Clinical trial NCT06593496: Addressing Cardiometabolic Health Inequities by Early Prevention in the Great Lakes Region Project 1 - Epidemiology (ACHIEVE P1-EPI)
Official title: Addressing Cardiometabolic Health Inequities by Early Prevention in the Great Lakes Region Project 1 - Epidemiology (ACHIEVE P1-EPI)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
High Blood Pressure
Keywords: Epidemiology
Mobile Health Unit
Prospective
Lead sponsor: Wayne State University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This project is part of the ACHIEVE GREATER (Addressing Cardiometabolic Health Inequities by Early PreVEntion in the GREAT LakEs Region) Center (IRB# 100221MP2A), the purpose of which is to reduce cardiometabolic health disparities and downstream Black-White lifespan inequality in two cities: Detroit, Michigan, and Cleveland, Ohio. The ACHIEVE GREATER Center involves separate but related projects that aim to mitigate and understand health disparities in risk factor control of chronic conditions, (hypertension, heart failure, and coronary heart disease) which drive downstream lifespan inequality. The present study is the prospective observational cohort component of ACHIEVE P1- EPI (Project 1) of the ACHIEVE GREATER Center and serves to characterize the population of patients with blood pressure (BP) levels above normal attending The Wayne Health Mobile Health Unit (MHU) events to better understand key factors (e.g., social determinants of health) that convey information about baseline BP levels and related clinical outcomes (e.g., follow-up clinic visits, BP control).

Detailed description: ACHIEVE P1- EPI aligns with the over-arching theme of the ACHIEVE GREATER center to reduce disparities in cardiovascular risk factors and disease faced by members of the adult, Black community in the urban Great Lakes region. It focuses on understanding key factors that drive the high prevalence and poor control of hypertension (HTN) in the Black community in Detroit. Much of this risk traces to social vulnerability and pervasive negative social determinants of health (SDoH) which impact access and quality of care. ACHIEVE P1- EPI is comprised of two main components: 1) a retrospective analysis of all MHU patients starting in April 2020 (IRB-23-04-5726); and 2) development of a prospective observational sub-cohort of MHU patients that consent to on-going follow up of their health care utilization and outcomes, a subset of whom will also consent to receive a home BP monitor where utilization of the device will be monitored.

This project focuses on the prospective component (ACHIEVE P1- EPI: Prospective), to enable the study team to characterize critical risk factors and track associations with subsequent health outcomes to inform a comprehensive preventative strategy to lower blood pressure (BP) and improve the control of early-stage HTN in the Detroit area.

ACHIEVE P1- EPI proposes an epidemiological approach to characterize key factors that convey information about baseline BP levels and/or that drive subsequent health outcomes. Using a combination of retrospective and prospective observational analytical approaches, the study team will leverage the Wayne Health Mobile Health Unit (MHU) platform to implement an observational cohort study that will characterize the antecedents, correlates and sequelae of abnormal blood pressure. The investigator and study team will also perform a nested randomized trial to determine if text message prompts improve the amount or quality of data collected remotely.

Key issues requiring elucidation are: the prevalence and predictors of negative SDoH among patients as well as their associations with screening BP levels and trajectories; the role of SDoH (and other factors) in determining the progression/remission of high BP over the following year; the rates and predictors of successful linkages with follow-up medical visits and receiving social services; the rates and predictors of the initiation of BP-lowering medications in subsequent clinical care; the persistence and predictors of follow-up clinical visits and treatments; the barriers and facilitators of linkages into the healthcare system; and the ultimate success rates and predictors of reaching BP goals. Answers to these questions will provide invaluable information to help guide data-driven improvements to the MHU program moving forward and inform future scalability in other regions and locations. These results will assist us in the optimizing and up-scaling of the program, including the development of improved strategies to successfully link individuals to social services and follow-up healthcare. The findings will help enhance the study team's overall care delivery pathways with the goals of improved BP control and reduced cardiometabolic health inequities in Detroit and beyond.

The specific aims are:

AIM-1: To develop a prospective observational cohort to observe subsequent health outcomes (e.g., blood pressure levels, cardiometabolic risk factors, clinic visits, medications, cardiovascular events) following MHU participation using Wayne health EMR dataset for follow-up. The study team will assess baseline predictors (e.g., SDoH, medications, demographics) of subsequent health outcomes and plan to probe area- and person-level profiles as potential sources of variation in appropriately developed multilevel models.

AIM-2: To develop a nested randomized trial of a sub-cohort to test for differences in adherence to a blood pressure measurement protocol among an intervention group that receives text message reminders and controls who instead receive standard of care without text message reminders. We will also test for differences in blood pressure profiles and, secondarily, emergency department utilization at 12-month follow-up.

Eligibility criteria: Inclusion Criteria:

* Mobile Health Unit Patients with blood pressure above normal (≥120 systolic and/or ≥80 mmHg)
* Has a phone with the ability to receive text messages
* 18+ years old
* Consent to allow prospective follow-up including through EHR review

Exclusion Criteria:

* Non-mobile health unit patients
* MHU patients with systolic BP \&lt; 120 mmHg AND diastolic BP \&lt; 80 mmHg
* Pregnant Women
* Children less than 18 years old
* Individuals viewed by the investigative team as unable to understand and sign the informed consent form
* Currently enrolled in another on-going interventional trial initiated on the mobile health unit

Primary outcomes:
measure: Measure Blood Pressure Protocol Fidelity
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne Health Mobile Units
state: Michigan
Study officials:
affiliation: Wayne State University
name: Steven J Korzeniewski, PhD
role: PRINCIPAL_INVESTIGATOR
References: