Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00383110
Status:
COMPLETED
Last Update Posted:
2015-04-28
First Post:
2006-09-28
Brief Title:
RacialEthnic Differences in TrustMistrust and Its Effect on Diabetes Outcomes
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
RacialEthnic Differences in TrustMistrust and Its Effect on Diabetes Outcomes
Status:
COMPLETED
Status Verified Date:
2014-06
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:
1 Determine racialethnic 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
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:
BackgroundSignificance 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 racialethnic 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 peoples 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 racialethnic 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 Raceethnicity 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 6961 patients with Type 2 Diabetes at this site of which 491 3417 are White Americans 315 2189 are Black Americans and 194 1355 are Hispanic or other Approximately 975 are men and 90 are aged 50 years or older
Sample size calculation
Specific Aim 1 Sample Power V20 SPSS was used for sample size calculation based on the convention outlined by Cohen6 Overall experiment wise error was held to 005 and power to 80 using medium 025 effect sizes Correction for multiplicity of tests 2 tests for primary hypotheses involved using 0025 0052 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 trustmistrust 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 trustmistrust on acceptance of the influenza vaccine controlling for covariates STATA V80 will be used for data analysis and all tests will be two-tailed with overall p005 for each hypothesis
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 racialethnic 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 peoples 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 racialethnic 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 Raceethnicity 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 6961 patients with Type 2 Diabetes at this site of which 491 3417 are White Americans 315 2189 are Black Americans and 194 1355 are Hispanic or other Approximately 975 are men and 90 are aged 50 years or older
Sample size calculation
Specific Aim 1 Sample Power V20 SPSS was used for sample size calculation based on the convention outlined by Cohen6 Overall experiment wise error was held to 005 and power to 80 using medium 025 effect sizes Correction for multiplicity of tests 2 tests for primary hypotheses involved using 0025 0052 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 trustmistrust 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 trustmistrust on acceptance of the influenza vaccine controlling for covariates STATA V80 will be used for data analysis and all tests will be two-tailed with overall p005 for each hypothesis
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HR11259 | OTHER | MUSCVA IRB | None |