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Provider Notification for High B-type Natriuretic Peptide Values

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clinical Reminder
Sponsored by
VA Palo Alto Health Care System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Heart Failure focused on measuring B type natriuretic peptide, heart failure, cardiac imaging, quality of care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • BNP >= 200 pg/ml in last 2 months

Exclusion Criteria:

  • Measure of LVEF in the last 12 months
  • Last measure of LVEF < 40%

Sites / Locations

  • VA Palo Alto Health Care System

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

Clinical Reminder

Arm Description

Usual care

A note is sent to the primary care provider using the electronic medical record indicating the high BNP result and potential benefit of measurement of the left ventricular ejection fraction. A draft order is placed for an echocardiogram for the provider to accept or delete.

Outcomes

Primary Outcome Measures

Measurement of left ventricular ejection fraction
numerator: Measurement of left ventricular ejection fraction within 6 months of randomization. denominator: All randomized patients

Secondary Outcome Measures

Identification of LVEF < 40%
Numerator: number of patients identified with an LVEF< 40% Denominator: all randomized patients
Treatment of Low LVEF
Numerator: number of patients with an LVEF < 40% and treatment with either an angiotensin converting enzyme inhibitor, angiotensin receptor blocker or evidence based beta-blocker (carvedilol, metoprolol succinate, bisoprolol). Denominator: all randomized patients.

Full Information

First Posted
November 20, 2012
Last Updated
April 26, 2016
Sponsor
VA Palo Alto Health Care System
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1. Study Identification

Unique Protocol Identification Number
NCT01734135
Brief Title
Provider Notification for High B-type Natriuretic Peptide Values
Official Title
Trial of Provider Notification for Patients With High B-type Natriuretic Peptide and no Imaging to Identify Unsuspected Heart Failure.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
VA Palo Alto Health Care System

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This proposal examines use of a clinical reminder to the primary provider of patient with a high B type natriuretic peptide but no prior imaging. Electrical Medical Record-based Intervention to Determine whether Clinical Reminders Improve Heart Failure Management in Patients with High BNP Values and Unknown LVEF.
Detailed Description
Rationale: B type natriuretic peptide is known to be elevated (> 100 pg/ml) in patients with heart failure. Furthermore, treatments are available to improve survival and reduce hospitalization if the left ventricular ejection fraction (LVEF) is < 40%. Accordingly, guidelines recommend an LVEF measure for patients with suspected heart failure. Prior work has demonstrated that patients with high BNP values do not always have a measure of left ventricular ejection. Hypothesis: A reminder to patients with BNP and no imaging may prompt providers to order appropriate imaging potentially leading to 1) identification of unsuspected depressed ejection fraction and 2) more appropriate treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
B type natriuretic peptide, heart failure, cardiac imaging, quality of care

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
115 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual care
Arm Title
Clinical Reminder
Arm Type
Experimental
Arm Description
A note is sent to the primary care provider using the electronic medical record indicating the high BNP result and potential benefit of measurement of the left ventricular ejection fraction. A draft order is placed for an echocardiogram for the provider to accept or delete.
Intervention Type
Other
Intervention Name(s)
Clinical Reminder
Intervention Description
A note is sent to the primary care provider using the electronic medical record indicating the high BNP result and potential benefit of measurement of the left ventricular ejection fraction. A draft order is placed for an echocardiogram for the provider to accept or delete.
Primary Outcome Measure Information:
Title
Measurement of left ventricular ejection fraction
Description
numerator: Measurement of left ventricular ejection fraction within 6 months of randomization. denominator: All randomized patients
Time Frame
6 months after randomization
Secondary Outcome Measure Information:
Title
Identification of LVEF < 40%
Description
Numerator: number of patients identified with an LVEF< 40% Denominator: all randomized patients
Time Frame
6 months following randomizaiton
Title
Treatment of Low LVEF
Description
Numerator: number of patients with an LVEF < 40% and treatment with either an angiotensin converting enzyme inhibitor, angiotensin receptor blocker or evidence based beta-blocker (carvedilol, metoprolol succinate, bisoprolol). Denominator: all randomized patients.
Time Frame
6 months following randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: BNP >= 200 pg/ml in last 2 months Exclusion Criteria: Measure of LVEF in the last 12 months Last measure of LVEF < 40%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul A Heidenreich, MD, MS
Organizational Affiliation
VA Palo Alto HCS
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Palo Alto Health Care System
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Provider Notification for High B-type Natriuretic Peptide Values

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