Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05626699 |
Other study ID # |
RTA II-01 |
Secondary ID |
5R44HL146012-03 |
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
January 31, 2024 |
Est. completion date |
March 31, 2024 |
Study information
Verified date |
August 2023 |
Source |
Convergent Engineering, Inc. |
Contact |
Neil Euliano, PhD |
Phone |
3523784899 |
Email |
neil[@]conveng.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Respiratory Therapists (RTs) have difficulty maintaining compliance with protocols and making
efficient handoff communication. This project will evaluate the effectiveness of an
electronic tool that will display a dashboard of key information on all the RTs patients and
provide reminders that indicate whether evidence-based practice protocols are being followed.
In addition, it will collect data from medical devices and the EMR and outline key
information in the appropriate format to help standardize and improve handoff communication.
The study will first collect blind baseline data for comparison with protocol adherence and
silently evaluate shift change handoffs. In the second stage, the electronic tool will be
installed and used to evaluate whether protocol compliance and shift change handoff is
improved.
Description:
Background:
Respiratory Therapists (RTs) face challenges to provide high quality patient care including
maintaining compliance with evidence-based practice protocols using lung protective
ventilation (LPV) (tidal volume [VT] 4 to 8 ml predicted body weight and plateau pressure
[Pplt] < 30 cm H2O), efficient communication during patient handoffs at shift changes and
maintaining situational awareness amidst a high patient-to-clinician ratio and elevated
acuity of patient care. Lung-protective ventilation (LPV) guidelines, initially published by
ARDS Net and supported by the American Thoracic Society, Society of Critical Care Medicine
and European Society of Intensive Care Medicine. LPV guidelines recommend use of low tidal
volume (VT) (6 to 8 ml predicted body weight [PBW]) and inspiratory plateau pressure (Pplt)
(≤ 30 cm H2O), proven to lower mortality in patients with adult respiratory distress syndrome
(ARDS). However, several studies revealed that many clinicians and institutions are not
effectively implementing LPV guidelines many years after their publication in the New England
Journal of Medicine in 2000. Clinicians who are unable and/or unwilling to apply low VT and
Pplt as defined above jeopardize patient safety and risk increased mortality. One study found
only 27% of patients received low VT and Pplt within 48 hours of the onset of ARDS. It was
also found that ". . . adoption of evidence-based mechanical ventilation in real world
practice has been disturbingly slow."
Another daily challenge faced by an RRT is the transfer of vital patient information during
shift changes. A less than optimal "patient hand-off" or communication of relevant patient
care information during shift changes appears to be a major factor in preventable medical
errors directly affecting patient safety. The primary objective of a patient hand-off is to
provide accurate information about the patient's care, treatment and services, current
condition and any recent or anticipated changes. While appearing to be relatively easy task,
a comprehensive, high-quality patient hand-off can be a complex communication procedure. One
study found that patient hand-off communication failures were responsible for 30% of
malpractice claims in U.S. hospitals, resulting in 1,744 deaths and $1.7 billion in
malpractice costs over five years. While the use of computerized patient handoff methods are
likely to promote improved information transfer during patient hand-offs, there is a dearth
of such easy-to-use, portable communication tools available for RTs. Other contributing
factors adversely affecting patient hand-off communication appear to be unrecognized patient
needs due to lack of accurate and real time electronic monitoring, task interruption from
nuisance alarms and inability to quickly determine the correct clinical decision.
RT Assistant, a bedside, portable and hand-held electronic tool, was designed to help the RT
with these challenges.
Goals:
Evaluate the clinical effectiveness of RT Assistant software for the following:
Maintaining patients according to established LPV guidelines for ventilator-dependent
patients Maintaining established low oxygen therapy guidelines Improving patient shift report
communication Collect baseline data from the selected ICU passively through the SickBay data
aggregator, including percentage of time patients are within the LPV and oxygenation
guidelines.
Collect baseline data on shift report quality by passively monitoring shift reports between
RTs during the above baseline data collection Install the RT Assistant software, train
participating RTs, and compare baseline data with the same data collected in the same ICU
during the use of the RT Assistant software