Monitoring and Adjustment of Medication Therapy for Patients With Heart Disease

NCT ID: NCT01427218

Last Updated: 2011-09-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2012-12-31

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.

Conditions

Coronary Heart Disease; Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Medication Therapy Management (MTM)

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.

Group Type: EXPERIMENTAL

Titration of medications

Intervention Type: OTHER

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).

Lifestyle Counseling

Intervention Type: BEHAVIORAL

The pharmacist will provide counseling on diet modification, smoking cessation, and physical activity

Medication Counseling

Intervention Type: BEHAVIORAL

The pharmacist will counsel the patient on adherence aids and medication safety and efficacy self and clinical monitoring.

Usual Care

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).

Group Type: PLACEBO_COMPARATOR

Usual Care with Medication Reconciliation

Intervention Type: OTHER

A medication history and assessment of adherence will be completed by the pharmacist.

Interventions

Titration of medications

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).

Intervention Type: OTHER

Lifestyle Counseling

The pharmacist will provide counseling on diet modification, smoking cessation, and physical activity

Intervention Type: BEHAVIORAL

Medication Counseling

The pharmacist will counsel the patient on adherence aids and medication safety and efficacy self and clinical monitoring.

Intervention Type: BEHAVIORAL

Usual Care with Medication Reconciliation

A medication history and assessment of adherence will be completed by the pharmacist.

Intervention Type: OTHER

Other Intervention Names

Medication Therapy Management; Medication Therapy Management; Medication Therapy Management; Usual Physician Care

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Society of Health-System Pharmacists Research and Education Foundation

OTHER

Sponsor Role: collaborator

Middle Tennessee Research Institute

OTHER

Sponsor Role: lead

Responsible Party

James A S Muldowney, III MD

Assistant Professor of Medicine, Vanderbilt Univ. School of Med

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James AS Muldowney, III, MD

Role: PRINCIPAL_INVESTIGATOR

VA Tennessee Valley Healthcare System

Locations

VA Tennessee Valley Healthcare System

Nashville, Tennessee, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Cassandra D Benge, PharmD

Role: CONTACT

cassandra.benge2@va.gov

615-873-6019

M. Shawn McFarland, PharmD

Role: CONTACT

michael.mcfarland2@va.gov

615-867-6000 ext. 24796

Other Identifiers

2010100590

Identifier Type: -

Identifier Source: org_study_id