Monitoring and Adjustment of Medication Therapy for Patients With Heart Disease
NCT01427218 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170
Last updated 2011-09-01
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
Interventions
- OTHER
-
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).
- BEHAVIORAL
-
Lifestyle Counseling
The pharmacist will provide counseling on diet modification, smoking cessation, and physical activity
- BEHAVIORAL
-
Medication Counseling
The pharmacist will counsel the patient on adherence aids and medication safety and efficacy self and clinical monitoring.
- OTHER
-
Usual Care with Medication Reconciliation
A medication history and assessment of adherence will be completed by the pharmacist.
Sponsors & Collaborators
-
American Society of Health-System Pharmacists Research and Education Foundation
collaborator OTHER -
Middle Tennessee Research Institute
lead OTHER
Principal Investigators
-
James AS Muldowney, III, MD · VA Tennessee Valley Healthcare System
Study Design
- Allocation
- RANDOMIZED
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 60 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-11-30
- Primary Completion
- 2012-09-30
- Completion
- 2012-12-31
Countries
- United States
Study Locations
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