Nutritional and Metabolic Diseases Clinical Trial
Official title:
Smart Phone/Device Application to Improve Delivery of Enteral Nutrition in Adult Patients Admitted to the Medical Intensive Care Unit
| 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 |
| Verified date | June 2019 |
| Source | University of Oklahoma |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| University of Oklahoma |
| 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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