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Table 1 Comparison of pragmatic design elements in Hyperlink 1 and Hyperlink 3

From: Comparison of explanatory and pragmatic design choices in a cluster-randomized hypertension trial: effects on enrollment, participant characteristics, and adherence

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

  1. Abbreviations: MTM Medication therapy management, BP blood pressure, EHR electronic health record, DM diabetes mellitus, CKD chronic kidney disease, MI myocardial infarction, PCP primary care professional, SBP systolic blood pressure