Cut Your Blood Pressure 3



Status:Recruiting
Conditions:High Blood Pressure (Hypertension)
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:35 - 79
Updated:11/4/2018
Start Date:November 1, 2018
End Date:January 15, 2020
Contact:Florian Rader, MD
Email:Florian.Rader@cshs.org
Phone:310 498 5740

Use our guide to learn which trials are right for you!

Telemedicine and the Barbershop Model of Hypertension Care for Black Men

The recently published LA Barbershop in the New England Journal of Medicine (Victor et al. N
Engl J Med 2018; 378: 1291-301) solid evidence of the efficacy of a pharmacist-led medication
management intervention to reduce blood pressure in black men that patronize barbershops.

One of the most significant logistical inefficiencies of the LA Barbershop Study was the
amount of time the pharmacists spent driving for face-to-face visits with participants. On
average, each round trip was 40 miles and pharmacists drove 2 hours per day. By using
telemedicine, the study team can minimize the number of face-to-face in-person visits and
increase pharmacist efficiency by 25%. the study team aim to increase the scalability of our
novel, evidence-based barbershop model by addressing this inefficiency with the pilot study.

In the LA Barbershop trial, each participant averaged 7 in-person visits in 6 months. the
study team found that the initial in-person visits between the pharmacist, barber, and patron
were essential for establishing trust as well as obtaining baseline electrolyte and serum
creatinine levels (with our validated point-of-care device, iSTAT). However, once rapport has
been established and blood pressure control achieved, the study team postulate that the
effect can be maintained remotely with telemedicine. Our data indicate that most patients'
can achieve their blood pressure goal in 3 months or less. the study team propose replacing
additional in-person visits with telemonitoring (via Skype or FaceTime) at this juncture,
provided blood chemistries are stable.

the study team plan to pilot this in 20 patients from 2 to 3 barbershops for 12 months.

recently published in the New England Journal of Medicine (Victor et al. N Engl J Med 2018;
378: 1291-301) solid evidence of the efficacy of a pharmacist-led medication management
intervention to reduce blood pressure in black men that patronize barbershops.

the study enrolled a cohort of 319 hypertensive non-Hispanic black male patrons from 52
black-owned barbershops in Los Angeles County into a cluster-randomized trial in which
barbershops (non-traditional health care setting) were assigned to either a pharmacist-led
intervention (in which barbers encouraged in-person meetings with pharmacists who then
prescribed drug therapy under a collaborative practice agreement with the participants'
doctors) or an active control approach (in which barbers encouraged lifestyle modification
and doctor appointments).

At 6 months, the mean systolic blood pressure fell by 27.0 mmHg in the intervention group and
by 9.3 mmHg in the control group. A blood pressure level of less than 130/80 was achieved in
64% of the participants in the intervention versus 12% of participants in the control group.

the study team are applying for this grant as a first step in transitioning this
evidence-based intervention into a scalable program. Specifically, the study team will do a
pilotstudy to test whether the impressive effects on blood pressure can be maintained just as
well if face-to face meetings are substituted with telemonitoring after blood pressure is at
goal. If successful this approach would markedly increase efficiency by increasing the number
of patients a single pharmacist can manage.

Non-Hispanic black men have the highest rate of hypertension-related death of any racial,
ethnic, or sex group in the United States. Black men have less physician interaction than
black women and lower rates of hypertension treatment and control, necessitating community
outreach. Because black men with hypertension often have multiple cardiovascular risk
factors, marked reductions in blood pressure - if sustained with the use of our approach and
then initiated more widely - might reduce the high rates of hypertension-related disability
and death among black men in the United States.

The study team want to demonstrate that participants in this pilot can achieve similar blood
pressure reduction at 12 months (as compared to those in our previous trial) when
telemedicine is substituted for in-person pharmacist visits after 3 months.

Inclusion Criteria:

- Non-Hispanic Black Men

- Age 35 to 79 years-old

- Able to give informed consent

- Long-term/frequent barbershop patronage (>8 haircuts at the same barbershop in the
last 12 months)

- systolic BP ≥140 on 2 different screening days, and complete set of baseline data

- Each participant should have their own personal smart cell phone with video chat
capability (needed for telemedicine)

Exclusion Criteria:

- Women

- Men < 35 years old or Men >79 years old

- Non-black

- Hispanic Ethnicity

- New/infrequent patronage (<8 haircuts at same barbershop in last 12 months);

- Kidney dialysis.

- Receiving chemotherapy for cancer. Systolic BP <140 at either screening and incomplete
baseline data.
We found this trial at
1
site
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Phone: 310-498-5740
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials