Trial Outcomes & Findings for Implementation of Practice Standards for ECG Monitoring (NCT NCT01269736)

Last Updated: 2017-08-31

Results Overview

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)

Recruitment status

COMPLETED

Study phase

Target enrollment

92057 participants

Primary outcome timeframe

Baseline, 15 months, 30 months

Results posted on

2017-08-31

Participant Flow

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.

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.

Unit of analysis: Hospitals

Participant milestones

Participant milestones
Measure	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.	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.
Nurses' Knowledge Assessments STARTED	1428 8	1585 9
Nurses' Knowledge Assessments Baseline Assessment	866 8	873 9
Nurses' Knowledge Assessments 15 Months Assessment	782 8	1108 9
Nurses' Knowledge Assessments 30 Months Assessment	926 8	741 8
Nurses' Knowledge Assessments COMPLETED	1428 8	1585 8
Nurses' Knowledge Assessments NOT COMPLETED	0 0	0 1
Patient Quality of Care Assessments STARTED	2288 8	2299 9
Patient Quality of Care Assessments Baseline Assessment	889 8	915 9
Patient Quality of Care Assessments 15 Months Assessment	773 8	687 8
Patient Quality of Care Assessments 30 Months Assessment	626 7	697 8
Patient Quality of Care Assessments COMPLETED	2288 7	2299 8
Patient Quality of Care Assessments NOT COMPLETED	0 1	0 1
Patient Outcomes (Hospital Admissions) STARTED	43799 6	52085 7
Patient Outcomes (Hospital Admissions) Baseline Assessment	16549 6	17352 7
Patient Outcomes (Hospital Admissions) 15 Months Assessment	14075 6	18031 7
Patient Outcomes (Hospital Admissions) 30 Months Assessment	13265 6	16702 7
Patient Outcomes (Hospital Admissions) COMPLETED	43799 6	52085 7
Patient Outcomes (Hospital Admissions) NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Age missing for 11 patients.

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Online ECG Education n=1585 Participants 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.	Standard Care Then Online ECG Monitoring n=1428 Participants 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.
Nurses' Knowledge and Skills Related to ECG Monitoring Baseline	49.2 percentage of items correctly answered Standard Deviation 12.8	47.2 percentage of items correctly answered Standard Deviation 10.8
Nurses' Knowledge and Skills Related to ECG Monitoring 15 Months	70.2 percentage of items correctly answered Standard Deviation 15.5	49.4 percentage of items correctly answered Standard Deviation 11.6
Nurses' Knowledge and Skills Related to ECG Monitoring 30 Months	59.4 percentage of items correctly answered Standard Deviation 16.0	71.0 percentage of items correctly answered Standard Deviation 14.3

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Online ECG Education n=2299 Participants 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.	Standard Care Then Online ECG Monitoring n=2288 Participants 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.
Quality of Patient Care Related to ECG Monitoring Baseline: V Lead	106 Participants	178 Participants
Quality of Patient Care Related to ECG Monitoring 30 Months: Appropriate monitoring, telemetry units	465 Participants	536 Participants
Quality of Patient Care Related to ECG Monitoring Baseline: ST-segment monitoring when indicated	51 Participants	33 Participants
Quality of Patient Care Related to ECG Monitoring 15 Months: ST-segment monitoring when indicated	60 Participants	51 Participants
Quality of Patient Care Related to ECG Monitoring 30 Months: ST-segment monitoring when indicated	60 Participants	38 Participants
Quality of Patient Care Related to ECG Monitoring Baseline: QTc measurement when indicated	19 Participants	28 Participants
Quality of Patient Care Related to ECG Monitoring 15 Months: QTc measurement when indicated	83 Participants	35 Participants
Quality of Patient Care Related to ECG Monitoring 30 Months: QTc measurement when indicated	84 Participants	51 Participants
Quality of Patient Care Related to ECG Monitoring Baseline: Right Arm	579 Participants	572 Participants
Quality of Patient Care Related to ECG Monitoring Baseline: Left Arm	565 Participants	529 Participants
Quality of Patient Care Related to ECG Monitoring Baseline: Left Leg	497 Participants	494 Participants
Quality of Patient Care Related to ECG Monitoring 15 Months: Right Arm	416 Participants	520 Participants
Quality of Patient Care Related to ECG Monitoring 15 Months: Left Arm	411 Participants	503 Participants
Quality of Patient Care Related to ECG Monitoring 15 Months: Left Leg	406 Participants	511 Participants
Quality of Patient Care Related to ECG Monitoring 15 Months: V Lead	229 Participants	221 Participants
Quality of Patient Care Related to ECG Monitoring 30 Months: Right Arm	447 Participants	461 Participants
Quality of Patient Care Related to ECG Monitoring 30 Months: Left Arm	440 Participants	457 Participants
Quality of Patient Care Related to ECG Monitoring 30 Months: Left Leg	435 Participants	467 Participants
Quality of Patient Care Related to ECG Monitoring 30 Months: V Lead	256 Participants	280 Participants
Quality of Patient Care Related to ECG Monitoring Baseline: Accurate Rhythm Interpretation	75 Participants	71 Participants
Quality of Patient Care Related to ECG Monitoring 15 Months: Accurate Rhythm Interpretation	72 Participants	51 Participants
Quality of Patient Care Related to ECG Monitoring 30 Months: Accurate Rhythm Interpretation	80 Participants	81 Participants
Quality of Patient Care Related to ECG Monitoring Baseline: Cardiac Arrest	11 Participants	5 Participants
Quality of Patient Care Related to ECG Monitoring 15 Months: Cardiac Arrest	0 Participants	10 Participants
Quality of Patient Care Related to ECG Monitoring 30 Months: Cardiac Arrest	5 Participants	2 Participants
Quality of Patient Care Related to ECG Monitoring Baseline: Cardiac Arrest Initiated by Arrhythmia	10 Participants	4 Participants
Quality of Patient Care Related to ECG Monitoring 15 Months: Cardiac Arrest Initiated by Arrhythmia	0 Participants	9 Participants
Quality of Patient Care Related to ECG Monitoring 30 Months: Cardiac Arrest Initiated by Arrhythmia	1 Participants	1 Participants
Quality of Patient Care Related to ECG Monitoring Baseline: Appropriate monitoring, telemetry units	450 Participants	543 Participants
Quality of Patient Care Related to ECG Monitoring 15 Months: Appropriate monitoring, telemetry units	382 Participants	433 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Online ECG Education n=52085 Participants 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.	Standard Care Then Online ECG Monitoring n=43799 Participants 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 Outcomes Baseline: Not Survive Cardiac Arrest	8 Participants	15 Participants
Patient Outcomes 30 Months: Mortality	416 Participants	223 Participants
Patient Outcomes 30 Months: In-hospital MI	225 Participants	311 Participants
Patient Outcomes 30 Months: Not Survive Cardiac Arrest	12 Participants	7 Participants
Patient Outcomes Baseline: Mortality	348 Participants	218 Participants
Patient Outcomes Baseline: In-hospital MI	355 Participants	419 Participants
Patient Outcomes 15 Months: Mortality	376 Participants	194 Participants
Patient Outcomes 15 Months: In-hospital MI	303 Participants	403 Participants
Patient Outcomes 15 Months: Not Survive Cardiac Arrest	10 Participants	8 Participants

Adverse Events

Online ECG Education- Patient Outcomes

Serious events: 883 serious events

Other events: 0 other events

Deaths: 1140 deaths

Standard Care Then Online ECG Monitoring- Patient Outcomes

Serious events: 1045 serious events

Other events: 0 other events

Deaths: 635 deaths

Online ECG Education- Quality of Care

Serious events: 16 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Care Then Online ECG Monitoring- Quality of Care

Serious events: 17 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Online ECG Education- Patient Outcomes n=52085 participants at risk 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.	Standard Care Then Online ECG Monitoring- Patient Outcomes n=43799 participants at risk 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.	Online ECG Education- Quality of Care n=2299 participants at risk 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.	Standard Care Then Online ECG Monitoring- Quality of Care n=2288 participants at risk 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.
Cardiac disorders Myocardial Infarction (MI)	1.7% 883/52085 • Number of events 883 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.	2.4% 1045/43799 • Number of events 1045 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.	— 0/0 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.	— 0/0 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.
Cardiac disorders Cardiac Arrest	— 0/0 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.	— 0/0 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.	0.70% 16/2299 • Number of events 16 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.	0.74% 17/2288 • Number of events 17 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.

Other adverse events

Adverse event data not reported

Additional Information

Professor Marjorie Funk, PhD, RN

Yale University

Phone: (203) 737-2346

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Nurses n=3013 Participants Nurses on participating units who received education at the time hospital assigned to the standard training or online ECG education training.	Patients n=4587 Participants Patients on participating units on whom quality of care data was obtained.	Total n=7600 Participants Total of all reporting groups
Age, Continuous	37.53 years STANDARD_DEVIATION 11.05 • n=3013 Participants • Age missing for 11 patients.	65.54 years STANDARD_DEVIATION 5.28 • n=4576 Participants • Age missing for 11 patients.	NA years STANDARD_DEVIATION NA • n=7589 Participants • Age missing for 11 patients.
Sex: Female, Male Female	2691 Participants n=3013 Participants • Sex missing for 8 patients.	1954 Participants n=4579 Participants • Sex missing for 8 patients.	4645 Participants n=7592 Participants • Sex missing for 8 patients.
Sex: Female, Male Male	322 Participants n=3013 Participants • Sex missing for 8 patients.	2625 Participants n=4579 Participants • Sex missing for 8 patients.	2947 Participants n=7592 Participants • Sex missing for 8 patients.
Ethnicity (NIH/OMB) Hispanic or Latino	81 Participants n=3013 Participants • Ethnicity missing for 112 patients.	226 Participants n=4475 Participants • Ethnicity missing for 112 patients.	307 Participants n=7488 Participants • Ethnicity missing for 112 patients.
Ethnicity (NIH/OMB) Not Hispanic or Latino	2932 Participants n=3013 Participants • Ethnicity missing for 112 patients.	4249 Participants n=4475 Participants • Ethnicity missing for 112 patients.	7181 Participants n=7488 Participants • Ethnicity missing for 112 patients.
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=3013 Participants • Ethnicity missing for 112 patients.	0 Participants n=4475 Participants • Ethnicity missing for 112 patients.	0 Participants n=7488 Participants • Ethnicity missing for 112 patients.
Education Diploma	291 Participants n=3013 Participants • Education data not obtained from patients.	—	291 Participants n=3013 Participants • Education data not obtained from patients.
Education Associate's Degree	534 Participants n=3013 Participants • Education data not obtained from patients.	—	534 Participants n=3013 Participants • Education data not obtained from patients.
Education Bachelor's Degree	1959 Participants n=3013 Participants • Education data not obtained from patients.	—	1959 Participants n=3013 Participants • Education data not obtained from patients.
Education Master's Degree	208 Participants n=3013 Participants • Education data not obtained from patients.	—	208 Participants n=3013 Participants • Education data not obtained from patients.
Education Doctoral Degree	11 Participants n=3013 Participants • Education data not obtained from patients.	—	11 Participants n=3013 Participants • Education data not obtained from patients.
Education None of the above	10 Participants n=3013 Participants • Education data not obtained from patients.	—	10 Participants n=3013 Participants • Education data not obtained from patients.
Type of Unit Medicine	1329 Participants n=3013 Participants • Unit data not obtained from patients.	—	1329 Participants n=3013 Participants • Unit data not obtained from patients.
Type of Unit Surgery	830 Participants n=3013 Participants • Unit data not obtained from patients.	—	830 Participants n=3013 Participants • Unit data not obtained from patients.
Type of Unit Combined	854 Participants n=3013 Participants • Unit data not obtained from patients.	—	854 Participants n=3013 Participants • Unit data not obtained from patients.