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Clinical Trials/NCT00383110
NCT00383110CompletedNot Applicable

Racial/Ethnic Differences in Trust/Mistrust and Its Effect on Diabetes Outcomes

US Department of Veterans Affairs1 site in 1 country300 target enrollmentStarted: November 2004Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
300
Locations
1
Primary Endpoint
Health Care System Distrust Scale

Study Overview

Brief Summary

  1. Determine racial/ethnic differences in trust in physicians and mistrust of the health care system among veterans with Type 2 Diabetes.
  2. Determine the predictive power of trust in physicians and mistrust of the health care system on personal health practices and health outcomes in a prospective cohort of veterans with Type 2 Diabetes

Detailed Description

Background/Significance: Diabetes mellitus is a chronic and progressive disease that causes significant morbidity and mortality and increases health care utilization and costs in both Veteran Administration (VA) and non-VA settings. 1. Diabetes and its complications are more prevalent in minority populations. Black Americans have two-fold increased age adjusted rates of diabetes, are more likely to develop and experience greater disability from diabetes complications compared to White Americans. 1. Black Americans with diabetes have higher rates of retinopathy, end-stage renal disease, lower limb amputations, and overall death rates. 2. Therefore, diabetes is a significant public health problem and Black American patients have disproportionately higher morbidity and mortality than their White American counterparts.

Several factors have been postulated to explain the disproportionately higher morbidity and mortality from diabetes in Black Americans and these include their mistrust of the health care system. 3. It is thought that distrustful patients are less likely to seek routine medical care, take prescribed medications consistently, adhere to treatments recommendations, and maintain continuity with health care providers and health care systems. 4. Recent studies show that Black Americans are less trusting of physicians and the health care system. 5. However, little is known about the association between trust and diabetes outcomes and whether distrust of physicians and the health care system contributes to the observed racial/ethnic differences in diabetes outcomes.

Theoretical Framework: The conceptual and theoretical framework of this study is the revised behavioral model of health services use (Andersen 1974, 1968, 1983, 1995). The model posits that people's use of health services is a function of their predisposition to use services, factors that enable or impede use, and their need for care (Andersen 1995). Trust in physicians and the health system falls under health beliefs (attitudes toward health services), which is one of the predisposing factors that is thought to predict health services utilization and health outcomes. Thus, people with high levels of trust in physicians and the health care system are expected to have more effective access, appropriate health utilization, and better health outcomes. The model has been revised to include veteran-specific variables such as level of service entitlement, period of service, duration in the VA system, and disability status and to measure both health services use and health outcomes.

Research Design and Methods: This is a prospective cohort study with five hypotheses organized under their specific aims as follows:

Specific Aim #1: Determine racial/ethnic differences in trust in physicians and mistrust of the health care system among veterans with Type 2 Diabetes.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients for this study will be recruited from the Ralph H. Johnson VAMC in Charleston, South Carolina.
  • American veterans aged 18 years and older with Type 2 Diabetes will be recruited.

Exclusion Criteria

  • Children will not be included as this study pertains to type 2 diabetes, which is not a disease of children.
  • Non-English speaking patients are excluded to eliminate bias in the response to questionnaires because these questionnaires have only been validated in English speaking patients.
  • We decided to exclude cognitively impaired individuals because of the complexity of the survey instruments.

Outcomes

Primary Outcomes

Health Care System Distrust Scale

Time Frame: 12 months after enrollment

Health Care System Distrust Scale is a valid and reliable 10-item measure of distrust of the health care system, measuring honesty confidentiality and confidence. All questions are measured on a Likert scale, with scores ranging from a minimum of 10 to a maximum of 50. Higher scores indicate more distrust in the health care system.

General Trust in Physicians Scale (GTIPS)

Time Frame: 12 months following enrollment

The GTIPS is a valid and reliable 11-item measure of general trust in physicians in the domains of dependability, confidence, and confidentiality of information. All items are fashioned in a 5-point Likert format with a minimum score of 11 and maximum of 55. Higher scores indicate more trust in physicians.

Secondary Outcomes

  • LDL-cholesterol(12-months after enrollment)
  • Diastolic Blood Pressure(12-months after enrollment)
  • Hemoglobin A1c(12 months after enrollment)
  • Systolic Blood Pressure(12-months after enrollment)

Investigators

Sponsor Class
Fed
Responsible Party
Sponsor

Study Sites (1)

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