NCT00105703

Brief Summary

Despite established clinical practice guidelines, wide variations exist in the care of chronic heart failure (CHF) patients in Veterans Health Administration. Previous randomized, controlled studies have suggested that a nurse case management model may improve the outcomes of care for patients with CHF. However, these studies involved selected groups of patients (i.e., those who agreed to participate in randomized trials) in selected settings (i.e., tertiary care facilities); so, the findings are not likely to be indicative of the true effectiveness of case management in a large population of CHF patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
969

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2002

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

March 16, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2005

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

April 7, 2015

Status Verified

September 1, 2007

First QC Date

March 16, 2005

Last Update Submit

April 6, 2015

Conditions

Heart Failure, Congestive

Keywords

Nurse practitionersCase management

Outcome Measures

Primary Outcomes (1)

  • The following outcomes will be measured at one and two years following each participant's enrollment in the study: mortality, health related quality of life, patient satisfaction with care, resource utilization (outpatient visits, admissions.

Secondary Outcomes (1)

  • Feedback regarding the intervention from the directors, chiefs of staff, cardiologists, nurse practitioners, and primary care providers at the participating sites.

Study Arms (1)

Arm 1

OTHER
Behavioral: Case management using advanced nurse practitioners

Interventions

Case management using advanced nurse practitionersBEHAVIORAL
Arm 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient receives all cardiology care at a VISN 11 VAMC.
  • Must have chronic heart failure (CHF) secondary to systolic or diastolic dysfunction, as defined by meeting (1) or (2) below:
  • Systolic Dysfunction, defined by a history or documentation of LVEF = 40% (or fractional shortening = 20%-if LVEF not documented)
  • AND at least ONE of the following:
  • Current diagnosis or history of CHF and/or
  • Physical findings and/or symptoms of CHF within two months of enrollment and/or
  • Hospitalization for CHF within 12 months OR
  • Diastolic Dysfunction, defined by a history of documentation of LVEF \> 40% (or fractional shortening \> 20% if LVEF not documented) AND Physical findings and/or symptoms of CHF within two months of enrollment.

You may not qualify if:

  • Based on medical record data, patient does not have any co-morbidity other than CHF which, in the opinion of the investigator, limits life expectancy to less than six months (e.g., metastatic CA, hospice care, renal failure with a creatinine above 5.0 mg/dL or on dialysis, HIV).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

VA Illiana Health Care System, Danville, IL

Danville, Illinois, 61832, United States

Location

Richard L. Roudebush VA Medical Center, Indianapolis, IN

Indianapolis, Indiana, 46202-2884, United States

Location

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105, United States

Location

John D. Dingell VA Medical Center, Detroit, MI

Detroit, Michigan, 48201, United States

Location

Related Publications (4)

  • Subramanian U, Weinberger M, Eckert GJ, L'Italien GJ, Lapuerta P, Tierney W. Geographic variation in health care utilization and outcomes in veterans with acute myocardial infarction. J Gen Intern Med. 2002 Aug;17(8):604-11. doi: 10.1046/j.1525-1497.2002.11048.x.

    PMID: 12213141RESULT

  • Subramanian U, Sutherland J, Hopp F, Lowery J, Doebbeling B. Patient self-efficacy, provider self-management counseling and health status among patients with chronic heart failure. Journal of general internal medicine. 2005 Oct 1; 20(Supplement 1):70.

    RESULT

  • Subramanian U, Weinberger M, Fihn SD, Tierney WM. Diagnostic challenges defining heart failure when using echocardiograms. Am J Cardiol. 2003 Apr 15;91(8):1015-7, A8. doi: 10.1016/s0002-9149(03)00130-9. No abstract available.

    PMID: 12686354RESULT

  • Subramanian U, Hopp F, Mitchinson A, Lowery J. Impact of provider self-management education, patient self-efficacy, and health status on patient adherence in heart failure in a Veterans Administration population. Congest Heart Fail. 2008 Jan-Feb;14(1):6-11. doi: 10.1111/j.1751-7133.2008.07174.x.

    PMID: 18256563RESULT

Related Links

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Julie C Lowery, PhD MHSA

    VA Ann Arbor Healthcare System, Ann Arbor, MI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2005

First Posted

March 17, 2005

Study Start

February 1, 2002

Study Completion

June 1, 2007

Last Updated

April 7, 2015

Record last verified: 2007-09

Locations

US(4)