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Insulin Treatment Variation in Southwestern Diabetics - Article


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Insulin

Humulin; Iletin II; Novolin; Velosulin


Clinical Trial: Insulin Treatment Variation in Southwestern Diabetics

This study is not yet open for patient recruitment.
Verified by Department of Veterans Affairs September 2005

Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00148304

Purpose

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
Condition
Diabetes
Insulin
Blood Glucose Monitoring

MedlinePlus related topics:  Diabetes

Study Type: Observational
Study Design: Psychosocial, Cross-Sectional, Defined Population, Retrospective/Prospective Study

Official Title: Insulin Treatment Variation in Southwestern Diabetics - Therapeutic Decision-Making

Further Study Details: 

Expected Total Enrollment:  600

Study start: September 2005;  Expected completion: May 2008
Last follow-up: January 2007

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

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.

Findings:

No results at this time.

Status:

IRB approvals have been received from two of three sites, personnel are being hired, and materials purchased. Provider Nominal Group format has been specified, and a Group Guide completed. A thorough review of the provider decsion-making literature is being performed, and an annotated bibliography completed. A review manuscript is being prepared regarding provider decision-making in regards to insulin prescribing for submission to Diabetes Care and for use in the Provider Groups as background material for Group participants.

Impact:

Obstacles must be overcome to optimize therapy for all patients with T2DM, but especially minority patients, in order to reduce long-term complications of this disease. This study will add to the body of T2DM disease-management knowledge generalizable to veterans in VA care, including variations in care by race and Mexican-American Hispanic ethnicity. Anticipated results include actionable strategies targeted to insulin-prescribing providers and insulin-using patients to better manage outcomes in insulin-u

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both
Criteria

Inclusion Criteria:

Must be in VISN 18 VISTA database T2 Diabetic Using insulin

Exclusion Criteria:

Unwilling to participate

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00148304


Arizona
      Tucson, Tucson,  Arizona,  85723,  United States
Martha J Mohler, PhD MPH   mohlerconsulting@theriver.com 
Martha Jane Mohler, PhD MPH,  Principal Investigator

Study chairs or principal investigators

Martha Jane Mohler, PhD MPH,  Principal Investigator,  Tucson   

More Information

Study ID Numbers:  IIR 04-176
Last Updated:  September 9, 2005
Record first received:  September 2, 2005
ClinicalTrials.gov Identifier:  NCT00148304
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-09-13


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October 6, 2008



Page Updated: September 6, 2005
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