An interventional study of Titration of medications and Lifestyle Counseling in Coronary Heart Disease and Myocardial Infarction, sponsored by Middle Tennessee Research Institute. Status unknown at 1 site in United States. Open to participants aged 60 Years to 90 Years. Per ClinicalTrials.gov, last updated 2011-09-01.
Sponsored by Middle Tennessee Research Institute · Not applicable, Interventional, and Health services research
Existing trials for the patient with coronary heart disease evaluate the interdisciplinary team dynamic where pharmacists (pharmacotherapists) provide therapeutic recommendations in the inpatient environment. To our knowledge, only other trial has evaluated the addition of a pharmacist (or nurse practitioner) in an outpatient collaborative cardiology practice and has found no benefit. However, the investigators believe that since a cardiology based pharmacist (pharmacotherapist) in the Veterans Health Administration has physical assessment skills, a shorter cycle length between appointments, and the ability to provide medication therapy management, the pharmacotherapist should be similarly successful as seen with other pharmacist based medication therapy management practices. The investigators will assess effectiveness by using the combined endpoint of blood pressure and lipid treatment. Additionally the investigators will conduct three substudies to evaluate if the pharmacist can improve all cause mortality and cardiovascular morbidity, adherence to antihypertensives, and patient satisfaction.
Existing trials for the patient with coronary heart disease evaluate the interdisciplinary team dynamic where pharmacists (pharmacotherapists) provide therapeutic recommendations in the inpatient environment. To our knowledge, only other trial has evaluated the addition of a pharmacist (or nurse practitioner) in an outpatient collaborative cardiology practice and has found no benefit. However, the investigators believe that since a cardiology based pharmacist (pharmacotherapist) in the Veterans Health Administration has physical assessment skills, a shorter cycle length between appointments, and the ability to provide medication therapy management, the pharmacotherapist should be similarly successful as seen with other pharmacist based medication therapy management practices. The investigators will assess effectiveness by using the combined endpoint of blood pressure and lipid treatment. Additionally the investigators will conduct three substudies to evaluate if the pharmacist can improve all cause mortality and cardiovascular morbidity, adherence to antihypertensives, and patient satisfaction.
This is a randomized study comparing the use of a medication therapy management clinic improves cardiac risk factors and recurrent hospitalization in patients admitted with an acute coronary syndrome.
100 subjects will be enrolled as a minimum. Patients will be randomized to usual care or enrollment in the MTM clinic where they will be seen every two months for 8 months.
The primary endpoint is blood pressure and lipid changes. Secondary endpoints include satisfaction with pharmacists, medication habit changes, recurrent events.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's planned enrollment of 170 is above the median of 100 across 1,779 interventional studies indexed under Heart Diseases.
Browse Heart Diseases studies →Middle Tennessee Research Institute is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients with a diagnosis of ACS at the VA Tennessee Valley Healthcare System who
will benefit from Medication Therapy Management (MTM):
AND
Exclusion Criteria:
Patients who
Medication Therapy Management visits with a pharmacotherapist will occur at a minimum of 6-9 weeks, 20-24 weeks, and 28-32 weeks. Additional interim face to face and telephonic visits may be scheduled based on patient's progress with meeting treatment goals and need for follow-up physical assessment and laboratory analysis.
Other: Titration of medications · Behavioral: Lifestyle Counseling · Behavioral: Medication Counseling
Visits with a pharmacotherapist to create an accurate list of medications for those patients randomized to placebo (who receive usual care by their cardiologist and primary care provider).
Other: Usual Care with Medication Reconciliation
Titration of medications for cholesterol, blood pressure, heart failure, and angina will occur. Cholesterol medications will be titrated according to labs at intervals nor more frequently than every 6 weeks until target LDL reached. Blood pressure (BP) medications will be titrated no more frequently than every 1-2 weeks until target BP reached. Heart failure medications will be titrated no more frequently than every 1-2 weeks until target doses reached or clinical status goals achieved. Anginal (chest pain) medications will be titrated no more frequently than every 1-2 weeks until control of chest pain occurs. Some patients will require more titrations than other patients (titration is patient specific).
Also known as: Medication Therapy Management
The pharmacist will provide counseling on diet modification, smoking cessation, and physical activity
Also known as: Medication Therapy Management
The pharmacist will counsel the patient on adherence aids and medication safety and efficacy self and clinical monitoring.
Also known as: Medication Therapy Management
A medication history and assessment of adherence will be completed by the pharmacist.
Also known as: Usual Physician Care
Percentage of patients at guideline goal for both blood pressure and lipids
The Primary endpoint is the percentage of patients in each group who have BOTH their lipids AND their BP controlled within guideline specifications at the end of the study in order to determine if the clinic improves control of BOTH of these risk factors. (e.g. on the final study visit, 75% in the intervention arm and 50% in the control arm have controlled lipids AND blood pressure, given the I/E criteria, both groups start out at 0% at entry).
Time frame: 28-32 weeks after enrollment (final study visit)
Composite cardiovascular morbidity and all-cause mortality
A between group comparison of all cause mortality or VA cardiovascular readmission.
Time frame: 6-9 weeks and 28-32 weeks after enrollment
Patient Satisfaction with Clinical Pharmacist Services
A descriptive analysis to assess patients' feelings about the pharmacist being involved in their CHD care
Time frame: 28-32 weeks
Change in Adherence with 8-item Morisky Adherence Tool
A within group comparison of the adherence score to determine if the relationship with the pharmacist may assist with (subjective) adherence with antihypertensive therapy.
Time frame: 6-9 weeks and 28-32 weeks
This study is status unknown, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.
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Middle Tennessee Research Institute