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NCT Number: NCT06391073

Reach Out 2: Emergency Department-Initiated Hypertension Mobile Health Intervention Connecting Multiple Health Systems

Emergency department visits provide an opportunity to identify people with undiagnosed, untreated, or uncontrolled high blood pressure. In Reach Out, we will test whether a mobile health intervention yields a greater reduction in blood pressure than usual care among individuals identified with high blood pressure during a safety-net emergency department visit. Subsequently, we will estimate the reduction in heart attack, stroke, and dementia if Reach Out were implemented across all U.S. safety-net emergency departments.

Recruiting

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hurley Medical Center

Flint, Michigan, 48503, United States

Location status: Recruiting

Location contact

Rockefeller Oteng, MD

CONTACT

About this study

Hypertension is the most important modifiable risk factor for cardiovascular disease. Black Americans have the highest prevalence of hypertension and the lowest rates of blood pressure (BP) control of any racial or ethnic group in the U.S., contributing to cardiovascular disease disparities. Low-income Americans are also disproportionally burdened by hypertension. To achieve health equity, new approaches to hypertension management leveraging safety-net healthcare systems to reach underserved populations are needed.

One approach to addressing the hypertension epidemic is to identify and treat people undiagnosed, untreated, or with undertreated hypertension - people who have fallen through the cracks in the healthcare system. We did this in Reach Out 1 (R01MD011516), a mobile health (mHealth) 8-arm factorial trial of hypertensive patients recruited from a safety-net ED. Overall, systolic BP declined by 9.2 mmHg (95% CI -12.2 to - 6.3) after 6 months, without differences across treatment arms. Reach Out 1 successfully enrolled a hypertensive, medically underserved population into a mHealth intervention. Despite a very large reduction in BP overall, the efficacy of the Reach Out mHealth intervention is uncertain, given the lack of a control group.

Reach Out 2 proposes to test the most promising components of Reach Out 1 in a randomized open, blinded-endpoint (PROBE) controlled trial. Reach Out 2, continues our work with the same safety-net ED and Federally Qualified Health Centers. In Reach Out 2, we will compare usual care, to 6-months of prompted self-monitored blood pressure (SMBP) monitoring with tailored feedback and facilitated primary care appointment and transportation. The usual care group will receive instructions to follow up with a primary care provider after ED discharge. After 6 months, the intervention participants will enter an extended treatment period of long-term SMBP monitoring. To contextualize our findings, we will use our chronic disease agent-based simulation model to estimate the reduction in myocardial infarction, stroke, and dementia if Reach Out 2 were to be implemented in safety-net EDs across the US. The overarching goal of our proposal is to determine whether a low-tech mHealth intervention will reduce BP more than usual care among patients recruited from a safety-net ED and to understand the potential national impact of such an intervention. Because safety-net EDs are anchor institutions that care for large populations of medically underserved hypertensive people, mHealth strategies initiated here have tremendous potential to reduce cardiovascular inequities. To reach this potential, evidence based interventions to reduce BP must be identified (aim 1), long-term engagement evaluated (aim 2), and their impact understood (aim 3).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

While in the ED, the patient must meet all of the following:

  • Adult (≥18 y/o)
  • At least one BP with Systolic BP ≥160 or a Diastolic BP ≥100 (criteria 1)
  • If the patient has repeated measurements after achieving Criteria 1, at least one of the repeat BP remains systolic BP ≥140 or a diastolic BP ≥90
  • Must have cell phones with text-messaging capability
  • Likely to be discharged from the ED

Exclusion criteria

for Main Trial Participants:

  • Critical illness
  • Unable to read English (<1% at study site)
  • Incarcerated
  • Pregnant
  • Pre-existing condition making 6-month follow-up unlikely

Treatment and study plan

Self-Measured Blood Pressure Monitoring

Behavioral

Prompted SMBP with tailored feedback

Physician appointment and transportation scheduling

Behavioral

Physician appointment and transportation scheduling or none dependent on current BP control

Primary outcomes

  1. Change in systolic blood pressure

    Time frame: 6 month

    Change in 6-month Systolic Blood Pressure (SBP)

Secondary outcomes

  1. Change in diastolic blood pressure

    Time frame: 6 month

    Change in 6-month Diastolic Blood Pressure (DBP)

  2. BP Control (130/80mmHg)

    Time frame: 6 month

    Proportion of participants with controlled BP at 6-months. BP control is defined as BP less than 130/80 mmHg.

Other outcomes

  1. BP Control (140/90mmHg)

    Time frame: 6 month

    Proportion of participants with controlled BP at 6-months. BP control defined as BP less than 140/90

  2. Initiation of antihypertensive medication

    Time frame: 6 month

  3. Change in antihypertensive medication

    Time frame: 6 month

  4. Establishment of primary care

    Time frame: 6 month

    Time from ED visit to arrival at first primary care visit

  5. Participant adherence with self-measured blood pressure monitoring

    Time frame: 6 month

    Proportion of BPs received after a BP prompt

Study contacts

Contact information is provided by the study sponsor or research team.

Lesli Skolarus, MD, MS

CONTACT

[email protected]

312-503-0644

William Meurer, MD

CONTACT

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Ohio State University
  • University of Michigan

Registry information

Official study title

Reach Out 2: Randomized Clinical Trial of Emergency Department-Initiated Hypertension Mobile Health Intervention Connecting Multiple Health Systems

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Apr 30, 2024
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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