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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
Results First Submitted: June 1, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Health Services Research
Condition: Cardiovascular Disease
Intervention: Behavioral: Education

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Units Details
Units for given values
Values given as pairs: 1) number of participants and 2) number of units (Hospitals)

Reporting Groups
  Description
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.
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.

Participant Flow for 3 periods

Period 1:   Nurses' Knowledge Assessments
    Online ECG Education   Standard Care Then Online ECG Monitoring
Participants Units (Hospitals) Participants Units (Hospitals)
STARTED   1585 [1]   9   1428 [2]   8 
Baseline Assessment   873 [3]   9   866 [4]   8 
15 Months Assessment   1108 [5]   9   782 [4]   8 
30 Months Assessment   741 [6]   8   926 [7]   8 
COMPLETED   1585 [8]   8   1428 [9]   8 
NOT COMPLETED   0      0    
[1] 873 unique nurses were assessed at 9 hospitals at the initiation of the study.
[2] 866 unique nurses were assessed at 8 hospitals at the initiation of the study.
[3] 873 unique nurses, assessed at 9 hospitals.
[4] 866 unique nurses, assessed at 8 hospitals.
[5] 1108 unique nurses, assessed at 9 hospitals.
[6] 741 unique nurses, assessed at 8 hospitals.
[7] 926 unique nurses, assessed at 8 hospitals.
[8] 1585 unique nurses assessed overall (at any time point) by end of study.
[9] 1428 unique nurses assessed overall (at any time point) by end of study.

Period 2:   Patient Quality of Care Assessments
    Online ECG Education   Standard Care Then Online ECG Monitoring
Participants Units (Hospitals) Participants Units (Hospitals)
STARTED   2299 [1]   9   2288 [2]   8 
Baseline Assessment   915 [3]   9   889 [4]   8 
15 Months Assessment   687 [5]   8   773 [6]   8 
30 Months Assessment   697 [7]   8   626 [8]   7 
COMPLETED   2299 [9]   8   2288 [10]   7 
NOT COMPLETED   0      0    
[1] 915 unique patients were assessed at 9 hospitals at the initiation of the study.
[2] 889 unique patients were assessed at 8 hospitals at the initiation of the study.
[3] 915 unique patients, assessed at 9 hospitals.
[4] 889 unique patients, assessed at 8 hospitals.
[5] 687 unique patients, assessed at 8 hospitals.
[6] 773 unique patients, assessed at 8 hospitals.
[7] 697 unique patients, assessed at 8 hospitals.
[8] 626 unique patients, assessed at 7 hospitals.
[9] 2299 unique patients assessed overall (at any time point) by end of study.
[10] 2288 unique patients assessed overall (at any time point) by end of study.

Period 3:   Patient Outcomes (Hospital Admissions)
    Online ECG Education   Standard Care Then Online ECG Monitoring
Participants Units (Hospitals) Participants Units (Hospitals)
STARTED   52085 [1]   7   43799 [2]   6 
Baseline Assessment   17352 [3]   7   16549 [4]   6 
15 Months Assessment   18031 [5]   7   14075 [6]   6 
30 Months Assessment   16702 [7]   7   13265 [8]   6 
COMPLETED   52085 [9]   7   43799 [10]   6 
NOT COMPLETED   0      0    
[1] 17352 unique patients were assessed at 7 hospitals at the initiation of the study.
[2] 16459 unique patients were assessed at 6 hospitals at the initiation of the study.
[3] 17352 unique patients, assessed at 7 hospitals.
[4] 16549 unique patients, assessed at 6 hospitals.
[5] 18031 unique patients, assessed at 7 hospitals.
[6] 14075 unique patients, assessed at 6 hospitals.
[7] 16702 unique patients, assessed at 7 hospitals.
[8] 13265 unique patients, assessed at 6 hospitals.
[9] 52085 unique patients assessed overall (at any time point) by end of study.
[10] 43799 unique patients assessed overall (at any time point) by end of study.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Nurses Nurses on participating units who received education at the time hospital assigned to the standard training or online ECG education training.
Patients Patients on participating units on whom quality of care data was obtained.
Total Total of all reporting groups

Baseline Measures
   Nurses   Patients   Total 
Overall Participants Analyzed 
[Units: Participants]
 3013   4587   7600 
Age [1] [2] 
[Units: Years]
Mean (Standard Deviation)
     
Participants Analyzed 
[Units: Participants]
 3013   4576   7589 
   37.53  (11.05)   65.54  (5.28)   NA [1] 
[1] Overall age across study groups was not calculated for the different population samples.
[2] Age missing for 11 patients.
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 3013   4579   7592 
Female      2691  89.3%      1954  42.7%      4645  61.2% 
Male      322  10.7%      2625  57.3%      2947  38.8% 
[1] Sex missing for 8 patients.
Ethnicity (NIH/OMB) [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 3013   4475   7488 
Hispanic or Latino      81   2.7%      226   5.1%      307   4.1% 
Not Hispanic or Latino      2932  97.3%      4249  94.9%      7181  95.9% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
[1] Ethnicity missing for 112 patients.
Education [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 3013   0   3013 
Diploma      291   9.7%         291   9.7% 
Associate's Degree      534  17.7%         534  17.7% 
Bachelor's Degree      1959  65.0%         1959  65.0% 
Master's Degree      208   6.9%         208   6.9% 
Doctoral Degree      11   0.4%         11   0.4% 
None of the above      10   0.3%         10   0.3% 
[1] Education data not obtained from patients.
Type of Unit [1] 
[Units: Participants]
Count of Participants
     
Participants Analyzed 
[Units: Participants]
 3013   0   3013 
Medicine      1329  44.1%         1329  44.1% 
Surgery      830  27.5%         830  27.5% 
Combined      854  28.3%         854  28.3% 
[1] Unit data not obtained from patients.


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Nurses' Knowledge and Skills Related to ECG Monitoring   [ Time Frame: Baseline, 15 months, 30 months ]

2.  Secondary:   Quality of Patient Care Related to ECG Monitoring   [ Time Frame: Baseline, 15 months, 30 months ]

3.  Secondary:   Patient Outcomes   [ Time Frame: Baseline, 15 months, 30 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Professor Marjorie Funk, PhD, RN
Organization: Yale University
phone: (203) 737-2346
e-mail: marjorie.funk@yale.edu


Publications of Results:
Other Publications:

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01269736     History of Changes
Other Study ID Numbers: 0711003292
R01HL081642 ( U.S. NIH Grant/Contract )
First Submitted: January 3, 2011
First Posted: January 4, 2011
Results First Submitted: June 1, 2017
Results First Posted: August 31, 2017
Last Update Posted: August 31, 2017