Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00101478
Status:
COMPLETED
Last Update Posted:
2021-05-11
First Post:
2005-01-10
Brief Title:
Improving Cardiovascular Treatment Approaches Among Minorities
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Partnership Programs to Reduce Cardiovascular Disparities - Baltimore Partnership
Status:
COMPLETED
Status Verified Date:
2021-05
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:
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
Detailed Description:
BACKGROUND
While there has been great progress in reducing CVD morbidity and mortality in the US 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 andor 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
DESIGN NARRATIVE
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 andor 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 knowledgeawareness 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
While there has been great progress in reducing CVD morbidity and mortality in the US 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 andor 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
DESIGN NARRATIVE
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 andor 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 knowledgeawareness 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 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 |
|---|---|---|---|
| U01HL079151 | NIH | None | httpsreporternihgovquickSearchU01HL079151 |