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Implementation of Practice Standards for ECG Monitoring (PULSE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01269736
First Posted: January 4, 2011
Last Update Posted: August 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Yale University
January 3, 2011
January 4, 2011
June 1, 2017
August 31, 2017
August 31, 2017
August 2008
March 2014   (Final data collection date for primary outcome measure)
Nurses' Knowledge and Skills Related to ECG Monitoring [ Time Frame: Baseline, 15 months, 30 months ]
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)
Nurses' Knowledge and Skills Related to ECG Monitoring [ Time Frame: 4 years ]
Complete list of historical versions of study NCT01269736 on ClinicalTrials.gov Archive Site
  • Quality of Patient Care Related to ECG Monitoring [ Time Frame: Baseline, 15 months, 30 months ]
    Percentage of patients with accurate electrode placement, accurate rhythm interpretation, cardiac arrest, cardiac arrest initiated by arrhythmia, appropriate monitoring, telemetry units only, ST-segment monitoring when indicated, and QTc measurement when indicated
  • Patient Outcomes [ Time Frame: Baseline, 15 months, 30 months ]
    Mortality, in-hospital MI, and not surviving a cardiac arrest were obtained using administrative data and laboratory data (eg, troponin, CK-MB) for all patients. Mortality was defined as death that occurred on one of the participating units. To identify the occurrence of in-hospital MI, laboratory data, timing of procedures, and location of patient at the time of the first blood draw indicating the event were used. Cardiac arrest was defined as an event initiated by an arrhythmia that required immediate intervention and was initiated on a PULSE participating unit. For each qualifying cardiac arrest, it was determined whether the patient survived the event.
  • Quality of Patient Care Related to ECG Monitoring [ Time Frame: 4 years ]
  • Patient Outcomes [ Time Frame: 4 years ]
Not Provided
Not Provided
 
Implementation of Practice Standards for ECG Monitoring
Implementation of Practice Standards for ECG Monitoring
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Cardiovascular Disease
Behavioral: Education
Online ECG monitoring education program and strategies to implement and sustain change for nurses
  • Experimental: Education
    Online ECG monitoring education program and strategies to implement and sustain change for nurses
    Intervention: Behavioral: Education
  • No Intervention: Control
    Usual in-service education for nurses

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
92057
March 2014
March 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Senior
Yes
Contact information is only displayed when the study is recruiting subjects
Canada,   China,   United States
 
 
NCT01269736
0711003292
R01HL081642 ( U.S. NIH Grant/Contract )
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Yale University
Yale University
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Marjorie Funk, PhD, RN Yale University School of Nursing
Yale University
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP