Trial Outcomes & Findings for Comparison of Nutrition Risk Screens (NCT NCT02585245)

NCT ID: NCT02585245

Last Updated: 2017-11-06

Results Overview

Sensitivity: True Positives/ (True Positives +False Negatives) Specificity: True Negatives/ (True Negatives + False Positives)

• Recruitment status: COMPLETED
• Target enrollment: 607 participants
• Primary outcome timeframe: 24 hr within admission to the hospital
• Results posted on: 2017-11-06

Participant Flow

Participant milestones

Measure	All Participants All patients received both the NRS 2002 and the ThedaCare Nutrition Risk Screen. Patients identified at HIgh, medium or Low Risk in Hospitalized patients. Determining accuracy of identifiying patients affected by malnutrition.
Overall Study STARTED	607
Overall Study COMPLETED	594
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison of Nutrition Risk Screens

Baseline characteristics by cohort

Measure	All Participants n=594 Participants All patients received both the NRS 2002 and the ThedaCare Nutrition Risk Screen. Patients identified at HIgh, medium or Low Risk in Hospitalized patients. Determining accuracy of identifiying patients affected by malnutrition.
Age, Continuous	63 years STANDARD_DEVIATION 16 • n=5 Participants
Sex: Female, Male Female	318 Participants n=5 Participants
Sex: Female, Male Male	276 Participants n=5 Participants
Region of Enrollment United States	594 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hr within admission to the hospital

Sensitivity: True Positives/ (True Positives +False Negatives) Specificity: True Negatives/ (True Negatives + False Positives)

Outcome measures

Measure	NRS2002 Nutrition Risk Screen n=594 Participants Patients identified at HIgh, medium or Low Risk in Hospitalized patients. Determining accuracy of identifiying patients affected by malnutrition.	ThedaCare RD/RN Nutrition Risk Screen n=594 Participants Patients identified at HIgh, medium or Low Risk in Hospitalized patients. Determining accuracy of identifiying patients affected by malnutrition.
The Percent of Participants Identified With Malnutrition Using the NRS 2002 and ThedaCare Nutrition Risk Screen Sensitivity	63.5 percentage of participants Interval 58.3 to 68.7	98.8 percentage of participants Interval 97.6 to 99.9
The Percent of Participants Identified With Malnutrition Using the NRS 2002 and ThedaCare Nutrition Risk Screen Specificity	94.3 percentage of participants Interval 91.5 to 97.1	74 percentage of participants Interval 68.7 to 79.2

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 113 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lori Hartz MS, RDN Manager of Nutrition and Diabetes Education

ThedaCare

Phone: 920 831-5077

Email: lori.hartz@thedacare.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place