Improving Cardiovascular Treatment Approaches Among Minorities
Recruitment status was Active, not recruiting
|First Received Date ICMJE||January 10, 2005|
|Last Updated Date||April 10, 2009|
|Start Date ICMJE||September 2004|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00101478 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Improving Cardiovascular Treatment Approaches Among Minorities|
|Official Title ICMJE||Partnership Programs to Reduce Cardiovascular Disparities - Baltimore Partnership|
The purpose of this study is to improve cardiovascular disease (CVD) outcomes in racial and ethnic minorities. Specifically, the study will aim to improve provider and patient approaches to treatment of hypertension and diabetes, respectively.
While there has been great progress in reducing CVD morbidity and mortality in the U.S. over the past 40 years, some minority groups have not shared fully in this progress and continue to have lower life expectancy and higher CVD morbidity. On average, minorities have less access to medical care, receive less aggressive care and fewer diagnostic and therapeutic cardiac procedures, and adhere poorly to prescribed medical regimens. Thus, research to reduce health disparities by improving CVD outcomes in minorities offers potential for a substantial positive public heath impact. Academic medical centers and institutions capable of carrying out such research, however, often lack access to and the trust of minority patients. Minority patients often receive fragmented care because they lack access to regular medical care, present to emergency departments rather than primary care physicians for complications of an advanced chronic CVD condition, and are less likely to follow medical regimens. Minority communities often harbor distrust of clinical research. Minority patients report greater satisfaction when receiving care from minority providers and are reluctant to receive treatment outside their minority healthcare serving systems.
In general, minorities have high rates of hypertension, elevated cholesterol, cigarette smoking, obesity, metabolic syndrome, and diabetes, as well as other behavioral, environmental, and occupational risk factors for cardiovascular diseases, such as sleep problems. These are all elements that contribute to excess CVD morbidity and mortality. The causes of minority health disparities are complex and incompletely understood. Although evidence of genetic, biologic, and environmental factors is well documented, poor outcomes are also attributed to under-treatment. Such under-treatment may be due to limited access to health care or, in some cases, break-down of the medical system, or failure of the physician and/or patient to allow for optimal health care, even when access is not impaired. The complex interactions of behavior, socio-economic status (SES), culture, and ethnicity are important predictors of health outcomes and sources of health disparities. Despite efforts to elucidate genetic and environmental risk factors and to promote cardiovascular health in high-risk populations, trends in CVD outcomes suggest that CVD health disparities continue to widen.
The Partnerships Program to Reduce Cardiovascular Health Disparities involves collaboration between minority healthcare serving systems (MSSs) that lack a strong research program and research-intensive medical centers (RIMCs) that have a track record of NIH-supported research and patient care. Each Partnership Program will: a) design and carry out multiple interdisciplinary research projects that investigate complex biological, behavioral, and societal factors that contribute to CVD health disparities and facilitate clinical research within the MSS to improve CVD outcomes and reduce health disparities, and b) provide reciprocal educational and skills development programs so that investigators are able to conduct research aimed at reducing cardiovascular disparities, thereby enhancing research opportunities and enriching cultural sensitivity and cardiovascular research capabilities at both institutions.
The Request for Applications for Partnership Programs to Reduce Cardiovascular Disparities was released in September 2003. The awards were made in September 2004.
The collaborative partnership between the Bon Secours Baltimore Health System (BSBHS) and the University of Maryland Baltimore (UMB) seeks to improve provider and patient approaches to treatment of hypertension and diabetes, respectively. UMB also aims to modify physician-related barriers to minority enrollment in clinical trials, and BSBHS to improve patient adherence to treatment plans. Through didactic training, UMB aims to build a sustainable research program at BSBHS; through cultural sensitivity training, BSBHS expects to enhance the disparities program at UMB. The relative impact of physician and/or patient interventions for controlling hypertension and diabetes will be assessed. This will be a hypothesis-testing, prospective study, with an experimental 2 X 2 factorial design; it will be a four-arm randomized controlled trial. Outcomes will include adherence and improved knowledge/awareness of guidelines (of patients and their physicians), as well as patient clinical and quality of life measures. The study will be powered for the proportion of patients who attain the set goal. There will be a target enrollment of 800 patients (400 each for hypertension and diabetes), to afford 80% (up to 90%) power and allow for 25% attrition. Logistic regression will be used for the probability of reaching goal, multiple linear regression will be used for relative changes in mmHg (hypertension) and HbAlc (diabetes), and survival analysis will be used to model time to reach goal. Measurements will be taken of improved adherence of diabetes patients as a result of BSBHS actively identifying access barriers. Measurements will also be taken of changes in the willingness of patients to enroll in clinical trials as a result of physician-targeted education. The study seeks to demonstrate a best practice model, based on a collaborative partnership, and build a self-sustained research program at BSBHS and an enhanced cardiovascular disparities program at UMB. Community entities will have full access to resources at both institutions, which in turn will have access to invaluable input and support from community groups.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Observational Model: Case Control|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Probability Sample|
The study groups will be selected from primary and family health clinics, community, and patients of physicians participating in the study.
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Active, not recruiting|
|Estimated Enrollment ICMJE||800|
|Completion Date||August 2009|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00101478|
|Other Study ID Numbers ICMJE||1283, U01 HL79151|
|Has Data Monitoring Committee||Yes|
|Responsible Party||Elijah Saunders, MD, University of Maryland School of Medicine|
|Study Sponsor ICMJE||National Heart, Lung, and Blood Institute (NHLBI)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Heart, Lung, and Blood Institute (NHLBI)|
|Verification Date||April 2009|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP