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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL081642 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Education | Experimental | Online ECG monitoring education program and strategies to implement and sustain change for nurses |
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| Control | No Intervention | Usual in-service education for nurses |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education | Behavioral | Online ECG monitoring education program and strategies to implement and sustain change for nurses |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Patient Care Related to ECG Monitoring | 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 | Baseline, 15 months, 30 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marjorie Funk, PhD, RN | Yale University School of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Long Beach Memorial Medical Center | Long Beach | California | 90806 | United States | ||
| University of California, San Francisco Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21045576 | Background | 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. | |
| 20832819 | Result | 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. |
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Hospitals were the unit of randomization, nurses received ECG education in each hospital. Outcomes were assessed in nurses and the patients cared for on the participating units.
In addition to the nurses and patients consented in each hospital, 95,884 hospital admission records were reviewed for patient outcomes, representing 84,392 unique patients from 13 hospitals.
| ID | Title | Description |
|---|---|---|
| FG000 | Online ECG Education | The intervention consisted of an online ECG monitoring education program (9 mo) and strategies to implement and sustain change in practice (6 mo). Data were collected from both groups at time 2 after group 1 received the intervention. Final data collection occurred at time 3 after group 2 received the intervention. Data collection time points were 15 mo apart. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Nurses' Knowledge Assessments |
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| Patient Outcomes | 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. | Baseline, 15 months, 30 months |
| San Francisco |
| California |
| 94122 |
| United States |
| Yale-New Haven Hospital | New Haven | Connecticut | 06510 | United States |
| Maine Medical Center | Portland | Maine | 04102 | United States |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | United States |
| United Hospital | Saint Paul | Minnesota | 55102 | United States |
| Erie County Medical Center | Buffalo | New York | 14215 | United States |
| University of North Carolina Hospitals | Chapel Hill | North Carolina | 27516 | United States |
| Aultman Hospital | Canton | Ohio | 44710 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Seton Medical Center | Austin | Texas | 78705 | United States |
| Baylor University Medical Center | Dallas | Texas | 75252 | United States |
| Meriter Heart Hospital | Madison | Wisconsin | 53715 | United States |
| University of Ottawa Heart Institute, Ottawa, Canada | Ottawa | Ontario | K1Y 4W7 | Canada |
| Hong Kong Sanatorium & Hospital | Hong Kong | China |
| 28174175 | 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. |
| FG001 | Standard Care Then Online ECG Monitoring | Hospitals were randomized to administer usual in-service education for nurses for 15 months, then received an online ECG monitoring education program (9 mo) and strategies to implement and sustain change in practice (6 mo). Data were collected from both groups at time 2 after group 1 received the intervention. Final data collection occurred at time 3 after group 2 received the intervention. Data collection time points were 15 mo apart. |
| Baseline Assessment |
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| 15 Months Assessment |
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| 30 Months Assessment |
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| NOT COMPLETED |
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| Patient Quality of Care Assessments |
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| Patient Outcomes (Hospital Admissions) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Nurses | Nurses on participating units who received education at the time hospital assigned to the standard training or online ECG education training. |
| BG001 | Patients | Patients on participating units on whom quality of care data was obtained. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Overall age across study groups was not calculated for the different population samples. | Age missing for 11 patients. | Mean | Standard Deviation | years |
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| Sex: Female, Male | Sex missing for 8 patients. | Sex missing for 8 patients. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Ethnicity missing for 112 patients. | Count of Participants | Participants |
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| Education | Education data not obtained from patients. | Count of Participants | Participants |
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| Type of Unit | Unit data not obtained from patients. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | The overall number of unique nurses assessed at any timepoint. The numbers presented at each time point reflect the number of people assessed at that time point. | Posted | Mean | Standard Deviation | percentage of items correctly answered | Baseline, 15 months, 30 months |
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| Secondary | Quality of Patient Care Related to ECG Monitoring | 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 | The overall number of unique patients assessed at any timepoint. The numbers presented at each time point reflect the number of people assessed at that time point. | Posted | Count of Participants | Participants | Baseline, 15 months, 30 months |
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| Secondary | Patient Outcomes | 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. | The overall number of unique patients reviewed at any timepoint. The numbers presented at each time point reflect the number of people reviewed at that time point for that outcome. | Posted | Count of Participants | Participants | Baseline, 15 months, 30 months |
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Only cardiac arrest adverse events were assessed in the Quality of Care patients. Only all-cause mortality (while on a study unit) and Myocardial Infarction adverse events were assessed in the Patient Outcomes patients. These distinctions in data collection methods are why the at risk numbers differ by event and study arm.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Online ECG Education- Patient Outcomes | The intervention consisted of an online ECG monitoring education program (9 mo) and strategies to implement and sustain change in practice (6 mo). Data were collected from both groups at time 2 after group 1 received the intervention. Final data collection occurred at time 3 after group 2 received the intervention. Data collection time points were 15 mo apart. These are Adverse Events reported for the Patient Outcomes groups. | 1,140 | 40,200 | 883 | 52,085 | 0 | 52,085 |
| EG001 | Standard Care Then Online ECG Monitoring- Patient Outcomes | Hospitals were randomized to administer usual in-service education for nurses for 15 months, then received an online ECG monitoring education program (9 mo) and strategies to implement and sustain change in practice (6 mo). Data were collected from both groups at time 2 after group 1 received the intervention. Final data collection occurred at time 3 after group 2 received the intervention. Data collection time points were 15 mo apart. These are Adverse Events reported for the Patient Outcomes groups. | 635 | 27,216 | 1,045 | 43,799 | 0 | 43,799 |
| EG002 | Online ECG Education- Quality of Care | The intervention consisted of an online ECG monitoring education program (9 mo) and strategies to implement and sustain change in practice (6 mo). Data were collected from both groups at time 2 after group 1 received the intervention. Final data collection occurred at time 3 after group 2 received the intervention. Data collection time points were 15 mo apart. These are Adverse Events reported for the Patient Quality of Care groups. | 0 | 0 | 16 | 2,299 | 0 | 2,299 |
| EG003 | Standard Care Then Online ECG Monitoring- Quality of Care | Hospitals were randomized to administer usual in-service education for nurses for 15 months, then received an online ECG monitoring education program (9 mo) and strategies to implement and sustain change in practice (6 mo). Data were collected from both groups at time 2 after group 1 received the intervention. Final data collection occurred at time 3 after group 2 received the intervention. Data collection time points were 15 mo apart. Patient Quality of Care groups. | 0 | 0 | 17 | 2,288 | 0 | 2,288 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial Infarction (MI) | Cardiac disorders | Systematic Assessment | Event only assessed in Patient Outcomes groups. |
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| Cardiac Arrest | Cardiac disorders | Systematic Assessment | Event only assessed in Patient Quality of Care groups. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Marjorie Funk, PhD, RN | Yale University | (203) 737-2346 | marjorie.funk@yale.edu |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D001145 | Arrhythmias, Cardiac |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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