Implementation of Practice Standards for ECG Monitoring

Cardiovascular Disease Clinical Trial

— PULSE  

Official title:

Implementation of Practice Standards for ECG Monitoring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01269736
• Other study ID #: 0711003292
• Secondary ID: R01HL081642
• Status: Completed
• Phase: N/A
• First received: January 3, 2011
• Last updated: August 28, 2017
• Start date: August 2008
• Est. completion date: March 2014

Study information

• Verified date: June 2017
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to test the effect of implementing new practice standards for electrocardiographic (ECG) monitoring on nurses' knowledge and skills, quality of care, and patient outcomes. The investigators hypothesize that increased knowledge and skills of nurses will lead to enhanced quality of care, which will result in improved outcomes for patients.

Description:

Despite advances in hospital electrocardiographic (ECG) monitoring technology, monitoring practices are inconsistent and often inadequate. The investigators recently published practice standards for ECG monitoring. The primary purpose of this 5-year multisite randomized clinical trial is to test the effect of implementing these standards on nurses' knowledge and skills, quality of care, and patient outcomes. The investigators expect that increased knowledge and skills of nurses will lead to enhanced quality of care, which will result in improved outcomes for patients. Units serving cardiac patients in 17 hospitals will participate. Hospitals will be randomized to the experimental or control group after baseline measures of knowledge and skills, quality of care, and patient outcomes are obtained. The intervention will include ECG monitoring education and strategies to implement and sustain change. The online education will include 4 modules: essentials of ECG monitoring, arrhythmia monitoring, ischemia monitoring, and QT interval monitoring. The strategies to implement and sustain change in the clinical area include reinforcement of education, incentives, and the designation of "champions" on each unit who will actively promote the implementation of the practice standards.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92057
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Nurses (and monitor technicians): All nurses (and monitor technicians) working on participating units serving patients with cardiac disease

• Patients: All patients cared for on participating units

Exclusion Criteria:

• Nurses (and monitor technicians): No nurses (or monitor technicians) will be excluded

• Patients: No patients on the participating units will be excluded, even if their primary diagnosis is not cardiac

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Behavioral:
• Education
Online ECG monitoring education program and strategies to implement and sustain change for nurses

Locations

Country	Name	City	State
Canada	University of Ottawa Heart Institute, Ottawa, Canada	Ottawa	Ontario
China	Hong Kong Sanatorium & Hospital	Hong Kong
United States	Seton Medical Center	Austin	Texas
United States	Erie County Medical Center	Buffalo	New York
United States	Aultman Hospital	Canton	Ohio
United States	University of North Carolina Hospitals	Chapel Hill	North Carolina
United States	Baylor University Medical Center	Dallas	Texas
United States	Long Beach Memorial Medical Center	Long Beach	California
United States	Meriter Heart Hospital	Madison	Wisconsin
United States	Yale-New Haven Hospital	New Haven	Connecticut
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	Maine Medical Center	Portland	Maine
United States	United Hospital	Saint Paul	Minnesota
United States	University of California, San Francisco Medical Center	San Francisco	California
United States	Baystate Medical Center	Springfield	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Heart, Lung, and Blood Institute (NHLBI)

Countries where clinical trial is conducted

United States,  Canada,  China, 

References & Publications (3)

Funk M, Fennie KP, Stephens KE, May JL, Winkler CG, Drew BJ; PULSE Site Investigators. Association of Implementation of Practice Standards for Electrocardiographic Monitoring With Nurses' Knowledge, Quality of Care, and Patient Outcomes: Findings From the — View Citation

Funk M, Rose L, Fennie K. Challenges of an Internet-based education intervention in a randomized clinical trial in critical care. AACN Adv Crit Care. 2010 Oct-Dec;21(4):376-9. doi: 10.1097/NCI.0b013e3181e6765d. — View Citation

Funk M, Winkler CG, May JL, Stephens K, Fennie KP, Rose LL, Turkman YE, Drew BJ. Unnecessary arrhythmia monitoring and underutilization of ischemia and QT interval monitoring in current clinical practice: baseline results of the Practical Use of the Lates — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nurses' Knowledge and Skills Related to ECG Monitoring	Participants took a 20-item online test on essentials of ECG monitoring, and arrhythmia, ischemia, and QT interval monitoring. Scores represent the percentage of correct answers. (Test scores range from 0 to 100 with higher scores representing more correct answers)	Baseline, 15 months, 30 months
Secondary	Quality of Patient Care Related to ECG Monitoring	Percentage of patients with accurate electrode placement, accurate rhythm interpretation, cardiac arrest, cardiac arrest initiated by arrhythmia, appropriate monitoring, telemetry units only, ST-segment monitoring when indicated, and QTc measurement when indicated	Baseline, 15 months, 30 months
Secondary	Patient Outcomes	Mortality, in-hospital MI, and not surviving a cardiac arrest were obtained using administrative data and laboratory data (eg, troponin, CK-MB) for all patients. Mortality was defined as death that occurred on one of the participating units. To identify the occurrence of in-hospital MI, laboratory data, timing of procedures, and location of patient at the time of the first blood draw indicating the event were used. Cardiac arrest was defined as an event initiated by an arrhythmia that required immediate intervention and was initiated on a PULSE participating unit. For each qualifying cardiac arrest, it was determined whether the patient survived the event.	Baseline, 15 months, 30 months