Implementation of Practice Standards for ECG Monitoring (PULSE)

• ClinicalTrials.gov Identifier: NCT01269736
• Recruitment Status: Completed
• First Posted: January 4, 2011
• Results First Posted: August 31, 2017
• Last Update Posted: August 31, 2017
• Sponsor: Yale University
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): Yale University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Cardiovascular Disease	Behavioral: Education	Not Applicable

Detailed 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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 92057 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Implementation of Practice Standards for ECG Monitoring
• Study Start Date: August 2008
• Actual Primary Completion Date: March 2014
• Actual Study Completion Date: March 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: Education; Online ECG monitoring education program and strategies to implement and sustain change for nurses	Behavioral: Education; Online ECG monitoring education program and strategies to implement and sustain change for nurses
No Intervention: Control; Usual in-service education for nurses

Outcome Measures

Primary Outcome Measures :

1. Nurses' Knowledge and Skills Related to ECG Monitoring [ Time Frame: Baseline, 15 months, 30 months ]
   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)

Secondary Outcome Measures :

1. Quality of Patient Care Related to ECG Monitoring [ Time Frame: Baseline, 15 months, 30 months ]
   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
2. Patient Outcomes [ Time Frame: Baseline, 15 months, 30 months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, California

Long Beach Memorial Medical Center

Long Beach, California, United States, 90806

University of California, San Francisco Medical Center

San Francisco, California, United States, 94122

United States, Connecticut

Yale-New Haven Hospital

New Haven, Connecticut, United States, 06510

United States, Maine

Maine Medical Center

Portland, Maine, United States, 04102

United States, Massachusetts

Baystate Medical Center

Springfield, Massachusetts, United States, 01199

United States, Minnesota

United Hospital

Saint Paul, Minnesota, United States, 55102

United States, New York

Erie County Medical Center

Buffalo, New York, United States, 14215

United States, North Carolina

University of North Carolina Hospitals

Chapel Hill, North Carolina, United States, 27516

United States, Ohio

Aultman Hospital

Canton, Ohio, United States, 44710

United States, Pennsylvania

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States, 19107

United States, Texas

Seton Medical Center

Austin, Texas, United States, 78705

Baylor University Medical Center

Dallas, Texas, United States, 75252

United States, Wisconsin

Meriter Heart Hospital

Madison, Wisconsin, United States, 53715

Canada, Ontario

University of Ottawa Heart Institute, Ottawa, Canada

Ottawa, Ontario, Canada, K1Y 4W7

China

Hong Kong Sanatorium & Hospital

Hong Kong, China

Sponsors and Collaborators

Yale University

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Marjorie Funk, PhD, RN; Yale University School of Nursing

More Information

Publications of Results:

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 Latest Standards for Electrocardiography trial. J Electrocardiol. 2010 Nov-Dec;43(6):542-7. doi: 10.1016/j.jelectrocard.2010.07.018. Epub 2010 Sep 15.

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 Practical Use of the Latest Standards of Electrocardiography (PULSE) Trial. Circ Cardiovasc Qual Outcomes. 2017 Feb;10(2). pii: e003132. doi: 10.1161/CIRCOUTCOMES.116.003132. Erratum in: Circ Cardiovasc Qual Outcomes. 2017 Oct;10(10):.

Other Publications:

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.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT01269736
• Other Study ID Numbers: 0711003292; R01HL081642 ( U.S. NIH Grant/Contract )
• First Posted: January 4, 2011
• Results First Posted: August 31, 2017
• Last Update Posted: August 31, 2017
• Last Verified: June 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yale University:

electrocardiographic monitoring; arrhythmia; myocardial ischemia

Additional relevant MeSH terms:

Cardiovascular Diseases