Recruiting

Medication Therapy

Sponsor:

Middle Tennessee Research Institute

Code:

NCT01427218

Conditions

Coronary Heart Disease

Myocardial Infarction

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

Interventions

Titration of medications

Lifestyle Counseling

Medication Counseling

Usual Care with Medication Reconciliation

Study Details

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

Study ID

NCT01427218

Start date

Nov, 2010

Status verified date

Aug, 2011

Completion date

Dec, 2012

Anticipated

Primary completion date

Sep, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 60 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

170 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: 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.

placebo comparator: 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).

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).

Lifestyle Counseling

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

Medication Counseling

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

Usual Care with Medication Reconciliation

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

Primary outcome measure

  • Percentage of patients at guideline goal for both blood pressure and lipids [ Time Frame: 28-32 weeks after enrollment (final study visit) ]

Central Contacts and Locations

Central contacts

Cassandra D Benge, PharmD

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

M. Shawn McFarland, PharmD

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

Locations

VA Tennessee Valley Healthcare System

Recruiting

Nashville, Tennessee, United States, 37212

More Information

Sponsor

Middle Tennessee Research Institute

Last update posted

Sep 1, 2011

Last verified

Aug, 2011

Keywords

  • pharmacist
  • medication therapy management
  • evidence based medicine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Middle Tennessee Research Institute on 2011-09-01.