Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00012649
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2001-03-14
Brief Title:
Improving Diabetes Care Via Telephone Assessment and Patient Education
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Improving Diabetes Care Via Telephone Assessment and Patient Education
Status:
COMPLETED
Status Verified Date:
2005-01
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:
The purpose of this study is to improve the quality of VA diabetes care using an automated telephone disease management ATDM system that administers patient assessments and targeted self-care education between clinic visits
Detailed Description:
Background
The purpose of this study is to improve the quality of VA diabetes care using an automated telephone disease management ATDM system that administers patient assessments and targeted self-care education between clinic visits
Objectives
In this ongoing study we are determining 1 the reliability and validity of Automated Telephone Disease Management ATDM assessments of patients glycemic control health-related quality of life HRQL self-care and satisfaction with care 2 the extent to which these assessments identify patients at risk for poor outcomes and 3 the cost-effectiveness of an intervention in which ATDM assessment reports are provided regularly to patients primary care providers
Methods
We are refining and expanding previously-developed ATDM assessment instruments by incorporating measures of patient-centered outcomes We are enrolling 450 patients from VISN 12 and VISN 21 Patients receive weekly ATDM assessments for six months Other data on their health status and service use are being collected from medical records laboratory tests telephone surveys and Austin Automation Center files After determining the concurrent reliability validity and prognostic significance of the ATDM assessments we will examine variation in ATDM-reported outcomes across Networks facilities and patient groups In the second phase of the study we will conduct an effectiveness trial with a one year follow up period We will use the findings from our process evaluation to modify the ATDM assessments and design provider feedback reports We will enroll 240 patients from the two Networks ie 480 patients overall Patients will be assigned to experimental or usual care control groups using a combination of randomization and cutoff-based assignment We will measure the interventions impact on patients glycemic control symptoms self-care and patient-centered outcomes We will use VA costing database and Medicare claims files to evaluate cost-effectiveness
Status
Analyses of ATDM assessment data suggest that this method is feasible with VA diabetes patients and provides comparable data regarding patients satisfaction with care and functioning to telephone surveys Other analysis suggest that VA interpersonal processes of care and rates of cost-related medication adherence problems are as good or better than that experienced by patients with comparable characteristics treated in other systems of care
The purpose of this study is to improve the quality of VA diabetes care using an automated telephone disease management ATDM system that administers patient assessments and targeted self-care education between clinic visits
Objectives
In this ongoing study we are determining 1 the reliability and validity of Automated Telephone Disease Management ATDM assessments of patients glycemic control health-related quality of life HRQL self-care and satisfaction with care 2 the extent to which these assessments identify patients at risk for poor outcomes and 3 the cost-effectiveness of an intervention in which ATDM assessment reports are provided regularly to patients primary care providers
Methods
We are refining and expanding previously-developed ATDM assessment instruments by incorporating measures of patient-centered outcomes We are enrolling 450 patients from VISN 12 and VISN 21 Patients receive weekly ATDM assessments for six months Other data on their health status and service use are being collected from medical records laboratory tests telephone surveys and Austin Automation Center files After determining the concurrent reliability validity and prognostic significance of the ATDM assessments we will examine variation in ATDM-reported outcomes across Networks facilities and patient groups In the second phase of the study we will conduct an effectiveness trial with a one year follow up period We will use the findings from our process evaluation to modify the ATDM assessments and design provider feedback reports We will enroll 240 patients from the two Networks ie 480 patients overall Patients will be assigned to experimental or usual care control groups using a combination of randomization and cutoff-based assignment We will measure the interventions impact on patients glycemic control symptoms self-care and patient-centered outcomes We will use VA costing database and Medicare claims files to evaluate cost-effectiveness
Status
Analyses of ATDM assessment data suggest that this method is feasible with VA diabetes patients and provides comparable data regarding patients satisfaction with care and functioning to telephone surveys Other analysis suggest that VA interpersonal processes of care and rates of cost-related medication adherence problems are as good or better than that experienced by patients with comparable characteristics treated in other systems of care
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