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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06391073
• Other study ID #: 1R01MD019124
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: November 30, 2028

Study information

• Verified date: April 2024
• Source: Northwestern University
• Contact: Lesli Skolarus, MD, MS
• Phone: 312-503-0644
• Email: lesli.skolarus[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: November 30, 2028
• Est. primary completion date: March 1, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Hypertension

Intervention

Behavioral:
• Self-Measured Blood Pressure Monitoring
Prompted SMBP with tailored feedback
• Physician appointment and transportation scheduling
Physician appointment and transportation scheduling or none dependent on current BP control

Locations

Country	Name	City	State
United States	Hurley Medical Center	Flint	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
Northwestern University	Ohio State University, University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	BP Control (140/90mmHg)	Proportion of participants with controlled BP at 6-months. BP control defined as BP less than 140/90	6 month
Other	Initiation of antihypertensive medication		6 month
Other	Change in antihypertensive medication		6 month
Other	Establishment of primary care	Time from ED visit to arrival at first primary care visit	6 month
Other	Participant adherence with self-measured blood pressure monitoring	Proportion of BPs received after a BP prompt	6 month
Primary	Change in systolic blood pressure	Change in 6-month Systolic Blood Pressure (SBP)	6 month
Secondary	Change in diastolic blood pressure	Change in 6-month Diastolic Blood Pressure (DBP)	6 month
Secondary	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