Insulin Treatment Variation in Southwestern Diabetics
| Tracking Information | |||||
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| First Received Date ICMJE | September 2, 2005 | ||||
| Last Updated Date | April 18, 2013 | ||||
| Start Date ICMJE | September 2005 | ||||
| Primary Completion Date | August 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
diabetes self-care/attitudes [ Time Frame: single survey ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00148304 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Insulin Treatment Variation in Southwestern Diabetics | ||||
| Official Title ICMJE | Insulin Treatment Variation in Southwestern Diabetics - Therapeutic Decision-making | ||||
| 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. |
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| 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. 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | insulin-using diabetics in VISN 18 |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Group 1 | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 1248 | ||||
| Completion Date | June 2008 | ||||
| Primary Completion Date | August 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: - Unwilling to participate |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00148304 | ||||
| Other Study ID Numbers ICMJE | IIR 04-176 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Department of Veterans Affairs | ||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Department of Veterans Affairs | ||||
| Verification Date | December 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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