Implementation of Practice Standards for ECG Monitoring

NCT01269736 | Completed Results DMC

• 2 other identifiers: 0711003292R01HL081642
• Study Type: interventional
• Target: 92,057
• Locations: 3 countries
• Sites: 16

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.

Conditions

Cardiovascular Disease

Keywords

electrocardiographic monitoring; arrhythmia; myocardial ischemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Quality of Patient Care Related to ECG Monitoring

  Baseline, 15 months, 30 months

• Patient Outcomes

  Baseline, 15 months, 30 months

Study Arms (2)

Education

EXPERIMENTAL

Online ECG monitoring education program and strategies to implement and sustain change for nurses

Behavioral: Education

Control

NO INTERVENTION

Usual in-service education for nurses

Interventions

Education BEHAVIORAL

Online ECG monitoring education program and strategies to implement and sustain change for nurses

Education

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (16)

Long Beach Memorial Medical Center

Long Beach, California, 90806, United States

Location

University of California, San Francisco Medical Center

San Francisco, California, 94122, United States

Location

Yale-New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Maine Medical Center

Portland, Maine, 04102, United States

Location

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

United Hospital

Saint Paul, Minnesota, 55102, United States

Location

Erie County Medical Center

Buffalo, New York, 14215, United States

Location

University of North Carolina Hospitals

Chapel Hill, North Carolina, 27516, United States

Location

Aultman Hospital

Canton, Ohio, 44710, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Seton Medical Center

Austin, Texas, 78705, United States

Location

Baylor University Medical Center

Dallas, Texas, 75252, United States

Location

Meriter Heart Hospital

Madison, Wisconsin, 53715, United States

Location

University of Ottawa Heart Institute, Ottawa, Canada

Ottawa, Ontario, K1Y 4W7, Canada

Location

Hong Kong Sanatorium & Hospital

Hong Kong, China

Location

Related Publications (3)

• 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.

  PMID: 21045576 BACKGROUND

• 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.

  PMID: 20832819 RESULT

• 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):e003132. doi: 10.1161/CIRCOUTCOMES.116.003132.

  PMID: 28174175 RESULT

MeSH Terms

Conditions

Cardiovascular Diseases; Arrhythmias, Cardiac; Myocardial Ischemia

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Results Point of Contact

• Title: Professor Marjorie Funk, PhD, RN
• Organization: Yale University

marjorie.funk@yale.edu

(203) 737-2346

Study Officials

• Marjorie Funk, PhD, RN

  Yale University School of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2011
• First Posted: January 4, 2011
• Study Start: August 1, 2008
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: August 31, 2017
• Results First Posted: August 31, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1); CA (1); US (14)