Please select the eligibility criteria that correspond to the clinical trial below.
Title: Trial of Low And High Intensity Strategies to Maintain Blood Pressure Control
Brief Summary: The long-range goal of this research is to advance understanding of long-term blood pressure (BP) control in patients with uncontrolled hypertension (HTN). The work builds on our experience in implementing new models of care in Veterans Affairs (VA) and non-VA settings, including three National Institute of Health (NIH) studies of pharmacist-based HTN management. The long-term effectiveness of such models, especially in veterans, is unknown. Thus, the primary goal of this study is to evaluate how to sustain long-term BP control in veterans with HTN following a 6-month intensive pharmacist intervention.

This study will enroll veterans with uncontrolled HTN into a 6-month intensive pharmacist-based intervention. Following this initial intervention, participants will be randomized to continued intervention or a one-time patient and provider education intervention. BP will be compared in the two groups over a 2-year follow-up period. The intervention to control and sustain BP will follow VA guidelines and include: 1) comprehensive medication assessment by the pharmacist; 2) an explicit plan to intensify treatment if indicated; 3) strategies to improve adherence; and 4) follow-up pharmacist visits to sustain BP control. The intervention is based on models identified in a recent Agency for Healthcare Research and Quality (AHRQ) report as being the most potent strategies to improve BP. The study will benefit from a strong research team with expertise in guideline development, implementation science, quality measurement, and behavioral science. The study will also provide important information on the degree to which BP control deteriorates after patients are referred back to usual care. The specific aims and related hypotheses of the study are to:

Aim 1:Compare BP control in patients randomized to long-term continuation of the pharmacist intervention or to a less intense one-time patient and provider education intervention.

Hypothesis 1a: Patients randomized to the continued pharmacist intervention will have higher rates of BP control 24 months after randomization.

Hypothesis 1b: Patients randomized to the continued pharmacist intervention will have lower mean BP 24 months after randomization.

Aim 2: Compare antihypertensive medication intensification in patients randomized to the continued pharmacist intervention or the less intense intervention.

Hypothesis 2: A higher proportion of patients who continued the pharmacist intervention will have medication intensification over the 24-month follow-up.

Aim 3: Compare medication adherence in the two intervention groups. Hypothesis 3a: Medication adherence will be higher in patients randomized to the continued pharmacist intervention group during the 24 month follow-up period.

Hypothesis 3b: Improvements in medication adherence will be associated with improvements in BP during each study interval.


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:

* Male or Female over 18 years of age
* Type 2 diabetes for at least 6 months
* Taking 1 or more oral hypoglycemic agents
* Patient attending your community pharmacy where you decided that addition of insulin glargine may be of benefit to the patient
* Baseline HbA1c 7.5 - 11%
* Signed informed consent

Exclusion Criteria:

* Have used, or currently using, Insulin
* History of ketoacidosis
* Pregnant
* Works night shift
* Renal impairment(Serum Creatinine: females ≥ 124 mmol/l, males ≥ 133 mmol/l)
* Clinically unstable
* Unwilling/unable to attend follow up visits
* Unlikely to adhere to study procedures (eg. due to cognitive limitations, severe psychiatric disorder or alcoholism)
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:

* Patients with last recorded blood pressure greater or equal to the British Hypertension Society audit standard

Exclusion Criteria:

* Secondary hypertension
* Housebound
* Non-English speaking
* Another major illness likely to dominate pattern of care e.g. advanced cancer, dementia

Answer: A