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OpenTrials
Completed

NCT Number: NCT00012649

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

VA Palo Alto Health Care System, Palo Alto, CA, Palo Alto, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients enrolled in VISN 12 and VISN 21

Exclusion criteria

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Important dates

Study completion
2003
First posted
Mar 16, 2001
Registry last updated
Apr 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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