Implementation of Practice Standards for ECG Monitoring - Full Text View

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

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:

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. Epub 2010 Sep 15.

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. No abstract available.

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 May 16, 2013

Implementation of Practice Standards for ECG Monitoring (PULSE)