Coronary ArteriosclerosisNCT00426231
Culturally-Tailored Approach to Improve Medication Use in Patients With Heart Attacks
A study testing Navigation by a health worker in people with Coronary Arteriosclerosis and Myocardial Infarction, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Coronary Arteriosclerosis, Myocardial Infarction
- What is being tested?
- Navigation by a health worker
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Dec 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted to Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center
- Diagnoses of Myocardial Infarction, unstable angina, percutaneous intervention, coronary artery bypass surgery
- One of the following:
- Less than a high school education (defined as completion of the 12th grade)
- No insurance for medications with a household income of $50,000. or less
- Any difficulty in co-pay even with a household income of >$50,000.
Who cannot join
- physician contraindicates statin use
- chronic glucocorticosteroid therapy
- autoimmune disease (i.e. lupus erythematosus)
- current chemotherapy or radiation
- immediate life-threatening comorbidity (i.e. HIV-AIDS, end-stage renal disease, or cancer)
- history of hepatic or renal failure
Show all 11Show fewer
- myositis with creatine kinase (CK) elevations
- any prior adverse response to statin therapy
- statin allergy
- rhabdomyolysis
- pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Culturally-Tailored Hospital-based Model to Improve Statin Use and Outcomes in Patients With Coronary Disease
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.
Read the 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.
- Conditions
- Coronary Arteriosclerosis, Myocardial Infarction
- Being tested
- Navigation by a health worker, Information control
- Keywords
- Randomized Controlled Trials, Health Education, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Patient Nonadherence
- Medical subject headings
- Coronary Artery Disease, Myocardial Infarction, Health Education, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navigation by a health workerBehavioural
Help provided by health worker to navigate medication access programs
Information controlBehavioural
Also called Enhanced usual care
Information about medication access programs provided to the participant and their healthcare provider
| Study group | Role | What they receive |
|---|---|---|
| Patient Navigator intervention | Experimental | Patient Navigator intervention Receives: Behavioral: Navigation by a health worker |
| Information control | Active comparator | Information control Receives: Behavioral: Information control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Achievement of LDL-cholesterol Goals
Achieving the goal of an LDL cholesterol level of < 100 mg/dL. For intention to treat analysis the randomization visit status is carried forward if data are missing for the 6-month follow-up visit.
Measured: 6 months
Secondary outcomes (1)
Self-reported Medication Adherence
Only individuals with 6-month follow-up data were included in this analysis
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2007 (estimated)
- Study startMar 2006
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary ArteriosclerosisStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dhananjay Vaidya, Johns Hopkins University
- Investigators
- Dhananjay Vaidya, MBBS PhD MPH, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00426231
- Sponsor's protocol ID
- NA_00001948
- Other IDs
- AHA 0670015N
- Status last verified
- Jan 2014
- First submitted
- 23 Jan 2007
- Last updated
- 24 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally-Tailored Hospital-based Model to Improve Statin Use and Outcomes in Patients With Coronary Disease
- ClinicalTrials.gov ID
- NCT00426231
- Acronym / sponsor ID
- NA_00001948
- Conditions
- Coronary Arteriosclerosis, Myocardial Infarction
- Keywords
- Randomized Controlled Trials, Health Education, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Patient Nonadherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 24 Jan 2007 (estimated)
- Results
- Posted 24 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Navigator intervention | Experimental | Behavioral: Navigation by a health workerPatient Navigator intervention |
| Information control | Active comparator | Behavioral: Information controlInformation control |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Admitted to Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center
- Diagnoses of Myocardial Infarction, unstable angina, percutaneous intervention, coronary artery bypass surgery
- One of the following:
Key exclusion criteria (11 listed)
- physician contraindicates statin use
- chronic glucocorticosteroid therapy
- autoimmune disease (i.e. lupus erythematosus)
- current chemotherapy or radiation
- immediate life-threatening comorbidity (i.e. HIV-AIDS, end-stage renal disease, or cancer)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Navigation by a health workerHelp provided by health worker to navigate medication access programs | Behavioural | Patient Navigator intervention |
| Information controlAlso: Enhanced usual careInformation about medication access programs provided to the participant and their healthcare provider | Behavioural | Information control |
Primary outcome
Achievement of LDL-cholesterol Goals
Time frame: 6 months
Achieving the goal of an LDL cholesterol level of < 100 mg/dL. For intention to treat analysis the randomization visit status is carried forward if data are missing for the 6-month follow-up visit.
1 secondary outcome
Self-reported Medication Adherence
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dhananjay Vaidya, MBBS PhD MPH principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Navigation by a health worker in people with Coronary Arteriosclerosis and Myocardial Infarction, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Achievement of LDL-cholesterol Goals (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2014.