RTLS for Healthcare Process Validation

NCT04116957 | Completed Results

• 1 other identifier: 2016906
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the project is to develop a new way to understand patient care data analytics by using a real-time location system (RTLS). The investigators will deploy the RTLS-based nursing activity analysis system at an ICU at the University Hospital, University of Missouri Health Care in Columbia, Missouri. The investigators will validate location system performance against manual observation of nursing activity. The investigators will correlate nursing activity metrics against patient outcomes as measured by SOFA score.

Conditions

Workflow; Nursing

Outcome Measures

Primary Outcomes (3)

• In-Room Activity Time Difference Between RTLS System and Manual Observation

  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).

  Up to 12 hours

• Patient Severity of Illness - Sequential Organ Failure Assessment (SOFA) Score

  Sequential 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.

  Assessed at ICU admission

• Out-of-Room Activity Time Difference Between RTLS System and Manual Observation

  To 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)

  Up to 12 hours

Study Arms (2)

Tracking System

OTHER

Nurse location data collection using the original NFER system at an ICU at the University Hospital, University of Missouri Health Care in Columbia, Missouri.

Device: RTLS current tag

New Tracking System

OTHER

Nurse location data collection using the upgraded NFER system at an ICU at the University Hospital, University of Missouri Health Care in Columbia, Missouri.

Device: RTLS tag revised

Interventions

RTLS current tag DEVICE

Validate location system performance against manual observation of nursing activity

Tracking System

RTLS tag revised DEVICE

Test a next-generation RTLS tag for healthcare process validation

New Tracking System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking, RN or LPN licensure

You may not qualify if:

• Nurses helping to provide care but not having a patient assignment and nurse managers

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University Hospital, MU Health Care

Columbia, Missouri, 65211, United States

Location

Results Point of Contact

• Title: Jung Hyup Kim
• Organization: University of Missouri

kijung@missouri.edu

5738840354

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 2, 2019
• First Posted: October 7, 2019
• Study Start: February 17, 2020
• Primary Completion: April 16, 2021
• Study Completion: May 31, 2021
• Last Updated: August 19, 2024
• Results First Posted: August 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)