Nashville - Hypertension Management Model
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      Black men face a shorter life expectancy than white men due to poorer health outcomes
      associated with many chronic diseases, most notably hypertension and its cardiovascular
      complications. A lack of access to healthcare resources and poor engagement with healthcare
      providers drive these inequities. A seminal trial conducted in the Metro Los Angeles area
      demonstrated the effectiveness of using collaborative care partnerships between black-owned
      barbershops and pharmacists to reduce blood pressure in black men.

      The purpose of this study is to test the feasibility and success of implementing a
      single-arm, smaller-scale version of the Los Angeles study in the Nashville area to provide
      additional empiric support for collaborative care partnerships to treat hypertension in other
      geographic locations.
    

Detailed description: 
      Uncontrolled hypertension (HTN) is a significant risk factor for mortality among non-Hispanic
      black men, and black men have the highest incidence of death from HTN of any race, ethnic, or
      gender group in the United States. Sustained, trusting interactions with healthcare
      professionals and a lack of access to healthcare resources are both significant drivers of
      these disparities. A cluster, randomized controlled trial in the Metro Los Angeles area
      demonstrated that health promotion by black barbers resulted in greater reductions in blood
      pressure (BP) when combined with medication management by specialty-trained pharmacists, as
      compared to health promotion by barbers alone.

      The purposes of this single arm, pre-test/post-test study are to a) establish an effective
      network of barbershop research hubs in Nashville, b) test the feasibility of engaging with a
      specialty-trained pharmacist in collaboration with a barbershop to treat blood pressure in
      black men, and c) create a local registry of potential subjects as a platform for enrolling
      black men in future studies. There is no central hypothesis in this pilot implementation
      study, but the study will evaluate the ability of the barbershop-based research methodology
      to recruit and retain black men in a study; the fidelity to the intervention by barbers, the
      pharmacist, and the hypertensive male participants; and the effectiveness of the intervention
      on systolic blood pressure reduction and patient satisfaction. All participants will also be
      offered the opportunity to participate in a separate research registry for recruitment into
      future studies.

      Research staff will offer free BP screening to all adult black men entering each shop for
      approximately 4 weeks, or until recruitment targets have been met. Patrons with a systolic BP
      > 140 mm Hg on two separate occasions will be eligible to participate. The patrons' existing
      physician or the lead physician or a study physician will sign a collaborative practice
      agreement for a specialty-trained pharmacist to provide care and prescribe BP medications
      within the study protocol. All participants in this study will execute a visit with the study
      physician for an evaluation to establish care, supported by the funding for this proposal.

      Barbers will participate in training related to skills on BP measurement and counseling
      performed by either collaborating researchers from the University of California, Los
      Angeles-Cedars Sinai or from local study personnel. Barbers will frequently check and
      transmit the BP readings of their enrolled patrons and motivate them to work with the
      clinical pharmacist, who will meet them in their barbershops to optimize BP medication. The
      pharmacist will promote patient activation, intensify drug therapy under a collaborative
      practice agreement as permitted by Tennessee state law, send progress notes to the
      participant's physicians, and ensure appropriate safety monitoring after each medication
      change.
    

Intervention name(s): Hypertension Management Model
Intervention type(s): Behavioral
Intervention description(s): Blood Pressure readings by barbers
Clinical Pharmacist evaluation and counseling
Blood pressure measurement
Point of care basic metabolic panel measurement
Intervention model: Single Group Assignment
Intervention model description: Execute a smaller version of the LA Barbershop BP Study through the new Nashville network as the test case for: A) recruiting regular patrons with uncontrolled HTN, B) conducting a research protocol and evaluating a HTN intervention; and C) creating a local registry of potential subjects as platform for enrolling black men in future research studies.
Masking: None (Open Label)
Primary purpose: Treatment