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

6 de abril de 2015 atualizado por: US Department of Veterans Affairs
  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

Visão geral do estudo

Status

Concluído

Condições

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Real)

300

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

    • South Carolina
      • Charleston, South Carolina, Estados Unidos, 29401-5799
        • Ralph H. Johnson VA Medical Center, Charleston, SC

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

equal number of White and Black Americans over the age of 18 with Type II diabetes

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Group 1
Adults (age 18 or older) with type 2 diabetes.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
General Trust in Physicians Scale (GTIPS)
Prazo: 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.
12 months following enrollment
Health Care System Distrust Scale
Prazo: 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.
12 months after enrollment

Medidas de resultados secundários

Medida de resultado
Prazo
Hemoglobin A1c
Prazo: 12 months after enrollment
12 months after enrollment
Systolic Blood Pressure
Prazo: 12-months after enrollment
12-months after enrollment
Diastolic Blood Pressure
Prazo: 12-months after enrollment
12-months after enrollment
LDL-cholesterol
Prazo: 12-months after enrollment
12-months after enrollment

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Leonard E. Egede, MD MS, Ralph H. Johnson VA Medical Center, Charleston, SC

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de novembro de 2004

Conclusão Primária (Real)

1 de janeiro de 2009

Conclusão do estudo (Real)

1 de janeiro de 2009

Datas de inscrição no estudo

Enviado pela primeira vez

28 de setembro de 2006

Enviado pela primeira vez que atendeu aos critérios de CQ

28 de setembro de 2006

Primeira postagem (Estimativa)

2 de outubro de 2006

Atualizações de registro de estudo

Última Atualização Postada (Estimativa)

28 de abril de 2015

Última atualização enviada que atendeu aos critérios de controle de qualidade

6 de abril de 2015

Última verificação

1 de junho de 2014

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • LIP 82-001
  • HR#11259 (Outro identificador: MUSC/VA IRB)

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