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

Overview

This study evaluates a health theory based mobile health behavioral intervention to reduce blood pressure (BP) among hypertensive patients evaluated in a community Emergency Department (ED) setting.

Full Title of Study: “Reach Out: Randomized Clinical Trial of Emergency Department-Initiated Hypertension Behavioral Intervention Connecting Multiple Health Systems”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Factorial Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 2021

Detailed Description

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

We originally planned to enroll approximately 960 patients into the eligibility phase. From this group, we estimate that 480 participants will report qualifying BPs and will be randomized to one of the eight intervention arms. We anticipate 240 participants will fully complete the 12 month, in person follow up visits. However, after accruing approximately 400 randomized participants, we noted lower than expected retention at 6 month visits. Therefore, we adjusted the maximum total number of enrollments and randomizations upwards by 50% each. The overall intention is to achieve approximately 240 protocol completers (attendees at 12-month visit). We will continue to monitor accrual and retention in order to achieve this target.

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.

Interventions

  • Behavioral: Healthy Behavior Texts
    • Participants receive motivational health behavior texts
  • Behavioral: No healthy behavior texts
    • Participants do not receive healthy behavior texts
  • Behavioral: BP Monitoring Daily Via Text Messaging
    • Daily text messages will prompt participants for BP by home cuff
  • Behavioral: BP Monitoring Weekly Via Text Messaging
    • Weekly text messages will prompt participants for BP by home cuff
  • Behavioral: Physician appointment and transportation scheduling
    • Participants receive assistance scheduling physician appointment and transportation to those appointments
  • Behavioral: No physician appointment and transportation scheduling
    • Participants do not receive assistance scheduling physician appointment or transportation

Arms, Groups and Cohorts

  • Experimental: Arm 1
    • No healthy behavior texts BP Monitoring Weekly Via Text Messaging No physician appointment and transportation scheduling
  • Experimental: Arm 2
    • Healthy Behavior Texts BP Monitoring Weekly Via Text Messaging No physician appointment and transportation scheduling
  • Experimental: Arm 3
    • No healthy behavior texts BP Monitoring Daily Via Text Messaging No physician appointment and transportation scheduling
  • Experimental: Arm 4
    • Healthy Behavior Texts BP Monitoring Daily Via Text Messaging No physician appointment and transportation scheduling
  • Experimental: Arm 5
    • No healthy behavior texts BP Monitoring Weekly Via Text Messaging Physician appointment and transportation scheduling
  • Experimental: Arm 6
    • Healthy Behavior Texts BP Monitoring Weekly Via Text Messaging Physician appointment and transportation scheduling
  • Experimental: Arm 7
    • No healthy behavior texts BP Monitoring Daily Via Text Messaging Physician appointment and transportation scheduling
  • Experimental: Arm 8
    • Healthy Behavior Texts BP Monitoring Daily Via Text Messaging Physician appointment and transportation scheduling

Clinical Trial Outcome Measures

Primary Measures

  • Change in systolic blood pressure
    • Time Frame: 12 month
    • Change in 12-month Systolic Blood Pressure (SBP) reduction associated with each level of the three intervention components

Secondary Measures

  • Arrival at first primary care visit
    • Time Frame: Baseline ED visit (in days)
    • Time from ED visit to arrival at first primary care visit
  • Attendance at primary care visits
    • Time Frame: 12 months
    • Attendance at two or more primary care visits within 12 months of randomization

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Michigan
  • Collaborator
    • National Institutes of Health (NIH)
  • Provider of Information About this Clinical Study
    • Principal Investigator: William J Meurer, Associate Professor of Emergency Medicine – University of Michigan
  • Overall Official(s)
    • William Meurer, MD, Principal Investigator, University of Michigan
    • Lesli Skolarus, MD, Principal Investigator, University of Michigan
    • Mackenzie Dinh, MS, Study Director, University of Michigan

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