Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00426231
Status:
COMPLETED
Last Update Posted:
2014-02-24
First Post:
2007-01-23
Brief Title:
Culturally-Tailored Approach to Improve Medication Use in Patients With Heart Attacks
Sponsor:
Johns Hopkins University
Organization:
Johns Hopkins University
Study Overview
Official Title:
Culturally-Tailored Hospital-based Model to Improve Statin Use and Outcomes in Patients With Coronary Disease
Status:
COMPLETED
Status Verified Date:
2014-01
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:
Our research aims to improve the use of medicines known to prevent recurrent heart attacks In particular we know that statin treatment is useful after heart attacks but many patients do not use it There are a few possible reasons for this Patients cannot find affordable medicine Their doctor may not prescribe the medicine after they leave the hospital Some people may culturally mistrust using the medicine So they may decide not to take it even if it is prescribed We are developing a hospital based culturally attuned program to target this problem In this program a community health worker counsels and helps patients in accessing pharmacy assistance programs We will test whether this program can improve appropriate statin use
We will enroll patients who have heart attacks We will compare patients who are counseled by the community health worker with those who get the usual care at baseline and at 6 and 12 months participants enrolled during the early phase of the recruitment will have an additional study visit at 24 months We will test if their bad cholesterol levels are controlled We will find out how regularly they have filled their questionnaire and taken the medicine Finally we will test if they are getting benefit from the statin treatment We will do this using blood tests and imaging the patients arteries with ultrasound We will also measure how cost-effective it is for a hospital to run the program
It is our goal to develop a community health worker model that is culturally sensitive for people with cultural educational or educational barriers Statin use is known to benefit patients in theory such a culturally competent program will improve health outcomes in practice After we test it a cost-effective program such as this can be implemented in other hospitals
We will enroll patients who have heart attacks We will compare patients who are counseled by the community health worker with those who get the usual care at baseline and at 6 and 12 months participants enrolled during the early phase of the recruitment will have an additional study visit at 24 months We will test if their bad cholesterol levels are controlled We will find out how regularly they have filled their questionnaire and taken the medicine Finally we will test if they are getting benefit from the statin treatment We will do this using blood tests and imaging the patients arteries with ultrasound We will also measure how cost-effective it is for a hospital to run the program
It is our goal to develop a community health worker model that is culturally sensitive for people with cultural educational or educational barriers Statin use is known to benefit patients in theory such a culturally competent program will improve health outcomes in practice After we test it a cost-effective program such as this can be implemented in other hospitals
Detailed Description:
The lipid-specific and pleiotropic benefits of statin therapy and secondary prevention of coronary artery disease CAD mortality have been demonstrated Statin therapy in particular is underutilized in both white and Black American populations who have CAD and who do not have access to therapy or who cannot afford it Systems factors related to these findings involve a lack of continuous access to medications following hospital discharge for many Black Americans and for white Americans who do not have the ability to readily afford their medicines or who do not have the educational background to understand the importance of therapy In many cases there is failure by primary care physicians to continue statin therapy after discharge in patients who have poor access to therapy or who do not comply with pharmacotherapy Patient factors include mistrust and volitional nonadherence related to beliefs and personal priorities and a lack of education and support related to preventive therapy
This trial will thus take place in lower income and lower educational level Black and white American patients identified at the time of hospitalization and will continue for two years after a myocardial infarction coronary artery bypass graft or percutaneous intervention The overall hypothesis is that a quality of care intervention delivered to Black and white American patients with lower incomes and or education by a culturally competent community health worker CHW within an existing hospital system will result in improved outcomes The CHW will counsel patients and help them access resources including Maryland and private pharmacy assistance programs The specific aims are to compare the impact of a hospital-based CHW intervention versus usual care UC on 1 the percent who achieve LDL cholesterol goals 2 adherence to the statin regimen and 3 health outcomes including inflammatory markers and vascular function at 6 and 12 months after hospitalization for the premature CAD event Participants enrolled during the early phase of the recruitment will have an additional study visit at 24 months We will determine the cost of achieving the LDL-C goal in each group Outcome measures include patient adherence pill counts modified Hill-Bone questionnaire lipid parameters hs-CRP and brachial artery reactivity as a marker of endothelial function
Intention to treat analyses will be used Multivariable adjusted analysis using generalized linear models or generalized estimating equations will be used to determine the independent effect of the interventions after adjusting for covariates A sample size of 68 subjects per group can detect hypothesized differences in the proportion of participants meeting goal levels of LDL-C with 92 power as the primary outcome at 1 years This proposal will demonstrate the effectiveness of a potentially generalizable model of culturally competent care that will improve the use of statin therapy and its health outcomes in Black and white Americans with documented CAD and poor access to statin pharmacotherapy
This trial will thus take place in lower income and lower educational level Black and white American patients identified at the time of hospitalization and will continue for two years after a myocardial infarction coronary artery bypass graft or percutaneous intervention The overall hypothesis is that a quality of care intervention delivered to Black and white American patients with lower incomes and or education by a culturally competent community health worker CHW within an existing hospital system will result in improved outcomes The CHW will counsel patients and help them access resources including Maryland and private pharmacy assistance programs The specific aims are to compare the impact of a hospital-based CHW intervention versus usual care UC on 1 the percent who achieve LDL cholesterol goals 2 adherence to the statin regimen and 3 health outcomes including inflammatory markers and vascular function at 6 and 12 months after hospitalization for the premature CAD event Participants enrolled during the early phase of the recruitment will have an additional study visit at 24 months We will determine the cost of achieving the LDL-C goal in each group Outcome measures include patient adherence pill counts modified Hill-Bone questionnaire lipid parameters hs-CRP and brachial artery reactivity as a marker of endothelial function
Intention to treat analyses will be used Multivariable adjusted analysis using generalized linear models or generalized estimating equations will be used to determine the independent effect of the interventions after adjusting for covariates A sample size of 68 subjects per group can detect hypothesized differences in the proportion of participants meeting goal levels of LDL-C with 92 power as the primary outcome at 1 years This proposal will demonstrate the effectiveness of a potentially generalizable model of culturally competent care that will improve the use of statin therapy and its health outcomes in Black and white Americans with documented CAD and poor access to statin pharmacotherapy
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 |
|---|---|---|---|
| AHA 0670015N | None | None | None |