Clinical trial NCT01269736: Implementation of Practice Standards for ECG Monitoring
Official title: Implementation of Practice Standards for ECG Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: electrocardiographic monitoring
arrhythmia
myocardial ischemia
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2011-01-04
Enrollment: 92057
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Nurses' Knowledge and Skills Related to ECG Monitoring
timeFrame: Baseline, 15 months, 30 months
Secondary outcomes:
measure: Quality of Patient Care Related to ECG Monitoring
timeFrame: Baseline, 15 months, 30 months
measure: Patient Outcomes
timeFrame: Baseline, 15 months, 30 months
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Long Beach Memorial Medical Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco Medical Center
state: California
city: New Haven
country: United States
facility: Yale-New Haven Hospital
state: Connecticut
city: Portland
country: United States
facility: Maine Medical Center
state: Maine
city: Springfield
country: United States
facility: Baystate Medical Center
state: Massachusetts
city: Saint Paul
country: United States
facility: United Hospital
state: Minnesota
city: Buffalo
country: United States
facility: Erie County Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Hospitals
state: North Carolina
city: Canton
country: United States
facility: Aultman Hospital
state: Ohio
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Austin
country: United States
facility: Seton Medical Center
state: Texas
city: Dallas
country: United States
facility: Baylor University Medical Center
state: Texas
city: Madison
country: United States
facility: Meriter Heart Hospital
state: Wisconsin
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute, Ottawa, Canada
state: Ontario
city: Hong Kong
country: China
facility: Hong Kong Sanatorium & Hospital
Study officials:
affiliation: Yale University School of Nursing
name: Marjorie Funk, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.