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Provider Notification for High B-type Natriuretic Peptide Values

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Paul Heidenreich, VA Palo Alto Health Care System
ClinicalTrials.gov Identifier:
NCT01734135
First received: November 20, 2012
Last updated: February 13, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Heart Failure
 Other: Clinical Reminder

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Trial of Provider Notification for Patients With High B-type Natriuretic Peptide and no Imaging to Identify Unsuspected Heart Failure.

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure
Drug Information available for: Nesiritide
U.S. FDA Resources

Further study details as provided by VA Palo Alto Health Care System:

Primary Outcome Measures:
  • Measurement of left ventricular ejection fraction [ Time Frame: 6 months after randomization ] [ Designated as safety issue: No ]

    numerator: Measurement of left ventricular ejection fraction within 6 months of randomization.

    denominator: All randomized patients



Secondary Outcome Measures:
  • Identification of LVEF < 40% [ Time Frame: 6 months following randomizaiton ] [ Designated as safety issue: No ]
    Numerator: number of patients identified with an LVEF< 40% Denominator: all randomized patients

  • Treatment of Low LVEF [ Time Frame: 6 months following randomization ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 100
Study Start Date: October 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual Care
Usual care
Experimental: Clinical Reminder
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.
 Other: Clinical Reminder
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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%
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01734135

Locations
United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304
Sponsors and Collaborators
VA Palo Alto Health Care System
Investigators
Principal Investigator: Paul A Heidenreich, MD, MS VA Palo Alto HCS
  More Information

No publications provided

Responsible Party: Paul Heidenreich, Investigator, VA Palo Alto Health Care System
ClinicalTrials.gov Identifier: NCT01734135     History of Changes
Other Study ID Numbers: CHFQUERI-1101
Study First Received: November 20, 2012
Last Updated: February 13, 2013
Health Authority: United States: Federal Government

Keywords provided by VA Palo Alto Health Care System:
B type natriuretic peptide
heart failure
cardiac imaging
quality of care

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Natriuretic Peptide, Brain
Natriuretic Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013