CClinicalTrials.gg
CompletedNCT00105703CHF ENCOREUpdated Apr 7, 2015

Evaluation of a Nurse Case Management Model for Chronic Heart Failure

An interventional study of Case management using advanced nurse practitioners in Heart Failure, Congestive, sponsored by US Department of Veterans Affairs. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-07.

Sponsored by US Department of Veterans Affairs · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
969
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

BACKGROUND / RATIONALE:

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.

OBJECTIVE(S):

This study will evaluate the impact of a nurse practitioner case management model compared with usual care in patients with congestive heart failure (CHF). Outcomes include health-related quality of life, patient satisfaction, compliance with medication guidelines, mortality, readmissions, bed days of care, outpatient visits, emergency room visits, and pharmacy costs.

METHODS:

Patients with CHF will be identified by review of admission/discharge logs, review of clinic schedules, and referrals from medical personnel. All patients in the northern half of VISN 11 (Ann Arbor, Detroit, Saginaw, and Battle Creek) will participate in a case management program, in which they will receive care from nurse practitioners who will be supported by practice guidelines, treatment algorithms, and guidance from cardiologists at the VA Ann Arbor Health Care System. Patients in the southern half of the VISN (Indianapolis and Danville) will make up the comparison group and will receive usual care for CHF patients.

All study participants will complete baseline and one and two year follow-up questionnaires on health related quality of life, including the SF-36V and the Minnesota Living With Heart Failure Questionnaire. Patient satisfaction will be assessed using the VA National Ambulatory Care Survey. Additional data on the use of health care resources over the two years following each patient�s index hospitalization will be collected from the Patient Treatment File (PTF) and the Outpatient Census (OPC) File. Data on compliance with medication guidelines will be obtained from the VISN 11 pharmacy database. Multivariate analyses will be used, with the main study outcomes as dependent variables and intervention vs. comparison group membership as independent variables, controlling for baseline differences between intervention and comparison groups. Additional analyses will compare the study outcomes for patients served by primary versus tertiary sites.

Semi-structured interviews will be conducted with participating providers at the beginning, middle, and end of the study, to determine satisfaction with the program, as well as specific components that were perceived to help or hinder its effectiveness.

STATUS:

All two-year follow-up questionnaires have been received and entered. Medical record abstraction, which includes data on severity of disease, will continue through Dec 2007. All interviews with medical center staff have been conducted, transcribed, and coded. We are in the process of pulling one-year prior and one and two-year post data on comorbidities and resource utilization. Analysis of survey, medical record, interview, and secondary data will continue through spring of 2008, when the final report will be written.

02

Conditions studied

  • Heart Failure, Congestive

Browse trials for

Keywords

  • Nurse practitioners
  • Case management
03

In context

Heart Failure

5,701 studies on the registry are indexed under Heart Failure; 1,220 are open to participants now.

This study's enrollment of 969 is above the median of 72 across 3,736 interventional studies indexed under Heart Failure.

Browse Heart Failure studies →

Lead sponsor

US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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:

    1. 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
    2. 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.

Exclusion criteria

Exclusion Criteria:

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).

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
969 participants (actual)

Study arms

  • Other
    Arm 1

    Behavioral: Case management using advanced nurse practitioners

Interventions

  • BehavioralCase management using advanced nurse practitioners
06

What researchers measure

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.

07

Study locations

4 sites
  • VA Illiana Health Care System, Danville, IL
    Danville, Illinois 61832, United States
  • Richard L. Roudebush VA Medical Center, Indianapolis, IN
    Indianapolis, Indiana 46202-2884, United States
  • VA Ann Arbor Healthcare System, Ann Arbor, MI
    Ann Arbor, Michigan 48105, United States
  • John D. Dingell VA Medical Center, Detroit, MI
    Detroit, Michigan 48201, United States
08

References and documents

Publications

  • 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. PubMed 12213141 ↗
  • 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.
  • 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. PubMed 12686354 ↗
  • 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. PubMed 18256563 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00105703
Lead sponsor
US Department of Veterans Affairs
Responsible party
Sponsor
First posted
Mar 17, 2005
Start date
Feb 2002
Completion
Jun 2007
Last update
Apr 7, 2015

Study contacts

Julie C Lowery, PhD MHSA
principal investigator · VA Ann Arbor Healthcare System, Ann Arbor, MI

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2007. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion