Clinical trial NCT05330221: Project 2: ACHIEVE- HF
Official title: ACHIEVE GREATER: Addressing Cardiometabolic Health Inequities by Early PreVEntion in the GREAT LakEs Region
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Hypertension
Keywords: Health Disparities
African American
Prevention
Heart Failure
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: Wayne State University
First posted: 2022-04-15
Enrollment: 364
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 will involve three separate but related projects that aim to mitigate health disparities in risk factor control for three chronic conditions, hypertension (HTN, Project 1), heart failure (HF, Project 2) and coronary heart disease (CHD, Project 3), which drive downstream lifespan inequality. All three projects will involve the use of Community Health Workers (CHWs) to deliver an evidence-based practice intervention program called PAL2. All three projects will also utilize the PAL2 Implementation Intervention (PAL2-II), which is a set of structured training and evaluation strategies designed to optimize CHW competence and adherence (i.e., fidelity) to the PAL2 intervention program. The present study is Project 2 of the ACHIEVE GREATER Center.

Detailed description: Heart failure (HF) is one of the most common, costly, and deadly diseases affecting humans. Hypertension is the largest single risk factor for HF, accounting for over half of all new cases. Moreover, Black adults with hypertension have a much greater risk, perhaps 20-fold, of developing HF compared with White adults. The data the investigators collected in Detroit, MI, where the population is predominantly Black, features a mortality rate from heart disease that is nearly twice the national average. Among patients with hypertension and no history of HF, more than 50% already have abnormalities of cardiac function seen on echocardiogram. Notably, high rates of hypertension in the Black community comingle with diabetes and kidney dysfunction, further amplifying HF risk.

Accordingly, early interventions to prevent HF, in particular blood pressure (BP) control, are critical. However, implementation of effective treatments remains suboptimal among Black communities, especially in low-income urban settings. While many factors are involved, mounting evidence shows that adverse social determinants of heath (SDoH) such as poor access to healthcare, food insecurity, and lack of safe places for physical activity are critical barriers to the implementation of recommended therapies. To achieve health equity, improved strategies must be developed to overcome these negative SDoH. To better engage the at-risk community, the team of investigators developed an innovative mobile health unit (MHU) program that uses geospatial health and social vulnerability data to direct health services to communities in highest need, who may not otherwise engage with traditional health care settings.

Project 2 (ACHIEVE HF) of ACHIEVE GREATER (Addressing Cardiometabolic Health Inequities by Early Prevention in the Great Lakes Region) will address multiple domains and levels of impact to reduce the large gaps in care of stage A HF patients in the Black community and prevent progression towards later stages of disease. The project proposes an innovative approach to identify and control hypertension (HTN) at it's earliest stages in undiagnosed Black adults. This study will use a Mobile Health Unit (MHU) platform to implement a multi-level intervention called Pharm-PAL2 to identify and reduce large gaps in care of stage A HF in untreated Black adults. The Pharm-PAL2 intervention will be delivered to the intervention arm participants in two phases: Intervention phase (first 12 months) and Durability Phase (Year 2, an additional 12 months).

The Pharm-PAL2 intervention will link Detroit-area resident adults with 1 of the inclusion factors below to collaborative care delivered by non-physicians, community health workers (CHWs) and Pharmacists via MHUs.

1. screening systolic blood pressure \>= 140 and/or diastolic blood pressure \>= 90 mmHg or
2. screening blood pressure 130-139 mmHg plus \>= 1 additional heart failure risk factor (1. diabetes (HbA1c \>=6.5% or 2. CKD stage 3 (i.e. eGFR 30-60 mL/min/m\^2)) or
3. treated (1-2 antihypertensive medications) stage 1 hypertension (systolic BP 130-139 and/or diastolic BP 80-89) with or without additional heart failure risk factors
4. treated stage 1 HTN w/ systolic BP 120-129 with additional HF risk factors: diabetes (HbA1c \>6.5%) or CKD stage 3 (i.e. eGFR 30-60 ml/min/m\^2)

Eligibility criteria: Inclusion:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Detroit-area resident (defined as those who attended a Detroit-area community event)
2. ≥18 years of age
3. At least one of the following:

A) Screening systolic BP ≥ 140 and/or diastolic BP ≥ 90 mm Hg OR

B) Screening BP 130-139 mm Hg plus ≥1 additional HF risk factors:

i. Diabetes (HbA1c ≥ 6.5%) ii. CKD stage 3(i.e. eGFR 30-60 mL/min/m2) OR C) Treated (1-2 antihypertensive medications) stage 1 HTN (systolic BP 130-139 and/or diastolic BP 80-89) with or without \>1 additional HF risk factors OR

D) Treated stage 1 HTN w/ systolic BP 120-129 with additional HF risk factors:

i. Diabetes (HbA1c ≥ 6.5%) ii. CKD stage 3(i.e. eGFR 30-60 mL/min/m2)

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Previous diagnosis of HF
2. Uncontrolled diabetes (HbA1C ≥8.0% from SOC screening labs)
3. Chronic use of insulin or \>1 anti-diabetic medication
4. Self-reported pregnancy (or planning to become pregnant in the next year)
5. Severely uncontrolled BP at screening visits (SBP ≥180 mm Hg and/or diastolic BP ≥110 mmHg)
6. Point of care (POC) BNP measurement ≥400 ng/L. If POC BNP was not obtained, then NTproBNP ≥ 1000 ng/L from screening labs will be excluded.
7. eGFR \<45 ml/min/sq-m on SOC screening labs

Primary outcomes:
measure: Systolic blood pressure (BP)
timeFrame: 12 months
measure: NT-proB-type Natriuretic Peptide (NT-proBNP)
timeFrame: 12 months
Secondary outcomes:
measure: Utilization rates for anti-RAS medications and SGLT2 inhibitors
timeFrame: 12 months
measure: Geospatial outreach
timeFrame: 24 months
Other outcomes:
measure: Patient satisfaction
timeFrame: 24 months
measure: Patient wellbeing
timeFrame: 24 months
measure: Cost effectiveness
timeFrame: 12 months
measure: The number of hospitalizations, emergency department visits and deaths
timeFrame: 12 months
measure: BP Control (<130/80)
timeFrame: 12 months
measure: NT pro BNP (> 125 ng/L)
timeFrame: 12 months
measure: Change in creatinine
timeFrame: 12 months
measure: Change in glycated hemoglobin
timeFrame: 12 months
measure: Utilization rates of other cardiovascular medications
timeFrame: 24 months
Locations:
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
Study officials:
References: