PULSE: Implementation of Practice Standards for ECG Monitoring

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01269736
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 92,057
• Locations: 16
• Arms: 2
• Duration (Months): 67
• Patients Per Site: 5753.6
• Patients Per Site Per Month: 85.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease	Behavioral: Education	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 92057 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Implementation of Practice Standards for ECG Monitoring
• Study Start Date: Aug 1, 2008
• Actual Primary Completion Date: Mar 1, 2014
• Actual Study Completion Date: Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Education Online ECG monitoring education program and strategies to implement and sustain change for nurses	Behavioral: Education; Online ECG monitoring education program and strategies to implement and sustain change for nurses
No Intervention: Control Usual in-service education for nurses

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Long Beach Memorial Medical Center	Long Beach	California	United States	90806
2	University of California, San Francisco Medical Center	San Francisco	California	United States	94122
3	Yale-New Haven Hospital	New Haven	Connecticut	United States	06510
4	Maine Medical Center	Portland	Maine	United States	04102
5	Baystate Medical Center	Springfield	Massachusetts	United States	01199
6	United Hospital	Saint Paul	Minnesota	United States	55102
7	Erie County Medical Center	Buffalo	New York	United States	14215
8	University of North Carolina Hospitals	Chapel Hill	North Carolina	United States	27516
9	Aultman Hospital	Canton	Ohio	United States	44710
10	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
11	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania	United States	19107
12	Seton Medical Center	Austin	Texas	United States	78705
13	Baylor University Medical Center	Dallas	Texas	United States	75252
14	Meriter Heart Hospital	Madison	Wisconsin	United States	53715
15	University of Ottawa Heart Institute, Ottawa, Canada	Ottawa	Ontario	Canada	K1Y 4W7
16	Hong Kong Sanatorium & Hospital	Hong Kong		China

Sponsors and Collaborators

• Yale University
• National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Marjorie Funk, PhD, RN, Yale University School of Nursing

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT01269736
• Other Study ID Numbers: 0711003292; R01HL081642
• First Posted: Jan 4, 2011
• Last Update Posted: Aug 31, 2017
• Last Verified: Jun 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Yale University: electrocardiographic monitoring; arrhythmia; myocardial ischemia
• Additional relevant MeSH terms: Cardiovascular Diseases

Study Results

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 Detail	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.

Arm/Group Title	Online ECG Education	Standard Care Then Online ECG Monitoring
Arm/Group Description	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.	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.
Period Title: Nurses' Knowledge Assessments
STARTED	1585	1428
Baseline Assessment	873	866
15 Months Assessment	1108	782
30 Months Assessment	741	926
COMPLETED	1585	1428
NOT COMPLETED	0	0
Period Title: Nurses' Knowledge Assessments
STARTED	2299	2288
Baseline Assessment	915	889
15 Months Assessment	687	773
30 Months Assessment	697	626
COMPLETED	2299	2288
NOT COMPLETED	0	0
Period Title: Nurses' Knowledge Assessments
STARTED	52085	43799
Baseline Assessment	17352	16549
15 Months Assessment	18031	14075
30 Months Assessment	16702	13265
COMPLETED	52085	43799
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Nurses	Patients	Total
Arm/Group Description	Nurses on participating units who received education at the time hospital assigned to the standard training or online ECG education training.	Patients on participating units on whom quality of care data was obtained.	Total of all reporting groups
Overall Participants	3013	4587	7600
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	37.53 (11.05)	65.54 (5.28)	NA (NA)
Sex: Female, Male (Count of Participants)
Female	2691 89.3%	1954 42.6%	4645 61.1%
Male	322 10.7%	2625 57.2%	2947 38.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	81 2.7%	226 4.9%	307 4%
Not Hispanic or Latino	2932 97.3%	4249 92.6%	7181 94.5%
Unknown or Not Reported	0 0%	0 0%	0 0%
Education (Count of Participants)
Diploma	291 9.7%	291 6.3%
Associate's Degree	534 17.7%	534 11.6%
Bachelor's Degree	1959 65%	1959 42.7%
Master's Degree	208 6.9%	208 4.5%
Doctoral Degree	11 0.4%	11 0.2%
None of the above	10 0.3%	10 0.2%
Type of Unit (Count of Participants)
Medicine	1329 44.1%	1329 29%
Surgery	830 27.5%	830 18.1%
Combined	854 28.3%	854 18.6%

Outcome Measures

1. Primary Outcome

Title	Nurses' Knowledge and Skills Related to ECG Monitoring
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Online ECG Education	Standard Care Then Online ECG Monitoring
Arm/Group Description	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.	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.
Measure Participants	1585	1428
Baseline	49.2 (12.8)	47.2 (10.8)
15 Months	70.2 (15.5)	49.4 (11.6)
30 Months	59.4 (16.0)	71.0 (14.3)

2. Secondary Outcome

Title	Quality of Patient Care Related to ECG Monitoring
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Online ECG Education	Standard Care Then Online ECG Monitoring
Arm/Group Description	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.	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.
Measure Participants	2299	2288
Baseline: Right Arm	579 19.2%	572 12.5%
Baseline: Left Arm	565 18.8%	529 11.5%
Baseline: Left Leg	497 16.5%	494 10.8%
Baseline: V Lead	106 3.5%	178 3.9%
15 Months: Right Arm	416 13.8%	520 11.3%
15 Months: Left Arm	411 13.6%	503 11%
15 Months: Left Leg	406 13.5%	511 11.1%
15 Months: V Lead	229 7.6%	221 4.8%
30 Months: Right Arm	447 14.8%	461 10.1%
30 Months: Left Arm	440 14.6%	457 10%
30 Months: Left Leg	435 14.4%	467 10.2%
30 Months: V Lead	256 8.5%	280 6.1%
Baseline: Accurate Rhythm Interpretation	75 2.5%	71 1.5%
15 Months: Accurate Rhythm Interpretation	72 2.4%	51 1.1%
30 Months: Accurate Rhythm Interpretation	80 2.7%	81 1.8%
Baseline: Cardiac Arrest	11 0.4%	5 0.1%
15 Months: Cardiac Arrest	0 0%	10 0.2%
30 Months: Cardiac Arrest	5 0.2%	2 0%
Baseline: Cardiac Arrest Initiated by Arrhythmia	10 0.3%	4 0.1%
15 Months: Cardiac Arrest Initiated by Arrhythmia	0 0%	9 0.2%
30 Months: Cardiac Arrest Initiated by Arrhythmia	1 0%	1 0%
Baseline: Appropriate monitoring, telemetry units	450 14.9%	543 11.8%
15 Months: Appropriate monitoring, telemetry units	382 12.7%	433 9.4%
30 Months: Appropriate monitoring, telemetry units	465 15.4%	536 11.7%
Baseline: ST-segment monitoring when indicated	51 1.7%	33 0.7%
15 Months: ST-segment monitoring when indicated	60 2%	51 1.1%
30 Months: ST-segment monitoring when indicated	60 2%	38 0.8%
Baseline: QTc measurement when indicated	19 0.6%	28 0.6%
15 Months: QTc measurement when indicated	83 2.8%	35 0.8%
30 Months: QTc measurement when indicated	84 2.8%	51 1.1%

3. Secondary Outcome

Title	Patient Outcomes
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Online ECG Education	Standard Care Then Online ECG Monitoring
Arm/Group Description	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.	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.
Measure Participants	52085	43799
Baseline: Mortality	348 11.5%	218 4.8%
Baseline: In-hospital MI	355 11.8%	419 9.1%
Baseline: Not Survive Cardiac Arrest	8 0.3%	15 0.3%
15 Months: Mortality	376 12.5%	194 4.2%
15 Months: In-hospital MI	303 10.1%	403 8.8%
15 Months: Not Survive Cardiac Arrest	10 0.3%	8 0.2%
30 Months: Mortality	416 13.8%	223 4.9%
30 Months: In-hospital MI	225 7.5%	311 6.8%
30 Months: Not Survive Cardiac Arrest	12 0.4%	7 0.2%

Adverse Events

Adverse Event Reporting Description	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.
Arm/Group Title	Online ECG Education- Patient Outcomes		Standard Care Then Online ECG Monitoring- Patient Outcomes		Online ECG Education- Quality of Care		Standard Care Then Online ECG Monitoring- Quality of Care
Arm/Group Description	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.		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.		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.		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.
All Cause Mortality
	Online ECG Education- Patient Outcomes		Standard Care Then Online ECG Monitoring- Patient Outcomes		Online ECG Education- Quality of Care		Standard Care Then Online ECG Monitoring- Quality of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1140/40200 (2.8%)		635/27216 (2.3%)		0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Online ECG Education- Patient Outcomes		Standard Care Then Online ECG Monitoring- Patient Outcomes		Online ECG Education- Quality of Care		Standard Care Then Online ECG Monitoring- Quality of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	883/52085 (1.7%)		1045/43799 (2.4%)		16/2299 (0.7%)		17/2288 (0.7%)
Cardiac disorders
Myocardial Infarction (MI)	883/52085 (1.7%)	883	1045/43799 (2.4%)	1045	0/0 (NaN)	0	0/0 (NaN)	0
Cardiac Arrest	0/0 (NaN)	0	0/0 (NaN)	0	16/2299 (0.7%)	16	17/2288 (0.7%)	17
Other (Not Including Serious) Adverse Events
	Online ECG Education- Patient Outcomes		Standard Care Then Online ECG Monitoring- Patient Outcomes		Online ECG Education- Quality of Care		Standard Care Then Online ECG Monitoring- Quality of Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/52085 (0%)		0/43799 (0%)		0/2299 (0%)		0/2288 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.