Monitoring and Adjustment of Medication Therapy for Patients With Heart Disease (MUMPS)

Middle Tennessee Research Institute

Status: Unknown

Conditions: Coronary Heart Disease; Myocardial Infarction

Treatments: Other: Usual Care with Medication Reconciliation; Behavioral: Lifestyle Counseling; Behavioral: Medication Counseling; Other: Titration of medications

Study type: Interventional

Funder types: Other

Identifiers

NCT01427218

2010100590

Details and patient eligibility

About

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.

Full 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.

Enrollment: 170 estimated patients

Sex: All

Ages: 60 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

All patients with a diagnosis of ACS at the VA Tennessee Valley Healthcare System who

1. are greater than or equal to 60 years of age

2. 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.

3. are enrolled or will be enrolled in outpatient cardiovascular services at the VA Tennessee Valley Healthcare System

Exclusion criteria

Patients who

1. are transferred to a long-term care facility or skilled nursing facility
2. are assigned to another Veterans Health Administration medical center,
3. have a discharge primary or secondary discharge diagnosis code for dementia, schizophrenia, or organic brain syndrome,
4. cannot speak or understand English or give written informed consent,
5. are enrolled in hospice or palliative care
6. are participating in another trial that prohibits participation in this trial
7. have a baseline LDL> 200mg/dL in proximity to admission suggestive of familial hypercholesterolemia (FH) or a known diagnosis of FH
8. require clonidine or minoxidil for blood pressure control prior to the index admission
9. are enrolled in the Nashville preventative cardiovascular clinic for hypertension
10. have a urinary drug screen positive for cocaine in the last 12 months
11. have plans to move in the next 6 months

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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170 participants in 2 patient groups, including a placebo group

Medication Therapy Management (MTM)

Experimental group

Description:

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.

Treatment:

Other: Titration of medications

Behavioral: Medication Counseling

Behavioral: Lifestyle Counseling

Usual Care

Placebo Comparator group

Description:

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).

Treatment:

Other: Usual Care with Medication Reconciliation