Cardiovascular DiseasePULSENCT01269736
Implementation of Practice Standards for ECG Monitoring
A study testing Education in people with Cardiovascular Disease, run by Yale University at 16 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92,057 participants
- Where
- 16 sitesin 3 countries
- Study dates
- Aug 2008to Mar 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
16 sites in 3 countries.
16 sites in 3 countries
United States14 sites
Seton Medical Center
Austin, Texas, 78705
Erie County Medical Center
Buffalo, New York, 14215
Aultman Hospital
Canton, Ohio, 44710
University of North Carolina Hospitals
Chapel Hill, North Carolina, 27516
Baylor University Medical Center
Dallas, Texas, 75252
Long Beach Memorial Medical Center
Long Beach, California, 90806
Meriter Heart Hospital
Madison, Wisconsin, 53715
Yale-New Haven Hospital
New Haven, Connecticut, 06510
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Maine Medical Center
Portland, Maine, 04102
United Hospital
Saint Paul, Minnesota, 55102
University of California, San Francisco Medical Center
San Francisco, California, 94122
Baystate Medical Center
Springfield, Massachusetts, 01199
Canada1 site
University of Ottawa Heart Institute, Ottawa, Canada
Ottawa, Ontario, K1Y 4W7
About this study
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.
Read the 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.
- Conditions
- Cardiovascular Disease
- Being tested
- Education
- Keywords
- electrocardiographic monitoring, arrhythmia, myocardial ischemia
- Medical subject headings
- Cardiovascular Diseases, Arrhythmias, Cardiac, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
Online ECG monitoring education program and strategies to implement and sustain change for nurses
| Study group | Role | What they receive |
|---|---|---|
| Education | Experimental | Online ECG monitoring education program and strategies to implement and sustain change for nurses Receives: Behavioral: Education |
| Control | No intervention | Usual in-service education for nurses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline, 15 months, 30 months
Secondary outcomes (2)
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
Measured: Baseline, 15 months, 30 months
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.
Measured: Baseline, 15 months, 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2011 (estimated)
- Study startAug 2008
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 92,057 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Marjorie Funk, PhD, RN, Principal investigator, Yale University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01269736
- Sponsor's protocol ID
- 0711003292
- Other IDs
- R01HL081642
- Acronym
- PULSE
- Status last verified
- Jun 2017
- First submitted
- 3 Jan 2011
- Last updated
- 31 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 21045576Funk 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.
PubMed 20832819Funk 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.
PubMed 28174175
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Practice Standards for ECG Monitoring
- ClinicalTrials.gov ID
- NCT01269736
- Acronym / sponsor ID
- PULSE / 0711003292
- Conditions
- Cardiovascular Disease
- Keywords
- electrocardiographic monitoring, arrhythmia, myocardial ischemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92,057 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 2008
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 4 Jan 2011 (estimated)
- Results
- Posted 31 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education | Experimental | Behavioral: EducationOnline ECG monitoring education program and strategies to implement and sustain change for nurses |
| Control | No intervention | –Usual in-service education for nurses |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EducationOnline ECG monitoring education program and strategies to implement and sustain change for nurses | Behavioural | Education |
Primary outcome
Nurses' Knowledge and Skills Related to ECG Monitoring
Time frame: 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)
2 secondary outcomes
Quality of Patient Care Related to ECG Monitoring
Time frame: Baseline, 15 months, 30 months
Patient Outcomes
Time frame: Baseline, 15 months, 30 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21045576Funk 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.
- Results publication: PubMed 20832819Funk 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.
- Results publication: PubMed 28174175Funk 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marjorie Funk, PhD, RN principal investigator
Yale University School of Nursing
16 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education in people with Cardiovascular Disease, run by Yale University at 16 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States, Canada, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nurses' Knowledge and Skills Related to ECG Monitoring (time frame: Baseline, 15 months, 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01269736, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2017.