Implementation of Practice Standards for ECG Monitoring (PULSE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Yale University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT01269736
First received: January 3, 2011
Last updated: NA
Last verified: January 2011
History: No changes posted
  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 ]

Estimated Enrollment: 50000
Study Start Date: August 2008
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Education Behavioral: Education
Online ECG monitoring education program and strategies to implement and sustain change
No Intervention: Usual care Behavioral: Education
Online ECG monitoring education program and strategies to implement and sustain change

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

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

Contacts
Contact: Marjorie Funk, PhD, RN 203-737-2346 marjorie.funk@yale.edu
Contact: Jeanine L May, MSN, MPH, RN 203-737-1855 jeanine.may@yale.edu

Locations
United States, California
Long Beach Memorial Medical Center Recruiting
Long Beach, California, United States, 90806
Contact: Peggy Kalowes, PhD, RN    562-933-3044    pkalowes@memorialcare.org   
Contact: Darice Hawkins, MN, RN    562-933-0596    DHawkins@memorialcare.org   
Principal Investigator: Peggy Kalowes, PhD, RN         
Sub-Investigator: Darice Hawkins, MN, RN         
University of California, San Francisco Medical Center Recruiting
San Francisco, California, United States, 94122
Contact: Cass Piper Sandoval, MS, RN    415-353-1122    cass.piper@ucsfmedctr.org   
Contact: Elise Hazlewood, MS, RN    415-353-1788    Elise.Hazlewood@ucsfmedctr.org   
Principal Investigator: Cass Piper Sandoval, MS, RN         
Sub-Investigator: Elise Hazlewood, MS, RN         
Sub-Investigator: Noraliza Salazar, MSN, RN         
United States, Connecticut
Yale-New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06510
Contact: Janet Parkosewich, DNSc, RN    203-688-1041    Janet.Parkosewich@ynhh.org   
Principal Investigator: Janet Parkosewich, DNSc, RN         
United States, Maine
Maine Medical Center Recruiting
Portland, Maine, United States, 04102
Contact: Cindy Honess, MSN, RN    207-662-4136    honesc@mmc.org   
Contact: Paula White, MS, RN    207-662-2290    whitep@mmc.org   
Principal Investigator: Cindy Honess, MSN, RN         
Sub-Investigator: Paula White, MS, RN         
United States, Massachusetts
Baystate Medical Center Recruiting
Springfield, Massachusetts, United States, 01199
Contact: Paula Lusardi, PhD, RN    413-794-4807    Paula.Lusardi@bhs.org   
Contact: Stephanie Calcasola, MSN, RN    413-794-8025    Stephanie.Calcasola@bhs.org   
Principal Investigator: Paula Lusardi, PhD, RN         
Sub-Investigator: Stephanie Calcasola, MSN, RN         
Sub-Investigator: Laura Currie, MN, RN         
United States, Minnesota
United Hospital Recruiting
St. Paul, Minnesota, United States, 55102
Contact: Kristin Sandau, PhD, RN    651-638-6487    k-sandau@bethel.edu   
Contact: Maureen Smith, MSN, RN    651-241-8229    Maureen.smith@allina.com   
Principal Investigator: Kristin Sandau, PhD, RN         
Sub-Investigator: Maureen Smith, MSN, RN         
United States, New York
Erie County Medical Center Recruiting
Buffalo, New York, United States, 14215
Contact: Mary Carey, PhD, RN    716-829-3034    mgcarey@buffalo.edu   
Principal Investigator: Mary Carey, PhD, RN         
United States, North Carolina
University of North Carolina Hospitals Recruiting
Chapel Hill, North Carolina, United States, 27516
Contact: Leslie Davis, MSN, RN    919-949-2718    lesd3392@aol.com   
Contact: Vickie Strang, BS, RN    919-966-3397    vstrang@unch.unc.edu   
Principal Investigator: Leslie Davis, MSN, RN         
Sub-Investigator: Vickie Strang, BS, RN         
United States, Ohio
Aultman Hospital Recruiting
Canton, Ohio, United States, 44710
Contact: Rhonda Fleischman, MSN, RN    330-363-4965    RFleischman@aultman.com   
Principal Investigator: Rhonda Fleischman, MSN, RN         
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: JoAnne Phillips, MSN, RN    215-662-4077    JoAnne.Phillips@uphs.upenn.edu   
Contact: Rebecca Stamm, MSN, RN    215-776-3419    rebecca.stamm@uphs.upenn.edu   
Principal Investigator: JoAnne Phillips, MSN, RN         
Sub-Investigator: Rebecca Stamm, MSN, RN         
Sub-Investigator: Kathleen McCauley, PhD, RN         
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Rose Shaffer, MSN, RN    215-955-8408    rose.shaffer@jeffersonhospital.org   
Contact: Eleanor Fitzpatrick, MSN, RN    215-955-5660    Eleanor.Fitzpatrick@jeffersonhospital.org   
Principal Investigator: Rose Shaffer, MSN, RN         
Sub-Investigator: Eleanor Fitzpatrick, MSN, RN         
United States, Texas
Seton Medical Center Recruiting
Austin, Texas, United States, 78705
Contact: Anne Robinson, MS, RN    512-324-1000 ext 14658    arobinson@seton.org   
Contact: Barbara Borman, MSN, RN    512-324-1036    BBorman@seton.org   
Principal Investigator: Anne Robinson, MS, RN         
Sub-Investigator: Barbara Borman, MSN, RN         
Baylor University Medical Center Recruiting
Dallas, Texas, United States, 75252
Contact: Bobbi Leeper, MN, RN    214-820-1922    bobbil@BaylorHealth.edu   
Principal Investigator: Bobbi Leeper, MN, RN         
United States, Wisconsin
Meriter Heart Hospital Recruiting
Madison, Wisconsin, United States, 53715
Contact: Joseph Liggett, MSN, RN    608-417-6993    jliggett@meriter.com   
Contact: Krisna Wells, BS, RN    608-277-5630    kwells@meriter.com   
Principal Investigator: Joseph Liggett, MSN, RN         
Sub-Investigator: Krisna Wells, BS, RN         
Canada, Ontario
University of Ottawa Heart Institute, Ottawa, Canada Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Contact: Nancy Tee, BN, RN    613-798-5555 ext 13484    ntee@ottawahospital.on.ca   
Contact: Heather Sherrard, MHA, RN    613-761-4826    hsherrard@ottawaheart.ca   
Principal Investigator: Nancy Tee, BN, RN         
Sub-Investigator: Heather Sherrard, MHA, RN         
Sub-Investigator: Sharon Ann Kearns, BScN, RN         
China
Hong Kong Sanatorium & Hospital Recruiting
Hong Kong, China
Contact: Anita Pang, MSN, RN       anitapang@hksh.com   
Contact: Manbo Man, MBA, RN    2835 8018    manboman@hksh.com   
Principal Investigator: Anita Pang, MSN, RN         
Sub-Investigator: Manbo Man, MBA, RN         
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Marjorie Funk, PhD, RN Yale University School of Nursing
  More Information

Publications:
Responsible Party: Marjorie Funk, Yale University School of Nursing
ClinicalTrials.gov Identifier: NCT01269736     History of Changes
Other Study ID Numbers: 0711003292, R01HL081642
Study First Received: January 3, 2011
Last Updated: January 3, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
electrocardiographic monitoring
arrhythmia
myocardial ischemia

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 20, 2014