Titrated Disease Management for Patients With Hypertension

Project Objectives: The investigators are conducting a two-arm 18-month randomized clinical
trial for patients with pharmaceutically treated hypertension for which systolic BP is not
controlled (>/=140 mmHg for non-diabetic or >/=130 mmHg for diabetic patients). The primary
aim will be to compare two treatment arms/strategies in terms of impact on systolic BP
control: Arm 1 - An intervention arm using titrated disease management in which patients'
hypertension control, assessed at baseline, 6 and 12 months, will be used to decide the
resource intensity of strategies: 1) Medium/level 1 resource intensity strategy: a registered
nurse will provide monthly tailored behavioral support telephone calls + home BP monitoring;
2) High/level 2 resource intensity strategy: a pharmacist will provide monthly tailored
behavioral support telephone calls + home BP monitoring + pharmacist-directed medication
management; and 3) Booster (low) resource intensity strategy: a license practice nurse (LPN)
will provide bi-monthly, non-tailored behavioral support telephone calls to patients whose
systolic BP comes under control. Arm 2 - A control arm, in which an LPN will provide
bi-monthly non-tailored behavioral support telephone calls (same procedures as the booster
(low) resource intensity strategy component of the titrated intervention).

Inclusion Criteria:

- Age >= 18 years.

- Assigned primary care provider in one of the clinics of the Durham VA Medical Center
(VAMC) (including Community Based Outpatient Clinics for example - Hillandale Clinic
and Greenville (CBOC)).

- Had at least 1 primary care visit at the Durham VA or affiliated CBOC in the last
year.

- Diagnosis of hypertension requiring medication, as determined by: ICD 401.0, 401.1, or
401.9 for >= 2 outpatient encounters during the prior year and Received a prescription
for at least 1 of the following classes of hypertensive medication in the previous
year: 1) ACE inhibitors; 2) alpha blockers; 3) angiogenesis II inhibitors; 4) beta
blockers; 5) calcium channel blockers; 6) diuretics; 7) antihypertensive combination;
and/or 8) antihypertensives, other.

- Out of control systolic blood pressure: Durham VAMC (including CBOCs or other
affiliated clinics captured in the Durham VAMC electronic health record) outpatient BP
measurements >= 150 mmHg for non-diabetic or >= 140 mmHg for diabetic patients over
the last year and last systolic BP measurement >= 140 mmHg for non-diabetic or >= 130
mmHg for diabetic patients. If additional patients need to be approached to be offered
the opportunity for further screening, non-diabetic patients with mean outpatient
systolic BP of >= 140 mmHg or diabetic patients with mean outpatient systolic BP of >=
130 mmHg over the past year may be approached.

Patients must indicate that they both:

- Have a VA or affiliated clinic provider that they consider to be their main PCP.

- Receive the majority of healthcare at the Durham VA Medical Center (or affiliated
clinic - such as Hillandale or Greenville).

Exclusion Criteria:

- Active diagnosis of psychosis.

- Diagnosis of metastatic cancer.

- Type 1 diabetes

- Class IV congestive heart failure (CHF).

- Currently receiving kidney dialysis or if estimated glomerular filtration rate (eGFR)
levels are <= 15.

- Chronic obstructive pulmonary disease (COPD) requiring oxygen.

- Resident in nursing home or receiving home healthcare.

- Patient is pregnant or reports planning to become pregnant in the next two years

- At the time of potential enrollment, participating in another ongoing hypertension,
diabetes, cholesterol, or cardiovascular disease clinical trial.

- Planning to leave the area prior to the anticipated end of participation.

- Inability or unwillingness to come to the Durham VAMC or affiliated clinic such as
Hillandale or Greenville for baseline-, 6-, 12-, and 18-month study visits.

- Does not have reasonable access to a telephone.

- Does not speak English.

- Severely impaired hearing or speech (Patients must be able to respond to phone
calls.).

- Severely impaired vision (Patients must be able to read mailed material).

- Refusal or inability to provide informed consent and HIPAA authorization form.

- Arm size > 50 cm

- Unable to obtain (including by arm) valid blood pressure readings

- Inadequate mental status to complete the protocol, as judged by five or more errors on
the Short Portable Mental Status Questionnaire (SPMSQ).

- Former, current or pending solid organ or bone marrow transplant patient.