NCT03419299

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
376

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2015

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2018

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 1, 2018

Completed
Last Updated

June 12, 2019

Status Verified

June 1, 2019

Enrollment Period

2.1 years

First QC Date

January 13, 2018

Last Update Submit

June 10, 2019

Conditions

Outcome Measures

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

    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 (2)

  • Total time to initiate EN

    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

    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

Study Arms (2)

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

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

Post- Application

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Medical ICU patients who can tolerate enteral nutrition

You may qualify if:

  • Admitted to the ICU
  • Require Mechanical Ventilation
  • Physician plans to order enteral nutrition for the patient

You may not qualify if:

  • Death likely within 24 hours
  • Needing parenteral nutrition
  • Cannot tolerate enteral nutrition for any reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Nutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2018

First Posted

February 1, 2018

Study Start

June 1, 2015

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

June 12, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share