Monitoring and Adjustment of Medication Therapy for Patients With Heart Disease

NCT01427218 | Unknown

• 1 other identifier: 2010100590
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Heart Disease; Myocardial Infarction

Keywords

pharmacist; medication therapy management; evidence based medicine

Outcome Measures

Primary Outcomes (1)

• 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).

  28-32 weeks after enrollment (final study visit)

Secondary Outcomes (3)

• Composite cardiovascular morbidity and all-cause mortality

  6-9 weeks and 28-32 weeks after enrollment

• Patient Satisfaction with Clinical Pharmacist Services

  28-32 weeks

• Change in Adherence with 8-item Morisky Adherence Tool

  6-9 weeks and 28-32 weeks

Study Arms (2)

Medication Therapy Management (MTM)

EXPERIMENTAL

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

Usual Care

PLACEBO COMPARATOR

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

Interventions

Titration of medications 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).

Also known as: Medication Therapy Management

Medication Therapy Management (MTM)

Lifestyle Counseling BEHAVIORAL

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

Also known as: Medication Therapy Management

Medication Therapy Management (MTM)

Medication Counseling BEHAVIORAL

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

Also known as: Medication Therapy Management

Medication Therapy Management (MTM)

Usual Care with Medication Reconciliation OTHER

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

Also known as: Usual Physician Care

Usual Care

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Middle Tennessee Research Institute: lead
• American Society of Health-System Pharmacists Research and Education Foundation: collaborator

Study Sites (1)

VA Tennessee Valley Healthcare System

Nashville, Tennessee, 37212, United States

RECRUITING

MeSH Terms

Conditions

Coronary Disease; Myocardial Infarction

Interventions

Medication Therapy Management; Medication Reconciliation

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Pharmaceutical Services; Health Services; Health Care Facilities Workforce and Services; Medicare Part D; Insurance, Pharmaceutical Services; Insurance, Health; Insurance; Financing, Organized; Economics; Health Care Economics and Organizations; Medicare; Patient Care Management; Health Services Administration; Medication Errors; Drug Therapy; Therapeutics; Medical Errors; Medication Systems; Organization and Administration

Study Officials

• James AS Muldowney, III, MD

  VA Tennessee Valley Healthcare System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cassandra D Benge, PharmD

CONTACT

615-873-6019; cassandra.benge2@va.gov

M. Shawn McFarland, PharmD

CONTACT

615-867-6000; michael.mcfarland2@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine, Vanderbilt Univ. School of Med

Study Record Dates

• First Submitted: January 14, 2011
• First Posted: September 1, 2011
• Study Start: November 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: September 1, 2011

Record last verified: 2011-08

Locations

US (1)