Nutritional and Metabolic DiseasesNCT03419299
Smart Phone Application for Enteral Nutrition
An observational study of Nutritional and Metabolic Diseases, run by University of Oklahoma.
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Nutritional and Metabolic Diseases
- What is being tested?
- Tube Feeding Application
- How many people
- 376 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Medical ICU patients who can tolerate enteral nutrition
Who may be able to join
- Admitted to the ICU
- Require Mechanical Ventilation
- Physician plans to order enteral nutrition for the patient
Who cannot join
- Death likely within 24 hours
- Needing parenteral nutrition
- Cannot tolerate enteral nutrition for any reason
About this study
Official title: 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.
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.
- Conditions
- Nutritional and Metabolic Diseases
- Being tested
- Tube Feeding Application
- Medical subject headings
- Nutritional and Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tube Feeding ApplicationOther
A smart device application was developed and used to help residents determine the best enteral nutrition prescription for patients admitted to the ICU
| Study group | Role | What they receive |
|---|---|---|
| Pre- Application | Patients admitted prior to use of tube feeding application | |
| Post- Application | Patients admitted when tube feeding application was being used. Receives: Other: Tube Feeding Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
total hours between admit and when enteral nutrition is ordered
Measured: 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
percent of calories received (a percent of the total recommended calories for the patient)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2018
- Study startJun 2015
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional and Metabolic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 376 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03419299
- Sponsor's protocol ID
- OU 4496
- Status last verified
- Jun 2019
- First submitted
- 13 Jan 2018
- Last updated
- 12 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smart Phone/Device Application to Improve Delivery of Enteral Nutrition in Adult Patients Admitted to the Medical Intensive Care Unit
- ClinicalTrials.gov ID
- NCT03419299
- Acronym / sponsor ID
- OU 4496
- Conditions
- Nutritional and Metabolic Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 376 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 1 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre- Application | – | –Patients admitted prior to use of tube feeding application |
| Post- Application | – | Other: Tube Feeding ApplicationPatients admitted when tube feeding application was being used. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Medical ICU patients who can tolerate enteral nutrition
Key inclusion criteria (3 listed)
- Admitted to the ICU
- Require Mechanical Ventilation
- Physician plans to order enteral nutrition for the patient
Key exclusion criteria (3 listed)
- Death likely within 24 hours
- Needing parenteral nutrition
- Cannot tolerate enteral nutrition for any reason
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tube Feeding ApplicationA smart device application was developed and used to help residents determine the best enteral nutrition prescription for patients admitted to the ICU | Other | Post- Application |
Primary outcome
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
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Nutritional and Metabolic Diseases, run by University of Oklahoma.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2019.