Implementation of Practice Standards for ECG Monitoring

NCT ID: NCT01269736

Last Updated: 2017-08-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 92057 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2014-03-31

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.

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.

Conditions

Cardiovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Education

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

Group Type: EXPERIMENTAL

Education

Intervention Type: BEHAVIORAL

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

Control

Usual in-service education for nurses

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Education

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

Intervention Type: BEHAVIORAL

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marjorie Funk, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Yale University School of Nursing

Locations

Long Beach Memorial Medical Center

Long Beach, California, United States

University of California, San Francisco Medical Center

San Francisco, California, United States

Yale-New Haven Hospital

New Haven, Connecticut, United States

Maine Medical Center

Portland, Maine, United States

Baystate Medical Center

Springfield, Massachusetts, United States

United Hospital

Saint Paul, Minnesota, United States

Erie County Medical Center

Buffalo, New York, United States

University of North Carolina Hospitals

Chapel Hill, North Carolina, United States

Aultman Hospital

Canton, Ohio, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Seton Medical Center

Austin, Texas, United States

Baylor University Medical Center

Dallas, Texas, United States

Meriter Heart Hospital

Madison, Wisconsin, United States

University of Ottawa Heart Institute, Ottawa, Canada

Ottawa, Ontario, Canada

Hong Kong Sanatorium & Hospital

Hong Kong, , China

Countries

United States; Canada; China

References

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.

Reference Type: BACKGROUND

PMID: 21045576 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20832819 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28174175 (View on PubMed)

Other Identifiers

R01HL081642

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0711003292

Identifier Type: -

Identifier Source: org_study_id