CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 140 enrolled
Drug / intervention
Navigation by a health worker +1 morebehavioral
Likely dose
Not stated in record
Key inclusion· 3
  • Admitted to Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center
  • Diagnosis of myocardial infarction, unstable angina, percutaneous coronary intervention, or coronary artery bypass surgery
  • Less than high school education (completion of 12th grade) OR no medication insurance with household income ≤$50,000 OR any difficulty with copay even with household income >$50,000
Key exclusion· 10
  • Physician contraindicates statin use
  • Chronic glucocorticosteroid therapy
  • Autoimmune disease (e.g., lupus erythematosus)
  • Current chemotherapy or radiation

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00426231
NCT00426231N/ACompleted

Culturally-Tailored Hospital-based Model to Improve Statin Use and Outcomes in Patients With Coronary Disease

Johns Hopkins University·interventional·Posted Jan 24, 2007·Updated Feb 24, 2014

In Brief

A clinical study evaluating Navigation by a health worker and Information control for Coronary Arteriosclerosis and Myocardial Infarction. Completed, enrolled 140 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 24, 2007
Enrollment StartMar 1, 2006
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 19.4 years ago

Interventions

Navigation by a health workerbehavioral

Help provided by health worker to navigate medication access programs

Information controlbehavioral

Information about medication access programs provided to the participant and their healthcare provider