Evaluation of a Nurse Case Management Model for Chronic Heart Failure (CHF ENCORE)
|ClinicalTrials.gov Identifier: NCT00105703|
Recruitment Status : Completed
First Posted : March 17, 2005
Last Update Posted : April 7, 2015
|First Submitted Date ICMJE||March 16, 2005|
|First Posted Date ICMJE||March 17, 2005|
|Last Update Posted Date||April 7, 2015|
|Study Start Date ICMJE||February 2002|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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.|
|Original Primary Outcome Measures ICMJE
|Change History||Complete list of historical versions of study NCT00105703 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Feedback regarding the intervention from the directors, chiefs of staff, cardiologists, nurse practitioners, and primary care providers at the participating sites.|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Evaluation of a Nurse Case Management Model for Chronic Heart Failure|
|Official Title ICMJE||Evaluation of a Nurse Case Management Model for Chronic Heart Failure|
|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.|
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.
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.
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.
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.
|Study Type ICMJE||Interventional|
|Study Phase||Not Applicable|
|Study Design ICMJE||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Condition ICMJE||Heart Failure, Congestive|
|Intervention ICMJE||Behavioral: Case management using advanced nurse practitioners|
|Study Arms||Arm 1
Intervention: Behavioral: Case management using advanced nurse practitioners
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Actual Enrollment ICMJE
|Original Enrollment ICMJE
|Actual Study Completion Date||June 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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).
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00105703|
|Other Study ID Numbers ICMJE||CHI 99-236|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||VA Office of Research and Development|
|Study Sponsor ICMJE||VA Office of Research and Development|
|Collaborators ICMJE||Not Provided|
|PRS Account||VA Office of Research and Development|
|Verification Date||September 2007|
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