Exploring the Acceptability and Feasibility of Remote Blood Pressure Measurements and Cognition Assessments Among Participants Recruited From a Safety-Net Emergency Department (Reach Out Cognition): Nonrandomized Mobile Health Trial.

BACKGROUND: Hypertension is a prevalent cardiovascular risk factor disproportionately affecting Black Americans, who also experience a higher incidence of Alzheimer disease and Alzheimer disease-related dementias. Monitoring blood pressure (BP) and cognition may be important strategies in reducing these disparities. OBJECTIVE: The objective of the Reach Out Cognition study was to explore the feasibility and acceptability of remote cognitive and BP assessments in a predominantly Black, low-income population. METHODS: Reach Out was a randomized, controlled, mobile health-based clinical trial to reduce BP among patients with hypertension at an emergency department in a safety-net hospital (ie, a US hospital in which 25% of the patients are Medicaid recipients). Upon conclusion of Reach Out, participants were given the option of continuing into an extension phase, Reach Out Cognition, that included Bluetooth-enabled BP monitoring and digital cognitive assessments for 6 months. Digital cognitive assessments were text message-linked online surveys of the Self-Administered Gerocognitive Exam and Quality of Life in Neurological Disorders scale. BP assessments were measured with Bluetooth-enabled BP cuffs paired with an app and the data were manually sent to the research team. Outcomes were feasibility (ie, enrollment and 3- and 6-month completion of digital cognitive and BP assessments) and acceptability of assessments using a 4-item validated survey, ranging from 1 (not acceptable) to 5 (completely acceptable). RESULTS: Of the 211 Reach Out participants, 107 (50.7%) consented and 71 (33.6%) completed enrollment in Reach Out Cognition. Participants had a mean age of 49.9 years; 70.4% were female and 57.8% identified as Black. Among the 71 participants, 51 (72%) completed cognitive assessments at 3 months and 34 (48%) completed these assessments at 6 months. BP assessments were completed by 37 (52%) and 20 (28%) of the 71 participants at 3 and 6 months, respectively. Participants were neutral on the acceptability of the digital cognitive assessments (mean 3.7) and Bluetooth self-measured BP (SMBP) monitoring (mean 3.9). Participants noted challenges syncing the BP cuff to the app, internet connection, and transmitting the data to the research team. CONCLUSIONS: Enrollment and assessment completion were low, while acceptability was moderate. Technological advances will eliminate some of the Bluetooth SMBP barriers and offer new strategies for cognitive assessments. Subsequent studies could benefit from offering more comprehensive support to overcome Bluetooth-related hurdles, such as personalized training materials, video conferencing, or in-person research team support. Alternatively, strategies that do not require pairing with an app and passive transmission of data could be considered. Overall, further research is warranted to optimize participant engagement and overcome technological challenges. TRIAL REGISTRATION: ClinicalTrials.gov NCT03422718; https://clinicaltrials.gov/study/NCT03422718.

Determinants of Bluetooth-Enabled Self-Measured Blood Pressure Monitoring in Federally Qualified Health Centers.

BACKGROUND: In 2021, the Health Resources and Services Administration (HRSA) launched the National Hypertension Control Initiative (HTN Initiative) with the goal to enhance HTN control through Bluetooth-enabled self-measured blood pressure (BT-SMBP) monitoring and use this data to inform clinical decisions in Federally Qualified Health Centers (FQHCs) with a large proportion of their population with uncontrolled blood pressure (BP). We sought to understand the experience of Michigan-based FQHCs in implementing the HTN initiative. METHODS: Staff from three Michigan-based FQHCs were invited to participate in semi-structured interviews from September to November 2022. Interviews were conducted in-person and were based on the Tailored Implementation in Chronic Diseases framework. Content analysis was performed by three coders. RESULTS: Ten staff participated in interviews (FQHC 1: n = 6, FQHC 2: n = 1, FQHC 3: n = 3). The FQHCs differed in their stage of implementation and their approach. FQHC 1 created a large-scale, community health worker driven program, FQHC 2 created a small-scale, short term, BP device loan program, and FQHC 3 created a primarily outsourced, large-scale program through a contracted partner. Positive staff attitudes and outcome expectations, previous experience with SMBP grants, supportive clinic leadership, social support, and free BP cuff resources were identified as facilitators to implementation. Patients' high social needs, SMBP-related Technology, and insufficient workforce and staff capacity were identified as barriers. CONCLUSION: BT-SMBP among FQHC patients is promising but challenges in integrating SMBP data into clinic workflow, workforce capacity to support the high social needs of participants, and to assist in reacting to the more frequent BP data remain to be overcome.

Correction: Community-Led, Cross-Sector Partnership of Housing and Health Care to Promote Aging in Place (Unite Health Project): Protocol for a Prospective Observational Study.

[This corrects the article DOI: 10.2196/47855.].

Determinants of Bluetooth-enabled Self Measured Blood Pressure monitoring in Federally Qualified Health Centers.

Background: In 2021, the Health Resources and Services Administration (HRSA) launched the National Hypertension Control Initiative (HTN Initiative) with the goal to enhance HTN control through Bluetooth-enabled self-measured blood pressure (BT SMBP) monitoring and use this data to inform clinical decisions in Federally Qualified Health Centers (FQHCs) with large proportion of their population with uncontrolled BP. We sought to understand the experience of Michigan-based FQHCs in implementing the HTN initiative. Methods: Staff from three Michigan-based FQHCs were invited to participate in semi-structured interviews from September to November 2022. Interviews were conducted in-person and were based on the Tailored Implementation of Chronic Diseases framework. Content analysis was performed by three coders. Results: Ten staff participated in interviews (FQHC 1: n=6, FQHC 2: n=1, FQHC 3: n=3). The FQHCs differed in their stage of implementation and their approach. FQHC 1 created a large-scale, community health worker driven program, FQHC 2 created a small-scale, short term, BP device loan program, and FQHC 3 created a primarily outsourced, large-scale program through a contracted partner. Positive staff attitudes and outcome expectations, previous experience with SMBP grants, and supportive clinic leadership were identified as facilitators to implementation; Patients high social needs, SMBP-related Technology, and insufficient workforce and staff capacity were identified as barriers. Conclusion: BT SMBP among FQHC patients is promising but challenges in integrating SMBP data into clinic workflow, workforce capacity to support the high social needs of participants and to assist in reacting to the more frequent BP data remain to be overcome.

Community-Led, Cross-Sector Partnership of Housing and Health Care to Promote Aging in Place (Unite Health Project): Protocol for a Prospective Observational Study.

BACKGROUND: For many older Americans, aging in place is their preferred living arrangement. Minoritized and socioeconomically disadvantaged older adults are up to 3 times more likely to experience disability than other groups, which increases their likelihood of being unable to age in place. Bold ideas to facilitate aging in place, particularly among vulnerable populations, are needed. One such idea is the Unite care model, a community-initiated, academic-supported, cross-sector initiative that combines 2 sectors: housing and health care. The Unite care model colocates a federally qualified health center clinic on an older adult affordable housing campus in Flint, Michigan. OBJECTIVE: There are two aims to this study. Aim 1 is to evaluate the implementation of the Unite care model in terms of acceptability, adoption, and penetration. Aim 2 is to determine which older adults use the care model and whether the care model promotes aging in place through risk factor reduction and improvement in the physical and social environment. METHODS: We will assess the care model using a concurrent, exploratory mixed methods design. For aim 1, acceptability will be assessed through semistructured interviews with key stakeholder groups; adoption and penetration will be assessed using housing and health care records. For aim 2, residents residing in the Unite clinic building will participate in structured outcome assessments at 6 and 12 months. Risk factor reduction will be measured by change in systolic blood pressure from baseline to 12 months and change in the physical and social environment (item counts) will also be assessed from baseline to 12 months. RESULTS: Data collection for aim 1 began in July 2021 and is anticipated to end in April 2023. Data collection for aim 2 began in June 2021 and concluded in November 2022. Data analysis for aim 1 is anticipated to begin in the summer of 2023 and analysis for aim 2 will begin in the spring of 2023. CONCLUSIONS: If successful, the Unite care model could serve as a new care model to promote aging in place among older adults living in poverty and older Black Americans. The results of this proposal will inform whether larger scale testing of this new model of care is warranted. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/47855.

Reach Out Emergency Department: A Randomized Factorial Trial to Determine the Optimal Mobile Health Components to Reduce Blood Pressure.

BACKGROUND: Mobile health (mHealth) strategies initiated in safety-net Emergency Departments may be one approach to address the US hypertension epidemic, but the optimal mHealth components or dose are unknown. METHODS: Reach Out is an mHealth, health theory-based, 2×2×2 factorial trial among hypertensive patients evaluated in a safety-net Emergency Department in Flint, Michigan. Reach Out consisted of 3 mHealth components, each with 2 doses: (1) healthy behavior text messaging (yes versus no), (2) prompted self-measured blood pressure (BP) monitoring and feedback (weekly versus daily), and (3) facilitated primary care provider appointment scheduling and transportation (yes versus no). The primary outcome was a change in systolic BP from baseline to 12 months. In a complete case analysis, we fit a linear regression model and accounted for age, sex, race, and prior BP medications to explore the association between systolic BP and each mHealth component. RESULTS: Among 488 randomized participants, 211 (43%) completed follow-up. Mean age was 45.5 years, 61% were women, 54% were Black people, 22% did not have a primary care doctor, 21% lacked transportation, and 51% were not taking antihypertensive medications. Overall, systolic BP declined after 6 months (-9.2 mm Hg [95% CI, -12.2 to -6.3]) and 12 months (-6.6 mm Hg, -9.3 to -3.8), without a difference across the 8 treatment arms. The higher dose of mHealth components were not associated with a greater change in systolic BP; healthy behavior text messages (point estimate, mmHG=-0.5 [95% CI, -6.0 to 5]; P=0.86), daily self-measured BP monitoring (point estimate, mmHG=1.9 [95% CI, -3.7 to 7.5]; P=0.50), and facilitated primary care provider scheduling and transportation (point estimate, mmHG=0 [95% CI, -5.5 to 5.6]; P=0.99). CONCLUSIONS: Among participants with elevated BP recruited from an urban safety-net Emergency Department, BP declined over the 12-month intervention period. There was no difference in change in systolic BP among the 3 mHealth components. Reach Out demonstrated the feasibility of reaching medically underserved people with high BP cared for at a safety-net Emergency Departments, yet the efficacy of the Reach Out mHealth intervention components requires further study. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT03422718.

Engagement in Self-measured Blood Pressure Monitoring Among Medically Underresourced Participants (the Reach Out Trial): Digital Framework Qualitative Study.

BACKGROUND: Mobile health (mHealth) interventions serve as a scalable opportunity to engage people with hypertension in self-measured blood pressure (SMBP) monitoring, an evidence-based approach to lowering blood pressure (BP) and improving BP control. Reach Out is an SMS text messaging-based SMBP mHealth trial that aims to reduce BP among hypertensive patients recruited from the emergency department of a safety net hospital in a low-income, predominately Black city. OBJECTIVE: As the benefits of Reach Out are predicated on participants' engagement with the intervention, we sought to understand participants' determinants of engagement via prompted SMBP with personalized feedback (SMBP+feedback). METHODS: We conducted semistructured telephone interviews based on the digital behavior change interventions framework. Participants were purposively sampled from 3 engagement categories: high engagers (≥80% response to SMBP prompts), low engagers (≤20% response to BP prompts), and early enders (participants who withdrew from the trial). RESULTS: We conducted interviews with 13 participants, of whom 7 (54%) were Black, with a mean age of 53.6 (SD 13.25) years. Early enders were less likely to be diagnosed with hypertension prior to Reach Out, less likely to have a primary care provider, and less likely to be taking antihypertensive medications than their counterparts. Overall, participants liked the SMS text messaging design of the intervention, including the SMBP+feedback. Several participants across all levels of engagement expressed interest in and identified the benefit of enrolling in the intervention with a partner of their choice. High engagers expressed the greatest understanding of the intervention, the least number of health-related social needs, and the greatest social support to engage in SMBP. Low engagers and early enders shared a mixed understanding of the intervention and less social support compared to high engagers. Participation decreased as social needs increased, with early enders sharing the greatest amount of resource insecurity apart from a notable exception of a high engager with high health-related social needs. CONCLUSIONS: Prompted SMBP+feedback was perceived favorably by all participants. To enhance SMBP engagement, future studies could consider greater support in the initiation of SMBP, evaluating and addressing participants' unmet health-related social needs, as well as strategies to cultivate social norms.

Supplement study update for Reach Out: a multi-arm randomized trial of behavioral interventions for hypertension initiated in the emergency department: Reach Out Cognition.

BACKGROUND: Reach Out is a factorial trial studying multicomponent behavioral interventions to reduce blood pressure in hypertensive emergency department patients. The original study protocol was published in June 2020. Here, we describe the updated protocol, including a supplemental study, Reach Out Cognition. Reach Out Cognition is a remote study that will assess the acceptability, feasibility, and satisfaction of digital, self-administered cognitive assessments and Bluetooth-enabled, self-measured blood pressure monitoring in the Reach Out population. We will also estimate the prevalence of mild cognitive impairment in Reach Out participants. METHODS: Reach Out Cognition includes remote enrollment and follow-up assessments. Reach Out Cognition extends Reach Out data collection past the current 12 months to 15 and 18 months. Participants will be Reach Out participants who complete their 12-month outcome assessments and opt to continue in the cohort study. Participants will continue to receive the Reach Out intervention, consisting of (1) daily healthy behavior text messaging and (2) weekly self-measured blood pressure monitoring. Blood pressure will be measured using Bluetooth-enabled self-measured blood pressure monitoring devices, and cognition will be measured using digital self-administered cognitive assessments at 12, 15, and 18 months. DISCUSSION: Reach Out Cognition will explore the potential of remote, digital, self-administered assessments of blood pressure and cognition among predominantly working-age Black Americans. Reach Out Cognition will inform future clinical trials and clinical remote monitoring of blood pressure and cognition that may lead to new approaches to treating and reducing hypertension and cognitive disparities. TRIAL REGISTRATION: ClinicalTrials.gov NCT03422718. The record was first available to the public on January 30, 2018, prior to the enrollment of patients on March 25, 2019.

Reach out behavioral intervention for hypertension initiated in the emergency department connecting multiple health systems: study protocol for a randomized control trial.

BACKGROUND: Hypertension is the most important modifiable risk factor for cardiovascular disease, the leading cause of mortality in the United States. The Emergency Department represents an underutilized opportunity to impact difficult-to-reach populations. There are 136 million visits to the Emergency Department each year and nearly all have at least one blood pressure measured and recorded. Additionally, an increasing number of African Americans and socioeconomically disadvantaged patients are overrepresented in the Emergency Department patient population. In the age of electronic health records and mobile health, the Emergency Department has the potential to become an integral partner in chronic disease management. The electronic health records in conjunction with mobile health behavior interventions can be leveraged to identify hypertensive patients to impact otherwise unreached populations. METHODS: Reach Out is a factorial trial studying multicomponent, behavioral interventions to reduce blood pressure in the Emergency Department patient population. Potential participants are identified by automated alerts from the electronic health record and, following consent, receive a blood pressure cuff to take home. During the initial screening phase, they are prompted to submit weekly blood pressure readings. Responders with persistent hypertension are then randomized into one of three component arms, consisting of varying intensity levels: (1) healthy behavior text messaging (daily vs. none), (2) blood pressure self-monitoring (daily vs. weekly), and (3) facilitated primary care provider appointment scheduling and transportation (yes vs. no). If participants are randomized to receive facilitated primary care provider appointment scheduling and are not established with a primary care provider, care will be established at a local Federally Qualified Health Center. Participants are followed for 12 months. DISCUSSION: The Reach Out study is designed to determine which behavioral intervention components or 'dose' of components contributes to a reduction in systolic blood pressure after 1 year (Aim 1). The study will also assess the effect of primary care provider appointment assistance on total primary care follow-up visits of hypertensive patients treated in an urban, safety net Emergency Department (Aim 2). Ideally, the Reach Out system will contribute to hypertension management, serving as a model for safety net hospitals and Federally Qualified Health Centers to improve chronic disease management in underserved communities. TRIAL REGISTRATION: This study was registered at clinicaltrials.gov, identifier NCT03422718. The record was first available to the public on January 30, 2018 prior to the enrollment of patients on March 25, 2019.

Reach Out Emergency Department: Partnering With an Economically Disadvantaged Community in the Development of a Text-Messaging Intervention to Address High Blood Pressure.

Background. Hypertension affects nearly 30% of the U.S. adult population. Due to the ubiquitous nature of mobile phone usage, text messaging offers a promising platform for interventions to assist in the management of chronic diseases including hypertension, including among populations that are historically underserved. We present the intervention development of Reach Out, a health behavior theory-based, mobile health intervention to reduce blood pressure among hypertensive patients evaluated in a safety net emergency department primarily caring for African Americans. Aims. To describe the process of designing and refining text messages currently being implemented in the Reach Out randomized controlled trial. Method. We used a five-step framework to develop the text messages used in Reach Out. These steps included literature review and community formative research, conception of a community-centered behavioral theoretical framework, draft of evidence-based text messages, community review, and revision based on community feedback and finalization. Results. The Reach Out development process drew from pertinent evidence that, combined with community feedback, guided the development of a community-centered health behavior theory framework that led to development of text messages. A total of 333 generic and segmented messages were created. Messages address dietary choices, physical activity, hypertension medication adherence, and blood pressure monitoring. Discussion. Our five-step framework is intended to inform future text-messaging-based health promotion efforts to address health issues in vulnerable populations. Conclusion. Text message-based health promotion programs should be developed in partnership with the local community to ensure acceptability and relevance.