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. Author manuscript; available in PMC: 2017 Sep 1.
Published in final edited form as: Contemp Clin Trials. 2016 Jul 12;50:5–15. doi: 10.1016/j.cct.2016.07.009

Table 2.

Inclusion and Exclusion Criteria

Inclusion Criteria
Inclusion Criteria Determined by Initial Review of the VA Electronic Health Record
  • Age ≥ 18 years

  • Assigned PCP in one of the clinics of the Durham VAMC (including CBOCs).

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

  • Diagnosis of hypertension requiring medication, as determined by:
    • International Classification of Disease Ninth Revision (ICD-9) 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 ≥ 150mmHg for non-diabetic or ≥ 140mmHg for diabetic patients over the last year. If additional patients need to be approached to be offered the opportunity for further screening, non-diabetic patients with mean outpatient systolic BP of ≥ 140mmHg or diabetic patients with mean outpatient systolic BP of ≥ 130mmHg over the past year may be approached. Systolic BP cutoffs are based on the Seventh Report of the Joint National Commission on Prevention, Detection, Evaluation and Treatment of High Blood Pressure (JNC 7).17 Initial screening BP levels were inflated because of evidence that patients frequently have lower study baseline BPs than would be expected based on the mean of clinic BP results over the last year.51

Inclusion Criteria Determined during the Initial Screening Phone Call
  • Has a VA or affiliated clinic provider that they consider to be their main PCP.

  • Receives the majority of healthcare at the Durham VAMC (or affiliated clinic).

Exclusion Criteria
Exclusion Criteria Determined by Initial Review of the VA Electronic Health Record by Chart Review
  • 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.

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

  • Chronic obstructive pulmonary disease (COPD) requiring oxygen.

  • Resident in nursing home or receiving home healthcare.

  • Patient is pregnant.

  • At the time of potential enrollment, participating in another ongoing hypertension, diabetes, cholesterol, or cardiovascular disease (CVD) clinical trial or patient-level hypertension and/or CVD related quality improvement management program that the study investigators consider likely to be a co-intervention.

Exclusion Criteria Determined during the Initial Screening Phone Call
  • Refusal or inability to consent to an in-person baseline visit.

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

  • Inability or unwillingness to come to the Durham VAMC for baseline-, 6-, 12-, and 18-month study visits

  • Does not have reasonable access to a telephone.

  • Does not speak English.

  • Resident in nursing home or receiving home healthcare.

  • 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).

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

  • Patient reports currently receiving dialysis (may or may not be at the VA).

  • Type 1 diabetes, as reported by the patient.

  • Patient indicates she is pregnant or planning to become pregnant in the next two years.

  • Patients with class IV CHF, dialysis-requiring renal disease, and type 1 diabetes have blood pressure and/or blood sugar management that are beyond the scope of a primary care pharmacist. Exclusion of patients with COPD requiring oxygen and class IV CHF is done (similar to our exclusion of patients with metastatic cancer) to keep patients with end-stage or near end-stage illness out of the study, both because their life expectancies minimize the importance of hypertension control.

Exclusion Criteria Determined during the Baseline In-Person Visit
  • Refusal or inability to provide informed consent and HIPAA authorization form.

  • Arm size > 50 cm in circumference

  • 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).5254

  • Patients who report that they are pregnant or have the potential to become pregnant during the study.

BP - blood pressure; CBOC - community-based outpatient clinic; CVD - cardiovascular disease; PCP - primary care provider; VAMC - Veterans Affairs Medical Center