2017, 25 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 13, 2018
First posted
Feb 1, 2018
StartActual
Jun 2015
Primary completionActual
Jul 2017
CompletionActual
Jul 2017
Last update
Jun 12, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 12, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03419299
Responsible party
Sponsor
First posted
Feb 1, 2018
Start date
Jun 2015
Primary completion
Jul 2017
Completion
Jul 2017
Last update
Jun 12, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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