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Insulin Treatment Variation in Southwestern Diabetics

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00148304
First received: September 2, 2005
Last updated: April 15, 2014
Last verified: April 2014

September 2, 2005
April 15, 2014
September 2005
August 2007   (final data collection date for primary outcome measure)
diabetes self-care/attitudes [ Time Frame: single survey ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00148304 on ClinicalTrials.gov Archive Site
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Insulin Treatment Variation in Southwestern Diabetics
Insulin Treatment Variation in Southwestern Diabetics - Therapeutic Decision-making

The purpose of this study is to better understand disparities in insulin dosing, hemoglobin A1c, and self-reported patient self-care behaviors among non-Hispanic white, Hispanic, and African American veterans with type 2 diabetes receiving VA care.

Background: Minority populations are disproportionately affected by type 2 diabetes mellitus (T2DM), likely due to an interaction of genetic and environmental risk factors. Several studies have documented a higher prevalence of insulin resistance, disparities in quality of care, and more microvascular and macrovascular complications in minority groups. Recent evidence by our research group indicates that insulin-using minority veterans have poorer glycemic control (as measured by HbA1c) and receive lower doses of insulin than do non-Hispanic white patients.

Objectives: The goal of this mixed methods descriptive, cross-sectional study is to elucidate the patient, provider and interactive patient/provider reasons for this discrepancy, to determine and validate these findings in a much larger sample, and to use what is discovered to develop strategies to remedy provider and patient behaviors in order to optimize health outcomes. The objective of this mixed method study is to unpack provider decision-making and patient self-care behaviors responsible for ethnic and racial variation in the use of insulin in veterans with T2DM receiving VA care, while adjusting for important covariates and confounders. Aim 1: Perform a qualitative provider Nominal Group Technique designed to elucidate insulin prescribing decision-making behaviors, and possible reasons for racial/ethnic variation in insulin use. Aim 2: Perform a qualitative content analysis of patient focus group data on insulin-using veterans in VA care across African American, Hispanic and non-Hispanic White (NHW) contrasts. Psychosocial determinants of self-care, diabetes care preferences, patient/provider relationship issues, and possible reasons for racial/ethnic variation in insulin use will be explored. Aim 3: Construct a) patient, and b) provider questionnaires reflective of qualitative focus group data, nominal group process and extant evidence-base findings, and Aim 4: Administer surveys to a) a racially/ethnically diverse random sample of insulin-using diabetic veterans receiving care within VISN 18, and b) their assigned primary care providers.

Methods: This is a mixed methods descriptive, cross-sectional study using 1) qualitative nominal group technique data (from providers), focus group data (from patients) and 2) provider and nested patient survey data. We will use qualitative methods to explicate and deconstruct the etiologic associations and management strategies of insulin-using patients and their providers using focus group content analytical methods. Next, we will use the extant evidence from the evidence-base, focus group data and conventional survey methods to construct two surveys-one targeted to providers and another to survey a randomly selected population of representative veterans nested within their providers VA care, following the recommendations of Hughes, O'Brien and Dillman.

Status: Completed.

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
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Non-Probability Sample

insulin-using diabetics in VISN 18

  • Diabetes
  • Self-Monitoring, Blood Glucose
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Group 1
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1248
June 2008
August 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Must be in VISN 18 VISTA database
  • Diabetic
  • Using insulin

Exclusion Criteria:

- Unwilling to participate

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00148304
IIR 04-176
No
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Glen H Murata, MD New Mexico VA Health Care System
Department of Veterans Affairs
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP