Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02466633 |
| Other study ID # |
Pro00053941 |
| Secondary ID |
1R01HS023387-01 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 2015 |
| Est. completion date |
February 26, 2020 |
Study information
| Verified date |
May 2021 |
| Source |
Duke University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
To increase the potential for timely detection and treatment of cardiac events, hospitals
have implemented a number of different cardio-respiratory monitoring methods for at-risk
patients. The goal of this study is to compare different monitoring methods to determine the
most efficient method to monitor hospitalized patients - the method that will lead to the
quickest response to critical heart rhythms. The investigators will then test the efficiency
of this monitoring method by implementing it in a new patient care unit.
Description:
Most patients in the hospital who are at lower risk for developing abnormal heart rhythms
have their vitals signs (e.g., heart rate, blood pressure) measured intermittently, such as
every 8 hours. In contrast, hospitalized patients who are at risk for cardiac arrest and
other arrhythmias are put on telemetry to continuously monitor their heart rhythm. A
telemetry monitor is a portable box that is attached to the patient's ECG leads and displays
his or her heart rate and rhythm at a central station. The monitor sends an alarm when it
detects an abnormal rhythm, notifying the person monitoring the patient to check on the
patient. Monitor watchers are dedicated nurses or technicians who monitor a bank of displays
. The watcher-to-patient ratio varies among hospitals, with a single watcher monitoring
between 16 and 72 patients at one time. There are also variations in the additional tasks
assigned to watchers, communication modalities between watchers and nurses (e.g., pagers,
overhead speakers, landline and cell phones, or bi-directional voice communication badges),
and alarm presentation to nurses (e.g., via bedside monitors, centrally located monitors,
automated phone notifications, or none at all, relying on telemetry watchers for
notifications).
A quick and efficient response to cardiac arrest is critical in order to increase the
patient's chance of survival. There is a need for a better understanding of the impact on
monitoring efficiency of factors such as the workload of monitor watchers, communication
methods, and supportive technologies including alarms and automated notification systems. The
objective of the proposed research is to identify and test determinants of efficient cardiac
monitoring methods. There are 3 phases to the study:
1. Characterize candidate monitoring methods (Phase 1). The investigators will study usual
care for monitored patients in 6 hospital units. As part of their usual care these units
have different monitoring methods. These methods vary in terms of 1) the location of the
monitor watchers, 2) the means of communicating routine and life-threatening events
(e.g., via pagers), and 3) monitor watchers' patient load and workload. For each of
these 6 units, the investigators will collect data through interviews, observations, and
20 cardiac arrest simulations.
2. Determine which monitoring method leads to consistently rapid response times to lethal
arrhythmias (Phase 2). Using interview, observation, and simulation data collected in
Phase 1, the investigators will develop a computer simulation model of each of the 6
monitoring methods that will allow them to identify the most efficient method.
3. Test a new monitoring method (Phase 3). In one of the units we had previously conducted
arrhythmia simulations, we will conduct 20 additional simulations after a change from
remote telemetry monitoring to local nurse-based monitoring. We will evaluate whether
response times decrease with the new monitoring method.
