Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00105703
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2005-03-16
Brief Title:
Evaluation of a Nurse Case Management Model for Chronic Heart Failure
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Evaluation of a Nurse Case Management Model for Chronic Heart Failure
Status:
COMPLETED
Status Verified Date:
2007-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHF ENCORE
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 ie those who agreed to participate in randomized trials in selected settings ie 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 ie those who agreed to participate in randomized trials in selected settings ie 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
OBJECTIVES
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 admissiondischarge 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 patients 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
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 ie those who agreed to participate in randomized trials in selected settings ie 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
OBJECTIVES
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 admissiondischarge 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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None