Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00013208
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2001-03-14
Brief Title:
Proactive Diabetes Case Management
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Proactive Diabetes Case Management
Status:
COMPLETED
Status Verified Date:
2007-02
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:
None
Brief Summary:
Despite a growing array of therapeutic options and efficacious treatment strategies to prevent or delay some of the most severe complications of type 2 diabetes there continue to be many individuals with outcomes that are far from optimal Interventions to improve diabetes care by educating providers and patients have been disappointing In the past several years case management has been widely advocated as a cost-effective approach to coordinate diabetes care and improve outcomes although there is little rigorous evidence demonstrating the benefits of this type of intervention
Detailed Description:
Background
Despite a growing array of therapeutic options and efficacious treatment strategies to prevent or delay some of the most severe complications of type 2 diabetes there continue to be many individuals with outcomes that are far from optimal Interventions to improve diabetes care by educating providers and patients have been disappointing In the past several years case management has been widely advocated as a cost-effective approach to coordinate diabetes care and improve outcomes although there is little rigorous evidence demonstrating the benefits of this type of intervention
Objectives
This study had the following specific aims 1 to evaluate the effect of a targeted proactive case management intervention for high risk veterans with type 2 diabetes on a glycemic control b intermediate cardiovascular outcomes c satisfaction d adherence to specific care standards and e short-term resource utilization and 2 using Monte Carlo simulation models to estimate the expected impact of changes in key processes of care and intermediate outcomes on end-stage outcomes
Methods
This study was conducted as a prospective randomized controlled trial Participating veterans with diabetes N 246 receiving care at two VAMCs were randomly assigned stratified by site and baseline hemoglobin A1c A1c to the intervention or control group The intervention consisted of two nurse practitioners who actively monitored and coordinated patient care guided by approved treatment algorithms Data for the study were collected through a baseline and exit examination a baseline and exit survey and the VA medical information system The primary outcome measure was the change in glycemic control as measured by A1c Secondary outcomes included serum LDL blood pressure satisfaction and resource utilization The data were analyzed using univariate and bi-variate t-test Wilcoxon rank-sum chi-square methods as well as multivariable regression
Status
Completed Manuscripts
Despite a growing array of therapeutic options and efficacious treatment strategies to prevent or delay some of the most severe complications of type 2 diabetes there continue to be many individuals with outcomes that are far from optimal Interventions to improve diabetes care by educating providers and patients have been disappointing In the past several years case management has been widely advocated as a cost-effective approach to coordinate diabetes care and improve outcomes although there is little rigorous evidence demonstrating the benefits of this type of intervention
Objectives
This study had the following specific aims 1 to evaluate the effect of a targeted proactive case management intervention for high risk veterans with type 2 diabetes on a glycemic control b intermediate cardiovascular outcomes c satisfaction d adherence to specific care standards and e short-term resource utilization and 2 using Monte Carlo simulation models to estimate the expected impact of changes in key processes of care and intermediate outcomes on end-stage outcomes
Methods
This study was conducted as a prospective randomized controlled trial Participating veterans with diabetes N 246 receiving care at two VAMCs were randomly assigned stratified by site and baseline hemoglobin A1c A1c to the intervention or control group The intervention consisted of two nurse practitioners who actively monitored and coordinated patient care guided by approved treatment algorithms Data for the study were collected through a baseline and exit examination a baseline and exit survey and the VA medical information system The primary outcome measure was the change in glycemic control as measured by A1c Secondary outcomes included serum LDL blood pressure satisfaction and resource utilization The data were analyzed using univariate and bi-variate t-test Wilcoxon rank-sum chi-square methods as well as multivariable regression
Status
Completed Manuscripts
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