Please select the eligibility criteria that correspond to the clinical trial below.
Title: Patient-Centered Adherence Intervention After ACS Hospitalization
Brief Summary: We propose to test the effectiveness of a multi-faceted patient-centered adherence intervention among veterans following ACS hospitalization to improve adherence to cardioprotective medications (primary aim). Secondary aims will assess whether the intervention improves achievement of secondary prevention blood pressure (BP) and low density lipoprotein (LDL)-cholesterol goals, reduces cardiac endpoints (myocardial infarction ) MI hospitalization, coronary revascularization, all-cause mortality) and is cost-effective.

ANTICIPATED IMPACT(S) : If successful, the proposed intervention will increase adherence to cardioprotective medications (i.e., -blockers, statins, clopidogrel, and ACE inhibitors) by helping veterans take their medications routinely as prescribed, the quality of cardiovascular care for veterans by helping patients achieve BP and LDL goals which have been associated with improved outcomes, and the efficiency of care by using telephone calls and tele-monitoring for communication with patients rather than clinic visits. The findings of the study will address an important gap in knowledge (i.e., how to improve adherence to medications following ACS discharge) and will be generalizable to other VA Medical Centers and veterans.


Options:
A: Inclusion Criteria:

* Diagnosis of Hypertension (HTN) captured by ICD-9-CM codes from prior outpatient visits;
* elevated BP (\>140/90 mmHg among non-diabetics; or \>140/80 mmHg among diabetics) during the most recent VA clinic visit or based on the average from the last 3 visits;
* elevated BP measured by the Research Medical Assistant (MA) at the baseline visit.

Exclusion Criteria:

Patients will be excluded for the following safety reasons:

* prior history or current signs of hypertensive emergency including symptoms of angina, stroke, or acute renal failure;
* severe HTN (systolic BP \>200 or diastolic BP \> 114mm Hg);
* history of acute MI, stroke, or unstable angina in the prior 6 months;
* Congestive Heart Failure (CHF) due to systolic dysfunction with a left ventricular ejection fraction \< 35% documented by echocardiography, nuclear medicine study, or ventriculography;
* renal insufficiency, defined by a glomerular filtration rate less than 30 ml/min or previously documented proteinuria \> 1 gram per day;
* significant hepatic disease, including prior diagnoses of cirrhosis, Hepatitis B or C infection, or laboratory abnormalities (serum ALT or AST \> 2 times control or total bilirubin \> 1.5 mg/dl) in the prior 6 months;
* pregnancy;
* prior diagnoses of pulmonary hypertension or sleep apnea (unless treated by continuous positive pressure ventilation);
* poor prognosis with a life expectancy estimated less than 2 years;
* residence in a nursing home or diagnosis of dementia;
* inability to give informed consent or impaired cognitive function (defined as \> 3 errors on the 10-item Pfeiffer Portable Mental Status Questionnaire, administered during study intake);
* no telephone for follow-up calls.
B: Inclusion Criteria:

* HIV-1 infected
* Current severe CDC Category B AIDS-defining illness (with the exception of a single episode of bacterial sepsis or a single episode of zoster), OR history of a severe CDC Category B or C AIDS-defining illness, OR one CD4 count less than 350 cells/mm3 within 6 months prior to study entry
* Antiretroviral naive. A participant who previously received 6 weeks or less of post-exposure prophylaxis or short course therapy for the prevention of mother-to-child transmission are not excluded. More information on this criterion can be found in the protocol.
* Willing to use acceptable forms of contraception
* Parent or guardian willing to provide informed consent, if applicable

Exclusion Criteria:

* Current newly diagnosed CDC Category C AIDS-defining opportunistic infection or condition requiring acute therapy at the time of study entry. More information on this criterion can be found in the protocol.
* Therapy with agents with significant systemic myelosuppressive, neurotoxic, pancreatotoxic, hepatotoxic, or cytotoxic potential within 30 days prior to study entry
* Require certain medications
* Current alcohol or substance abuse that, in the opinion of the investigator, may interfere with the study
* Uncontrolled diarrhea (more than 6 stools per day for 7 consecutive days) within 30 days prior to study entry
* Diagnosis of or suspected acute hepatitis within 30 days prior to study entry
* Signs or symptoms of bilateral peripheral neuropathy of Grade 2 or greater at screening
* Inability to tolerate oral medication
* Any other clinical condition that, in the opinion of the investigator, may interfere with the study
* In the first trimester of pregnancy
C: Inclusion Criteria:

All patients admitted with acute coronary syndrome (ACS) as the primary reason for hospital admission and use the VA for their usual source of care, defined as having 1 primary care visit within the 12 months prior to hospital admission will be screened for eligibility to participate. ACS is defined as acute myocardial infarction (both ST-elevation MI and non-ST elevation MI) or unstable angina. The presence of acute myocardial infarction will be defined using standard definitions from an international consensus statement, based on the following: a rise and/or fall of cardiac biomarkers (preferably troponin) with at least one value above the 99th percentile of the upper reference limit and at least one of the following:

* symptoms of ischemia;
* ECG change indicative of new ischemia (new ST-T changes or new left bundle branch block);
* development of pathological Q waves in the ECG; or
* imaging evidence of new loss of viable myocardium or new regional wall motion abnormality.42 Unstable angina will be defined by presence of ischemic symptoms and ECG changes indicative of new ischemia but without biomarker evidence of myonecrosis (i.e., biomarker elevation) and no evidence of new pathological Q waves, loss of viable myocardium or regional wall motion abnormality.

Exclusion Criteria:

* Patient admitted for primary non-cardiac diagnosis and develop ACS as a secondary condition (e.g. perioperative MI);
* planned discharge to nursing home or skilled nursing facility;
* irreversible, non-cardiac medical condition (e.g. metastatic cancer) likely to affect 6-month survival or ability to execute study protocol;
* lack of telephone/cell phone;
* VA is not primary source of care;
* regularly fill medications at non-VA pharmacy.
D: Inclusion Criteria:

* Enrolled at Minneapolis VAMC
* Type 1 or 2 diabetes
* Blood pressure at screening visit \> 140mmHg systolic or \> 90mmHg diastolic OR HgbA1C at screening visit \> 9.0% OR LDL at screening visit \> 100mg/dL

Exclusion Criteria:

* Primary care provider unwilling to have participant included in study
* Life expectancy \< 1 year
* Unable to give consent
* Severe mental health condition
* pregnant or planning on becoming pregnant

Answer: C