Cardiovascular Disease
Conditions
Keywords
electrocardiographic monitoring, arrhythmia, myocardial ischemia
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.
Interventions
BEHAVIORALEducation
Online ECG monitoring education program and strategies to implement and sustain change for nurses
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nurses' Knowledge and Skills Related to ECG Monitoring | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Patient Care Related to ECG Monitoring | 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 | 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. |
Countries
Canada, China, United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Nurses Nurses on participating units who received education at the time hospital assigned to the standard training or online ECG education training. | 3,013 |
| Patients Patients on participating units on whom quality of care data was obtained. | 4,587 |
| Total | 7,600 |
Baseline characteristics
| Characteristic | Total | Nurses | Patients |
|---|---|---|---|
| Age, Continuous | NA years | 37.53 years STANDARD_DEVIATION 11.05 | 65.54 years STANDARD_DEVIATION 5.28 |
| Education Associate's Degree | 534 Participants | 534 Participants | — |
| Education Bachelor's Degree | 1959 Participants | 1959 Participants | — |
| Education Diploma | 291 Participants | 291 Participants | — |
| Education Doctoral Degree | 11 Participants | 11 Participants | — |
| Education Master's Degree | 208 Participants | 208 Participants | — |
| Education None of the above | 10 Participants | 10 Participants | — |
| Ethnicity (NIH/OMB) Hispanic or Latino | 307 Participants | 81 Participants | 226 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7181 Participants | 2932 Participants | 4249 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 4645 Participants | 2691 Participants | 1954 Participants |
| Sex: Female, Male Male | 2947 Participants | 322 Participants | 2625 Participants |
| Type of Unit Combined | 854 Participants | 854 Participants | — |
| Type of Unit Medicine | 1329 Participants | 1329 Participants | — |
| Type of Unit Surgery | 830 Participants | 830 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 1,140 / 40,200 | 635 / 27,216 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 52,085 | 0 / 43,799 | 0 / 2,299 | 0 / 2,288 |
| serious Total, serious adverse events | 883 / 52,085 | 1,045 / 43,799 | 16 / 2,299 | 17 / 2,288 |
Outcome results
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)
Time frame: Baseline, 15 months, 30 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Online ECG Education | Nurses' Knowledge and Skills Related to ECG Monitoring | Baseline | 49.2 percentage of items correctly answered | Standard Deviation 12.8 |
| Online ECG Education | Nurses' Knowledge and Skills Related to ECG Monitoring | 15 Months | 70.2 percentage of items correctly answered | Standard Deviation 15.5 |
| Online ECG Education | Nurses' Knowledge and Skills Related to ECG Monitoring | 30 Months | 59.4 percentage of items correctly answered | Standard Deviation 16 |
| Standard Care Then Online ECG Monitoring | Nurses' Knowledge and Skills Related to ECG Monitoring | 30 Months | 71.0 percentage of items correctly answered | Standard Deviation 14.3 |
| Standard Care Then Online ECG Monitoring | Nurses' Knowledge and Skills Related to ECG Monitoring | Baseline | 47.2 percentage of items correctly answered | Standard Deviation 10.8 |
| Standard Care Then Online ECG Monitoring | Nurses' Knowledge and Skills Related to ECG Monitoring | 15 Months | 49.4 percentage of items correctly answered | Standard Deviation 11.6 |
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.
Time frame: Baseline, 15 months, 30 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Online ECG Education | Patient Outcomes | 30 Months: In-hospital MI | 225 Participants |
| Online ECG Education | Patient Outcomes | 30 Months: Not Survive Cardiac Arrest | 12 Participants |
| Online ECG Education | Patient Outcomes | Baseline: In-hospital MI | 355 Participants |
| Online ECG Education | Patient Outcomes | Baseline: Not Survive Cardiac Arrest | 8 Participants |
| Online ECG Education | Patient Outcomes | 15 Months: Mortality | 376 Participants |
| Online ECG Education | Patient Outcomes | 15 Months: In-hospital MI | 303 Participants |
| Online ECG Education | Patient Outcomes | 15 Months: Not Survive Cardiac Arrest | 10 Participants |
| Online ECG Education | Patient Outcomes | 30 Months: Mortality | 416 Participants |
| Online ECG Education | Patient Outcomes | Baseline: Mortality | 348 Participants |
| Standard Care Then Online ECG Monitoring | Patient Outcomes | 30 Months: Mortality | 223 Participants |
| Standard Care Then Online ECG Monitoring | Patient Outcomes | Baseline: Mortality | 218 Participants |
| Standard Care Then Online ECG Monitoring | Patient Outcomes | 30 Months: In-hospital MI | 311 Participants |
| Standard Care Then Online ECG Monitoring | Patient Outcomes | 15 Months: Mortality | 194 Participants |
| Standard Care Then Online ECG Monitoring | Patient Outcomes | 30 Months: Not Survive Cardiac Arrest | 7 Participants |
| Standard Care Then Online ECG Monitoring | Patient Outcomes | 15 Months: Not Survive Cardiac Arrest | 8 Participants |
| Standard Care Then Online ECG Monitoring | Patient Outcomes | Baseline: In-hospital MI | 419 Participants |
| Standard Care Then Online ECG Monitoring | Patient Outcomes | 15 Months: In-hospital MI | 403 Participants |
| Standard Care Then Online ECG Monitoring | Patient Outcomes | Baseline: Not Survive Cardiac Arrest | 15 Participants |
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
Time frame: Baseline, 15 months, 30 months
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Online ECG Education | Quality of Patient Care Related to ECG Monitoring | Baseline: Left Leg | 497 Participants |
| Online ECG Education | Quality of Patient Care Related to ECG Monitoring | 15 Months: Accurate Rhythm Interpretation | 72 Participants |
| Online ECG Education | Quality of Patient Care Related to ECG Monitoring | 30 Months: Accurate Rhythm Interpretation | 80 Participants |
| Online ECG Education | Quality of Patient Care Related to ECG Monitoring | Baseline: Cardiac Arrest | 11 Participants |
| Online ECG Education | Quality of Patient Care Related to ECG Monitoring | 30 Months: Cardiac Arrest | 5 Participants |
| Online ECG Education | Quality of Patient Care Related to ECG Monitoring | 15 Months: Cardiac Arrest Initiated by Arrhythmia | 0 Participants |
| Online ECG Education | Quality of Patient Care Related to ECG Monitoring | Baseline: Right Arm | 579 Participants |
| Online ECG Education | Quality of Patient Care Related to ECG Monitoring | Baseline: Left Arm | 565 Participants |
| Online ECG Education | Quality of Patient Care Related to ECG Monitoring | 15 Months: Left Arm | 411 Participants |
| Online ECG Education | Quality of Patient Care Related to ECG Monitoring | Baseline: V Lead | 106 Participants |
| Online ECG Education | Quality of Patient Care Related to ECG Monitoring | 15 Months: Right Arm | 416 Participants |
| Online ECG Education | Quality of Patient Care Related to ECG Monitoring | 15 Months: Left Leg | 406 Participants |
| Online ECG Education | Quality of Patient Care Related to ECG Monitoring | 15 Months: V Lead | 229 Participants |
| Online ECG Education | Quality of Patient Care Related to ECG Monitoring | 30 Months: Right Arm | 447 Participants |
| Online ECG Education | Quality of Patient Care Related to ECG Monitoring | 30 Months: Left Arm | 440 Participants |
| Online ECG Education | Quality of Patient Care Related to ECG Monitoring | 30 Months: Left Leg | 435 Participants |
| Online ECG Education | Quality of Patient Care Related to ECG Monitoring | 30 Months: V Lead | 256 Participants |
| Online ECG Education | Quality of Patient Care Related to ECG Monitoring | Baseline: Accurate Rhythm Interpretation | 75 Participants |
| Online ECG Education | Quality of Patient Care Related to ECG Monitoring | 15 Months: Cardiac Arrest | 0 Participants |
| Online ECG Education | Quality of Patient Care Related to ECG Monitoring | Baseline: Cardiac Arrest Initiated by Arrhythmia | 10 Participants |
| Online ECG Education | Quality of Patient Care Related to ECG Monitoring | 30 Months: Cardiac Arrest Initiated by Arrhythmia | 1 Participants |
| Online ECG Education | Quality of Patient Care Related to ECG Monitoring | Baseline: Appropriate monitoring, telemetry units | 450 Participants |
| Online ECG Education | Quality of Patient Care Related to ECG Monitoring | 15 Months: Appropriate monitoring, telemetry units | 382 Participants |
| Online ECG Education | Quality of Patient Care Related to ECG Monitoring | 30 Months: Appropriate monitoring, telemetry units | 465 Participants |
| Online ECG Education | Quality of Patient Care Related to ECG Monitoring | Baseline: ST-segment monitoring when indicated | 51 Participants |
| Online ECG Education | Quality of Patient Care Related to ECG Monitoring | 15 Months: ST-segment monitoring when indicated | 60 Participants |
| Online ECG Education | Quality of Patient Care Related to ECG Monitoring | 30 Months: ST-segment monitoring when indicated | 60 Participants |
| Online ECG Education | Quality of Patient Care Related to ECG Monitoring | Baseline: QTc measurement when indicated | 19 Participants |
| Online ECG Education | Quality of Patient Care Related to ECG Monitoring | 15 Months: QTc measurement when indicated | 83 Participants |
| Online ECG Education | Quality of Patient Care Related to ECG Monitoring | 30 Months: QTc measurement when indicated | 84 Participants |
| Standard Care Then Online ECG Monitoring | Quality of Patient Care Related to ECG Monitoring | 30 Months: V Lead | 280 Participants |
| Standard Care Then Online ECG Monitoring | Quality of Patient Care Related to ECG Monitoring | 15 Months: Left Arm | 503 Participants |
| Standard Care Then Online ECG Monitoring | Quality of Patient Care Related to ECG Monitoring | 30 Months: Appropriate monitoring, telemetry units | 536 Participants |
| Standard Care Then Online ECG Monitoring | Quality of Patient Care Related to ECG Monitoring | Baseline: Accurate Rhythm Interpretation | 71 Participants |
| Standard Care Then Online ECG Monitoring | Quality of Patient Care Related to ECG Monitoring | 30 Months: Accurate Rhythm Interpretation | 81 Participants |
| Standard Care Then Online ECG Monitoring | Quality of Patient Care Related to ECG Monitoring | 15 Months: Accurate Rhythm Interpretation | 51 Participants |
| Standard Care Then Online ECG Monitoring | Quality of Patient Care Related to ECG Monitoring | 15 Months: Cardiac Arrest | 10 Participants |
| Standard Care Then Online ECG Monitoring | Quality of Patient Care Related to ECG Monitoring | Baseline: Cardiac Arrest | 5 Participants |
| Standard Care Then Online ECG Monitoring | Quality of Patient Care Related to ECG Monitoring | 15 Months: QTc measurement when indicated | 35 Participants |
| Standard Care Then Online ECG Monitoring | Quality of Patient Care Related to ECG Monitoring | 15 Months: Right Arm | 520 Participants |
| Standard Care Then Online ECG Monitoring | Quality of Patient Care Related to ECG Monitoring | 30 Months: Cardiac Arrest | 2 Participants |
| Standard Care Then Online ECG Monitoring | Quality of Patient Care Related to ECG Monitoring | Baseline: Right Arm | 572 Participants |
| Standard Care Then Online ECG Monitoring | Quality of Patient Care Related to ECG Monitoring | Baseline: ST-segment monitoring when indicated | 33 Participants |
| Standard Care Then Online ECG Monitoring | Quality of Patient Care Related to ECG Monitoring | Baseline: Left Arm | 529 Participants |
| Standard Care Then Online ECG Monitoring | Quality of Patient Care Related to ECG Monitoring | Baseline: Cardiac Arrest Initiated by Arrhythmia | 4 Participants |
| Standard Care Then Online ECG Monitoring | Quality of Patient Care Related to ECG Monitoring | Baseline: Left Leg | 494 Participants |
| Standard Care Then Online ECG Monitoring | Quality of Patient Care Related to ECG Monitoring | 15 Months: Cardiac Arrest Initiated by Arrhythmia | 9 Participants |
| Standard Care Then Online ECG Monitoring | Quality of Patient Care Related to ECG Monitoring | Baseline: V Lead | 178 Participants |
| Standard Care Then Online ECG Monitoring | Quality of Patient Care Related to ECG Monitoring | Baseline: QTc measurement when indicated | 28 Participants |
| Standard Care Then Online ECG Monitoring | Quality of Patient Care Related to ECG Monitoring | 30 Months: Cardiac Arrest Initiated by Arrhythmia | 1 Participants |
| Standard Care Then Online ECG Monitoring | Quality of Patient Care Related to ECG Monitoring | 15 Months: Left Leg | 511 Participants |
| Standard Care Then Online ECG Monitoring | Quality of Patient Care Related to ECG Monitoring | 15 Months: ST-segment monitoring when indicated | 51 Participants |
| Standard Care Then Online ECG Monitoring | Quality of Patient Care Related to ECG Monitoring | 15 Months: V Lead | 221 Participants |
| Standard Care Then Online ECG Monitoring | Quality of Patient Care Related to ECG Monitoring | Baseline: Appropriate monitoring, telemetry units | 543 Participants |
| Standard Care Then Online ECG Monitoring | Quality of Patient Care Related to ECG Monitoring | 30 Months: Right Arm | 461 Participants |
| Standard Care Then Online ECG Monitoring | Quality of Patient Care Related to ECG Monitoring | 30 Months: QTc measurement when indicated | 51 Participants |
| Standard Care Then Online ECG Monitoring | Quality of Patient Care Related to ECG Monitoring | 30 Months: Left Arm | 457 Participants |
| Standard Care Then Online ECG Monitoring | Quality of Patient Care Related to ECG Monitoring | 15 Months: Appropriate monitoring, telemetry units | 433 Participants |
| Standard Care Then Online ECG Monitoring | Quality of Patient Care Related to ECG Monitoring | 30 Months: Left Leg | 467 Participants |
| Standard Care Then Online ECG Monitoring | Quality of Patient Care Related to ECG Monitoring | 30 Months: ST-segment monitoring when indicated | 38 Participants |