Monitoring and Adjustment of Medication Therapy for Patients With Heart Disease
- Conditions
- Coronary Heart DiseaseMyocardial Infarction
- Interventions
- Other: Titration of medicationsOther: Usual Care with Medication ReconciliationBehavioral: Lifestyle CounselingBehavioral: Medication Counseling
- Registration Number
- NCT01427218
- Lead Sponsor
- Middle Tennessee Research Institute
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 170
All patients with a diagnosis of ACS at the VA Tennessee Valley Healthcare System who
-
are greater than or equal to 60 years of age
-
will benefit from Medication Therapy Management (MTM):
- Have a baseline LDL >79mg/dL in the first 24 hours of acute coronary syndrome (ACS) OR if LDL not assessed in the first 24 hours of ACS, have a recent LDL >79mg/dL (in the last 15 months) OR not have an LDL assessed prior to or during admission.
AND
- Have outpatient blood pressures (BP) above goal on 65% or more of assessments within the last 15 months or a SBP >140mmHg or DBP>90mmHg or both on the last outpatient BP assessment.
-
are enrolled or will be enrolled in outpatient cardiovascular services at the VA Tennessee Valley Healthcare System
Patients who
- are transferred to a long-term care facility or skilled nursing facility
- are assigned to another Veterans Health Administration medical center,
- have a discharge primary or secondary discharge diagnosis code for dementia, schizophrenia, or organic brain syndrome,
- cannot speak or understand English or give written informed consent,
- are enrolled in hospice or palliative care
- are participating in another trial that prohibits participation in this trial
- have a baseline LDL> 200mg/dL in proximity to admission suggestive of familial hypercholesterolemia (FH) or a known diagnosis of FH
- require clonidine or minoxidil for blood pressure control prior to the index admission
- are enrolled in the Nashville preventative cardiovascular clinic for hypertension
- have a urinary drug screen positive for cocaine in the last 12 months
- have plans to move in the next 6 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Medication Therapy Management (MTM) Titration of medications 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. Medication Therapy Management (MTM) Lifestyle Counseling 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. Medication Therapy Management (MTM) Medication Counseling 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. Usual Care Usual Care with Medication Reconciliation 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).
- Primary Outcome Measures
Name Time Method Percentage of patients at guideline goal for both blood pressure and lipids 28-32 weeks after enrollment (final study visit) 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).
- Secondary Outcome Measures
Name Time Method Composite cardiovascular morbidity and all-cause mortality 6-9 weeks and 28-32 weeks after enrollment A between group comparison of all cause mortality or VA cardiovascular readmission.
Patient Satisfaction with Clinical Pharmacist Services 28-32 weeks A descriptive analysis to assess patients' feelings about the pharmacist being involved in their CHD care
Change in Adherence with 8-item Morisky Adherence Tool 6-9 weeks and 28-32 weeks A within group comparison of the adherence score to determine if the relationship with the pharmacist may assist with (subjective) adherence with antihypertensive therapy.
Trial Locations
- Locations (1)
VA Tennessee Valley Healthcare System
🇺🇸Nashville, Tennessee, United States