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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00383110
Enrollment
300
Registered
2006-10-02
Start date
2004-11-30
Completion date
2009-01-31
Last updated
2015-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Keywords

Diabetes, Health Outcomes, Racial Preference, Clinical Trial, Ethnic Differences

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. Hypothesis #1: There is a difference in mean scores on the general trust in physician scale (GTIPS) between White and Black American veterans with Type 2 diabetes. Hypothesis #2: There is a difference in mean scores on the Health Care System Distrust Scale between White and Black American veterans with Type 2 diabetes. Specific Aim #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 Hypothesis #1: Controlling for predisposing, enabling, need, and veteran-specific factors, diabetic veterans with lower trust scores or higher mistrust scores will be less likely to keep office appointments, take prescribed medications, and adhere to diabetes self-management recommendations after 12 months of follow-up. Hypothesis #2: Controlling for predisposing, enabling, need, and veteran-specific factors, diabetic veterans with lower trust scores or higher mistrust scores will have higher mean hemoglobin A1C, blood pressure, and LDL cholesterol levels after 12 months of follow-up. Hypothesis #3: Controlling for predisposing, enabling, need, and veteran-specific factors, diabetic veterans with lower trust scores or higher mistrust scores will be less likely to accept influenza vaccination after 12 months of follow-up. Study site & Subjects: Patients will be recruited from the Charleston VAMC. Equal number of White and Black American veterans aged 18 years and older with Type 2 Diabetes will be recruited. Race/ethnicity will be based on self-report. The diagnosis of type 2 Diabetes as well as health utilization and diabetes-specific health outcomes will be obtained from the VA electronic medical records system (CPRS). There are approximately 6,961 patients with Type 2 Diabetes at this site, of which 49.1% (3,417) are White Americans, 31.5% (2,189) are Black Americans, and 19.4% (1,355) are Hispanic or other. Approximately 97.5% are men and 90% are aged 50 years or older. Sample size calculation: Specific Aim #1: Sample Power V2.0 (SPSS) was used for sample size calculation based on the convention outlined by Cohen6. Overall experiment wise error was held to ?=0.05, and power to 80% using medium (0.25) effect sizes. Correction for multiplicity of tests (2 tests for primary hypotheses) involved using ?=0.025 (0.05/2). This yielded 125 patients per group. In addition, the sample was inflated to account for an estimated 20% attrition at 1 year of follow-up (death, relocation, or loss to follow-up). No more than 150 eligible patients need to be enrolled per group. Thus, 300 patients (150 Whites and 150 African Americans) will be recruited. Specific Aim #2: The sample size determination for a reliable regression equation offered by Stevens7 is 15 subjects per predictor variable. Using this standard, a sample size of 300, as determined above, would allow the inclusion of 20 predictor variables. Because none of the hypotheses for Specific Aim 2 exceed 20 predictor variables, a sample of 300 will be adequate. Survey Instruments: The GTIPS4 is a valid and reliable 11-item measure of general trust in physicians and the Health Care System Distrust Scale is a valid and reliable 10-item measure of mistrust of the health care system. Both instruments have been validated in Black and White Americans. Statistical Analysis Plan: Descriptive statistics will be used to describe the characteristics of participants in the study. Specific Aim #1: Mean scores on the trust and mistrust scales at baseline will be compared between White and Black Americans with the two-sample t-test and similar comparisons will be made while controlling for covariates (predisposing, enabling, need, and veteran-specific factors) using Analysis of Covariance (ANCOVA). Specific Aim #2: Multiple linear regression will be used to test the effect of mean trust/mistrust scores on health utilization and mean hemoglobin A1C, blood pressure, and LDL cholesterol after 12 months of follow-up controlling for covariates. Similarly, multiple logistic regression will be used to test the effect of trust/mistrust on acceptance of the influenza vaccine controlling for covariates. STATA V8.0 will be used for data analysis and all tests will be two-tailed with overall p=0.05 for each hypothesis.

Interventions

None listed

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
General Trust in Physicians Scale (GTIPS)12 months following enrollmentThe 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.
Health Care System Distrust Scale12 months after enrollmentHealth 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.

Secondary

MeasureTime frame
Hemoglobin A1c12 months after enrollment
Systolic Blood Pressure12-months after enrollment
Diastolic Blood Pressure12-months after enrollment
LDL-cholesterol12-months after enrollment

Countries

United States

Participant flow

Recruitment details

Patients were recruited from the Charleston VAMC. Veterans with Type 2 Diabetes identified through the VA electronic medical resources system (CPRS) were consented and enrolled between November 2004 and February 2006.

Participants by arm

ArmCount
White American Veterans
White American adult Veterans (age 18 or older) with type 2 diabetes
150
Black American Veterans
Black American adult Veterans (age 18 or older) with type 2 diabetes
150
Total300

Baseline characteristics

CharacteristicWhite American VeteransBlack American VeteransTotal
Age, Continuous68.11 years
STANDARD_DEVIATION 9.49
63.78 years
STANDARD_DEVIATION 10.84
65.93 years
STANDARD_DEVIATION 10.41
Comorbidity Index1.8 units on a scale
STANDARD_DEVIATION 1.3
2.0 units on a scale
STANDARD_DEVIATION 2.4
1.9 units on a scale
STANDARD_DEVIATION 1.9
Diabetes Duration11.6 years
STANDARD_DEVIATION 11.1
10.0 years
STANDARD_DEVIATION 8
10.8 years
STANDARD_DEVIATION 9.7
Education13.4 years
STANDARD_DEVIATION 2.9
12.3 years
STANDARD_DEVIATION 3.2
12.8 years
STANDARD_DEVIATION 3.1
Gender
Female
2 participants4 participants6 participants
Gender
Male
143 participants142 participants285 participants
Income
< $20,000
46 participants73 participants119 participants
Income
$20,000-$34,999
49 participants32 participants81 participants
Income
$35,000-$49,999
20 participants18 participants38 participants
Income
$50,000-$74,999
14 participants13 participants27 participants
Income
> $75,000
12 participants1 participants13 participants
Marital Status
Married
101 participants84 participants185 participants
Marital Status
Not Married
44 participants64 participants108 participants
Work Status
Disabled
29 participants48 participants77 participants
Work Status
Other
4 participants7 participants11 participants
Work Status
Retired
71 participants50 participants121 participants
Work Status
Working
39 participants34 participants73 participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 1500 / 150
serious
Total, serious adverse events
0 / 1500 / 150

Outcome results

Primary

General Trust in Physicians Scale (GTIPS)

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.

Time frame: 12 months following enrollment

Population: Discrepancies in number of participants analyzed is due to some participants choosing not to answer all questions.

ArmMeasureValue (MEAN)Dispersion
White American VeteransGeneral Trust in Physicians Scale (GTIPS)39.0 units on a scaleStandard Deviation 9.7
Black American VeteransGeneral Trust in Physicians Scale (GTIPS)39.5 units on a scaleStandard Deviation 7.6
p-value: 0.648ANOVA
Primary

Health Care System Distrust Scale

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.

Time frame: 12 months after enrollment

Population: Discrepancies in number of participants analyzed is due to some participants choosing not to answer all questions.

ArmMeasureValue (MEAN)Dispersion
White American VeteransHealth Care System Distrust Scale26.6 units on a scaleStandard Deviation 7.4
Black American VeteransHealth Care System Distrust Scale26.3 units on a scaleStandard Deviation 7.1
p-value: 0.675ANOVA
Secondary

Diastolic Blood Pressure

Time frame: 12-months after enrollment

Population: Discrepancies in number of participants analyzed is due to some participants having no data in their medical record for this measure.

ArmMeasureValue (MEAN)Dispersion
White American VeteransDiastolic Blood Pressure71.1 mmHgStandard Deviation 8.9
Black American VeteransDiastolic Blood Pressure75.9 mmHgStandard Deviation 8.8
p-value: <0.001ANOVA
Secondary

Hemoglobin A1c

Time frame: 12 months after enrollment

Population: Discrepancies in number of participants analyzed is due to some participants having no data in their medical record for this measure.

ArmMeasureValue (MEAN)Dispersion
White American VeteransHemoglobin A1c6.8 % HbA1cStandard Deviation 1.2
Black American VeteransHemoglobin A1c7.1 % HbA1cStandard Deviation 1.4
p-value: 0.14ANOVA
Secondary

LDL-cholesterol

Time frame: 12-months after enrollment

Population: Discrepancies in number of participants analyzed is due to some participants having no data in their medical record for this measure.

ArmMeasureValue (MEAN)Dispersion
White American VeteransLDL-cholesterol86.4 mg/dLStandard Deviation 22.5
Black American VeteransLDL-cholesterol101.2 mg/dLStandard Deviation 27.5
p-value: <0.001ANOVA
Secondary

Systolic Blood Pressure

Time frame: 12-months after enrollment

Population: Discrepancies in number of participants analyzed is due to some participants having no data in their medical record for this measure.

ArmMeasureValue (MEAN)Dispersion
White American VeteransSystolic Blood Pressure131.9 mmHgStandard Deviation 14.6
Black American VeteransSystolic Blood Pressure135.7 mmHgStandard Deviation 14.6
p-value: 0.03ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026