Design element | Hyperlink 1 | Hyperlink 3 |
---|---|---|
Patients enrolled | 450 | 3071 |
Setting | 16 primary care clinics with • MTM pharmacists | 21 primary care clinics with • MTM pharmacists • Automated BP monitors |
Recruitment period | Mar 2, 2009–Apr 29, 2011 | Nov. 15, 2017–Apr 16, 2019 |
Recruitment method | Mailings, telephone screening, and final determination of BP eligibility, informed consent, and enrollment at research clinic | Automated EHR algorithm for screening at primary care encounters, prompted staff and PCPs to complete follow-up orders for enrollment |
Eligibility | Age 21 or older 2 most recent ERH BPs >140/90 Ave of 3 research clinic BPs • >140/90 or • >130/80 if DM or CKD Major exclusions: • Pregnancy • Recent MI or stroke • Stage 4/5 CKD • Stage 3/4 heart failure | Age 18–85 2 most recent EHR BPs >150/95 Hypertension diagnosis PCP visit in last 12 months Major exclusions: • Pregnancy • Stage 5 CKD • Hospice • Nursing home resident |
Comparator name | Usual care | Best practice clinic-based care |
Intervention name | Telemonitoring, pharmacist care management | Telehealth care |
Organization (expertise and resources needed to deliver interventions) | For usual care, no additional expertise or resources; for telemonitoring, 8 h of pharmacist training, telemonitors paid for by study funds | For clinic-based care, no additional expertise or resources; for telehealth, 3.5 h of pharmacist training, telemonitors paid for by health system |
Flexibility of delivery | For usual care, very flexible; for telemonitoring, pharmacists followed protocol in addition to collaborative practice agreement | For clinic-based care, very flexible except initial follow-up recommended with medical assistant; for telehealth care, pharmacists followed protocol allowing more individualized care |
Flexibility of adherence | For usual care, routine attention to adherence; for telemonitoring, patients assisted with appointments and pharmacist encouraged adherence to intervention. | For clinic-based care, routine assistance with initial appointment; for telehealth care, routine assistance with initial appointment, but pharmacist encouraged adherence to intervention. |
Follow-up and data collection | Research clinic at 0, 6, 12, and 18 months for all participants to measure BP and administer surveys | No research clinic visits BP data extracted from routine visits in EHR, surveys for data not in EHR |
Primary outcome | BP control at 6 and 12 months | Change in SBP from baseline to 12 months |
Primary analysis | Intention-to-treat | Intention-to-treat |