Heart FailureNCT02858674
Health Information Technology in Heart Failure Care
A study testing Pop Up Interruption Alert and Side Bar Non Interruptive Provider Checklist in people with Heart Failure, run by NYU Langone Health at 1 site in United States.
Trial summary
The objective of this proposal is to develop, implement, and test the effectiveness of a computerized clinical decision support system for hospitalized patients with heart failure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Pop Up Interruption Alert and Side Bar Non Interruptive Provider Checklist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 958 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2017to 31 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients hospitalized 2 years prior and 18 months after the time of implementation of the Computerized clinical decision support systems (CDSS) in the (Electronic Health Record (EHR).
Who cannot join
- Patients on the obstetrical service, who died during hospitalization, or on hospice care.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
The objective of this proposal is to develop, implement, and test the effectiveness of a computerized clinical decision support system for hospitalized patients with heart failure.
Aim 1: Develop an electronic health record (EHR) based search method that uses both structured data and natural language processing of unstructured text to identify hospitalized patients with heart failure while they are still in the hospital.
Read more
Aim 2: Develop and test the usability of an electronic health record (EHR) based clinical decision support system (CDSS) to support delivery of evidence-based care to hospitalized heart failure patients using human computer interaction methods.
Aim 3: Assess the effect of an electronic health record (EHR) based clinical decision support system (CDSS) on processes of care for heart failure patients who are hospitalized for other causes. As part of the evaluation, we will test two implementation strategies, one of which will introduce the CDSS as an interruptive alert to providers, the second of which will introduce the CDSS as part of a provider checklist that exists on the side of the screen for each patient.
- Conditions
- Heart Failure
- Being tested
- Pop Up Interruption Alert, Side Bar Non Interruptive Provider Checklist
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pop Up Interruption AlertOther
Traditional Pop Up Alert used in Epic
Side Bar Non Interruptive Provider ChecklistOther
Noninterruptive alert that sits in the checklist
| Study group | Role | What they receive |
|---|---|---|
| Active Alerting Mechanism | Experimental | Traditional Pop Up Alert used in Epic Receives: Other: Pop Up Interruption Alert |
| Passive Alerting Mechanism | Active comparator | Noninterruptive alert that sits in the checklist Receives: Other: Side Bar Non Interruptive Provider Checklist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Patients with a Secondary Diagnoses of Heart Failure
These patients will also have had of left ventricular function (LV) Assessment either prior to or during the hospitalization or planned for post discharge
Measured: 90 Days
Percentage of patients with a secondary diagnosis of heart failure and LV systolic dysfunction who have been prescribed an Angiotensin-converting enzyme (ACE) inhibitor or Angiotensin II receptor blockers (ARB)
Measured: 90 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2016 (estimated)
- Study start1 Apr 2017
- Primary completion31 Mar 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 958 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Saul Blecker, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02858674
- Sponsor's protocol ID
- 14-01555
- Status last verified
- Nov 2019
- First submitted
- 3 Aug 2016
- Last updated
- 8 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Blecker S, Austrian JS, Horwitz LI, Kuperman G, Shelley D, Ferrauiola M, Katz SD. Interrupting providers with clinical decision support to improve care for heart failure. Int J Med Inform. 2019 Nov;131:103956. doi: 10.1016/j.ijmedinf.2019.103956. Epub 2019 Sep 4.
PubMed 31525580
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Information Technology in Heart Failure Care
- ClinicalTrials.gov ID
- NCT02858674
- Acronym / sponsor ID
- 14-01555
- Conditions
- Heart Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 958 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 8 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this proposal is to develop, implement, and test the effectiveness of a computerized clinical decision support system for hospitalized patients with heart failure.
Aim 1: Develop an electronic health record (EHR) based search method that uses both structured data and natural language processing of unstructured text to identify hospitalized patients with heart failure while they are still in the hospital.
Aim 2: Develop and test the usability of an electronic health record (EHR) based clinical decision support system (CDSS) to support delivery of evidence-based care to hospitalized heart failure patients using human computer interaction methods.
Aim 3: Assess the effect of an electronic health record (EHR) based clinical decision support system (CDSS) on processes of care for heart failure patients who are hospitalized for other causes. As part of the evaluation, we will test two implementation strategies, one of which will introduce the CDSS as an interruptive alert to providers, the second of which will introduce the CDSS as part of a provider checklist that exists on the side of the screen for each patient.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Alerting Mechanism | Experimental | Other: Pop Up Interruption AlertTraditional Pop Up Alert used in Epic |
| Passive Alerting Mechanism | Active comparator | Other: Side Bar Non Interruptive Provider ChecklistNoninterruptive alert that sits in the checklist |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients hospitalized 2 years prior and 18 months after the time of implementation of the Computerized clinical decision support systems (CDSS) in the (Electronic Health Record (EHR).
Key exclusion criteria (1 listed)
- Patients on the obstetrical service, who died during hospitalization, or on hospice care.
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 |
|---|---|---|
| Pop Up Interruption AlertTraditional Pop Up Alert used in Epic | Other | Active Alerting Mechanism |
| Side Bar Non Interruptive Provider ChecklistNoninterruptive alert that sits in the checklist | Other | Passive Alerting Mechanism |
Primary outcome
Percent of Patients with a Secondary Diagnoses of Heart Failure
Time frame: 90 Days
These patients will also have had of left ventricular function (LV) Assessment either prior to or during the hospitalization or planned for post discharge
Percentage of patients with a secondary diagnosis of heart failure and LV systolic dysfunction who have been prescribed an Angiotensin-converting enzyme (ACE) inhibitor or Angiotensin II receptor blockers (ARB)
Time frame: 90 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2019.
- Derived from this study: PubMed 31525580Blecker S, Austrian JS, Horwitz LI, Kuperman G, Shelley D, Ferrauiola M, Katz SD. Interrupting providers with clinical decision support to improve care for heart failure. Int J Med Inform. 2019 Nov;131:103956. doi: 10.1016/j.ijmedinf.2019.103956. Epub 2019 Sep 4.
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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.
Saul Blecker, MD principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pop Up Interruption Alert and Side Bar Non Interruptive Provider Checklist in people with Heart Failure, run by NYU Langone Health at 1 site in United States.
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 1 inclusion and 1 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 8 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percent of Patients with a Secondary Diagnoses of Heart Failure (time frame: 90 Days). The study lists 2 primary outcomes in all. 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 NCT02858674, which also lists 1 linked publication.
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 8 Nov 2019.