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

Reach Out 2: Randomized Clinical Trial of 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: Self-Measured Blood Pressure Monitoring; Behavioral: Physician appointment and transportation scheduling

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Estimated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lesli Skolarus, MD, MS; Phone Number: 312-503-0644; Email: lesli.skolarus@northwestern.edu
• Study Contact Backup: Name: William Meurer, MD

Study Locations

• United States
  • Michigan
    • Flint, Michigan, United States, 48503
      • Hurley Medical Center
      • Contact: Rockefeller Oteng, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care Group; The usual care group is standard of care. They will receive the standard ED discharge materials available as recommended by their ED physician. These materials recommend lifestyle changes, dietary changes, medication as directed, and follow-up with a PCP as directed.
Experimental: REACH OUT; REACH OUT messaging is based on BP control. Control is defined as SMBP <135/85. Every 4 weeks SMBP measurements will be assessed and mHealth components will be escalated, de-escalated, or remain the same. If BP is controlled, SMBP prompts will be sent once a week and there will be no facilitated appointments. If BP is uncontrolled, SMBP prompts will be sent three times per week and facilitated provider scheduling and transportation will occur. Participants will have the option include a partner, friend, or family member with text-messaging capability who could support them on their BP journey. The partner will receive Reach Out materials and text messages to remind the participant to engage in SMBP and of their upcoming appointments (if uncontrolled).	Behavioral: Self-Measured Blood Pressure Monitoring; Prompted SMBP with tailored feedback; Behavioral: Physician appointment and transportation scheduling; Physician appointment and transportation scheduling or none dependent on current BP control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in systolic blood pressure	Change in 6-month Systolic Blood Pressure (SBP)	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in diastolic blood pressure	Change in 6-month Diastolic Blood Pressure (DBP)	6 month
BP Control (130/80mmHg)	Proportion of participants with controlled BP at 6-months. BP control is defined as BP less than 130/80 mmHg.	6 month

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
BP Control (140/90mmHg)	Proportion of participants with controlled BP at 6-months. BP control defined as BP less than 140/90	6 month
Initiation of antihypertensive medication		6 month
Change in antihypertensive medication		6 month
Establishment of primary care	Time from ED visit to arrival at first primary care visit	6 month
Participant adherence with self-measured blood pressure monitoring	Proportion of BPs received after a BP prompt	6 month

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: University of Michigan; Ohio State University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): November 30, 2028

Study Registration Dates

• First Submitted: April 25, 2024
• First Submitted That Met QC Criteria: April 25, 2024
• First Posted (Actual): April 30, 2024

Study Record Updates

• Last Update Posted (Actual): May 2, 2024
• Last Update Submitted That Met QC Criteria: April 30, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Disease Attributes; Hypertension; Emergencies
• Other Study ID Numbers: 1R01MD019124 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data in which direct and indirect identifiers have been removed will be made available through data-sharing website
• IPD Sharing Time Frame: Before completion of trial data collection.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No