Diabetes Clinical Trial
Official title:
Improving Diabetes Care Via Telephone Assessment and Patient Education
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.
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
(i.e., 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 intervention's 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.
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