Mobilizing Community Hypertension Access Pilot

Official title

Live Healthy Chicago - Community Pilot

Overview

The Live Healthy Chicago (LHC) Community Pilot is a prospective, community-based study evaluating the feasibility, effectiveness, and economic impact of a pharmacist-led hypertension management program delivered in trusted community settings on the West and South Sides of Chicago. Adults with uncontrolled hypertension will be identified and enrolled through community-based organizations, where a mobile clinical team-including community health workers, a pharmacist, and a registered nurse-will provide blood pressure screening, medication management, health education, and care coordination over a 3-month period. The study will assess participant engagement and acceptability, changes in systolic blood pressure. This pilot aims to address disparities in hypertension control by improving access to care in underserved communities and informing scalable, community-based models of chronic disease management.

Detailed description

Uncontrolled hypertension is a leading contributor to cardiovascular disease and preventable morbidity and mortality in the United States, with disproportionate burden among underserved populations. In Chicago, structural inequities, limited access to primary care, and mistrust in healthcare systems contribute to significant disparities in hypertension control, particularly among Black residents on the West and South Sides. Community-based care delivery models have demonstrated success in improving blood pressure outcomes by engaging individuals in trusted, non-traditional healthcare settings.

The Live Healthy Chicago (LHC) Community Pilot is a prospective, community-based pilot study designed to evaluate the feasibility, effectiveness, and economic impact of a pharmacist-led hypertension management intervention embedded within community-based organizations. The study will enroll approximately 200 adults with uncontrolled hypertension identified through community health worker (CHW)-led screening and outreach efforts at participating sites, including churches and organizations providing social services.

Participants will receive a 3-month intervention delivered by a mobile clinical team consisting of CHWs, a pharmacist, and a registered nurse (RN). CHWs will conduct outreach, facilitate recruitment, provide health education, and support care navigation. RNs will collect baseline clinical data, provide counseling, support medication adherence, and conduct follow-up assessments. Pharmacists will perform medication reconciliation and manage antihypertensive therapy, including initiation and titration of medications under a collaborative practice agreement with supervising physicians.

Participants will be followed for 12 weeks, with regular in-person or telehealth visits to monitor blood pressure, assess medication adherence, and address social determinants of health. Home blood pressure monitoring will be encouraged, and participants may be provided with blood pressure cuffs when available. Data collection will occur at baseline and at 3-month follow-up and will include blood pressure measurements, medication adherence (via validated questionnaires), medical history, social determinants of health, and participant-reported outcomes such as satisfaction and intervention acceptability.

The primary effectiveness outcome is change in systolic blood pressure over the 3-month intervention period, including the proportion of participants achieving a clinically meaningful reduction (≥10 mmHg). Feasibility and acceptability outcomes include recruitment, retention, and participant satisfaction. Economic analyses will estimate the cost per participant and model potential cost savings associated with reduced healthcare utilization, including emergency department visits and hospitalizations.

This pilot study aims to generate preliminary evidence to support scalable, community-based hypertension care models that improve access, reduce disparities, and enhance chronic disease management in underserved urban populations.

Interventions

• Behavioral Community-Based Multidisciplinary Hypertension Management Program
  A 12-week community-based hypertension management intervention delivered in community settings. The program includes pharmacist-led medication management under collaborative practice agreement, RN-led clinical monitoring and follow-up, and CHW-led outreach, education, and care navigation. Participants receive blood pressure screening, medication titration when indicated, home blood pressure monitoring support, and linkage to primary care and social services.

Primary outcome measures

• Change in Systolic Blood Pressure (SBP) [Time frame: Baseline to 3 months (12 weeks)]

Secondary outcome measures (9)

• SBP Reduction ≥10 mmHg [Time frame: 12 weeks]
• Blood Pressure Control [Time frame: 12 weeks]
• Medication Adherence [Time frame: Baseline and 12 weeks]
• Feasibility (Recruitment and Retention) [Time frame: Through 12 weeks]
• Acceptability of Intervention [Time frame: 12 weeks]
• Patient Satisfaction [Time frame: 12 weeks]
• Social Determinants of Health (SDOH) [Time frame: Baseline and 12 weeks]
• Healthcare Utilization (Exploratory) [Time frame: 12 weeks]
• Primary Care Re-engagement Within 9 Months Post-Intervention [Time frame: 9 months post-intervention]

Eligibility criteria

Inclusion criteria

• Adults 18 years or older
• Record of two blood pressure readings of SBP>130 on two separate occasions (days) within the past 3 months

Exclusion criteria

• Person is receiving dialysis
• Person has had a heart or kidney transplant
• Person is pregnant

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Prevention

Study locations

United States · 1 center

• Rush University Medical Center — Chicago

Publications

• Bryant KB, Moran AE, Kazi DS, Zhang Y, Penko J, Ruiz-Negron N, Coxson P, Blyler CA, Lynch K, Cohen LP, Tajeu GS, Fontil V, Moy NB, Ebinger JE, Rader F, Bibbins-Domingo K, Bellows BK. Cost-Effectiveness of Hypertension Treatment by Pharmacists in Black Barbershops. Circulation. 2021 Jun 15;143(24):2384-2394. doi: 10.1161/CIRCULATIONAHA.120.051683. Epub 2021 Apr 15. PMID 33855861
• Bennett GG, Warner ET, Glasgow RE, Askew S, Goldman J, Ritzwoller DP, Emmons KM, Rosner BA, Colditz GA; Be Fit, Be Well Study Investigators. Obesity treatment for socioeconomically disadvantaged patients in primary care practice. Arch Intern Med. 2012 Apr 9;172(7):565-74. doi: 10.1001/archinternmed.2012.1. Epub 2012 Mar 12. PMID 22412073
• Ursua RA, Aguilar DE, Wyatt LC, Trinh-Shevrin C, Gamboa L, Valdellon P, Perrella EG, Dimaporo MZ, Nur PQ, Tandon SD, Islam NS. A community health worker intervention to improve blood pressure among Filipino Americans with hypertension: A randomized controlled trial. Prev Med Rep. 2018 May 9;11:42-48. doi: 10.1016/j.pmedr.2018.05.002. eCollection 2018 Sep. PMID 29984137
• Schoenthaler AM, Lancaster KJ, Chaplin W, Butler M, Forsyth J, Ogedegbe G. Cluster Randomized Clinical Trial of FAITH (Faith-Based Approaches in the Treatment of Hypertension) in Blacks. Circ Cardiovasc Qual Outcomes. 2018 Oct;11(10):e004691. doi: 10.1161/CIRCOUTCOMES.118.004691. PMID 30354579
• Kaholokula JK, Look M, Mabellos T, Ahn HJ, Choi SY, Sinclair KA, Wills TA, Seto TB, de Silva M. A Cultural Dance Program Improves Hypertension Control and Cardiovascular Disease Risk in Native Hawaiians: A Randomized Controlled Trial. Ann Behav Med. 2021 Oct 4;55(10):1006-1018. doi: 10.1093/abm/kaaa127. PMID 33677520
• Kim KB, Han HR, Huh B, Nguyen T, Lee H, Kim MT. The effect of a community-based self-help multimodal behavioral intervention in Korean American seniors with high blood pressure. Am J Hypertens. 2014 Sep;27(9):1199-208. doi: 10.1093/ajh/hpu041. Epub 2014 Mar 26. PMID 24671049
• Islam NS, Wyatt LC, Ali SH, Zanowiak JM, Mohaimin S, Goldfeld K, Lopez P, Kumar R, Beane S, Thorpe LE, Trinh-Shevrin C. Integrating Community Health Workers into Community-Based Primary Care Practice Settings to Improve Blood Pressure Control Among South Asian Immigrants in New York City: Results from a Randomized Control Trial. Circ Cardiovasc Qual Outcomes. 2023 Mar;16(3):e009321. doi: 10.1161/C PMID 36815464
• Svarstad BL, Kotchen JM, Shireman TI, Brown RL, Crawford SY, Mount JK, Palmer PA, Vivian EM, Wilson DA. Improving refill adherence and hypertension control in black patients: Wisconsin TEAM trial. J Am Pharm Assoc (2003). 2013 Sep-Oct;53(5):520-9. doi: 10.1331/JAPhA.2013.12246. PMID 24030130

Identifiers

NCT: NCT07547345 · 25061903-IRB01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗