Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00148304
Status:
COMPLETED
Last Update Posted:
2016-06-06
First Post:
2005-09-02
Brief Title:
Insulin Treatment Variation in Southwestern Diabetics
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Insulin Treatment Variation in Southwestern Diabetics - Therapeutic Decision-making
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 patientprovider 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 racialethnic 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 patientprovider relationship issues and possible reasons for racialethnic 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 raciallyethnically 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 OBrien and Dillman
Status Completed
Objectives The goal of this mixed methods descriptive cross-sectional study is to elucidate the patient provider and interactive patientprovider 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 racialethnic 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 patientprovider relationship issues and possible reasons for racialethnic 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 raciallyethnically 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 OBrien and Dillman
Status Completed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None