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Implementation of Practice Standards for ECG Monitoring (PULSE)

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Marjorie Funk, Yale University
ClinicalTrials.gov Identifier:
NCT01269736
First received: January 3, 2011
Last updated: July 11, 2016
Last verified: July 2016
  Purpose
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 Intervention
Cardiovascular Disease
Behavioral: Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Implementation of Practice Standards for ECG Monitoring

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Nurses' knowledge and skills related to ECG monitoring [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of patient care related to ECG monitoring [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • Patient outcomes [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Enrollment: 92057
Study Start Date: August 2008
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01269736

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
St. 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:
Responsible Party: Marjorie Funk, Helen Porter Jayne and Martha Prosser Jayne Professor of Nursing, Yale University
ClinicalTrials.gov Identifier: NCT01269736     History of Changes
Other Study ID Numbers: 0711003292  R01HL081642 
Study First Received: January 3, 2011
Last Updated: July 11, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Yes

Keywords provided by Yale University:
electrocardiographic monitoring
arrhythmia
myocardial ischemia

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on December 02, 2016