Insulin Treatment Variation in Southwestern Diabetics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00148304
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : June 6, 2016
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
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.

Condition or disease
Diabetes Self-Monitoring, Blood Glucose

Detailed Description:

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. The investigators 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, the investigators 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.

Study Type : Observational
Actual Enrollment : 1248 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Insulin Treatment Variation in Southwestern Diabetics - Therapeutic Decision-making
Study Start Date : September 2005
Actual Primary Completion Date : August 2007
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin
U.S. FDA Resources

Group 1

Primary Outcome Measures :
  1. diabetes self-care/attitudes [ Time Frame: single survey ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
insulin-using diabetics in VISN 18

Inclusion Criteria:

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

Exclusion Criteria:

- Unwilling to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00148304

United States, Arizona
Phoenix VA Health Care System, Phoenix, AZ
Phoenix, Arizona, United States, 85012
Southern Arizona VA Health Care System, Tucson, AZ
Tucson, Arizona, United States, 85723
United States, New Mexico
New Mexico VA Health Care System, Albuquerque, NM
Albuquerque, New Mexico, United States, 87108-5153
Sponsors and Collaborators
VA Office of Research and Development
Principal Investigator: Glen H Murata, MD New Mexico VA Health Care System, Albuquerque, NM

Responsible Party: VA Office of Research and Development Identifier: NCT00148304     History of Changes
Other Study ID Numbers: IIR 04-176
First Posted: September 7, 2005    Key Record Dates
Last Update Posted: June 6, 2016
Last Verified: June 2016

Keywords provided by VA Office of Research and Development:
Treatment Variation

Additional relevant MeSH terms:
Hypoglycemic Agents
Physiological Effects of Drugs