Blood Pressure-Improving Control Among Alaska Native People" (BP-ICAN)
Blood Pressure-Improving Control Among Alaska Native People" (BP-ICAN)
The investigators have designed a group randomized, multi-level, sustainable stroke and
 cardiovascular disease (CVD) prevention trial - "Blood Pressure: Improving Control among
 Alaska Native People" (BP-ICAN) - that targets blood pressure control among Alaska Native and
 American Indian people diagnosed with hypertension. Washington State University will assist
 with design, provides general scientific and clinical consulting, and will help guide
 implementation and conduct statistical analyses. The purpose of the study is to see if
 monitoring blood pressure at home improves the management of hypertension.

 Participants will include adults who have a diagnosis of hypertension and have not achieved
 blood pressure control. This study will include both a control arm (treatment as usual) and
 an intervention arm. Primary Care Center (PCC) provider teams and associated panels of Alaska
 Native or American Indian (ANAI) adults will be randomized into the control or intervention
 arm. The investigators will recruit up to 10 ANAI adults per PCC provider for a total of 324
 participants.

 Intervention participants will receive a home blood pressure monitor (HBPM), upload personal
 home blood pressure values into a data mall, and be encouraged to communicate with providers
 and pharmacists about HBPM results using an online electronic health record application,
 telephone, or other existing clinical processes. HBPM measurements for each intervention arm
 participant will be provided to provider teams and integrated pharmacists. Control
 participants will receive care as usual.

 The investigators will collect data from study participants in both the intervention and
 control arms over a 12 month period. Participants will meet with investigators at time of
 consent (baseline), and 3, 6, and 12 months after baseline. At each visit, participants will
 have blood pressure measured using 3 methods (aneroid sphygmomanometer, automated Omron upper
 arm cuff device, and automated Omron wrist cuff device), complete surveys, and have height,
 weight, and arm circumference measured. Clinical and service utilization information will be
 electronically queried with participant consent.

 The investigators will examine whether participants in the intervention arm have better blood
 pressure control at the end of the 12 month period than participants in the control arm.
Background:

 Cardiovascular disease (CVD) and stroke have become leading causes of mortality among ANAI
 people, who experience CVD disparities in incidence, risk factors, and mortality, especially
 for stroke, compared to the general population. From 1994-2003 stroke mortality in ANAIs was
 at least 25% higher than for Whites in Alaska. Over the same period, stroke mortality for
 ANAIs under age 45 increased 400%, but declined in Whites. In addition, the decline in
 age-adjusted CVD mortality observed in recent decades within the general population does not
 extend to ANAIs. Controlling hypertension is a pillar of prevention for CVD and stroke.

 Although ANAIs were formerly thought to have a very low prevalence of stroke and CVD, more
 reliable newer data indicate high levels of hypertension and associated mortality. A recent
 systematic review of 141 publications on hypertension in ANAI people documented a significant
 increase in recorded prevalence over the past 3 decades, as well as a significantly higher
 prevalence in ANAI adults than in reference populations, usually White. Aggregated data from
 the Behavioral Risk Factor Surveillance System (BRFSS) also show a higher prevalence of
 self-reported hypertension in ANAIs than in non-Hispanic Whites (27% vs. 22%). The National
 Health Interview Survey found a similar disparity of 35% vs 26% in ANAIs vs. Whites. As in
 non-Hispanic Whites, 61% of ANAIs with hypertension were taking anti-hypertensive medication.
 In a previous study, an investigator on the present proposal examined the health records of
 524 ANAI elders, finding that 23% had undiagnosed hypertension, and 38% had diagnosed
 hypertension. Of those with diagnoses, 81% were taking medication, 37% had well-controlled
 blood pressure (BP), and lifestyle counseling was rare.

 Ongoing management of high BP often requires healthcare providers to initiate or intensify
 therapy in response to uncontrolled high BP. A recent review concluded that the
 patient/provider relationship, patient/provider communication, and patient-centered decision
 making were essential to appropriate decisions on medication change. Another study using
 electronic health record (EHR) data on military veterans found that ~60% of patients with
 hypertension had poorly controlled systolic BP, yet less than half of clinicians made
 medication changes after a computer-generated notification.

 Improving BP control requires the involvement not only of individuals but of healthcare
 systems and social environments. Communications must extend care to patients "where patients
 are" outside the clinic; facilitate BP self-management; and minimize barriers to care AN/AIs
 face in healthcare access. Across Alaska, 60% of residents are medically underserved, and in
 75% of Alaskan communities, regardless of residents' race, comprehensive healthcare services
 are accessible only by air or water. Even in urban areas, health disparities among AN/AIs
 persist, and access to care is affected by factors such as lack of transportation.

 CVD morbidity, mortality, and organ damage are more accurately predicted by home blood
 pressure monitoring (HBPM) than by in-office measurements. HBPM avoids over-treating sporadic
 high BP readings and "white coat" hypertension while facilitating control of both resistant
 and "masked" hypertension (high at home and normal in the clinic), which are associated with
 stroke. Compared to usual care or HBPM alone, HBPM combined with self-titration of
 medications or with physician, pharmacist, or nurse management leads to better use of
 medications and BP control. Research shows the value of using HBPM values to trigger
 modifications in anti-hypertensive regimens, and the addition of provider feedback, patient
 and provider education, and decision-making support to encourage treatment adjustments
 improves control even more. HBPM can support patient decision making, provide data to
 providers, facilitate patient/provider communication, and engage, educate, and empower
 patients. HBPM devices are widely accepted by patients, who prefer them to clinic-based
 measurements. HBPM interventions appear to be most effective in patients with less
 well-controlled BP at baseline. Therefore, tailored HBPM interventions have been developed
 for minorities, who may receive more benefit from HBPM than Whites.

 Significance:

 BP-ICAN is innovative in many ways. First, it will be the only rigorous, population-based
 study about BP control for prevention of CVD and stroke in ANs, and one of very few
 multilevel interventions in any minority population. Second, the South Central Foundation
 (SCF) service area includes rural, suburban, and urban locations. Third, the intervention
 design addresses therapeutic inertia, a well-recognized barrier to hypertension control that
 is often neglected in clinical trials, so the approach to improve self-efficacy and ownership
 should lead to more timely communication with providers and titration of medications.

 The investigators will conduct a group-randomized trial for improving BP control among ANAI
 adults with diagnosed hypertension (Figure 2). Study group assignment will occur by
 randomizing all SCF primary care panels to the BP-ICAN or usual care control arms; adults
 with uncontrolled hypertension will be nested within groups defined by panel, which
 corresponds to one provider. For each panel, investigators will recruit up to 10 ANAI adults
 (expecting average of 8-9 per provider, for a total n = 324) who have had systolic BP ≥ 130
 mmHg measured at one or more clinic visits in the past 18 months OR who have previously
 diagnosed hypertension and systolic BP ≥ 130 mmHg measured at the study screening visit. The
 study period for all participants will last 12 months.

 Participants who are randomized to the BP-ICAN arm will receive education about BP control,
 CVD and stroke and the importance of hypertension management for prevention, other lifestyle
 changes that can prevent or reduce morbidity from hypertension, and educational materials
 about the importance of timely response to uncontrolled hypertension. BP-ICAN arm
 participants will also receive HBPM equipment (Omron device) and training in its use,
 interpretation of results, and assistance with communicating high BP values to healthcare
 providers. Lastly, participants will receive culturally tailored text messages to reinforce
 the educational material and motivate adherence to HBPM and provider communication
 strategies. Participants whose providers have been randomized to the control condition will
 continue to receive care as usual.

 Patient-initiated communication about uncontrolled BP will serve as one component of the
 provider-level intervention. Participants will be trained to sync HBPM and smart phone to
 automatically upload BP measurements into a data repository using Omron's free wellness
 application. This will update the participant's data on Omron's Wellness Application website.
 Investigators plan to use a cloud-based technology platform to serve as a data repository and
 are working with tribal leadership, institutional privacy officers, compliance officers, and
 providers on how data will displayed and stored within the health care system. The goal is to
 make aggregate BP measure data available to providers in either a personal health record
 (PHR) and/or health information exchange (HIE) that allows for transmission of select
 measures into the electronic health and or population health record. Note that this protocol
 was developed based on extensive collaboration with SCF providers.

 At the individual level, the primary outcome is within-person change in systolic BP.
 Secondary outcomes are diastolic BP, anti-hypertensive medication use and adherence, physical
 activity, weight, and tobacco use. Individual-level outcomes will be measured at baseline, 3
 months, 6 months, and 1 year post-baseline. At the provider level, the primary outcome is
 change in prescribing behavior for medication and other relevant lifestyle changes. At the
 systems level, the primary outcome is change in systolic BP for all adults with hypertension
 whose providers are randomized to the BP-ICAN arm vs. the care as usual arm, regardless of
 whether the adults were directly enrolled into the study.
Inclusion Criteria:

 1. At least one visit to SCF providers or Community Health Aides within the previous year

 2. Alaska Native or American Indian

 3. At least 18 years old

 4. Hypertension diagnosis based on International Classification of Disease (ICD) version
 9 and/or ICD version10 codes

 5. Systolic BP ≥ 130 mmHg recorded at 1 or more clinic visits in the past 18 months, OR
 systolic BP ≥ 130 mmHg at the study screening visit

 6. Ability to provide informed consent

 7. Willingness and ability to use a HBPM

 8. Willingness to complete the necessary data collection procedures, including
 transmission of BP measurements and permission for study staff to access EHR and/or
 PHR data.

 Exclusion Criteria:

 1. Currently pregnant