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Evaluation of a Nurse Case Management Model for Chronic Heart Failure (CHF ENCORE)

Primary Purpose

Heart Failure, Congestive

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Case management using advanced nurse practitioners
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure, Congestive focused on measuring Nurse practitioners, Case management

Eligibility Criteria

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

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: 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. 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).

Sites / Locations

  • VA Illiana Health Care System, Danville, IL
  • Richard L. Roudebush VA Medical Center, Indianapolis, IN
  • VA Ann Arbor Healthcare System, Ann Arbor, MI
  • John D. Dingell VA Medical Center, Detroit, MI

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

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 Outcome Measures

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

Full Information

First Posted
March 16, 2005
Last Updated
April 6, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00105703
Brief Title
Evaluation of a Nurse Case Management Model for Chronic Heart Failure
Acronym
CHF ENCORE
Official Title
Evaluation of a Nurse Case Management Model for Chronic Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
September 2007
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive
Keywords
Nurse practitioners, Case management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
969 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Case management using advanced nurse practitioners
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Feedback regarding the intervention from the directors, chiefs of staff, cardiologists, nurse practitioners, and primary care providers at the participating sites.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: 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. 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie C Lowery, PhD MHSA
Organizational Affiliation
VA Ann Arbor Healthcare System, Ann Arbor, MI
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Illiana Health Care System, Danville, IL
City
Danville
State/Province
Illinois
ZIP/Postal Code
61832
Country
United States
Facility Name
Richard L. Roudebush VA Medical Center, Indianapolis, IN
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-2884
Country
United States
Facility Name
VA Ann Arbor Healthcare System, Ann Arbor, MI
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
John D. Dingell VA Medical Center, Detroit, MI
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12213141
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
PubMed Identifier
12686354
Citation
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.
Results Reference
result
PubMed Identifier
18256563
Citation
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.
Results Reference
result
Links:
URL
http://www.annarbor.hsrd.research.va.gov/
Description
Ann Arbor HSR&D Center of Excellence Web page

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Evaluation of a Nurse Case Management Model for Chronic Heart Failure

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