Effect of Monitoring System Design on Response Time to Cardiac Arrhythmias
Primary Purpose
Arrhythmias, Cardiac
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
In-hospital cardiac monitoring method
Sponsored by
About this trial
This is an interventional health services research trial for Arrhythmias, Cardiac
Eligibility Criteria
Inclusion Criteria:
- Care providers including the individuals responsible for monitoring patients (monitoring technicians and nurses), individuals communicating life threatening events (monitoring technicians, health unit coordinators, and nurses) and the individuals responsible for the initial check on a patient in the event of life-threatening cardiac arrhythmias (generally the patient's nurse).
- Patients for whom cardiac monitoring was ordered by their physician.
Exclusion Criteria:
- NA
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Change in in-hospital cardiac monitoring method
Arm Description
Pre- and post-intervention, where the intervention is a change in in-hospital cardiac monitoring method
Outcomes
Primary Outcome Measures
Response time to a simulated (not real) critical cardiac arrhythmia (pulseless ventricular tachycardia or ventricular fibrillation)
Secondary Outcome Measures
Full Information
NCT ID
NCT02466633
First Posted
June 3, 2015
Last Updated
May 27, 2021
Sponsor
Duke University
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
1. Study Identification
Unique Protocol Identification Number
NCT02466633
Brief Title
Effect of Monitoring System Design on Response Time to Cardiac Arrhythmias
Official Title
Effect of Monitoring System Design on Response Time to Cardiac Arrhythmias
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
February 26, 2020 (Actual)
Study Completion Date
February 26, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Agency for Healthcare Research and Quality (AHRQ)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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:
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.
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmias, Cardiac
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Change in in-hospital cardiac monitoring method
Arm Type
Experimental
Arm Description
Pre- and post-intervention, where the intervention is a change in in-hospital cardiac monitoring method
Intervention Type
Other
Intervention Name(s)
In-hospital cardiac monitoring method
Intervention Description
Method for monitoring hospitalized patients at risk for cardiac arrhythmias (non-ICU)
Primary Outcome Measure Information:
Title
Response time to a simulated (not real) critical cardiac arrhythmia (pulseless ventricular tachycardia or ventricular fibrillation)
Time Frame
After critical arrhythmia is simulated (approximately 1-5 minutes)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Care providers including the individuals responsible for monitoring patients (monitoring technicians and nurses), individuals communicating life threatening events (monitoring technicians, health unit coordinators, and nurses) and the individuals responsible for the initial check on a patient in the event of life-threatening cardiac arrhythmias (generally the patient's nurse).
Patients for whom cardiac monitoring was ordered by their physician.
Exclusion Criteria:
NA
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noa Segall, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
12. IPD Sharing Statement
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Effect of Monitoring System Design on Response Time to Cardiac Arrhythmias
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