Trial Outcomes & Findings for RTLS for Healthcare Process Validation (NCT NCT04116957)
NCT ID: NCT04116957
Last Updated: 2024-08-19
Results Overview
To compare the time difference between the RTLS system and manual observation data, all In-Room activity times collected from the RTLS system are statistically compared to the In-Room activity time collected from the time study data done by observers. A paired t-test is used to determine whether the means of the two groups are statistically different from each other. The anticipated outcome is actionable, location-based data to describe, analyze, or validate healthcare processes with a maximum error of 5% relative to manual observation. In other words, the time difference between the RTLS system and manual observation should be less than 15 minutes during the day shift (up to 12 hours).
COMPLETED
NA
19 participants
Up to 12 hours
2024-08-19
Participant Flow
Participant milestones
| Measure |
Tracking System
Nurse location data collection (300 mins per day) using the original NFER system at an ICU at the University Hospital, University of Missouri Health Care in Columbia, Missouri.
RTLS current tag: Validate location system performance against manual observation of nursing activity
|
New Tracking System
Nurse location data collection (300 mins per day) using the upgraded NFER system at an ICU at the University Hospital, University of Missouri Health Care in Columbia, Missouri.
RTLS tag with upgraded software: Test a RTLS tag with upgraded software for healthcare process validation
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
10
|
|
Overall Study
COMPLETED
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
RTLS for Healthcare Process Validation
Baseline characteristics by cohort
| Measure |
Time 1
n=9 Participants
Two months of data collection at an ICU at the University Hospital, University of Missouri Health Care in Columbia, Missouri.
RTLS current tag: Validate location system performance against manual observation of nursing activity
|
Time 2
n=10 Participants
Two months of data collection at an ICU at the University Hospital, University of Missouri Health Care in Columbia, Missouri.
RTLS tag with upgraded software: Test a RTLS tag with upgraded software for healthcare process validation
|
Total
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 12 hoursTo compare the time difference between the RTLS system and manual observation data, all In-Room activity times collected from the RTLS system are statistically compared to the In-Room activity time collected from the time study data done by observers. A paired t-test is used to determine whether the means of the two groups are statistically different from each other. The anticipated outcome is actionable, location-based data to describe, analyze, or validate healthcare processes with a maximum error of 5% relative to manual observation. In other words, the time difference between the RTLS system and manual observation should be less than 15 minutes during the day shift (up to 12 hours).
Outcome measures
| Measure |
Tracking System
n=9 Participants
Nurse location data collection using the original NFER system at an ICU at the University Hospital, University of Missouri Health Care in Columbia, Missouri.
RTLS current tag: Validate location system performance against manual observation of nursing activity
|
New Tracking System
n=10 Participants
Nurse location data collection using the upgraded NFER system at an ICU at the University Hospital, University of Missouri Health Care in Columbia, Missouri.
RTLS tag with upgraded software: Test RTLS tag with upgraded software for healthcare process validation
|
|---|---|---|
|
In-Room Activity Time Difference Between RTLS System and Manual Observation
|
34.61 minutes
Standard Deviation 21.19
|
6.63 minutes
Standard Deviation 12.46
|
PRIMARY outcome
Timeframe: Assessed at ICU admissionSequential Organ Failure Assessment (SOFA) score is a measuring system that determines the extent of a person's organ function or failure rate. This scoring system consists of six organ systems (respiratory, coagulation, liver, cardiovascular, renal, and neurologic). It assesses critically ill patients in an intensive care unit. The SOFA score has shown decent predictive validity for inpatient mortality. Each system is assigned a score from 0 to 4 based on the degree of dysfunction, with higher scores indicating more severe dysfunction. The sum of the scores for each organ system is reported. The total score can range from 0 to 24. A higher total score indicates greater organ dysfunction and a higher risk of mortality. The anticipated outcome is that there is no significant difference in the patient severity of illness between the first and second data collection.
Outcome measures
| Measure |
Tracking System
n=9 Participants
Nurse location data collection using the original NFER system at an ICU at the University Hospital, University of Missouri Health Care in Columbia, Missouri.
RTLS current tag: Validate location system performance against manual observation of nursing activity
|
New Tracking System
n=10 Participants
Nurse location data collection using the upgraded NFER system at an ICU at the University Hospital, University of Missouri Health Care in Columbia, Missouri.
RTLS tag with upgraded software: Test RTLS tag with upgraded software for healthcare process validation
|
|---|---|---|
|
Patient Severity of Illness - Sequential Organ Failure Assessment (SOFA) Score
|
5.662 score on a scale
Standard Deviation 3.428
|
6.381 score on a scale
Standard Deviation 3.84
|
PRIMARY outcome
Timeframe: Up to 12 hoursTo compare the time difference between the RTLS system and manual observation data, all Out-of-Room activity times collected from the RTLS system are statistically compared to the Out-of-Room activity times collected from the time study data done by observers. A paired t-test is used to determine whether the means of the two groups are statistically different from each other. The anticipated outcome is actionable, location-based data to describe, analyze, or validate healthcare processes with a maximum error of 5% relative to manual observation. In other words, the time difference between the RTLS system and manual observation should be less than 15 minutes for the day shift (up to 12 hours)
Outcome measures
| Measure |
Tracking System
n=9 Participants
Nurse location data collection using the original NFER system at an ICU at the University Hospital, University of Missouri Health Care in Columbia, Missouri.
RTLS current tag: Validate location system performance against manual observation of nursing activity
|
New Tracking System
n=10 Participants
Nurse location data collection using the upgraded NFER system at an ICU at the University Hospital, University of Missouri Health Care in Columbia, Missouri.
RTLS tag with upgraded software: Test RTLS tag with upgraded software for healthcare process validation
|
|---|---|---|
|
Out-of-Room Activity Time Difference Between RTLS System and Manual Observation
|
33.83 minutes
Standard Deviation 23.67
|
8.68 minutes
Standard Deviation 22.43
|
Adverse Events
Tracking System
New Tracking System
Serious adverse events
| Measure |
Tracking System
n=9 participants at risk
Nurse location data collection (300 mins per day) using the original NFER system at an ICU at the University Hospital, University of Missouri Health Care in Columbia, Missouri.
RTLS current tag: Validate location system performance against manual observation of nursing activity
|
New Tracking System
n=10 participants at risk
Nurse location data collection (300 mins per day) using the upgraded NFER system at an ICU at the University Hospital, University of Missouri Health Care in Columbia, Missouri.
RTLS tag with upgraded software: Test a RTLS tag with upgraded software for healthcare process validation
|
|---|---|---|
|
Product Issues
Fatigue caused by wearing RTLS tag
|
0.00%
0/9 • 72 days
In this project, the performance of the RTLS system was measured by comparing the traditional manual observation technique (i.e., time-motion study). Each nurse wore a small RTLS tag during his or her shift. Hence, the only possible adverse event could be unexpected fatigue caused by wearing the tag during the data collection.
|
0.00%
0/10 • 72 days
In this project, the performance of the RTLS system was measured by comparing the traditional manual observation technique (i.e., time-motion study). Each nurse wore a small RTLS tag during his or her shift. Hence, the only possible adverse event could be unexpected fatigue caused by wearing the tag during the data collection.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place