Reach Out: Emergency Department-Initiated Hypertension Behavioral Intervention Connecting Multiple Health Systems

Hypertension is the most important modifiable risk factor for cardiovascular disease, the
leading cause of mortality in the United States. African Americans have the highest
prevalence of hypertension of any race/ethnic group in the United States which largely
contributes to their increased burden of stroke compared to non-Hispanic whites. In addition,
uncontrolled hypertension is more common among socioeconomically disadvantaged populations
than their counterparts. To improve health equity, new approaches to hypertension treatment
focusing on health care systems and difficult-to-reach populations are needed.

The Emergency Department (ED) represents a missed opportunity to identify and treat
hypertension in difficult-to-reach populations. Currently, there are 136 million ED visits
per year and nearly all have at least one blood pressure measured and recorded. African
Americans and socioeconomically disadvantaged patients are disproportionally represented in
the ED patient population and both are increasing. In the age of electronic health records
and mobile health, the ED can feasibly become an integral partner in chronic disease
management by programming the electronic health record to identify hypertensive patients and
dispense a mobile health behavioral intervention. Facilitating ED follow up at primary care
clinics is a key feature of the proposed intervention. Thereby leveraging the strengths of
the ED and its large patient volume of uncontrolled, difficult-to-reach, hypertensive
patients, with the strengths of the primary care clinics, continuity of care is the key to
improving community wide utilization of health services and receipt of guideline concordant
medical care.

This study looks to determine which behavioral intervention components best contribute to a
reduction in systolic blood pressure at one year through a multi-component theory based
mobile health behavioral intervention.

Sample Size and Population

The investigators plan to enroll approximately 960 patients into the eligibility phase. From
this group, it is estimated that 480 subjects will report qualifying BPs and will be
randomized to one of the eight intervention arms. Reach Out anticipates 240 subjects will
fully complete the 12 month, in person follow up visits.

Data Analysis

The primary analysis will fit a linear regression model with the outcome of SBP change
(baseline minus 12 months) and main effect-coded binary predictors of healthy behavior texts
(yes vs. no), prompted BP self-monitoring frequency (high vs. low), and primary care provider
visit scheduling and transportation (active vs. passive). Initial analyses will focus on the
main effects. Additional analyses will include all the two-way interactions of the three
intervention components (only considering interactions where at least one of the factors in
the interaction demonstrates a sufficiently large main effect).

The main secondary analyses will use time-to event (Cox Proportional Hazards) and logistic
regression. For the endpoint of interest, (either time to first primary care visit, or the
binary variable indicating attendance at two or more primary care visits within 1 year of
randomization), the investigators will fit an adjusted regression model.

Inclusion Criteria:

- Age of 18 or greater

- At least one BP with Systolic Blood Pressure (SBP) ≥ 160 or a Diastolic Blood Pressure
(DBP) ≥ 100 (criteria 1)

- If the patient has repeated measurements after achieving Criteria 1, at least one of
the repeat BP remains SBP ≥ 140 or a DBP ≥ 90

- Must have cell phones with text-messaging capability and willingness to receive texts

- Likely to be discharged from the ED

Exclusion Criteria:

- Unable to read English (<1% at study site)

- Prisoners

- Pregnant

- Pre-existing condition making one year follow-up unlikely

- Terminal illness with death expected within 90 days

- Current use of 3 or more antihypertensive agents

- Patients with other serious medical conditions that prevent self-monitoring of BP

- Critical illness with placement in resuscitation bay

- Dementia/cognitive impairment