Implementing the Los Angeles Barber - Pharmacist Model Hypertension Management in Nashville
Phase: NA
Conditions: Hypertension
Sponsor: Vanderbilt University Medical Center

Protocol Title: Implementing the Los Angeles Barber-Pharmacist 
Model of Hypertension Management in Nashville
Protocol Date: 2/25/2020
NCT # NCT04232124

 
 
 
 
 
Implementing the Los Angeles Barber-Pharmacist 
Model of HYPERTENSION MANAGEMENT  
IN NASHVILLE 
 
 
A Barber-Pharmacist-Physician Partnership for  
Blood Pressure Management 
 
 
Principal Investigator: 
David Harrison, MD 
 
 
Department: 
Internal Medicine  
 
 
Institution: 
Vanderbilt University Medical Center (VUMC) 
 
 
Study Support Provided By: 
The National Institutes of Health (NIH) grant: UL1TR001881-03S2 
 
 
Contact: 
 
 
Nashville, 
 
615-875-3049 
david.g.harrison@vumc.org 
 
 
Version 2.0 
2/25/2020 
 
 
 

 
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TABLE OF CONTENTS 
 
Abbreviations ............................................................................................................................ 4 
Amendments ............................................................................................................................. 5 
Study Summary ......................................................................................................................... 6 
Background ............................................................................................................................... 7 
Study Objective and Aim .......................................................................................................... 8 
Study Design and Overview ..................................................................................................... 8 
Participant Selection and Withdrawal ...................................................................................... 8 
Study Intervention .................................................................................................................. 10 
Ascertainment of Outcomes  ................................................................................................. 11 
Study Procedures and Visits .................................................................................................. 13 
Statistical Analysis Plan ......................................................................................................... 14 
Adverse Events ....................................................................................................................... 16 
Data Management ................................................................................................................... 18 
Study Oversight ...................................................................................................................... 19 
References .............................................................................................................................. 20 
Appendix 1: Participating VUMC Researchers ..................................................................... 22 
Appendix 2: Study Schedule .................................................................................................. 23 
Appendix 3: Clinical Pharmacist Collaborative Practice Agreement .................................. 24 
Appendix 4: Tennessee State Pharmacy Law ....................................................................... 35 
Appendix 5: Study Hypertension Algorithm (standard of care) ........................................... 37 
Appendix 6: Study Forms, Materials, and Surveys ............................................................... 41 
6A: Barbershop/Owner Letter of Collaboration ......................................................... 41 
6B.1: Screening Questionnaire 1 ................................................................................ 43 
6B.2: Screening Questionnaire 2 ................................................................................ 54 
6B.3: 3-Month Telephone Survey ............................................................................... 73 
6B.4: 6-Month Visit Survey ......................................................................................... 77 
6B.5: Barber Exit Interview……….……….………………………….……………………..92 
6C: Blood pressure Information Card ........................................................................ 93 
6D: Template Pharmacist Note ................................................................................... 94 
6E: Adverse Event Form ............................................................................................. 97 
6F: Template Letter to Physician ……………………………………………………….....99 
6G: Participant Treatment Report ………………………………………………………..101    
Appendix 7: Data Safety Monitoring Committee Plan/Serious Adverse Event Forms  .... 103 

 
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Appendix 8: Relevant Definitions of Safety Terms per NHLBI Policy ............................... 107 
Appendix 9: Flow Diagram for Expedited Reporting of Serious Adverse Events and  
          Serious Unanticipated Problems.................................................................... 108 
Appendix 10: Research Coordinator-AE/UP Form .............................................................. 109 
Appendix 11: Clinical Pharmacist AE/UP Form  ................................................................. 110 
Appendix 12: Physician Monitor SAE/UP Report Form  ..................................................... 111 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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ABBREVIATIONS 
 
ACE – Angiotensin-converting enzyme 
ARB – Angiotensin II Receptor Blocker 
BP – Blood Pressure 
CAPI – Computer Assisted Personal Interviewing 
CCB – Calcium-channel blocker 
CLIA – Clinical Laboratory Improvement Amendments 
CRF – Case Report Form 
CS – Cedars-Sinai 
CTSI – Clinical and Translational Science Institute 
DCC – Data Coordinating Center 
DSMB – Data Safety Monitoring Committee 
GFR – Glomerular Filtration Rate 
Hg – Mercury 
HIPAA – Health Insurance Portability and Accountability Act 
HTN – Hypertension 
IRB – Institutional Review Board 
LA – Los Angeles 
MD – Doctor of Medicine 
mm – millimeters 
NCATS – National Center for Advancing Translational Science 
NH – Non-Hispanic 
NHLBI – National Heart, Lung, and Blood Institute 
NIH – National Institutes of Health 
PHI – Protected Health Information 
PI – Principal Investigator 
SAE/UPs – Serious Adverse Events and serious Unanticipated Problems 
UCLA – University of California, Los Angeles 
 
 
 
 
 
 
 
 
 
 
 
 
 

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STUDY SUMMARY 
Title 
IMPLEMENTING THE LOS ANGELES BARBER-PHARMACIST MODEL 
OF HYPERTENSION MANAGEMENT IN NASHVILLE 
Short Title 
Barbershop Nashville 
NIH Grant Number 
UL1TR001881-03S2 
Protocol Number 
NSH-BP001 
Clinicaltrials.gov 
Registration 
NCT04232124 
Phase 
2A 
Design 
Open label, single arm pre-test/post-test design, with no comparator 
Study Duration 
6-Months
Clinical Site(s) 
Vanderbilt University Medical Center; Community partners (Barbershops) 
Data Coordinating 
Center 
Cedars-Sinai Health System & University of California Los Angeles (UCLA) 
Program contact: 
, PhD (UCLA) 
Primary Objectives 
Establish network of Nashville barbershops engaged in clinical research; 
localized version of the LA-BP program 
Secondary 
Objectives 
Evaluate the impact of a pilot multicomponent intervention to optimize blood 
pressure control among adult black men in Nashville 
Number of 
Participants 
56 clients 
Inclusion criteria 
Adults 35-79 years old, non-Hispanic black males, patron of one of the 
participating barbershops (> 4 haircuts in the last 6 months), Systolic BP > 
140 on two screening days 
Interventions 
Clinical pharmacist counseling & medication management; Barber 
encouragement & BP measurement 
Primary outcomes 
a. Recruitment/retention of participants
b. Intervention Fidelity
c. Clinical efficacy: BP at 6-months; participant satisfaction
Statistical 
methodology 
Primary analyses will estimate the average change in systolic blood 
pressure from baseline to 6 months and derive its 95% confidence interval. 
Secondary analyses will measure associations between relevant baseline 
covariates and BP at 6-months. Logistic regression will be used to identify 
covariates that predict a participant’s response. Longitudinal analyses using 
mixed effects models of serial systolic BP measurements obtained at each 
individual visit from baseline to 6 months will also be conducted. 
Study oversight 
Data Safety Monitoring Committee 
Reviewed and approved by: 
David Harrison, MD, Principal Investigator 
Date: 
Barry Carter, PharmD, Chair, Data Safety Monitoring Committee 
Date: 

 
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INTRODUCTION  
1. Background 
Black men face a shorter life expectancy than white men because of higher prevalence and worse 
outcome from many diseases: most notably hypertension (HTN) and its cardiovascular 
complications but also chronic kidney disease, tobacco-related diseases, prostate and lung 
cancer, depression, and HIV/AIDS.1 Much more clinical research is needed to identify underlying 
causes and develop effective countermeasures to reduce this pervasive disparity. The first critical 
step is to find more effective means of engaging black men in clinical research. Several barriers 
have been proposed, especially distrust of physicians and fear of being exploited by researchers. 
Black men are less likely than black women to see the need for regular medical check-ups and 
thus are under-represented in standard medical settings where most research is based. Black 
barbershops are uniquely positioned in the community for promoting health and health research 
among male patrons in a relaxed social setting.  
 
Engaging underrepresented groups in clinical research is both a challenge and a public health 
priority for reducing health disparities.2 Engaging non-Hispanic black individuals—particularly 
black men—in research has been especially challenging. For example, the age-adjusted death 
rate from prostate cancer is 3-times higher for black men than white men but black men comprise 
<4% of patients in National Cancer Institute prostate cancer trials.3 The HTN-related death rate 
also is 3 times higher in black men than white men.4 However, in the Dallas Heart Study, which 
addressed this disparity, the in-home phlebotomy participation rate was 64% among black men 
vs. 72% among black women and 82% and 86% among white men and women, respectively.5 
Black men are under-represented in traditional medical settings, where most clinical research is 
based. However, traditional outreach efforts have not been very productive. In Dallas County 
Community Oriented Primary Care Clinics, <20% of black clinic patients with HTN are men. In a 
recent trial that recruited black patients from community pharmacies in Wisconsin for an 
intervention trial to improve medication refill rates, only 1/3 of the ~ 600 black patients enrolled 
were men.6 Together, all these data underscore the need to reach out to non-traditional 
community partners and develop health messages that resonate with black men.  
 
Black barbershops are a unique social setting in which black men to openly discuss important 
issues in their lives—including health—with barbers (trusted community members with a loyal 
clientele) and other black men. Barbershop health outreach is well-established but previously 
untested as a vehicle to engage black men as participants in research. A series of successful 
intervention trials in other cities serve as a model to evaluate the implementation of a pilot trial in 
Nashville. A key issue is distrust of doctors and fear exploitation by researchers—a reaction to 
unequal medical treatment9 and prior scientific misconduct as in the Tuskegee Syphilis Study.10 
In the 1920s, indigent black men in Alabama were recruited by the U.S. Public Health Service for 
this natural history study before penicillin was discovered as effective treatment for syphilis; 
however, participants were not informed of the study’s true purpose and they were not offered 
appropriate antibiotic treatment for 30 years after the discovery of penicillin. Thus, before asking 
barbers to encourage their loyal male patrons to engage in research, participation should entail 
some medical benefit. In this case, the clientele of each barbershop is offered a free in-shop BP 
screening with specific instructions for appropriate medical follow-up. Men with uncontrolled HTN 
who enroll in the Nashville intervention pilot will get accurate BP checks in the barbershop and a 
concierge clinical pharmacist to meet them regularly in their barbershop, prescribe BP medicine 
under the supervision of a physician, optimize BP, and check blood electrolytes.   
 
Addressing high BP is an excellent way to build trust. BP measurement is non-invasive. The BP 
cuff is a familiar iconic symbol of healthcare and community screening programs. HTN is 

 
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particularly devastating for black men and is the main reason why average life expectancy is still 
less than for white men.11 High BP medication reduces the risk of heart attack, stroke, heart failure, 
and premature death for all patient groups, including black men.12 HTN exemplifies the barriers 
to effective chronic disease management in general. High BP signifies multiple related health 
issues (such as dyslipidemia, metabolic syndrome, diabetes, tobacco addiction) that also will 
come to medical attention. 
 
Prior research trials in Dallas, Texas and then Los Angeles, California, supported by NIH NHLBI, 
showed that barbershops can support health services research and provide effective HTN 
screening, referral, and follow up centers for black men. The Los Angeles study developed a 
network of 60 black barbershops across Los Angeles county and leveraged this network to 
evaluate an enhanced barber-pharmacist team approach to manage chronic diseases (starting 
with HTN) in barbershops. The barbershops enrolled 320 hypertensive black male patrons to 
participate in a 12-month HTN trial with 97% cohort retention. Also, the screening process 
generated a local registry of >2,500 LA County black male barbershop patrons who consented to 
be re-contacted about potential participation in future research studies. This protocol builds on 
this considerable progress by conducting a proof-of-concept study to evaluate the implementation 
of a study protocol over a 6-month period in Nashville.  
 
2. Study Objective and Aim 
The overall objective of this study is to establish an effective network of barbershop research hubs 
in Nashville.  
 
Aim 1. 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. 
 
There is no formal hypothesis testing regarding patient-level outcomes, however this study will 
evaluate: 
 
a) the ability of the barbershop-based research methodology to recruit and retain black men 
in a clinical trial;    
 
b) intervention fidelity by the barbers, pharmacist, and hypertensive male participants; and  
 
c) intervention effectiveness on the primary outcome of systolic BP and patient satisfaction. 
 
All screening participants will also be offered opportunity to participate in a separate research 
registry (Patients’ Research Networking and Engagement Registry for Cardiovascular and Kidney 
Disease: PARTNER CKD; VUMC IRB# 191374).  
 
3. Study Design and Overview 
Single arm, pre-test/post-test (Phase 2A) design, with no comparator group. 
 
4. Participant Selection and Withdrawal 
4.1 Barbers & Barbershops 
North Nashville has approximately 1.6 black barbershops per square mile, with only 3.4 miles 
being the maximum distance between shops. Thus, North Nashville is well-suited to develop 
barbershops as hubs for much needed HTN health services research. Barbershops in this area 
will be prioritized, however other areas will be considered as needed to meet participation goals. 
 

 
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A lead study barber or investigator will identify and recruit 8 Nashville barbershops with civic-
minded owners and large well-established clienteles to serve as the initial core group of research 
hubs. Barbershop owners will be approached to have an in-person meeting with study personnel 
to fully discuss the project, the activities and expectations and answer any questions or concerns. 
If the barbershop owner agrees to participate as a location, they will sign a Letter of Collaboration 
(Appendix 6A). The target will be 8 barbershops. 
  
Barbershops will meet these general selection criteria: a) NH black owner; b) estimated >95% 
black male clientele as reported by the owner; c) 10+ years in business; d) barbers’ commitment 
to the study; and e) large enough clientele to enroll >7 patrons with high BP. 
 
Once a barbershop has agreed to participate, each barber working within that shop will be 
approached for participation in the study as a barber (secondary participant). The only inclusion 
criteria are that the barber is fluent in English and willing to commit to training. They will be 
approached in person to discuss the activities of participation. All barber questions will be 
answered. If the barber agrees to participate, he will sign the VUMC IRB approved barber consent 
form. The barber will agree to participate in study training. If they do not complete study training, 
they will not participate. Barbers may withdraw from participation at any time by informing the 
study personnel verbally or in writing. 
 
4.2 Participant Inclusion & Exclusion Criteria for participants 
Inclusion criteria: 
a. Adults 35-79 years old 
b. Self-identify as Non-Hispanic black male  
c. Patron of one of the participating barbershops (> 4 haircuts in the last 6 months) 
d. Systolic BP > 140 mm Hg on two screening days at least one day apart 
 
Exclusion criteria: 
a. Severe cognitive impairment  
b. Non-fluent in English 
c. Women 
d. Age < 35 years or > 79 years 
e. Systolic BP < 140 mm Hg at either screening 
f. Currently receiving chemotherapy for cancer 
g. Organ transplant patient 
h. Currently receiving dialysis 
i. 
Other conditions the physician investigators deem unsafe to participate 
j. 
Plans to move/relocate in next 12-months and/or travel out-of-area for > 1 month  
 
4.2.1 Pre-screening and enrollment of participants 
Trained study personnel will screen the black male clientele of the study barbershops to identify 
and enroll regular patrons 35-79 years of age with systolic BP >140 on two screening days to 
participate in a 6-month trial of medication therapy management and BP monitoring in their 
barbershops.  
 
The research staff will be on-site in each barbershop and will offer free BP screening to all adults 
entering each barbershop for a total of approximately 4 weeks, or until recruitment targets have 
been met for each barbershop. Those with systolic BP >140 mm Hg will be asked to return within 
3 weeks to: (a) complete a 2nd set of BPs, (b) complete the visit screening questionnaires (see 
Appendices 6B.1-6B.2), and (c) bring their pill bottles to screening visit 2 so that medication data 
can be transcribed.  

 
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Eligible participants at screening visit 2 will be offered the opportunity to participate in the study. 
An informed discussion will occur with the study personnel during which all questions may be 
answered. If the participant agrees, written informed consent will be obtained emphasizing this is 
a voluntary study and participation may be withdrawn at any time. 
 
The participant’s existing physician (VUMC) or Dr. 
 (or other study physician), must sign 
the collaborative practice agreement (see Appendix 3) for the pharmacist to provide care and also 
to prescribe medications within this study protocol. All participants in this study will execute a visit 
with the study MD for an evaluation to establish care, supported by the funding for this proposal 
(e.g. NIH).  If the participant is seen by a VUMC physician, and that physician would prefer to 
serve as the supervising physician of the pharmacist including all regulatory oversight this will be 
permitted. These visits will be performed after enrollment, but prior to any hypertension 
management. 
 
Interviewers will invite patrons who screen-fail to join a new separately VUMC IRB approved 
registry (IRB# 191374) by giving their informed written consent to be re-contacted about their 
potential participation in future research studies. Those completing the 6-month HTN study also 
will be invited to join the registry.  
 
4.3 Participant member cards 
Participants enrolled in the study will be given information about the study and this may include a 
study member card inclusive of study contact information. 
 
5. Study Intervention 
5.1 Blood pressure readings by barbers 
Barbers will participate in training prior to implementation of the trial. This training will include skills 
training on BP measurement and use of the BP machine, the study protocol, and educational 
counseling for participants. The training will be performed by either collaborating researchers from 
the UCLA-CS CTSI or from local study personnel, led by the local study clinical pharmacist or an 
investigator.  
 
Barbers will frequently check and transmit the BP readings (See Section 5.4) of their enrolled 
patrons and motivate them to work with the clinical pharmacist, who will meet them in their 
barbershops or other mutually agreed location to optimize BP medication.  
 
5.2 Clinical Pharmacist evaluation and counseling 
With the VUMC or study physicians’ permission and oversight, 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 participants’ physicians with their permission, 
and ensure appropriate safety monitoring after each medication change. The study clinical 
pharmacist will follow the trial’s medication algorithm, which is consistent and not different than 
standard of care. The pharmacist will preferably be certified as a Clinical Hypertension Specialist 
from the American Society of Hypertension.  
 
The pharmacist will meet each participant in his barbershop or other mutually agreed location 
every week at first and then less often (monthly) once the target BP goal has been achieved. The 
pharmacist will send progress notes to the participants’ physicians after each encounter. 
Pharmacist will share treatment/BP reports with enrolled participants during their visits. These 
reports are generated by the data collection center (UCLA) and shared with the study team. 
(Appendix 6G). The pharmacist will work with the research assistant to schedule participant 

 
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appointments with the pharmacist, make reminder calls, and obtain or share medical records from 
the participants’ physicians. 
 
5.3 Role model posters 
Prior research has shown that role model posters of actual study participants contributes to 
successful retention of participants throughout the trial. The Nashville pharmacist and study team 
will interview the participants and those who achieve BP control will be invited to become a study 
role model.  
 
If they agree, the research assistant will take a photograph of the role model, and (with the model’s 
approval) have the poster generated at a copy shop and place it on the wall of the barbershop. 
Each poster models one of two desired behaviors (have the barber check the BP after every 
haircut or meet the pharmacist in the barbershop), and, in the model’s own words, briefly states 
one common barrier to the behavior change, one facilitating factor, and one positive outcome.  
 
5.4 Blood Pressure measurement and data transmission 
UCLA-CS will supply Nashville with Barbershop BP Carts. These nurses’ carts are modified with 
a highly-rated automated BP monitor that is programmed to take 5 readings, which upload 
immediately to a desktop computer that automatically transmits the readings by secure internet 
to the Westat server in Rockville, MD; then de-identified data are transmitted every evening to the 
UCLA-CS CTSI under the supervision of Dr. 
, or approved personnel at UCLA. Westat, 
Inc. is the data management company that collaborated with the LA Barbershop study and will 
offer ongoing support to this study, leveraging its already developed methodology.  
 
5.5 Laboratory Measurement  
Vanderbilt General Clinical Research, or a licensed trained clinician, will perform phlebotomy and 
facilitate lab services for study participants as needed. Most Common will be serum basic 
metabolic panel, but others may be considered as clinically indicated. Study pharmacist will 
review laboratory results, consult the physician, and determine an appropriate medication 
regimen for the subject based on the laboratory results. The pharmacist or study physician will 
generate relevant orders as needed & complete medical record documentation  
 
5.6 Monitoring the fidelity of the Intervention 
Treatment fidelity involves three components: 1) treatment delivery, 2) receipt, and 3) enactment. 
Treatment delivery by barbers (BP checks) will be assessed by the pharmacists who will provide 
extra training during the first intervention week. After observing a mock barber-patron interaction, 
the assistant will complete detailed checklists to evaluate performance of the desired 
competencies and intervention delivery, followed by constructive feedback.  
 
Treatment delivery by pharmacists will be reviewed by our HTN specialists (Dr. 
 or other 
study designated physician), who will review with the pharmacists each week their progress notes 
to ensure adherence to the study algorithm as well as perform quality performance review. 
Treatment receipt will be assessed a) by pharmacists during each in-person visit by reviewing 
shared goals with patrons and their understanding of BP levels and medications; and b) by patient 
satisfaction scores at a 6-month evaluation. Treatment enactment will be monitored throughout 
the trial by numbers of barber encounters, pharmacist encounters, and model posters. 
 
6. Ascertainment of Outcomes 
6.1 Recruitment and retention of black men 
All people screened at each of the screening days will be tabulated and descriptive statistics 
performed. For those that enroll, their activities throughout the 6-month study timeline will be 

 
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7. Study Procedures and Visits 
7.1 Screening 
Identification and consenting of eligible patrons for the HTN pilot study will be performed by 
research coordinators trained in BP measurement, study procedures, research ethics, and 
cultural competency. 
 
7.1.1 Initial screening day 
For the 1st month of the study, all adult black men entering the study barbershop will be offered 
free BP screenings. This will be in person. Men with systolic BP >140 mm Hg will be asked to 
return within 3 weeks for a second screening visit. They will be given a reminder appointment 
card. The research team member will call the potential participant to remind them of SV2 
appointment no more than 3 times in the eligibility interval. All men completing this initial screening 
visit will receive a water bottle or other similar gift as a token of appreciation. The script and 
content of the screening visit are described in Appendix 6B.1 (Screening Visit 1 Survey). All data 
collected in this screening visit will be directly entered into the on-site study computer to a secure 
web portal specific to this study. This is managed by study collaborator Westat, Inc.  
 
In addition, all men completing the first screening visit (regardless of their eligibility to join the HTN 
pilot trial), will be invited to join a registry by providing their contact information and informed 
written consent to be re-contacted about their potential participation in future research studies. 
This is a separate IRB approved study with its own procedures and documents (Patients’ 
Research Networking and Engagement Registry for Cardiovascular and Kidney Disease; 
PARTNER CKD; VUMC IRB# 191374). 
 
7.1.2 Second screening day 
Those invited to participate in the second screening visit will be asked to: (1) complete a 2nd set 
of BP measurements and health questionnaire (Appendix 6B.2; Screening Visit 2) and (2) bring 
their pill bottles to the barbershop for interviewers to transcribe medication data. Subjects with 
systolic BP >140 mmHg on both days who meet all other inclusion criteria will be enrolled after 
informed written consent has been obtained by the research coordinators. 
 
7.1.3 Enrollment & Initial activities 
Informed consent will be obtained, and the participant will provide written documentation.  
 
Visit questionnaires for baseline (Appendix 6B.2), 3-month telephone visit, and 6-month endpoint 
assessment visits will be completed by research coordinators when they interview subjects in 
barbershops, or by telephone interview. The data will include detailed demographic and 
identification information: marital status, phone number, address, and email address. Structured 
response items will include barbershop patronage, hypertension/medication history, comorbid 
conditions/family history, medication adherence, quality of life, health care access and utilization, 
and satisfaction with medical care. Five BP measurements will be taken and recorded at baseline 
using the same cuff size as recorded at screening.  
 
7.1.4 Intervention from enrollment through 6-months 
Pharmacist Progress Note forms will be completed by the pharmacist after each visit. This will be 
entered into a REDCap database maintained at VUMC by the VUMC study personnel. Data will 
include past medical history, medication allergies, list of current medications, subjective 
comments, objective observations, 5 blood pressure measurements, assessment, and plan. In 
addition, pharmacist will go through a complete checklist of medication-related problems, which 
is included in the Progress Note, at each encounter (see Appendix 6D & 6E). A checklist of 
actions/interventions will also be completed. If an adverse event is reported, the pharmacist will 

 
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complete an Adverse Event form. Pharmacist and/or physician will also record all necessary 
information in the VUMC electronic medical record. 
 
The research team will attempt to contact subjects who have not had a haircut in 4 weeks. We 
will make phone calls and send reminder cards to complete the pharmacist visits as well as 3-
month telephone and 6-month data collection. 
 
7.1.5 Study close visit (6-months) 
The research assistant will perform a blood pressure assessment and questionnaires as in 
Appendix 6B.4. 
 
Data will be collected on performance and acceptability of the study protocol using open ended 
interview questions. 
 
7.1.6 Barber survey 
All participating barbers will be asked to complete a brief survey about their experiences in the 
study (Appendix 6B.5). This data will be collected in REDCap and by hard copy and summarized 
for descriptive reporting. 
 
7.2 Client compensation 
Participants will be offered $25 at the completion of the second screening visit regardless of 
eligibility. Participants will be offered $25 for each visit completed with the study physician or the 
clinical pharmacist (up to 6 visits; the participant may have additional visits if needed without 
additional compensation), $15 for the telephone interview and $100 at the completion of the final 
6-month visit. Participants will also be offered a monthly $25 haircut voucher in addition to the 
above. The total potential compensation if all study activities are completed is $440 (direct 
payment and haircut vouchers). Participants may be asked to complete a W-9 form to receive 
payment. 
 
Mode of compensation will be through a Subject Participation Debit card program and / or pre-
paid gift cards, or check.  
 
7.3 Barber and barbershop compensation 
Each barbershop will receive a flat fee of $1000.00 ($500.00 at the beginning of the study and 
$500.00 after study completion). Each barber will receive $10.00 per BP measurement per client 
for up to 2 maximum per month for 6 months. Given that each barbershop will have approximately 
7 participants, this would equate to $840.00 per shop (14 x 6 months = 84 BP measurements = 
$840.00 per shop). Barbers will also redeem submitted study hair cut vouchers ($25.00/each). 
Barbers and barbershops may be asked to complete a W9 form to receive payment. Payment will 
be by check, or prepaid gift card for activity over the prior month. 
 
8. Statistical Analysis Plan 
Primary analysis (clinical outcomes):  
Since this study has no comparison group, our initial analysis will focus on estimating the average 
change in systolic BP from baseline to 6 months and derive its 95% confidence interval, that is, 
our goal is to estimate 𝑑 =  𝐸[𝑆𝐵𝑃6𝑚 – 𝑆𝐵𝑃0], where E stands for expectation, and 𝑆𝐵𝑃0 and 
𝑆𝐵𝑃6𝑚 denote baseline and 6 months systolic BP, respectively. Let 𝑑𝑖𝑗 be the systolic BP change 
score from baseline to 6 months on individual j in barbershop i. Define 

 
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𝑑̅𝑖=
∑
𝑑𝑖𝑗
𝑚𝑖
𝑗=1
𝑚𝑖
 
the observed mean change of systolic BP in barbershop i, where 𝑚𝑖 is the sample size for 
barbershop i. An estimate of 𝑑 can be derived using weighted average of 𝑑̅𝑖 over all the 
𝑛 barbershops (𝑛 = 8 in this study). The optimal weights are given by the reciprocal of the variance 
of each cluster summary:22 
𝑤𝑖=
𝑚𝑖
1+ 𝜌(𝑚𝑖−1), 
 where 𝜌 is the intracluster correlation coefficient (ICC). Thus, we estimate 𝑑 by 𝑑̅: 
𝑑̅ =
∑
𝑤𝑖𝑑̅𝑖
𝑛
𝑖=1
∑
𝑤𝑖
𝑛
𝑖=1
. 
The 95% confidence interval is given by 𝑑̅  ± 𝑡𝑣,0.025 𝑠𝑤/√∑
𝑤𝑖
𝑛
𝑖=1
, where the degrees of freedom 
𝑣 for the t-distribution is ∑
𝑤𝑖
𝑛
𝑖=1
−1 and 𝑠𝑤 is the square root of the empirical variance estimate 
calculated as  
𝑠𝑤2 =
∑
𝑤𝑖(𝑑̅𝑖−𝑑̅)2
𝑛
𝑖=1
𝑛−1
. 
Secondary Analyses: 
Three sets of secondary analyses will be conducted. First, we will examine the impact of baseline 
covariates on the outcome. We will focus on the same covariates used in the LA Barbershop 
study: baseline systolic BP, high cholesterol (yes/no), and whether there is a doctor for routine 
medical care (yes/no). Graphs for blood pressure trajectories and latent class growth analysis will 
be used to classify the participants into those who respond well to the intervention and those who 
do not respond well. Important covariates that predict participant’s response will be identified via 
logistic regression. Second, we will conduct longitudinal analysis of serial systolic BP obtained on 
each individual from baseline to 6 months via linear mixed effects models. The analysis will adjust 
for the covariates identified above. We will examine the trend (trajectory) by graphical tools and 
model it accordingly. This will be done for each barbershop separately. Third, we will compare 
data from this study with the intervention arm of the LA Barbershop study to see if there is a 
systematic difference. The comparison will be done for the change score of systolic BP at 6 
months as well as the longitudinal measurements of systolic BP. If no systematic difference is 
found, systolic BP data from this study will be merged with the intervention arm of the LA 
Barbershop study, and this combined intervention group will be compared to the control arm of 
the LA study via the same analytic approach in our previous publication.23 
Additionally, the PACIC and ARMS data will be reported descriptively. Unadjusted correlations 
between baseline characteristics and each of these measures will be performed. In exploratory 
analyses only, we will also examine correlations between baseline PACIC and BP outcomes. We 
will also describe any changes in the PACIC or ARMS scores over the two visits during the study.  
Plan for handling missing data 
We expect missing BP data due to dropout and/or intermittent missing data at the individual level 
but not at the shop level, where dropout is expected at baseline when accrual targets are unmet; 
after baseline, missing data will be from individuals not shops. The following analyses will be 

 
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conducted if the rate of missing data exceeds 10% at 6 months. Without knowing the exact 
missing data mechanism beforehand, we will compare results of two sets of analyses: (1) The 1st 
set is based on multiple imputations, i.e., missing BP data “filled in” by imputed values. Five 
imputed datasets are generated by the Markov Chain Monte Carlo method.24 Analysis will be 
conducted within each imputed dataset using linear mixed effects models. Results of imputed 
datasets will be combined to produce final estimates. This approach assumes data are missing 
at random (MAR): the mechanism that gives rise to missing data relies on observed data only. 
However, missing data from cohort attrition and intermittent missing data due to low treatment 
efficacy may be missing not at random (MNAR); the probability of missing data may be related to 
unobserved (and possibly high) BP. Here the multiple imputation method will produce biased 
efficacy estimates. (2) The 2nd approach relies on joint modeling of longitudinal BP data and 
missing data mechanisms for dropout and intermittent missing data MNAR.25 Latent random 
variables are used to associate linear mixed effects model of longitudinal outcome to missing data 
mechanisms. Thus, the MAR mechanism is a special case under this general joint model, which 
potentially allows comparison with multiple imputation results. But if the two approaches produce 
different results, missing data are likely MNAR and results from the joint model will be used. To 
handle missing data, we employ a less restrictive assumption that missing data are non-ignorable, 
where the probability of missingness is related to unobserved data. Extending from prior literature, 
we allow missingness probability depending on latent compliance category and unobserved 
outcomes. Note that this is a pre-test/post-test design; thus, the identification of missing data 
models is not as powerful as it would be in a longitudinal design. 
9. Adverse Events 
9.1 Potential Adverse Events from study interventions 
The likelihood of adverse events beyond those that may be expected as a result of hypertension 
medication management are minimal.  
 
Loss of confidentiality is a serious risk in any clinical research; however, is not likely given the 
safeguards we have established to protect and maintain the research data collection, 
transmission, and storage. 
 
Anxiety is a rare and typically not serious potential risk associated with high BP caused by learning 
that one’s BP is elevated. Study personnel will undergo training in all study procedures which will 
include appropriate interaction with subjects. 
 
Uncontrolled hypertension is associated with increased risks of known hypertensive 
complications including cardiovascular events, stroke, heart failure, and chronic kidney disease. 
These risks are not due to study procedures but are intrinsic to the condition of all subjects being 
enrolled. The purpose of our study is to reduce these risks by better management of HTN.  
 
During the data collection periods (baseline, 6-month follow-up), all subjects will receive a form 
with their BP reading, an explanation of the accepted cutoff values for normal and high BP, and 
suggestion for medical follow-up based on the degree of elevation as below: (Appendix 6C) 
▪ 
For normal BP range of below 120/80 mm Hg, subjects are advised to see a doctor at 
least once a year to maintain good health. 
▪ 
For high normal range BP of 120/80 mm Hg -139/89 mm Hg, subjects are advised to see 
a doctor within 6 months. 
▪ 
For elevated BP range of 140/90 mm Hg -159/99 mm Hg, subjects are advised to see a 
doctor within the next 1 month. 

 
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▪ 
For very elevated BP range of 160/100 mm Hg -179/109 mm Hg, subjects are advised to 
see a doctor within the next 2 weeks. 
▪ 
For extremely elevated BP range of 180/110 mm Hg -199/119 mm Hg, subjects are 
advised to see a doctor in the next 3 days. 
▪ 
For alarmingly elevated BP of 200/120 mm Hg or higher, subjects are advised to see their 
physician urgently or go to the nearest emergency room. 
 
During the intervention period, subjects will be referred to the pharmacist for personalized health 
management and to their barber for frequent BP monitoring and social support. The risks of 
uncontrolled HTN are not due to study procedures but are intrinsic to the condition of all subjects 
being enrolled.  
 
Adverse drug reactions:  
Although not common, there are potential serious adverse drug reactions associated with BP 
medication, but the most common side-effects from blood pressure medication are not serious 
and resolve within three days after the medication has been stopped. In addition, excessive fall 
in blood pressure is a potential serious risk of any blood pressure medication. 
 
9.2 Monitoring for Adverse Events 
Adverse Events procedures and forms are included in the Appendix (Appendices 8-12). These 
forms include description of the event, event onset and end date, disease-related complications, 
checklist of drug or non-drug related events, severity scale, whether or not the event was related 
to study procedures, event pattern, actions taken with study drug, whether or not hospitalization 
and/or medication(s) were required. 
 
To track potential adverse events from added medications, pharmacist will 1) provide details 
about potential adverse reactions to each drug prescribed, 2) instruct subjects to call the 
pharmacist immediately if they suspect an adverse drug reaction, 3) reduce or stop medication if 
systolic BP falls below 110 mmHg or diastolic BP falls below 60 mmHg as recommended by all 
current practice guidelines, 4) make an additional follow-up phone call one week after medication 
changes, 5) go through a complete check list of potential adverse events at each encounter (in 
person visit and via telephone) to assess the presence and severity of all reported reactions, 6) 
send a detailed Progress Note (Appendix 6D & 6F) to the subjects’ physicians after every in-
person and telephone encounter with the subjects. The Progress Note used for the in-person and 
telephone encounters will have a complete check list of potential adverse drug reactions to every 
class of blood pressure medication included in the signed treatment protocol. The adverse drug 
reaction check list includes the following items: 
▪ 
Calcium channel blocker: lower extremity edema, bradycardia, hypotension, gingival 
hyperplasia 
▪ 
Angiotensin converting enzyme inhibitor/angiotensin receptor: cough, hyperkalemia, 
acute renal failure, alopecia, angioedema 
▪ 
Thiazide/thiazide-like diuretic: erectile dysfunction, hyperglycemia, hyperuricemia, gout, 
hypokalemia, hyponatremia 
▪ 
Vasodilating beta-blocker: wheezing, erectile dysfunction, depression, heart block 
▪ 
Aldosterone antagonist: gynecomastia, hyperkalemia, acute renal failure, erectile 
dysfunction 
▪ 
Alpha blocker: dizziness, orthostatic hypotension, lower extremity edema, heart failure 
▪ 
Centrally acting sympatholytic: rebound hypertension, dry mouth, somnolence 
▪ 
Direct Vasodilator: headache, palpitations, shortness of breath, lupus (hydralazine), 
pericarditis (hydralazine) 
▪ 
Loop diuretic: acute renal failure, hypokalemia 

 
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In addition, the study physicians will meet regularly with the pharmacist to review Progress Note 
and ensure protocol adherence. Subjects will receive detailed instructions from the pharmacist 
about potential adverse reactions to each drug prescribed and to call the pharmacist immediately 
if they suspect an adverse drug reaction. This will occur locally at VUMC. In addition, the study 
physician at Cedars Sinai will review de-identified progress notes for adherence to the study 
hypertension algorithm and to offer any further oversight recommendations. 
 
9.3 Reporting of Adverse Events 
When a serious adverse event is reported pharmacist will complete the Adverse Event form 
immediately and will submit it to the IRB within 24 hours of the event. This will include notification 
of the study PI, the overseeing physician, and review by the DSMB of if the event is or may be 
related to the study activities. 
 
Pharmacist will instruct subjects experiencing non-serious adverse events to discontinue the 
medication causing the adverse event and will call these subjects back 3 days later to ensure that 
side-effects have completely resolved. All encounters will be documented as described above. 
Pharmacist will instruct subjects to call 911 and go to the nearest emergency room for any 
symptoms suggestive of heart attack, stroke, other serious medical condition, or extremely rare 
serious adverse events from BP medication (e.g., severe angioedema from an ACE inhibitor). 
 
10. Data Management 
10.1 Data coordinating Center and Data Entry Overview 
The coordinators/study personnel and the pharmacist will collect and transmit data electronically 
via a secure internet connection to the existing Westat server, which transmits the data to the 
UCLA CTSI Data Coordinating Center. 
 
Data collected by the designated pharmacist on the Progress Note will be collected and 
maintained in a VUMC REDCap Study database. This deidentified dataset will be shared with the 
coordinating center (UCLA) and other approved study investigators. Pharmacist Progress Note; 
copies of Adverse Event and Study Completion/Termination forms; copies of surveys conducted 
by research coordinators; copies of informed consent forms/HIPAA waivers; authorization for 
release of medical records; medical records sent by the subjects’ physicians; transmitted barber 
BP measurements; and signed collaborative practice agreements will be placed in the subject’s 
research chart which will be stored in a locked cabinet only accessible by the research team and 
maintained indefinitely. Hard copies of informed consent documents will be stored in a secured 
locked cabinet at Vanderbilt University Medical Center - Center for Health Services Research. 
Additionally, electronic files may be stored on password protected Center for Health Services 
Research servers that are only accessible to approved study personnel. 
 
The following individuals will have access to individually identifiable private information about 
human subjects: VUMC study personnel as designated to the IRB will have access to the data 
collected at screening, baseline, 3-month and 6-month assessment visits. The data management 
team, Westat Inc, will have access to identified information during screening and the study data 
collection. The database manager at the UCLA DCC will have access to the data collected by 
research coordinators but these will be de-identified. The pharmacist will have access to the data 
collected by research coordinators, data provided by the subject’s own physician, the BP 
measurements transmitted by the barber, and the information obtained directly from the subject. 
The study subject’s own physician will have access to the data collected by the barber and by the 
pharmacist. 
 

 
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10.2 Computer and Data Security 
Interviewer teams will collect the data on forms programmed onto the Westat CAPI Device that is 
a web-based portal and will be accessible only to approved and trained study personnel. To 
protect private health information: 1) each potential subject is given a unique code name upon 
screening, 2) CAPI devices are password protected; the data are continually uploaded to a 
secured server and the laptop is automatically erased- if the laptop is stolen, it contains no data; 
3) the survey data are encrypted and transferred via a secure web-based system to the data 
management software and hardware systems at Westat’s Rockville, Maryland central offices. 
Periodically, the encrypted de-identified data are transferred to the DCC at UCLA,  4) once the 
UCLA data manager reviews the validity and completeness of data, the data is deleted from the 
Westat servers and maintained solely at UCLA; 5) the linking file to PHI is locked and stored at 
Vanderbilt. Except for the Westat system, all other data management elements have been used 
in many previous NIH trials. Westat’s system has been used in many previous research projects. 
 
11. Study Oversight 
This trial will be monitored by the same DSMB board monitoring as The LA Barbershop Blood 
Pressure Study (R01 HL 117983), and it will utilize a similar DSMB plan. The DSMB is responsible 
for safeguarding the interests of study participants by assessing the safety and efficacy of study 
procedures, and by periodic monitoring of safety data and the overall conduct of the study. The 
DSMB reviews the following types of safety data: 1) quarterly reports from the UCLA DCC; 2) 
annual reports from DSMB meetings; and 3) expedited reports from the PI on individual SAE/UPs 
or concerning trends identified by the Physician Monitors. After reviewing pertinent reports, the 
DSMB determines whether any trend that may be identified is related to the trial. After each DSMB 
meeting, the study team will prepare a draft report for the  DSMB Chair to review and sign.  The 
VUMC PI will transmit it to the VUMC IRB. The report summarizes the recommendations of the 
DSMB regarding the safety and continuance of the study and should be sent to the PI within 60 
days after a DSMB meeting. If the DSMB identifies a concerning safety trend related to the trial, 
the Board makes a recommendation to NIH NCATS through the NCATS Project Officer, and to 
the PI, who will transmit the recommendations to the IRB at Vanderbilt and Westat. This 
recommendation includes actions that should be taken to protect current and potential 
participants. The DSMB is chaired by 
 (licensed pharmacist and board-
certified pharmacotherapy specialist) who is experienced with DSMBs. Other DSMB members 
are 
 (Emeritus Professor of Biostatistics, Cornell University, Ithaca, New 
York) and 
 (Professor of Medicine/Cardiology, Tulane University School of 
Medicine, New Orleans, Louisiana). 
 
 
 

 
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REFERENCES 
 
1. 
Barnett, E., et al., Men and heart disease: An atlas of racial and ethnic disparities in 
mortality. 2001. 
2. 
Prevention, U.S.D.o.H.a.H.S.C.f.D.C.a. A Closer Look at African American Men and High 
Blood 
Pressure 
Control. 
2018; 
Available 
from: 
http://www.cdc.gov/bloodpressure/docs/african american sourcebook.pdf. 
3. 
Randolph, T.C., et al., Associations Between Blood Pressure and Outcomes Among 
Blacks in the Jackson Heart Study. J Am Heart Assoc, 2016. 5(12). 
 
4. 
Go, A.S., Heart Disease and Stroke Statistics-2013 Update: A Report From the 
American Heart Association (vol 127, pg e6, 2013). Circulation, 2013. 127(23): p. E841-
E841. 
 
5. 
Jones, L. and K. Wells, Strategies for academic and clinician engagement in community-
participatory partnered research. JAMA, 2007. 297(4): p. 407-10. 
 
6. 
Merrill, R.M. and O.W. Brawley, Prostate cancer incidence and mortality rates among 
white and black men. Epidemiology, 1997. 8(2): p. 126-31. 
7. 
Victor, R.G., et al., The Dallas Heart Study: A population-based probability sample for the 
multidisciplinary study of ethnic differences in cardiovascular health. American Journal of 
Cardiology, 2004. 93(12): p. 1473-1480. 
8. 
Victor, R.G., et al., Factors associated with hypertension awareness, treatment, and 
control in Dallas County, Texas. Arch Intern Med, 2008. 168(12): p. 1285-93. 
9. 
Svarstad, B.L., et al., Improving refill adherence and hypertension control in black patients: 
Wisconsin TEAM trial. J Am Pharm Assoc (2003), 2013. 53(5): p. 520-9. 
10. 
White, R.M., Unraveling the Tuskegee Study of Untreated Syphilis. Arch Intern Med, 2000. 
160(5): p. 585-98. 
11. 
Wang, J.G., et al., Systolic and diastolic blood pressure lowering as determinants of 
cardiovascular outcome. Hypertension, 2005. 45(5): p. 907-13. 
12. 
Victor, R.G., et al., A Cluster-Randomized Trial of Blood-Pressure Reduction in Black 
Barbershops. New England Journal of Medicine, 2018. 378(14): p. 1291-1301. 
13. 
Franklin, S.S., Cardiovascular risks related to increased diastolic, systolic and pulse 
pressure - An epidemiologist's point of view. Pathologie Biologie, 1999. 47(6): p. 594-603. 
14. 
Franklin, S.S., et al., Single versus combined blood pressure components and risk for 
cardiovascular disease: the Framingham Heart Study. Circulation, 2009. 119(2): p. 243-
50. 
 
15. 
Parati, G., et al., European Society of Hypertension practice guidelines for home blood 
pressure monitoring. J Hum Hypertens, 2010. 24(12): p. 779-85. 
 
16. 
Whyte, J.L., et al., The challenge of controlling systolic blood pressure: data from the 
National Health and Nutrition Examination Survey (NHANES III), 1988--1994. J Clin 
Hypertens (Greenwich), 2001. 3(4): p. 211-6. 

 
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17. 
Anwar, Y.A., et al., Evaluation of the Datascope Accutorr Plus according to the 
recommendations of the Association for the Advancement of Medical Instrumentation. 
Blood Press Monit, 1997. 2(2): p. 105-110. 
 
18. 
Kronish, I.M., et al., Meta-analysis: impact of drug class on adherence to 
antihypertensives. Circulation, 2011. 123(15): p. 1611-21. 
 
19. 
Glasgow, R.E., et al., Development and validation of the Patient Assessment of Chronic 
Illness Care (PACIC). Med Care, 2005. 43(5): p. 436-44. 
20. 
Kripalani, S., et al., Development and evaluation of the Adherence to Refills and 
Medications Scale (ARMS) among low-literacy patients with chronic disease. Value 
Health, 2009. 12(1): p. 118-23. 
21. 
Andresen, E.M., et al., Retest reliability of surveillance questions on health related quality 
of life. J Epidemiol Community Health, 2003. 57(5): p. 339-43. 
22. 
Hayes, R.J. and L.H. Moulton, Cluster randomised trials. 2017: Chapman and Hall/CRC. 
 
23. 
Wong, M.D., et al., The contribution of specific causes of death to sex differences in 
mortality. Public Health Reports, 2006. 121(6): p. 746-754. 
 
24. 
Elashoff, R. and N. Li, Joint modeling of longitudinal and time-to-event data. 2016: CRC 
Press. 
 
25. 
Schafer, J.L., Analysis of incomplete multivariate data. 1997: Chapman and Hall/CRC. 
 
 

 
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APPENDIX 1: PARTICIPATING VUMC RESEARCHERS IN ADDITION TO PRINCIPAL 
INVESTIGATOR 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 

 
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 APPENDIX 3: CLINICAL PHARMACIST COLLABORATIVE PRACTICE AGREEMENT  
Collaborative Pharmacy Practice Agreement 
“Implementing the Los Angeles Barber-Pharmacist Model of Hypertension 
Management in Nashville” Study 
Medical Director: 
 
Definitions 
Collaborative Pharmacy Practice Agreement (“Agreement”): A formal, voluntary and mutual 
agreement between the pharmacist and healthcare providers listed herein to provide collaborative 
patient care services, optimize medication use, and achieve desired patient outcomes to patients 
under the care of Prescribers, and whose patients  are participants in the study titled 
“Implementing the Los Angeles Barber-Pharmacist Model of Hypertension Management in 
Nashville” for the treatment of hypertension. This Agreement defines the scope of patient care 
services authorized to be provided by the pharmacist, as well as the specific patient populations, 
prescription drugs, and diseases and conditions covered under this Agreement. 
Collaborating Professionals: Pharmacist and Prescribers, as defined below. 
 
 
  
 
   
Collaborative Pharmacy Practice Agreement 
I. 
Collaborative Pharmacy Practice and Pharmacist Qualifications. Each Pharmacist 
named above is authorized to provide professional services within the scope of pharmacy 
practice as defined under Tennessee state law and within the collaborative pharmacy 
practice guidelines as described under this Agreement. Each Pharmacist (i) has been 
awarded a Doctor of Pharmacy degree from a program accredited by the Accreditation 
Council for Pharmacy Education, or has been awarded a Bachelor of Science in pharmacy 
and been in the continuous, active practice of pharmacy; and (ii) holds a current 
unrestricted license in good standing to practice pharmacy in the State of Tennessee. 
II. 
Pharmacist Scope of Services. The Pharmacist is authorized to provide the collaborative 
pharmacy services (“Services”) as further described in Exhibit A, attached hereto and 
incorporated herein, as it relates to the care of Prescribers’ patients who Prescribers have 
identified as subject to the collaborative treatment plan in accordance with Section XII. 
 
 

 
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III. 
Pharmacist Responsibilities. 
A. 
Provide all Services in accordance with this Agreement under the 
supervision of, or in direct consultation with the applicable Prescriber and 
maintain contact with and document communication with each Prescriber; 
B. 
Provide Services only to patients for whom a current patient referral has 
been provided by Prescriber in accordance with Section XII; 
C. 
Document all services in the medical record on the same day the service is 
provided, including but not limited to patient/family education, patient 
assessments and plans and all medication orders; 
D. 
Utilize an area for in-person, telephonic or other approved consultations with 
patients that ensures the confidentiality of the communication; 
E. 
When issuing a prescription order, as defined in T.C.A. § 63-10-204, or 
medical order, as defined in T.C.A. §63-10-204, issue the prescription order 
or medical order in accordance with the requirements set forth in T.A.C. 
§ 1140-03-.03 and within the terms set forth in this Agreement; 
F. 
Provide documentation of an initial prescription or a modification or 
discontinuation of a prescription to the Prescriber within 24 hours of 
issuance through the medical record, unless more urgent notification is 
required under the circumstances and note the action taken in the patient’s 
medical record; 
G. 
Comply with all of the policies and procedures applicable to Vanderbilt 
University Medical Center (“VUMC”) pharmacy staff, all Tennessee Board of 
Pharmacy rules and regulations, all guidelines, rules and standards of 
practice of the Tennessee Board of Medical Examiners, the Tennessee Board 
of Osteopathic Examiners, and all other Tennessee Health Related Boards, 
and all applicable laws and regulations governing the rendering of Services 
hereunder; and 
H. 
Complete at least ten (10) hours of the biennially required thirty (30) hours 
of continuing education in topics related to the clinical practice of 
pharmacy, as mutually determined by the Collaborating Professionals.  
IV. 
Prescriber Responsibilities. 
A. 
Retain ultimate authority and professional responsibility for his/ her patients 
for the management of their drug therapy including routine review of 
pharmacy documentation in the electronic medical record. 
B. 
Establish and maintain a physician/provider-patient relationship with each 
patient receiving Services under this Agreement; 
C. 
Be available at all times through direct telecommunication for consultation, 
assistance and direction to the Pharmacist, or make arrangements for a 
substitute physician to be available; 

 
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D. 
Prepare a referral for each patient in accordance with Section XII and 
maintain the patient referral in the patient’s medical record; and 
E. 
Authorize only those Services within the routine scope of practice and 
services delivered by Prescriber to be provided by Pharmacist under this 
Agreement. 
V. Term and Termination. 
A. 
Term. This Agreement shall become effective on _____________, 201__ 
(“Effective Date”) and shall remain in effect for two (2) years. This Agreement 
shall automatically extend for additional terms of one (1) year each; 
provided, however, that the Agreement must be reviewed and updated at 
least every two (2) years as evidenced by signatures of all Collaborating 
Professionals, the Medical Director and the Pharmacy Director. 
B. 
Termination. This Agreement may be terminated at any time by mutual 
agreement of the Collaborating Professionals. Any individual Collaborating 
Professional may terminate his or her participation in this Agreement upon 
thirty (30) days written notice to the Medical Director and Pharmacy Director 
and all participating Collaborating Professionals. The Medical Director or the 
Pharmacy Director may terminate this Agreement immediately upon written 
notice to all other parties to the Agreement. 
C. 
Amendments. This Agreement may be amended, including the addition of 
prescriber(s) and pharmacist(s), by mutual agreement of all Collaborating 
Professionals, the Medical Director and the Pharmacy Director. 
VI. 
Termination of Collaborating Professional. A Collaborating Professional may be 
automatically excluded from participation in this Agreement upon the occurrence 
of any of the following, as determined by the Collaborating Professional’s 
supervisor in accordance with VUMC policies and procedures: 
A. 
If Collaborating Professional’s license to practice medicine or pharmacy in 
Tennessee, as applicable, is suspended, revoked, materially limited or not 
renewed. 
B. 
If Collaborating Professional’s right to prescribe is limited, suspended or 
revoked by VUMC or any applicable federal or state agency. 
C. 
If Collaborating Professional fails or refuses to abide by VUMC policies and 
procedures or the terms of this Agreement. 
D. 
If Collaborating Professional engages in “Willful Misconduct”. The term 
“Willful Misconduct” shall mean only (i) arrest or indictment for, or 
conviction of, any crime; (ii) disruptive, unprofessional, inappropriate or 
unethical conduct as determined by the Medical Director or Pharmacy 
Director, in his or her sole discretion; (iii) fraud or theft relating to the 
practice of medicine or pharmacy, or (iv) a determination made in good faith 
by VUMC that the Collaborating Professional has failed to provide adequate 
patient care or that the health, safety, or welfare of patients is jeopardized. 
E. 
If the Collaborating Professional is excluded from participation in any federal 
healthcare program. 

 
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F. 
If the Collaborating Professional consistently fails to meet the quality and 
performance measures set forth in Exhibit B in accordance with Section IX. 
VII. 
Documentation and Communication. All Services and communications related to each 
patient will be documented in VUMC’s electronic health record, which is accessible by all 
Collaborating Professionals. 
VIII. 
Method for Reporting Adverse Events to the Prescriber. All significant adverse effects 
or toxicities identified by the Pharmacist will be documented in the patient’s research 
record and communicated to the Prescriber in accordance with applicable VUMC policies 
and procedures. Significant events would include adverse events requiring therapy 
discontinuation planned for longer than 72 hours. 
IX. 
Quality Assessment. The Medical Director and Pharmacy Director shall evaluate the 
quality of care provided for the patients treated pursuant to the Agreement in accordance 
with the objective performance goals described in Exhibit B, attached hereto and made a 
part hereof by this reference. The results of the quality assessments shall be aggregated 
and reviewed by the Collaborating Professionals at least quarterly. In addition, the 
Prescribers shall also provide monthly patient record review consisting of at least five 
percent (5%) of his or her patients treated pursuant to the Agreement. The quality 
assessments performed pursuant to this Section IX shall be documented and retained by 
VUMC, and available for review by representatives of the applicable licensing boards for 
at least ten (10) years. All such quality assessments, reports, material and other 
documentation shall be created, used, annotated and maintained by a Quality 
Improvement Committee (QIC) pursuant to T.C.A. §§ 63-1-150 and 68-11-272. 
X. 
Override Protocol. A Prescriber shall override the actions taken by the Collaborating 
Pharmacist specific to services provided under the Agreement if he or she determines that 
the override is essential to the optimal health outcomes or safety of the patient and shall 
communicate such overrides to the Collaborating Pharmacist via VUMC’s electronic 
health record and to the patient in accordance with applicable VUMC policies and 
procedures. 
XI. 
Biannual Review. The Pharmacy, Therapeutics and Diagnostics (PT&D) Committee shall 
review this Agreement at least once every two years. 
XII. 
Patient Referrals. Each Prescriber must complete a referral for each patient, as described 
in Exhibit C, which shall include, but not be limited to, a drug-specific, disease or condition-
specific plan of care for the patient. The referral will be maintained in the patient’s medical 
record. VUMC pharmacy meets the definition of an Institutional-based pharmacy setting 
under T.C.A. § 1140-03-.17, and as such, is not required to obtain a general consent from 
patient’s subject to Collaborative Pharmacy Practice Agreements 
XIII. 
Medical Records. Each Collaborating Professional shall maintain appropriate, accurate 
and complete medical records and business records in accordance with applicable law 
and VUMC record retention policies. The medical records of the Services provided 
hereunder will be maintained for a period of at least ten (10) years. 
XIV. 
Accessibility. The Medical Director, Prescriber and Pharmacy Director shall maintain a 
copy of this Agreement, including any addendum, modification or termination at VUMC, 

 
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which shall be accessible to each Collaborating Professional and made available to the 
applicable regulatory board for review upon request. 
XV. 
Compliance with Laws. Each party represents and warrants that he or she shall comply 
with all applicable state and federal statutes, rules, regulations, including all laws and 
ethical principles concerning confidentiality of all individually identifiable health 
information, including, but not limited to, medical records. 
XVI. 
Written Attestation. The Medical Director and Pharmacy Director shall file a written 
attestation with the licensing boards for all Collaborating Professionals participating in this 
Agreement notifying those boards of the existence of this Agreement. The written 
attestation shall include the names of all signatories and Collaborating Professionals 
participating in this Agreement, the effective date of this Agreement and a description of 
the scope of the services covered by this Agreement. 
[Signature Pages Follow] 

 
 
 
 
 
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Collaborative Pharmacy Practice Agreement 
“Implementing the Los Angeles Barber-Pharmacist Model of Hypertension  
Management in Nashville” Study  
Signature Page 
 
The Pharmacy Practice Act allows pharmacists to practice under a Collaborative Pharmacy 
Practice Agreement with individual healthcare providers in order to provide patient care services, 
optimize medication use, and achieve desired patients’ outcomes. By signing this document, the 
named Physician(s) agree that the named Pharmacist may enter into a Collaborative Pharmacy 
Practice Agreement to provide care for their patients. 
PRESCRIBERS: 
___________________ 
 
_____________________________  
 
 
_____________________ 
[Insert Prescriber Name, Credentials, and Title] 
Date 
 
_____________________________  
 
 
_____________________ 
[Insert Prescriber Name, Credentials, and Title] 
 
 
Date 
 
_____________________________  
 
 
_____________________ 
[Insert Prescriber Name, Credentials, and Title] 
 
 
Date 
 
_____________________________  
 
 
_____________________ 
[Insert Prescriber Name, Credentials, and Title] 
 
 
Date 
 
 
PHARMACIST: 
 
________________________________ 
 
 
_____________________ 
[Insert Pharmacist Name, Credentials, and Title] 
 
 
Date 
 
[Additional Signature Page Follows] 

 
 
 
 
 
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COLLABORATIVE PHARMACY PRACTICE AGREEMENT APPROVED BY: 
MEDICAL DIRECTOR: 
________________________________ 
 
 
 
_____________________ 
[Insert Medical Director Name, Credentials, and Title] 
 
Date 
 
 
PHARMACY DIRECTOR: 
________________________________ 
 
 
 
_____________________ 
[Insert Pharmacy Director Name, Credentials, and Title] 
 
Date 
 
 
DATE APPROVED BY PT&D COMMITTEE: ______________ 
Expires 24 months from date of PT&D Committee VUMC Policy Reference: Collaborative 
Pharmacy Practice Agreements 
 
 

 
 
 
 
 
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Exhibit A 
Pharmacist Services 
A. Provide patient care and drug therapy management services to those patients who are 
being managed for hypertension. 
B. Provide drug therapy management services with respect to the medications commonly 
used to treat the above listed disorders. These medications may include angiotensin-
converting enzyme inhibitors, angiotensin receptor blockers, calcium channel blockers, 
diuretics, beta-blockers, aldosterone blockers, central sympatholytics, alpha blockers, 
nitrates or other vasodilators. Order medication-related laboratory tests or obtain results 
from a fingerstick using a CLIA-waived point of care device. These laboratory tests may 
include blood chemistry/electrolyte panels or serum creatinine.  
C. Obtain pertinent information about the patient’s medical condition including signs and 
symptoms of illness, past and present medications, adverse effects, and medication 
adherence. 
D. Continue, renew or order medications based on the below criteria: 
a. The medication is on patient’s medication list, or the Prescriber’s notes or other 
information documented in the patient’s medical record indicate need for 
medication. Controlled substances (Schedule 2-5) are not eligible under this 
Collaborative Pharmacy Practice Agreement. 
b. The patient must have been evaluated by a Prescriber in the within the past 6 
months and enrolled in the study titled “Implementing the Los Angeles Barber-
Pharmacist Model of Hypertension Management in Nashville.” For patients who 
are seen annually, the patient must have been seen within the past 12 months. 
c. Prior to authorizing a renewal of the medication, the Pharmacist evaluates the 
following: (i) Presence of medication on the patient summary and/or clinical 
communication, and (ii) Presence of requisite diagnostic testing or completed visit 
information. 
d. The Pharmacist may authorize renewals of an expired prescription previously 
prescribed by a Prescriber for up to 6 months. 
E. Authorize a change in prescriptions from 30-day supply to 90-day supply if requested by 
patient or required by insurance. 
F. Authorize a new prescription for dose or dosage form changes. 
G. Authorize prescriptions for new medications that are documented in a patient’s medical 
record but have not been generated as a prescription order.  
H. Discontinue medications causing clinically significant drug interactions or adverse 
reactions and report all such occurrences in accordance with Section VIII. 
I. Educate patients concerning disease states, medication benefits and potential adverse 
effects and toxicity, and medication adherence. 
 
 

 
 
 
 
 
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Exhibit B 
Quality Performance Review: Performance Metrics and Protocols 
Monthly Patient Record Review: 
 
Each month, the Collaborating Pharmacist will have 5% of treated patients reviewed by the 
authorizing Physician(s) for the following quality indicators: 
• 
Documentation of provider referral 
• 
Correct drug/therapy 
• 
Correct dose 
• 
Correct duration 
• 
Any prescription errors 
• 
Adherence to practice agreement requirements 
The reviewing Physician will communicate their findings with the pharmacist, Pharmacy Director 
and the Medical Director. Opportunities for improvement will be identified and implemented as 
appropriate. Monthly reports will be collated and included in the Quarterly Quality Assessments. 
Quarterly Quality Assessment: 
The Pharmacist and Medical Director meet quarterly in order to conduct a formal Quality 
Assessment of the Collaborative Pharmacy Practice Agreement in order to ensure that the patient 
care goals are being met and to identify opportunities for improvement. Such quarterly review 
shall include consideration of any changes necessary to the Agreement, authorized formulary, 
and patient orders, patient education and medication adherence strategies, increased or 
improved monitoring of side effects and the need for further testing and screening. In addition, 
data will be collected from the patient medical record for accuracy and completeness of treatment 
plans, and to meet the quality metrics specified below. 
Quality Indicators: 
• 
Medication history updated  
• 
Medication reconciliation documented 
• 
Allergy Documentation 
• 
Patient education documented 
• 
Summary of Adverse Drug Events reported 
• 
Quantitative review of number of patients cared for, new drug starts, drug or dose 
modifications, drug discontinuations and lab tests ordered 
• 
Any other quality assessments requested by Medical or Pharmacy Directors, 
Collaborating Providers, or Pharmacy, Therapeutics & Diagnostics Committee 
recommendations. 
The Quarterly Quality Assessment will be reviewed by the pharmacist, Pharmacy Director and 
Medical Director. Opportunities for improvement will be identified and implemented as 
appropriate. These reports will be presented to the appropriate Pharmacy & Therapeutics 
Subcommittee and Pharmacy, Therapeutics & Diagnostics Committee and retained for at least 
ten (10) years. 
 

 
 
 
 
 
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Exhibit C 
 
Pharmacy Collaborative Practice Referral Template 
Collaborating Prescribers document a referral for each patient subject to the Collaborative 
Pharmacy Practice Agreement in accordance with Section VII of the Agreement, which is 
maintained in the patient’s medical record, and the Collaborative Pharmacist provides services 
only to patients for whom a current patient referral has been provided by a Collaborating 
Prescriber. All patient referrals containing a drug-specific, disease or condition-specific plan of 
care shall be made part of each patient’s medical record. 
Collaborative Pharmacy Practice Referral – Participation in “Implementing the Los Angeles 
Barber-Pharmacist Model of Hypertension Management in Nashville” Study 
Collaborating Prescriber: ______________________ 
Collaborating Pharmacist: 
 
Date of Service: TBD 
I hereby refer this patient to the above-named Pharmacist(s) to carry out the plan of care stated 
in the electronic medical record for this patient per the criteria below.  
A. Provide patient care and drug therapy management services to those patients who are 
being managed for hypertension. 
B. Provide drug therapy management services with respect to the medications commonly 
used to treat the above listed disorders and order medication-related laboratory tests. 
These medications include angiotensin-converting enzyme inhibitors, angiotensin 
receptor blockers, calcium channel blockers, diuretics, beta-blockers, aldosterone 
blockers, central sympatholytics, alpha blockers, nitrates or other vasodilators. Order 
medication-related laboratory tests or obtain results from a fingerstick using a CLIA-
waived 
point 
of 
care 
device. 
These 
laboratory 
tests 
may 
include 
blood 
chemistry/electrolyte panels or serum creatinine. 
C. Obtain pertinent information about the patient’s medical condition including signs and 
symptoms of illness, past and present medications, adverse effects, and medication 
adherence. 
D. Continue, renew or order medications based on the below criteria: 
a. The medication is on patient’s medication list, or the Prescriber’s notes in the 
patient’s medical record indicate need for medication. Controlled substances 
(Schedule 2-5) are not eligible under this Collaborative Pharmacy Practice 
Agreement 
 
b. The patient must have been evaluated by the Prescriber within the past 6 months. 
For patients who are seen annually, the patient must have been seen within the 
past 12 months. 
 
c. Prior to authorizing a renewal of the medication, the Pharmacist evaluates the 
following: (i) Presence of medication on the patient summary and/or clinical 
communication, and (ii) Presence of requisite diagnostic testing or completed visit 
information. 
 

 
 
 
 
 
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d. The Pharmacist may authorize renewals of an expired prescription previously 
prescribed by a Prescriber for up to 6 months. 
 
E. Authorize a change in prescriptions from 30-day supply to 90-day supply if requested by 
patient or required by insurance. 
 
F. Authorize a new prescription for dose or dosage form changes. 
 
G. Authorize prescriptions for new medications that are documented in a patient’s medical 
record but have not been generated as a prescription order. 
 
H. Discontinue medications causing drug interactions or adverse reactions and report all 
such occurrences in accordance with Section VIII of the Agreement. 
 
I. Educate patients concerning disease states, medication benefits and potential adverse 
effects and toxicity, and medication adherence. 
 
Electronically Signed by:  
 
 
 

 
 
 
 
 
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APPENDIX 4: TENNESSEE STATE PHARMACY LAW (CHAPTER 1140-03) 
1In accordance with Tennessee State Pharmacy Law and the Rules of the Tennessee Board of 
Pharmacy Chapter 1140-03 Standards of Practice, a clinical pharmacist has the following 
responsibilities for pharmaceutical care: 
(1) Patient counseling  
(a) Upon the receipt of a medical or prescription order and following a review of the patient’s 
record, a pharmacist shall personally counsel the patient or caregiver “face-to- face” if the patient 
or caregiver is present. If the patient or caregiver is not present, a pharmacist shall make a 
reasonable effort to counsel through alternative means.  
(b) Alternative forms of patient information may be used to supplement, but not replace, face-to-
face patient counseling.  
(c) Patient counseling, as described herein, shall also be required for outpatients of hospitals or 
other institutional facilities dispensing medical and prescription orders and for patients when 
medications are dispensed on discharge from the hospital or other institutional facility.  
(d) Patient counseling as described in this rule shall not be required for inpatients of an institutional 
or long-term care facility.  
(e) Patient counseling shall cover matters, which in the exercise of the pharmacist’s professional 
judgement, the pharmacist deems significant including:  
1. The name and description of the medication;  
2. The dosage form, dose, route of administration, and duration of drug therapy;  
3. Special directions and precautions for preparation, administration, and use by the patient;  
4. Common side effects or adverse effects or interactions and therapeutic contraindications 
that may be encountered, including their avoidance, and the action required if they occur;  
5. Techniques for self-monitoring drug therapy;  
6. Proper storage;  
7. Prescription refill information; and  
8. Action to be taken in the event of a missed dose.  
(f)  Upon the receipt of a request for a refill of a medical or prescription order, a pharmacist or a 
person designated by the pharmacist shall offer for the pharmacist to personally counsel the 
patient or caregiver. Counseling as described in (e) above is not required unless requested by 
the patient or deemed necessary in the professional judgment of the pharmacist.  
(g)  A pharmacist shall not be required to counsel a patient or caregiver when the patient or 
caregiver refuses such counseling.  
(2)  Patient Profiling.  
(a)  A patient’s record system shall be maintained by all pharmacy practice sites for patients for 
whom medical and prescription orders are dispensed. The patient’s record system shall provide 
for the immediate retrieval of information necessary for the pharmacist to identify previously 

 
 
 
 
 
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dispensed medical and prescription orders at the time a medical or prescription order is 
presented.  
(b)  In order to effectively counsel patients, the pharmacist or a person designated by the 
pharmacist shall, through communication with the patient, caregiver, or agent make a reasonable 
effort to obtain, record, and maintain the following information for each patient of the individual 
pharmacy practice site.  
1. Name, address, telephone number.  
2. Date of birth (age), gender.  
3. An individual history where significant, including disease state or states, known allergies 
and drug reactions, and a comprehensive list of medications and relevant devices.  
4. Pharmacist’s comments as deemed relevant. This may be done manually or by computer.  
(3)  Drug Regimen Review.  
(a) A pharmacist shall be responsible for a reasonable review of a patient’s record prior to 
dispensing each medical or prescription order. The review shall include evaluating the medical 
and prescription order for:  
1. Over-utilization or under-utilization;  
2. Therapeutic duplication;  
3. Drug-disease contraindication;  
4. Drug-drug interactions;  
5. Incorrect drug dosage or duration of drug treatment;  
6. Drug-allergy interactions 
Footnotes: 
1The 
Tennessee 
Board 
of 
Pharmacy 
Standards 
of 
Practice 
2017 
Recommendations. 
https://publications.tnsosfiles.com/rules/1140/1140-03.20170220.pdf. Last accessed March 16, 2019. 

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APPENDIX 5: HYPERTENSION MANAGEMENT ALGORITHM 
Figure 1: Workflow
Figure 2. Hypertension standard of care treatment algorithm [references noted below]

 
 
 
 
 
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Figure 3. Sample Workflow 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
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Table 1. List of preferred drugs and doses* 
 
Calcium 
channel 
blocker 
Angiotensin-
converting-
enzyme 
inhibitor 
Angiotensin 
receptor 
blocker 
Thiazide 
diuretic 
Vasodilating 
beta blocker 
Aldosterone 
antagonist 
Direct 
vasodilator 
Central 
sympatholytic 
Alpha-
blocker 
Low 
dose 
2.5 mg 
amlodipine 
30 mg 
nifedipine 
10 mg 
lisinopril 
10 mg 
benazepril 
75 mg 
irbesartan 
20 mg 
telmisartan 
0.625 mg 
indapamide 
12.5 mg 
chlorthalidone 
6.25 mg 
carvedilol bid 
12.5 mg 
spironolactone 
25 mg 
eplerenone 
25 mg 
hydralazine 
tid 
0.5 mg 
guanfacine 
1 mg 
terazosin 
Medium 
dose 
5 mg 
amlodipine 
60 mg 
nifedipine 
20 mg 
lisinopril 
20 mg 
benazepril 
150 mg 
irbesartan 
40 mg 
telmisartan 
1.25 mg 
indapamide 
25 mg 
chlorthalidone 
12.5 mg 
carvedilol bid 
25 mg 
spironolactone 
50 mg 
eplerenone 
50 mg 
hydralazine 
tid 
1 mg 
guanfacine 
5 mg 
terazosin 
High 
dose 
10 mg 
amlodipine 
90 mg 
nifedipine 
40 mg 
lisinopril 
40 mg 
benazepril 
300 mg 
irbesartan 
80 mg 
telmisartan 
2.5 mg 
indapamide 
50 mg 
chlorthalidone 
25 mg 
carvedilol bid 
50 mg+ 
spironolactone 
50 mg+ 
eplerenone 
100 mg 
hydralazine 
tid 
2 mg 
guanfacine 
10 mg 
terazosin 
 
* Daily dosing unless otherwise specified. Does not encompass all possible combinations and individual treatment selection can still be up to the clinician in 
partnership with the patient 
 
 
Table 2. Preferred Anti-hypertensive Drugs in Specific Conditions 
Condition 
Drug(s) 
Hypertensive patients in general 
CCB, ACE-I or ARB, D 
Hypertension in older patients 
CCB, ACE-I or ARB, D 
Hypertension with left ventricular hypertrophy 
ARB, D, CCB 
Hypertension in patients with diabetes mellitus 
CCB, ACE-I or ARB, D 
Hypertension in patients with diabetic nephropathy 
ARB, D 
Hypertension in patients with non-diabetic chronic kidney disease 
ACE-I, BB, D 
Blood pressure reduction for secondary prevention of coronary events 
ACE-I, CCB, BB, D 
Blood pressure reduction for secondary prevention of stroke 
ACE-I + D, CCB 
Blood pressure management for patients with heart failure 
D, BB, ACE-I, ARB, aldosterone antagonists 
ACE, angiotensin-converting enzyme; ARB, angiotensin receptor blocker; BB, beta-blocker; BP, blood pressure; CCB, calcium channel blocker; D,diuretic 
Adapted from the 2013 ESH/ESC Guidelines for the Management of Arterial Hypertension. Mancia G. et al., J Hypertens. 2013; 31:1281-1356; and from 
Victor RG and Libby P: Systemic Hypertension: Management. Chp 44 In Braunwald’s Heart Disease, 10th Edition, DL Mann, DP Zipes, P Libby, and RO 
Bonow Eds., Elsevier, 2014.   
 
Footnotes: 
1 TG Pickering et al., Call to action on use and reimbursement for home blood pressure 
monitoring: executive summary: a joint scientific statement from the American Heart Association, 
American Society of Hypertension, and Preventive Cardiovascular Nurses Association. 
Hypertension. 2008;521-9. 
2 In accordance with multiple published hypertension treatment guidelines:  
• 
James PA, Oparil S, Carter BL et al. 2014 Evidence-Based Guideline for the Management 
of High Blood Pressure in Adults: Report From the Panel Members Appointed to the Eighth 
Joint National Committee (JNC 8). JAMA 2013; 311(5), 507-520 
• 
Weber MA, Schiffrin EL, White WB et al. Clinical Practice Guidelines for the Management 
of Hypertension in the community: a statement by the American Society of Hypertension 
and the International Society of Hypertension. J Clin Hypertens (Greenwich ) 2014;16:14-
26. 

 
 
 
 
 
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• 
Go AS, Bauman M, King SM et al. An Effective Approach to High Blood Pressure Control: 
A Science Advisory From the American Heart Association, the American College of 
Cardiology, and the Centers for Disease Control and Prevention. Hypertension 2013. : DA 
- 20131118 
• 
Mancia G, Fagard R, Narkiewicz K et al. 2013 ESH/ESC Guidelines for the management 
of arterial hypertension: The Task Force for the management of arterial hypertension of 
the European Society of Hypertension (ESH) and of the European Society of Cardiology 
(ESC). 2013. J.Hypertens. 31(7), 1281-1357 
• 
Canadian Hypertension Education Program (CHEP) 2013 Recommendations.  2013. 12-
26-2013.  
                http://www.hypertension.ca/chep. Last accessed 2-9-2014. 
• 
Flack JM et al., Management of High Blood Pressure in Blacks: An Update of the 
International Society on Hypertension in Blacks Consensus Statement. Hypertension 
2010;56:780-800.  
 
3 Combined use of an ACE inhibitor and an ARB is contraindicated. ONTARGET Investigators, 
Cardiovascular and renal outcomes with telmisartan, ramipril, or both in people at high risk for 
vascular events. N Engl J Med 2008;358:1547-1559.     
4 Amlodipine is the calcium channel blocker proven to reduce cardiovascular events in most 
hypertension trials. 
5 Chlorthalidone is the thiazide diuretic proven to reduce cardiovascular events in most 
hypertension trials. Chlorthalidone or a loop diuretic is indicated in chronic kidney disease. 
6Most hypertensive patients require combination drug therapy to achieve blood pressure 
treatment goals. 
7Vasodilating beta blockers (e.g., carvedilol) are stronger blood pressure-lowering agents than 
standard beta blockers and do not elevate blood glucose. Unless contraindicated, beta blockers 
are first-line therapy for treatment of angina pectoris, after myocardial infarction, and heart failure.  
8Aldosterone blockers can be added if on thiazide and eGFR > 60 ml/min/1.73m2 and serum K < 
4.5. 
9Long-acting central sympatholytic agents (e.g., guanfacine) are preferred over short-acting 
clonidine to avoid rebound hypertension.  
10 Alpha blockers are indicated for men with protatism. 
11 Nitrates and vasodilators (e.g., hydralazine) are only used if other agents are not effective.       
 
Within each class, specific drugs prescribed will vary somewhat based on individual insurance 
plans. Whenever possible, the pharmacist will prescribe high-dose pills which will be cut initially 
to cut cost and improve efficiency of dose-titration.  
 
Preferred drugs (once daily/long acting/evidence-based/cost): 
CCB- amlodipine, nifedipine 
ARB- telmisartan, irbesartan 
ACEI- Lisinopril, benazepril 
Thiazide- indapamide, chlorthalidone  
Vasodilating beta-blocker- carvedilol 
Aldosterone antagonist-spironolactone, eplerenone 
Direct vasodilator- hydralazine 
Central sympatholytic- guanfacine  
Alpha-blocker- terazosin 

 
 
 
 
 
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APPENDIX 6: STUDY FORMS, MATERIALS, AND SURVEYS 
Appendix 6A: Barbershop/Owner Letter of Collaboration 
 
MEMORANDUM OF AGREEMENT 
 
 
To: 
David Harrison, MD, FACC, FAHA 
 
 
 
 
 
Nashville, 
 
 
 
Re: 
Cut Your Pressure Too: Implementing the Barbershop Blood Pressure in Nashville 
 
 
Dear Dr. Harrison, 
 
My barbers and I understand that high blood pressure is a condition that can cause potentially 
deadly side effects that affects many of our customers.  I understand that you and your study 
team will approach customers in the barbershop to determine if they are eligible and would like to 
participate in the “Cut Your Pressure Too” study and that many of the study procedures (including 
blood pressure measurements and interviews) will take place in the barbershop. 
 
As one of the study’s designated barbershop owners/managers, I certify that I have the authority 
to agree to allow the “Cut Your Pressure Too” study to take place in the barbershop, specifically: 
 
Name of barbershop: ____________________________________________ 
 
Address of barbershop: ___________________________________________ 
 
And I agree to: 
• 
Permit the barbershop and the barbers to participate fully in the “Cut Your Pressure Too” 
study for the duration of the study, which I understand is approximately 9 – 12 months. 
• 
Provide space in the barbershop and permit study staff to interview customers and 
conduct the study for the duration of the study. 
• 
Permit training for participating barbers to measure blood pressure and to participate in 
other study-related procedures in the barbershop. 
• 
Permit barbers to offer blood pressure checks to each study-eligible customer who 
chooses to join the study 1 to 2 times per month for 6 months when they come in for 
haircuts.  
• 
Permit the transmission of the blood pressure readings from the barbershop to the study’s 
Clinical Pharmacist and other approved study personnel. 
• 
Permit the posting of Role Model Stories (posters) in the barbershop of customers who 
have joined the study. 
• 
Display the Role Model Story posters in my barbershop for the duration of the study. 
• 
The shop owner will be compensated $1000 over the course of the study, $500 will be 
received upon enrollment of the first participant at the shop and the other $500 will be 
received at the completion of the shop’s participation. This will be paid as a check. 

 
 
 
 
 
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• 
During the study, I agree to permit the barbers who join the study to be compensated by 
the study utilizing a debit card or pre-paid gift card system. The system allows the 
research team to directly add payments to each barber’s card instead of taking weeks to 
process a check and mail it. Payment requests will be checked and approved within 48 – 
hours on business days or by the following Tuesday if initiated on a weekend. The 
attached IRS W-9 form is required for tax purposes in order to receive compensation from 
the study. All personal information is stored by VUMC and the debit card vendor in a 
secure fashion and will be deleted from the debit card system once the study has been 
completed and the funds on the card have been exhausted. This information will not be 
shared with any third parties and will be kept confidential. 
• 
I understand that the “Cut Your Pressure Too” research study has been reviewed and 
approved by the Vanderbilt University Medical Center Institutional Review Board and that 
I can request a copy of that approval from you. 
 
I understand and agree to permit barbershop customers who choose to join the study to also be 
compensated by the study team with haircut vouchers ($25 per haircut) and $10 per blood 
pressure check with up to 2 blood pressures checks per eligible customer per month (maximum 
of 12 measurements; 2 per month per customer). As the owner/manager of this barbershop, I 
certify that I have the authority and hereby agree to redeem the haircut vouchers as described 
above with the understanding that those vouchers will be reimbursed to the barbershop by the 
study team. 
 
Sincerely yours, 
 
 
Barbershop Manager/Owner ___________________________________ Date: ____________ 
 
Dr. David Harrison (Principal Investigator): _________________________ Date: ____________ 
 
Authorized:  
 
, Director, Office of Contracts Management: _____________________  
 
Date: ______________ 
 
 
 
 

 
 
 
 
 
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Appendix 6B: Study Surveys/forms / Appendix 6B.1: Screening Visit 1 
CUT YOUR PRESSURE TOO: 
The Nashville Barbershop Blood Pressure Study 
Screening Visit 1 Questionnaire 
 
• 
Introduction and Verbal Consent 
My name is _______ and I am offering free blood pressure screening to all men in the barbershop 
who are at least 35 years old as part of the Nashville Barbershop Blood Pressure Study being 
conducted by Vanderbilt University Medical Center. Are you between 35-79 years old (born 
anytime from 1940 to 1984) and interested in having your blood pressure checked?” [NOTE: 
SCRIPT ABOVE WILL NOT BE IN CAPI.  WILL BE ON INTRODUCTION CARD PROVIDED TO 
INTERVIEWERS] 
▪ 
IF PERSON AGREES, ASSIGN CASE ID Number 
▪ 
REVIEW INFORMATION SHEET 
▪ 
SEE INFORMATION SHEET ON TWO-STEP SCREENING PROCEDURES 
 
• 
Screening Questions  
 
1. What is your Date of Birth?  Month _______Day_____Year_______ 
 
[INTERVIEWER: IF CUSTOMER DOES NOT WANT TO PROVIDE FULL DATE OF BIRTH, 
ASK FOR JUST MONTH AND YEAR - ENTER -8 (REFUSED) FOR DAY] 
 
2. What is your name?   
Prefix ________ 
First Name ________________  
Middle Name ___________________  
Last Name ________________ 
Suffix______________ 
Nickname___________ 
 
3. How long have you been a customer at this barbershop?  
IF 1 YEAR OR MORE ENTER YEARS ONLY. 
IF 0-11 MONTHS, ENTER MONTHS ONLY. 
IF REFUSED ENTER -8 IN YEARS ONLY. 
IF DON’T KNOW, ENTER -9 IN YEARS ONLY. 
___________ (YEARS) (varname:  BarbershopHowLong) 
___________ (MONTHS) ONLY ENTER IF 0-11 MONTHS  
(varname:  BarbershopHowLongMth) 
LESS THAN SIX MONTHS (INELIGIBLE) 
DON’T KNOW 
REFUSED 

 
 
 
 
 
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4. In the last 6 months, how many times did you come to this barbershop?  Would you say… 
[INTERVIEWER:  PROBE FOR BEST ESTIMATE, AS NEEDED] 
(varname:  BarbershopHowOften) 
a. 0 to 3 times, 
b. 4 to 6 times, 
c. 7 to 10 times, 
d. 11 to 15 times, or  
e. More than 15 times? 
  
DON’T KNOW 
REFUSED 
[INELIGIBLE IF = (a)] 
 
5. Is this your main barbershop?  (varname: YourBarbershop) 
a. YES 
b. NO (INELIGIBLE) 
c. DON’T KNOW 
d. REFUSED 
 
6. Do you have plans to change barbershops during the next 6 months?  (varname: 
BarbershopChange) 
a. YES (INELIGBLE) 
b. NO 
c. DON’T KNOW 
d. REFUSED 
 
7. Do you have plans to move away from the Nashville area during the next 6 months?  
(varname: NSHmove) 
a. YES (INELIGIBLE) 
b. NO 
c. DON’T KNOW 
d. REFUSED 
 
8. Do you consider yourself Black or African American?  (varname: RaceBlack) 
a. YES 
b. NO (INELIGIBLE) 
c. DON’T KNOW 
d. REFUSED 
 
9. Do you consider yourself to be of Hispanic, Latino, or Spanish origin? (varname: Latino) 
a. YES (INELGIBLE) 
b. NO 
c. DON’T KNOW 
d. REFUSED 
 
 

 
 
 
 
 
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• 
CV Disease risk factors and comorbid conditions 
 
10. How tall are you?  (varname: HeightFeet, HeightInches) 
 
 
 
 
 
[INTERVIEWER: ENTER -8 FOR REFUSED, ENTER -9 FOR DON'T KNOW] 
 
_________ Feet _________ Inches 
 
 
 
DON’T KNOW 
REFUSED 
 
11. How much do you weigh?  (varname: Weight)  
 
[INTERVIEWER: ENTER -8 FOR REFUSED, ENTER -9 FOR DON'T KNOW] 
 
_________ LBS  
 
 
 
 
 
DON’T KNOW 
REFUSED 
 
Next, I am going to ask you a few questions about your health. 
 
12. Has a doctor ever told you that you have… (check all that apply): 
a. High blood pressure (Hypertension) (varname: C_HBP) 
b. Diabetes (varname: C_Diabetes) 
c. Heart Attack (varname: C_HeartAttack) 
d. Heart Failure [INTERVIEWER:  THIS MEANS ENLARGED AND WEAKENED HEART] 
(varname: C_HeartFailure) 
e. High Cholesterol (varname: C_HighCholesterol) 
f. Enlarged Prostate (varname: C_EnlargedProstate) 
g. Prostate Cancer (varname: C_ProstateCancer) 
h. Stroke (varname: C_Stroke) 
i. 
Asthma (varname: C_Asthma) 
j. 
Sleep Apnea (varname: C_SleepApnea) 
k. Kidney Disease (varname: C_KidneyDisease) 
l. 
NONE OF THE ABOVE (varname: C_None) 
m. DON’T KNOW (varname: C_DK) 
n. REFUSED (varname: C_RF) 
 
• 
Medical Exclusion criteria 
 
13. a). Are you a kidney dialysis patient? (varname: Dialysis) 
a. YES (INELIGIBLE) 
b. NO 
c. DON’T KNOW 
d. REFUSED 
 
 

 
 
 
 
 
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13. b). Have you ever received an organ transplant? (varname: Transplant) 
a. YES (INELIGIBLE) 
b. NO 
c. DON’T KNOW 
d. REFUSED 
 
14. Are you currently a cancer patient receiving chemotherapy? (varname: Chemo) 
a. YES (INELIGIBLE) 
b. NO 
c. DON’T KNOW 
d. REFUSED 
 
• 
Current Medications 
 
15. Are you taking any of the following PRESCRIPTION medications? (check all that apply)  
a. Blood pressure pills (varname: M_BPPills) 
b. Water pills (diuretics) (varname: M_WaterPills) 
c. Insulin or pills for diabetes (varname: M_Insulin) 
d. Pills for enlarged prostate (varname: M_Prostate) 
e. NONE OF THE ABOVE (varname: M_None) 
f. DON’T KNOW (varname: M_DK) 
g. REFUSED (varname: M_RF) 
 
• 
Nocturia Questions 
 
16.  During the past 30 days, how many times per night did you most typically get up to urinate, 
from the time you went to bed at night until the time you got up in the morning?  
[INTERVIEWER: SHOWCARD 1, PROBE FOR AN AVERAGE ON TYPICAL NIGHT] 
(varname: Nocturnia) 
 
[INTERVIEWER: SHOW CARD 1] 
a. 0 (SKIP TO BP MEASUREMENT) 
b. 1 
c. 2 
d. 3 
e. 4 
f. 5 OR MORE 
g. DON’T KNOW (SKIP TO BP MEASUREMENT) 
h. REFUSED (SKIP TO BP MEASUREMENT) 
 
 
 
 

 
 
 
 
 
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17. Now, using a scale from 0 to 10, with 0 indicating ‘not at all’ and 10 being ‘a great deal, 
please tell me how much does it bother you? (INTERVIEWER:  REPEAT QUESTION IF 
NEEDED: to get up to urinate, from the time you went to bed at night until the time you got 
up in the morning?)  INTERVIEWER:  SHOWCARD 2 (varname: Nocturnia2) 
 
[INTERVIEWER:  SHOW CARD 2] 
 
☐     ☐     ☐     ☐     ☐     ☐    ☐    ☐     ☐     ☐     ☐        ☐     ☐    
            0      1       2      3       4      5     6      7      8       9      10   DK    REFUSED 
  Not at all  
 
 
 
 
 
 
 A great 
                            
 
• 
Blood Pressure Measurement   
Now, I will take your blood pressure readings. First, I need to determine your cuff size.  
 
18. MEASURE CUFF SIZE: (varname: CuffSize) 
SIZE CUFF [CHECK ONE]: 
a. SMALL (SMALL ADULT) 
b. MEDIUM (ADULT) 
c. LARGE (LARGE ADULT) 
 
NOTE:  CUFF SIZE WILL BE AUTOMATICALLY POPULATED FOR FUTURE VISITS. 
The machine will automatically take readings over the next few minutes.  
 INTERVIEWER: PLEASE HAVE PARTICIPANT SIT COMFORTABLY IN THE CHAIR 
▪ 
WITH FEET FLAT ON THE FLOOR  
▪ 
RIGHT ARM SUPPORTED AT HEART LEVEL 
▪ 
WAIT 5 MINUTES FOR PARTICIPANT TO REST BEFORE TAKING BP READINGS 
▪ 
TURN MACHINE AWAY FROM SUBJECT’S VIEW 
▪ 
INSTRUCT SUBJECT NOT TO TALK DURING BP’S 
▪ 
DO NOT SPEAK TO SUBJECT DURING BP 
▪ 
AFTER STARTING BP READINGS, WALK AWAY FOR A FEW MINUTES, AND THEN 
CHECK TO SEE IF 5 READINGS HAVE BEEN COMPLETED 
 
[INTERVIEWER: PROCEED TO CARETRENDS BLOOD PRESSURE PROCEDURE.] 
THE SUBJECT ID IS _______ 
19.  [INTERVIEWER: HOW MANY BLOOD PRESSURE READINGS WERE TAKEN?] ______ 
 
[INTERVIEWER: WAIT UNTIL BP MEASUREMENTS ARE COMPLETE, REMOVE BP  
CUFF, THEN CLICK NEXT TO RETRIEVE BP READINGS...] 
 
[INTERVIEWER: WAIT UNTIL BP MEASUREMENTS ARE COMPLETE, REMOVE BP 
CUFF, THEN CLICK NEXT TO RETRIEVE BP READINGS...] 
 
 
 
 

 
 
 
 
 
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NOW TRYING TO RETRIEVE PRESSURE READINGS FROM THE SERVER. 
 
Systolic 
 
 
Diastolic 
a. ___________  
 
___________ 
 
b. ___________  
 
___________ 
 
c. ___________  
 
___________ 
 
d. ___________  
 
___________ 
 
e. ___________  
 
___________ 
 
f. ___________  
 
___________ 
 
g. ___________  
 
___________ 
 
h. ___________  
 
___________ 
 
i. 
___________  
 
___________ 
 
j. 
___________  
 
___________ 
 
[INTERVIEWER: IF BP MEASUREMENTS ARE NOT DISPLAYED CLICK THE BUTTON 
BELOW. IF NO MEASURMENTS ARE RETURNED, CLICK NEXT TO PROCEED TO MANUAL 
BP ENTRY.] 
 
INTERVIEWER:  CHECK HERE TO FORCE MANUAL BP SCREEN TO DISPLAY ____ (NOTE 
THIS IS NEEDED IN CASE ALL OF CARETRENDS READINGS DO NOT TRANSMIT] 
 
IT WAS NOT POSSIBLE TO RETRIEVE THE READINGS FROM THE SERVIER.  PLEASE 
ENTER THEN MANUALLY [INTERVIEWER: ENTER BP READINGS IN THE ORDER TAKEN. 
NOTE: BP READINGS ARE LISTED IN REVERSE ORDER ON THE CARE TRENDS SCREEN.] 
 
READING DATE _______________________________________________ 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
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Systolic 
 
 
   Diastolic 
 
 
         Time 
1  ___________ 
 
 
___________  
 
______________ 
 
2. __________ 
 
 
___________  
 
______________ 
 
3. ___________  
 
___________  
 
______________ 
 
4 ___________  
 
___________  
 
______________ 
 
5. ___________  
 
___________  
 
______________ 
 
6. ___________  
 
___________  
 
______________ 
 
7. ___________  
 
___________  
 
______________ 
 
8. ___________  
 
___________  
 
______________ 
 
9. ___________  
 
___________  
 
______________ 
 
10. ___________  
 
___________  
 
______________ 
 
 
Compute average of BP Readings     Systolic_______ 
 
Diastolic ________ 
 
On the participant’s blood pressure card, record the following: 
• 
Participant name (from question 2) (CONFIRM NAME AND SPELLING) 
• 
Today’s date: ________________ 
• 
Average blood pressure readings [BASED ON READINGS 3, 4, AND 5 (IF 5 OR MORE 
READINGS); BASED ON READINGS 3 AND 4 (IF 4 READINGS); MINIMUM OF 4 TOTAL 
READINGS] 
• 
IF LESS THAN 4 READINGS, DISPLAY INSUFFICIENT READINGS AND TRY TO 
CONDUCT ANOTHER SESSION 
 
 
 
 
 
 
 

 
 
 
 
 
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If the BP is 200/120 or higher, say the following: 
 
 
Your blood pressure is dangerously high today and you need to seek medical attention without 
delay. Please call 911 to go to the nearest emergency room. Take this card with you to show to 
the emergency room doctor.  If they have any questions, the doctor may call the number listed on 
your card. 
• 
Statement was read to participant: Check YES. 
 
If the BP is 180/110 – 199/119, say the following: 
Your blood pressure is very high today.  Please see a doctor within the next 3 days.  Take this 
card with you to your doctor.  If they have any questions, the doctor may call the number listed on 
your card. 
 
• 
Statement was read to participant: Check YES  
 
• 
Eligibility for 2nd Screening Visit= YES if: 
 
o Age 35 to 79, AND 
 
o > 6 months of patronage at this barbershop, AND 
o Reports 4 or more visits to the barbershop over the previous 6 months, AND 
o Main barbershop, AND 
o Does not plan to change barbershops in the next 6, AND 
o Does not plan to move away from Nashville area in next 6 months, AND 
o Self-identified Black/African American, AND 
o Not Hispanic, Latino or Spanish origin, AND 
o Not on kidney dialysis and not an organ transplant patient AND 
o Not a cancer patient receiving chemotherapy, AND 
o Average of systolic blood pressure readings >140 mmHg 
 
If participant is ineligible for second screening, then say:  
 
Based on your information, you are not eligible for the next phase of this study. However, you 
may be eligible for future studies.  (varname: FutureStudiesS1)  
 
[INTERVIEWER, PLEASE FOLLOW CONSENT PROCEDURES FOR FUTURE STUDIES] 
 
[INTERVIEWER: DID CUSTOMER CONSENT TO BEING IN FUTURE STUDIES AND FILL OUT 
CONTACT INFORMATION?] 
 
YES 
NO 
 
Thank you for taking the time today to help us learn more about high blood pressure in 
African American men. Here is a gift (water bottle) as a small token of our appreciation. 
 

 
 
 
 
 
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IF CUSTOMER ASKS TO HAVE HIS BP READINGS, YOU WILL TAKE TWO BP READINGS 
AND PROVIDE THE SECOND READING TO HIM ON BP CARD. DO NOT START THE 
CARETRENDS PROGRAM ON THE LAPTOP IF VERY HIGH BP, READ SCRIPT FOR 
SEEKING MEDICAL CARE.  
 
IF PARTICIPANT MAY BE ELIGIBLE, BUT DID NOT PROVIDE INFORMATION FOR ONE OF 
THE ELIGIBILITY QUESTIONS, CAPI WILL ALLOW YOU TO GO BACK AND TRY TO RE-ASK 
MISSING QUESTIONS 
 
If participant is eligible for second screening, say the following: 
 
Based on your information, you are eligible for a 2nd screening visit.  We need a second visit to 
determine your eligibility for enrollment in the study.  
 
● Appointment for Second Screening and Personal Contact Information 
 
Let’s make an appointment for your second screening visit. The sooner the better, even 
tomorrow would be great. 
 
[INTERVIEWER: THE LAST DAY IS [_________________] 
 
a. Schedule appointment for second screening (varname: AppointDOW) 
i. Day of Week: 
1. MONDAY 
2. TUESDAY 
3. WEDNESDAY 
4. THURSDAY 
5. FRIDAY 
6. SATURDAY 
7. SUNDAY 
8. REFUSED 
9. DON’T KNOW 
 
ii. Date: ____/_____/_____ (varname: AppointDate) 
 
iii. Time: _________ (varname: AppointTime) 
 
b. I would like to record your contact information to send you a reminder 
 
Your Home Phone #: (_____) ________ - __________ 
Your Cell phone #: (_____) ________ - __________ 
Your Work phone #: (_____) ________ - __________ 
 
REFUSED PHONE 
 
NEED AT LEAST ONE ANSWER FOR PHONE OR REFUSED ABOVE 
TO CONTINUE 
 
 

 
 
 
 
 
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Phone # of a close friend (_____) ________ - __________ Name ______ 
Phone # of a relative: (_____) ________ - __________ Name _____ 
Your Email: ______________@________________ 
 
Your mailing address: 
Address 
Apt/Suite 
City 
State 
Zip Code 
REFUSED ADDRESS 
NEED ADDRESS OR REFUSED FILLED IN ABOVE TO CONTINUE 
 
c. What is the best way to contact you? (varname: BestWayToContact) 
a. HOME PHONE 
b. CELL PHONE: CALL 
c. CELL PHONE: TEXT  
d. WORK PHONE 
e. FRIEND PHONE 
f. RELATIVE PHONE 
g. EMAIL 
h. MAIL 
i. OTHER  
SPECIFY ____________ 
j. DON’T KNOW 
k. REFUSED 
 
d. What is the best time to reach you? (varname: BestTimeToContact) 
a. MORNING 
b. AFTERNOON 
c. EVENING 
d. REFUSED 
e. DON’T KNOW 
 
e. What are the best days to reach you? (varname: BestDaysToContact) 
a. Monday-Friday 
                        b. Saturday-Sunday 
 
 
 
      c. DON’T KNOW 
 
 
 
      d. REFUSED 
 
f. Who is your regular barber? (varname: BarberName) 
____________________________________ 
 
 
 
 

 
 
 
 
 
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DISPLAY PARTICIPANT NAME AND ID 
 
GIVE BAG WITH STUDY LOGO FOR THEIR PILL BOTTLES, DOCTOR’S CARD, AND 
INSURANCE CARD TO BRING BACK NEXT TIME. 
 
GIVE APPOINTMENT CARD WITH THE FOLLOWING INFORMATION: 
APPOINTMENT DATE & TIME 
BARBERSHOP NAME AND ADDRESS 
SUPERVISOR CONTACT INFORMATION FOR RESCHEDULING 
 
Thank you for taking the time today to help us learn more about high blood pressure in African 
American men. Here is a gift (water bottle) as a small token of our appreciation.  
 
ENTER COMMENTS, CORRECTIONS, OR ANY OTHER RELEVANT INFORMATION ABOUT 
THE RESPONDENT: (varname: CommentScreener1)    
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
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Appendix 6B.2: Screening Visit 2; Baseline (if enrolled) 
 
CUT YOUR PRESSURE TOO: 
The Nashville Barbershop Blood Pressure Study 
Health Questionnaire  
(Screening Visit 2/Baseline) 
Thank you for coming today. First, I need to bring up our information from your last visit and then 
I have a few questions. We can start now. 
 
CHECK ID AND NAME ON DATABASE TO ENSURE THEY COMPLETED THE SCREENING 
VISIT ONE, WERE FOUND ELIGIBLE, AND WERE SCHEDULED FOR SCREENING VISIT 2.  
 
INTERVIEWER:  PLEASE VERIFY THAT YOU HAVE SELECTED THE CORRECT SUBJECT  
 
SUBJECT NAME ____________________________ 
 
SUBJECT ID ________________________________ 
 
DATE OF BIRTH _____________________________ 
 
BARBERSHOP ______________________________  
 
[REVIEW INFORMATION SHEET – parts relevant to second screening]
 
Part 1: Blood Pressure Measurement 
 
[POPULATE CUFF SIZE USED IN SCREENING VISIT 1] 
 
Now, I will take your blood pressure readings. 
 
The machine will automatically take readings over the next few minutes.  
  INTERVIEWER: PLEASE HAVE PARTICIPANT SIT COMFORTABLY IN THE CHAIR 
▪ 
WITH FEET FLAT ON THE FLOOR  
▪ 
RIGHT ARM SUPPORTED AT HEART LEVEL 
▪ 
WAIT 5 MINUTES FOR PARTICIPANT TO REST BEFORE TAKING BP READINGS 
▪ 
TURN MACHINE AWAY FROM SUBJECT’S VIEW 
▪ 
INSTRUCT SUBJECT NOT TO TALK DURING BP’S 
▪ 
DO NOT SPEAK TO SUBJECT DURING BP 
▪ 
AFTER STARTING BP READINGS, WALK AWAY FOR A FEW MINUTES, AND THEN 
CHECK TO SEE IF 5 READINGS HAVE BEEN COMPLETED 
 
 

 
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[INTERVIEWER: PROCEED TO CARETRENDS BLOOD PRESSURE PROCEDURE.] 
THE SUBJECT ID IS ________ 
1.  [INTERVIEWER: HOW MANY BLOOD PRESSURE READINGS WERE TAKEN?] 
______ 
[INTERVIEWER: WAIT UNTIL BP MEASUREMENTS ARE COMPLETE, REMOVE BP CUFF, 
THEN CLICK NEXT TO RETRIEVE BP READINGS...] 
 
NOW TRYING TO RETRIEVE PRESSURE READINGS FROM THE SERVER. 
 
Systolic 
 
 
Diastolic 
a. ___________ 
 
 
___________ 
 
b. ___________ 
 
 
___________ 
 
c. ___________ 
 
 
___________ 
 
d. ___________ 
 
 
___________ 
 
e. ___________ 
 
 
___________ 
 
f. ___________ 
 
 
___________ 
 
g. ___________ 
 
 
___________ 
 
h. ___________ 
 
 
___________ 
 
i. 
___________ 
 
 
___________ 
 
j. 
___________ 
 
 
___________ 
 
[INTERVIEWER: IF BP MEASUREMENTS ARE NOT DISPLAYED CLICK THE BUTTON 
BELOW. IF NO MEASURMENTS ARE RETURNED, CLICK NEXT TO PROCEED TO MANUAL 
BP ENTRY.] 
 
INTERVIEWER:  CHECK HERE TO FORCE MANUAL BP SCREEN TO DISPLAY ____ (NOTE 
THIS IS NEEDED IN CASE ALL OF CARETRENDS READINGS DO NOT TRANSMIT] 
 
IT WAS NOT POSSIBLE TO RETRIEVE THE READINGS FROM THE SERVIER.  PLEASE 
ENTER THEN MANUALLY [INTERVIEWER: ENTER BP READINGS IN THE ORDER TAKEN. 
NOTE: BP READINGS ARE LISTED IN REVERSE ORDER ON THE CARE TRENDS SCREEN.] 
 
 
 

 
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Protocol Date: 02_25_2020 
READING DATE _______________________________________________ 
 
Systolic 
 
 
 
Diastolic 
 
 
Time 
1 ___________ 
 
 
___________  
 
______________ 
 
2. __________  
 
___________  
 
______________ 
 
3. ___________  
 
___________  
 
______________ 
 
4. ___________  
 
___________  
 
______________ 
 
5. ___________  
 
___________  
 
______________ 
 
6. ___________  
 
___________  
 
______________ 
 
7. ___________  
 
___________  
 
______________ 
 
8. ___________  
 
___________  
 
______________ 
 
9. ___________  
 
___________  
 
______________ 
 
10. ___________  
 
___________  
 
______________ 
 
 
Compute average of BP Readings Systolic _______ 
 
Diastolic ________ 
(varname: SysAvg, DiaAvg) 
 
On the participant’s blood pressure card, record the following: 
• 
Participant name (from question 2) (CONFIRM NAME AND SPELLING) 
• 
Today’s date: ________________ 
• 
Average blood pressure readings [BASED ON READINGS 3, 4, AND 5 (IF 5 OR MORE 
READINGS); BASED ON READINGS 3 AND 4 (IF 4 READINGS); MINIMUM OF 4 TOTAL 
READINGS] 
 
• 
IF LESS THAN 4 READINGS, DISPLAY INSUFFICIENT READINGS AND TRY TO 
CONDUCT ANOTHER SESSION 
 
 
 
 
 
 
 
 

 
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If the BP is 200/120 or higher, say the following: 
 
 
Your blood pressure is dangerously high today and you need to seek medical attention without 
delay. Please call 911 to go to the nearest emergency room. Take this card with you to show to 
the emergency room doctor.  If they have any questions, the doctor may call the number listed on 
your card. 
• 
Statement was read to participant: Check YES. 
 
If the BP is 180/110 – 199/119, say the following: 
 
Your blood pressure is very high today.  Please see a doctor within the next 3 days.  Take this 
card with you to your doctor.  If they have any questions, the doctor may call the number listed on 
your card. 
 
• 
Statement was read to participant: Check YES  
 
Ineligible Participant:  
 
Based on your information, you are not eligible for the next phase of this study. However, you 
may be eligible for future studies. [INTERVIEWER:  PLEASE FOLLOW CONSENT 
PROCEDURES FOR FUTURE STUDIES] 
 
INTERVIEWER:  DID CUSTOMER CONSENT TO BEING IN FUTURE STUDIES AND FILL 
OUT CONTACT INFORMATION. 
 
A. YES 
B. NO 
 
If yes, skip to gift card and then proceed to Registry Consent Form.  
If no, skip to gift card. 
 
Eligible Participant:  
 
IF PARTICIPANT PREVIOUSLY PROVIDED A HOME OR CELL PHONE AND ADDRESS, GO 
TO CONSENT FOR RESEARCH AND USE AND DISCLOSURE OF INFORMTION.  ELSE, WE 
WILL DISPLAY SCREEN TO TRY AND OBTAIN THIS INFO AS FOLLOWS: 
 
IF NO PHONE, DISPLAY THE FOLLOWING: 
 
CONTACT INFORMATION 
 
ELIGIBILITY WARNING 
 
 
 

 
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[INTERVIEWER: WE DO NOT HAVE A HOME OR CELL PHONE NUMBER FOR THIS 
CUSTOMER 
 
We don’t have a home or cell phone number on file for you.  It’s important we are able to 
contact you. 
 
Phone _________________________________ 
Phone Type 
A. Home 
B. Mobile/Cell 
 
IF NO ADDRESS, DISPLAY THE FOLLOWING: 
Note 
 
[INTERVIEWER: WE DO NOT HAVE AN ADDRESS FOR THIS CUSTOMER 
 
We don’t have a mailing address on file for you. 
 
Street Address 1 _________________________________ 
Street Address 2 _________________________________ 
City ___________________________________________ 
State __________________________________________ 
Zip ____________________________________________ 
 
Your high blood pressure readings today indicate that you meet the requirements to go on to the 
6- month study. We would now like to take the opportunity to fully explain the study to you and 
obtain your informed consent in writing and gather some information via a health questionnaire. 
May we proceed?   
 
INTERVIEWER CHECK: 
 
2. CONSENT FOR RESEARCH AND USE AND DISCLOSURE OF INFORMATION, 
including use of health information (HIPAA) 
 
____ CONSENT FOR RESEARCH AGREED (varname: Consent_Research) 
 
 
3. INTERVIEWER CHECK 
 
____ PARTICIPANT SIGNED INFORMED CONSENT (varname: ConsentResult) 
____ PARTICIPANT REFUSED    
  
4. REASONS FOR REFUSAL _____________________________________ (varname: 
ConsentRefusedReason) 
 
If decline participation skip to gift card/compensation for screening visit 2. 
 
 
 

 
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Part 1: Health and Healthcare Questions 
CV Disease and Risk  
 
5. Has anyone in your immediate family (for example, mother, father, sister, brother, or 
children) ever had high blood pressure? (varname: FamilyHighBP) 
a. YES 
b.  NO 
c. DON’T KNOW 
d. REFUSED 
 
6. Have you smoked at least 100 cigarettes or cigars in your lifetime? (varname: 
Smoke100) 
a. YES 
b.  NO  
 
(SKIP TO QUESTION 8) 
c. DON’T KNOW 
(SKIP TO QUESTION 8) 
d. REFUSED  
(SKIP TO QUESTION 8) 
 
7. Have you smoked at all in the last year? (varname: SmokeLastYear) 
a. YES 
b.  NO   
 
(SKIP TO QUESTION 7.3) 
c. DON’T KNOW  
(SKIP TO QUESTION 7.3) 
d. REFUSED  
 (SKIP TO QUESTION 7.3) 
 
7.1. 
Have you smoked at all in the last 30 days? (varname: 
SmokeLast30Days) 
a. YES 
b. NO (SKIP TO QUESTION 7.3) 
c. DON’T KNOW (SKIP TO QUESTION 7.3) 
d. REFUSED (SKIP TO QUESTION 7.3) 
 
7.2. 
During the past 30 days, on average, about how many cigarettes did you 
smoke in a day?  (varname: SmokeNumPerDay30) 
 
__________  (SKIP TO QUESTION 8) 
 
DON’T KNOW (SKIP TO QUESTION 8) 
REFUSED 
 (SKIP TO QUESTION 8) 
 
7.3. 
On average, over the entire time you have smoked, how many cigarettes 
have you usually smoked per day? (varname: 
SmokeNumPerDayLifetime) 
 
___________ 
 
DON’T KNOW 
REFUSED 

 
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7.4. 
How old were you when you quit smoking?  (varname: SmokeQuitAge) 
 
____________   
 
DON’T KNOW 
 
 
REFUSED 
 
Perceived Health 
 
8. Overall, how would you rate your health?  Would you say… (varname: OverallHealth) 
a. Excellent 
b. Very Good 
c. Good 
d. Fair 
e. Poor 
f. Very Poor 
g. DON’T KNOW 
h. REFUSED 
 
BP Medication Adherence (Adherence to Refills and Medications (ARMS) Scale  
9. Have you ever had blood pressure medication prescribed or refilled? (varname: 
BPMedsEver)
a. YES 
b. NO 
 
 
(SKIP TO QUESTION 22) 
c. DON’T KNOW 
(SKIP TO QUESTION 22) 
d. REFUSED 
 
(SKIP TO QUESTION 22) 
  
BP Medication Adherence (Adherence to Refills and Medications (ARMS) Scale) 
(Kripalani, Risser, Gatti, & Jacobson, 2009) 
 
It is common for people to miss taking their medicine from time to time, or to take it differently than 
prescribed. I would like to ask you about how you actually take your blood pressure medicines. There 
are no right or wrong answers. For each question, please answer “none of the time,” “some of the 
time,” “most of the time,” or “all of the time.” 
 
10. How often do you forget to take your medicine? (varname: forgetmed) 
(1) None 
(2) Some 
(3) Most 
(4) All 
DON’T KNOW 
REFUSED 
 
 
 
 
 

 
 
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11. How often do you decide not to take your medicine? (varname: decidenottakemed) 
(1) None 
(2) Some 
(3) Most 
(4) All 
DON’T KNOW 
REFUSED 
 
12. How often do you forget to get prescriptions filled? (varname: prescrip_fill) 
(1) None 
(2) Some 
(3) Most 
(4) All 
DON’T KNOW 
REFUSED 
 
13. How often do you run out of medicine? (varname: medrunout)  
(1) None 
(2) Some 
(3) Most 
(4) All 
DON’T KNOW 
REFUSED 
 
14.  How often do you skip a dose of your medicine before you go to the doctor? 
(varname_doseskip) 
(1) None 
(2) Some 
(3) Most 
(4) All 
DON’T KNOW 
REFUSED 
 
15. How often do you miss taking your medicine when you feel better? (varname: medfeelbetter) 
(1) None 
(2) Some 
(3) Most 
(4) All 
DON’T KNOW 
REFUSED 
 
16. How often do you miss taking your medicine when you feel sick?  (varname: medfeelsick)  
(1) None 
(2) Some 
(3) Most 
(4) All 
DON’T KNOW 
REFUSED 
 
 

 
 
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17. How often do you miss taking your medicine when you are careless? (varname: medcareless)   
(1) None 
(2) Some 
(3) Most 
(4) All 
DON’T KNOW 
REFUSED 
 
18. How often do you change the dose of your medicines to suit your needs (like when you take 
more or less pills than you’re supposed to)?  (varname: medchange) 
(1) None 
(2) Some 
(3) Most 
(4) All 
DON’T KNOW 
REFUSED 
 
19. How often do you forget to take your medicine when you are supposed to take it more than  
      once a day? (varname: forget_med_multiple)   
(1) None 
(2) Some 
(3) Most 
(4) All 
DON’T KNOW 
REFUSED 
 
20. How often do you put off refilling your medicines because they cost too much money?   
      (varname: medrefillmoney) 
(1) None 
(2) Some 
(3) Most 
(4) All 
DON’T KNOW 
REFUSED 
 
21. How often do you plan ahead and refill your medicines before they run out?  
(varname: medrefillplan) [PROGRAMMING: THESE ANSWERS ARE NUMBERED IN 
REVERSE ON PURPOSE]   
(4) None 
(3) Some 
(2) Most 
(1) All 
DON’T KNOW 
REFUSED 
 
 
 
 
 
 

 
 
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Patient Assessment of Chronic Illness Care (PACIC). (Glasgow RE et al. Med Care 2005; 43(5): 
436-44) 
 
22. Have you received medical care for high blood pressure in the last 6 months? (varname: 
BPCare6Mos) 
a. YES 
b. NO 
 
 
(SKIP TO QUESTION 43) 
c. DON’T KNOW 
(SKIP TO QUESTION 43) 
d. REFUSED 
 
(SKIP TO QUESTION 43) 
 
INTRO A: Staying healthy can be difficult when you have a chronic condition. We would like to learn 
about the type of help with your condition you get from your health care team. This might include your 
regular doctor, his or her nurse, or a physician’s assistant who treats your illness.  Your answers will 
be kept confidential and will not be shared with your physician or clinic. 
INTERVIEWER:  USE SHOWCARD 3 
Think about the following statement: 
Over the past 6 months, when I received care for my chronic conditions, I was: 
23. Asked for my ideas when we made a treatment plan.  (varname: CDIdeas) 
a. None of the time  
b. A little of the time 
c. Some of the time 
d. Most of the time 
e. Always 
f. DON’T KNOW 
g. REFUSED 
 
24. Given choices about treatment to think about. (varname: CDChoices) 
a.  None of the time  
b.  A little of the time 
c.  Some of the time 
d.  Most of the time 
e.  Always 
f.  DON’T KNOW 
g. REFUSED 
 
25. Asked to talk about any problems with my medicines or their effects. (varname: CDProblems) 
a. None of the time  
b. A little of the time 
c. Some of the time 
d. Most of the time 
e. Always  
f. DON’T KNOW 
g. REFUSED 
 
 
 
 
 

 
 
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26. Given a written list of things I should do to improve my health. (varname: CDImprove) 
a. None of the time  
b.  little of the time 
c. Some of the time 
d. Most of the time 
e. Always  
f. DON’T KNOW 
g. REFUSED 
 
27. Satisfied that my care was well-organized. (varname: CDOrganized) 
a. None of the time  
b. A little of the time 
c. Some of the time 
d. Most of the time 
e. Always  
f. DON’T KNOW 
g. REFUSED 
 
28. Shown how what I did to take care of myself influenced my condition. (varname: CDInfluenced) 
a. None of the time  
b. A little of the time 
c. Some of the time 
d. Most of the time 
e. Always 
f. DON’T KNOW 
g. REFUSED 
 
29. Asked to talk about my goals in caring for my condition. (varname: CDGoals) 
a. None of the time  
b. A little of the time 
c. Some of the time 
d. Most of the time 
e. Always 
f. DON’T KNOW 
g. REFUSED 
 
30. Helped to set specific goals to improve my eating or exercise. (varname: CDEating) 
a. None of the time  
b. A little of the time 
c. Some of the time 
d. Most of the time 
e. Always 
f. DON’T KNOW 
g. REFUSED 
 
 
 
 
 
 

 
 
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31. Given a copy of my treatment plan. (varname: CDWritten) 
a. None of the time  
b. A little of the time 
c. Some of the time 
d. Most of the time 
e. Always 
f. DON’T KNOW 
g. REFUSED 
32. Encouraged to go to a specific group or class to help me cope with my chronic condition. 
(varname: CDCope) 
a. None of the time  
b. A little of the time 
c. Some of the time 
d. Most of the time 
e. Always 
f. DON’T KNOW 
g. REFUSED 
 
33. Asked questions, either directly or on a survey, about my health habits. (varname: 
CDQuestions) 
a. None of the time  
b. A little of the time 
c. Some of the time 
d. Most of the time 
e. Always 
f. DON’T KNOW 
g. REFUSED 
 
34. Sure, that my doctor or, nurse thought about my values, beliefs, and traditions when they 
recommended treatments to me? (varname: CDValues) 
a. None of the time  
b. A little of the time 
c. Some of the time 
d. Most of the time 
e. Always 
f. 
DON’T KNOW 
g. REFUSED 
 
35. Helped to make a treatment plan that I could carry out in my daily life. (varname: CDDaily) 
a. None of the time  
b. A little of the time 
c. Some of the time 
d. Most of the time 
e. Always 
f. DON’T KNOW 
g. REFUSED 
 
 
 
36. Helped to plan ahead so I could take care of my condition even in hard times. (varname: 
CDHardTimes) 

 
 
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a. None of the time  
b. A little of the time 
c. Some of the time 
d. Most of the time 
e. Always 
f. DON’T KNOW 
g. REFUSED 
 
37. Asked how my chronic condition affects my life. (varname: CDAffects) 
a. 
None of the time  
b. 
A little of the time 
c. 
Some of the time 
d. 
Most of the time 
e. 
Always 
f. 
DON’T KNOW 
g. 
REFUSED 
 
38. Contacted after a visit to see how things were going. (varname: CDContacted) 
a. 
None of the time  
b. 
A little of the time 
c. 
Some of the time 
d. 
Most of the time 
e. 
Always 
f. 
DON’T KNOW 
g. 
REFUSED 
 
39. Encouraged to attend programs in the community that could help me. (varname: CDPrograms) 
a. 
None of the time  
b. 
A little of the time 
c. 
Some of the time 
d. 
Most of the time 
e. 
Always 
f. 
DON’T KNOW 
g. 
REFUSED 
 
40. Referred to a dietitian, health educator, or counselor. (varname: CDReferred) 
a. 
None of the time  
b. 
A little of the time 
c. 
Some of the time 
d. 
Most of the time 
e. 
Always 
f. 
DON’T KNOW 
g. 
REFUSED 
 
 
 
 
 
41. Told how my visits with other types of doctors, like an eye doctor or other specialist helped my 
treatment. (varname: CDDoctors) 
a. 
None of the time  

 
 
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b. 
A little of the time 
c. 
Some of the time 
d. 
Most of the time 
e. 
Always 
f. 
DON’T KNOW 
g. 
REFUSED 
 
42. Asked how my visits with other doctors were going. (varname: CDVisits) 
a. 
None of the time  
b. 
A little of the time 
c. 
Some of the time 
d. 
Most of the time 
e. 
Always 
f. 
DON’T KNOW 
g. 
REFUSED 
 
Demographics: Asked only on Screening Day 2 
43. Are you currently married, or living with someone as if you were married (i.e. domestic 
partner)? (varname: Married) 
a. YES 
b. NO 
c. DON’T KNOW 
d. REFUSED 
 
44. What is the highest degree or level of education you have completed? (varname: 
HighestEd) 
a. LESS THAN HIGH SCHOOL 
b. HIGH SCHOOL GRADUATE (INCLUDES EQUIVALENCY/GED) 
c. SOME COLLEGE OR ASSOCIATE’S DEGREE 
d. BACHELOR’S DEGREE 
e. GRADUATE OR PROFESSIONAL DEGREE. 
 
45. Which of the income group best represents your annual household income? 
       (INTERVIEWER: SHOW CARD 4) (varname: AnnualHHIncome) 
a. $0-$15,999 
b. $16,000-$24,999 
c. $25,000-$39,999 
d. $40,000-$49,999 
e. $50,000-$74,999 
f. $75,000-$99,999 
g. $100,00 or more 
h. DON’T KNOW    
i. 
REFUSED  
 
 
 
46/47. How many people, including yourself, do you support with this income? [NOTE IF 
DK/REF ABOVE, CHANGE QUESTION AS FOLLOWS: How many people, including 
yourself are supported with your annual household income?]  This could include your 

 
 
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spouse, your significant other, children, parents, or other household members. (varname: 
NumHHMembers) 
 
[INTERVIEWER: ENTER -8 FOR REFUSED, ENTER -9 FOR DON'T KNOW] 
 
_________ people 
(UNLESS 45 = DK/REF, SKIP TO 48) 
DON’T KNOW 
 
(SKIP TO 48) 
REFUSED 
 
(SKIP TO 48) 
 
48. [ONLY DISPLAY IN CAPI IF QUESTION 45 = DON’T KNOW OR REFUSED] Is your total 
household income above or below (pick household size)? (varname: HHSizeToIncome) 
   Family of 1 - $13,000 
Family of 2 - $15,500 
Family of 3 - $19,500 
Family of 4 - $23,500 
Family of 5 - $27,500 
Family of 6 - $32,000 
Family of 7 - $36,000 
Family of 8 - $40,000 
DON’T KNOW 
REFUSED
a. Above 
 
b. Below 
 
 
Access to Healthcare: Asked only at Screening Day 2 
Now I will need the information you brought with you. First let me ask you,  
 
49. Is there one medical clinic or office building that you go to for routine medical care? 
(varname: ClinicRoutine)  
a. YES 
b. NO 
 
 
(SKIP TO QUESTION 51) 
c. DON’T KNOW 
(SKIP TO QUESTION 51) 
d. REFUSED 
 
(SKIP TO QUESTION 51) 
 
50. I will need to record information about the medical clinic or office building: 
a. Name of clinic or office: _____________________________ 
b. Street Address: ________________________ 
c. City:  ______________________ 
d. Phone #: (_____) ________ - _________ 
e. Fax #: (_____) ________ - _________ 
f. Email: _____________________________ 
 
51. Is there one particular doctor whom you see for routine medical care? (varname: 
DoctorRoutine) 
a. YES 
b. NO 
 
 (SKIP TO QUESTION 53 IF QUESTION 49= YES; ELSE SKIP TO QUESTION 54) 
c. DON’T KNOW (SKIP TO QUESTION 53 IF QUESTION 49= YES; ELSE SKIP TO QUESTION 54) 
d.   REFUSED       (SKIP TO QUESTION 53 IF QUESTION 49= YES; ELSE SKIP TO QUESTION 54)

 
 
 
 
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52. Doctor’s Contact Information 
a. Doctor’s name: _____________________________ 
b. Doctor’s phone #: (_____) ________ - _________ 
c. Fax #: (_____) ________ - _________ 
d. Email: _____________________________ 
 
53.  In the last 3 months, how many times, if ever, have you visited this doctor or clinic for 
medical care? _______________ (varname: VisitDr3Mos) 
DON’T KNOW 
REFUSED 
 
54. Did you bring your medical insurance card with you today? (varname: InsuranceCard) 
a. YES 
b. NO 
 
 
(SKIP TO QUESTION 56) 
c. DON’T KNOW 
(SKIP TO QUESTION 56) 
d. REFUSED 
 
(SKIP TO QUESTION 56) 
  
55. Now I will record your medical insurance information from your medical insurance card. 
[Examples: Anthem Blue Cross Blue Shield HMO, Medicare Part A/B]  
a. Insurance carrier: _____________________________ (varname: InsuranceCarrier) 
b. Plan Type (HMO, PPO, EPO, POS): _____________________________ (varname: 
InsurancePlanType) 
 
56. Have you needed to go to the Emergency Room or been hospitalized in the past 3 
months? (varname: ER3Mos) 
a. YES 
b. NO 
 
 
(SKIP TO QUESTION 60) 
c. DON’T KNOW 
(SKIP TO QUESTION 60) 
d. REFUSED 
 
(SKIP TO QUESTION 60) 
 
57. For what reason? ____________________________________________ (varname: 
ERReason) 
 
58. What date were you in the hospital or emergency room?   Month __ Day ___ Year  
(varname: ERDate) 
 
59. What hospital or emergency room did you visit? _______________________ (varname: 
ERName) 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
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60.Have you experienced any of the following in the past 3 months? (CHECK ALL THAT 
APPLY) [INTERVIEWER: USE SHOWCARD 6] 
□ A) swollen ankles (varname: AR_SwollenAnkles, RS_SwollenAnkles) 
□ B) swollen gums (varname: AR_SwollenGums, RS_SwollenGums) 
□ C) swelling of the lips, throat, and/or tongue (varname: AR_SwelingLips, RS_SwelingLips) 
□ D) hair loss (varname: AR_HairLoss, RS_HairLoss) 
□ E) erectile dysfunction (varname: AR_ErectileDisfunction, RS_ErectileDisfunction) 
□ F) gout (varname: AR_Gout, RS_Gout) 
□ G) difficulty breathing or wheezing (varname: AR_DifficultyBreathing, 
RS_DifficultyBreathing) 
□ H) dry cough (varname: AR_DryCough, RS_DryCough) 
□ I) depression (varname: AR_Depression, RS_Depression) 
□ J) headache (varname: AR_Headache, RS_Headache) 
□ K) palpitations (feeling that your heart is pounding or racing) (varname: AR_Palpitations, 
RS_Palpitations) 
□ L) breast tenderness or enlargement (varname: AR_BreastTenderness, 
RS_BreastTenderness) 
□ M) excessive sleepiness during the day (varname: AR_ExcessiveSleepiness, 
RS_ExcessiveSleepiness) 
□ N) dizziness (varname: AR_Dizziness, RS_Dizziness) 
□ O) skin rash (varname: AR_SkinRash, RS_SkinRash) 
□ NONE OF THE ABOVE 
(SKIP TO QUESTION 75) (varname: AR_None) 
□ DON’T KNOW 
 
(SKIP TO QUESTION 75) (varname: AR_DK) 
□ REFUSED  
 
(SKIP TO QUESTION 75) (varname: AR_RF) 
 
60-74: 
[NOTE:  ONE QUESTION FOR EACH ITEM IDENTIFIED IN 60]   How severe was the reaction?  
Was it… [FOR EACH ITEM FOR 60, THIS QUESTION SHOULD INCLUDE BOTH THE ITEM 
AND THE LETTER, SO THAT WE CAN REFER TO SHOWCARD IF NEEDED] 
□ Mild (I did not need to see my doctor) 
□ Moderate (I needed to see my doctor) 
□ Severe (I was hospitalized) 
□ Life-threatening (I was hospitalized in the intensive care unit (ICU)) 
□ DON’T KNOW 
□ REFUSED 
AFTER ALL ITEMS ARE ASKED GO TO QUESTION 75 
 
Current Medications 
75. Are you taking any prescription medication for any medical condition? (varname: 
AnyMeds) 
a. Yes 
b. No 
 
 
(SKIP TO QUESTION 97) 
c. DON’T KNOW 
(SKIP TO QUESTION 97) 
 
d. REFUSED 
 
(SKIP TO QUESTION 97) 
 
 
76. Did you bring the medication with you today?  (varname: BringMeds) 
a. YES 
(SKIP TO QUESTION 80) 
b. NO 
 

 
 
 
 
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[If No, ask: When is the earliest you can bring in your medication? The sooner the better, 
even tomorrow would be great.  
[INTERVIEW:  THE LAST DAY IS ___] 
 
▪ 
Schedule follow up date: 
77. Day of Week:  
a. MONDAY 
b. TUESDAY 
c. WEDNESDAY 
d. THURSDAY 
e. FRIDAY 
f. SATURDAY 
g. SUNDAY 
 
78. Date: ____/_____/_____ 
 
79. Time: ____________________ 
                        
INTERVIEWER TO BREAK OFF HERE AND RE-START AFTER PARTICIPANT BRINGS 
MEDS. 
 
80-95.  Now I will record the name, dose, how often you are to take the medication(s) you 
brought in today and prescriber information.  
 
ALLOW FOR DROPDOWN LIST FOR BP MEDICATIONS.  OTHER NON-BP MEDICATIONS 
JUST ALLOW FOR ENTERING NAME OF MEDICINE (OTHER NON-BP MEDS IS FIRST 
OPTION ON LIST). 
 
FOR EACH BP MED: [CAN PUT IN UP TO 15 MEDS—QUESTIONS 80-95] 
 
(varname: DrugMed01 – DrugMed15) 
(varname: NonBPMed01– NonBPMed15) 
 
DOSE ________________ (varname: DoseMed01 – DoseMed15) 
 
DOSE PER DAY (response options = ½, 1, 2, 3, weekly, every night    
(varname: DosePerDayMed01– DosePerDayMed15) 
 
PRESCRIBER FIRST NAME ______________________  
(varname: PrescriberFirstMed01– PrescriberFirstMed15) 
 
PRESCRIBER LAST NAME _______________________ 
(varname: PrescriberLastMed01– PrescriberLastMed15) 
 
96. MEDICATION COMMENTS (varname: MedComment) 
____________________________________________________ 
 
TEMPORARY ID CARD – FILL OUT TEMPORARY ID CARD  
ONLY INTERVEIWER:  LET CUSTOMER KNOW HE SHOULD RECEIVE HIS PERMANENT 
STUDY ID CARD BY MAIL IN ABOUT 2 WEEKS.   

 
 
 
 
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DISPLAY PARTICIPANT NAME AND ID 
 
Incentives--Gift Cards 
 
Thank you for taking the time to participate in the second screening. You will be receiving $25 
for completion of this study visit either by pre-paid gift card, a reloadable gift card or check. 
 
[INTERVIEWER: AFTER ENTERING GIFT CARD NUMBER, VERIFY THAT THE NUMBERS 
WERE ENTERED CORRECTLY] 
 
ENTER GIFT CARD NUMBER(S)  
 
GIFT CARD FOR SCREEDING VISIT COMPLETION  
# ____________ (varname: 
VoucherNumVisitComplete) 
 
GIFT CARD FOR ENROLLED PATIENT Baseline Encounter completed  # ____________ 
(varname: VoucherNumMedDrInfo) 
 
Screening Visit 2/Baseline 
 
EXPLAIN NEXT STEPS— 
 
MENTION ABOUT STUDY PHARMACIST AND BARBER VISITS.  REFER TO STUDY 
INCENTIVES. BARBER WILL TAKE THEIR BLOOD PRESSURE DURING REGULAR 
HAIRCUT VISITS 1-2 TIMES PER MONTH.  IF PARTICIPANT HAS BP TAKEN AT LEAST 
ONCE PER MONTH, HE WILL RECEIVE ONE HAIRCUT VOUCHER EACH MONTH OVER 
THE NEXT 6 MONTHS.  FOR EACH IN PERSON VISIT WITH PHARMACIST, HE WILL GET 
A $25 GIFT CARD or payment to a reloadable debit card.      
 
MENTION THAT THE PHARMACIST WILL CALL THE PARTICIPANT WITHIN 24 HOURS 
TO SCHEDULE AN APPOINTMENT   
 
MENTION THAT THE NEXT STUDY CONTACT WILL BE A CALL IN 3 MONTHS TO 
CONDUCT A BRIEF PHONE INTERVIEW.  HE WILL GET A $15 GIFT CARD FOR 
COMPLETING THE PHONE INTERVIEW.  ALSO, THERE WILL BE AN IN PERSON 
INTERVIEW AT THE BARBERSHOP AFTER 6 MONTHS.  FOR COMPLETING THE 6 
MONTH VISIT, PARTICIPANT GETS A $100 GIFT CARD. 
 
Thank you for your time. 
 
[INTERVIEWER:  ENTER COMMENTS, CORRECTIONS, OR ANY OTHER RELEVANT 
INFORMATION ABOUT THE RESPONDENT] 
 
 
 
 
IMPORTANT--AFTER EXITING INTERVIEW VERIFY CONTACT INFORMATION IN SMS 
AND TRY TO OBTAIN ANY MISSING INFORMATION (FOR EXAMPLE, ADDRESS, PHONE 
NUMBERS) 
 

 
 
 
 
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Appendix 6B.3: 3-Month Telephone Survey 
 
Three-Month Telephone Interview 
 
PHONE NUMBERS [DISPLAY NUMBERS IN SMS] 
CONTACT HISTORY [DISPLAY CONTACT HISTORY OF 3 MONTH CALL] 
Subject Name: [DISPLAY PARTICIPANT NAME] 
Best Way to Contact: [DISPLAY BEST WAY TO CONTACT] 
Best Time to Contact: [DISPLAY BEST TIME TO CONTACT] 
Best Days to Contact: [DISPLAY BEST DAYS TO CONTACT] 
 
May I speak with <NAME OF PARTICIPANT>? 
RESULTS:  
Data Collector: 
             Codes 
                Interim Labels 
1 
RNA 
2 
Refusal 
5 
AM [GO TO SCRIPT] 
7 
Questionable ring 
8 
Problem 
11 
Number resolved  
31 
Busy 
32              
Dead Air                       
41 
General Call Back/ General 
Appt. 
42 
Exact Appt. 
61 
Language/Hearing-Speech 
ND 
Deceased 
NP 
Not available 
 
 
Answering Machine: 
Hello, my name is [NAME OF INTERVIEWER] from Vanderbilt University Medical Center. I’m 
calling {FIRST NAME} {LAST NAME} regarding a 5-minute telephone interview for the 
Barbershop Study. Upon completion of the interview, you will receive $15.  Please call us at 
[PHONE NUMBER]. Thank you. 
COMMENT ABOUT AM MESSAGE 
_________________________________________________ 
 
1. Just to confirm, am I speaking with [NAME]? 
☐YES ............................ 1 
 
(GO TO RESULT)  
☐NO .............................. 2   
(GO TO RESULT) 
 
Hi, my name is [NAME OF INTERVIEWER].  
I am a telephone interviewer with the Nashville Barbershop Blood Pressure Study in which 
you are participating at [NAME OF BARBERSHOP]  
This is a quick five-minute call to ask a few health questions. 
By completing this short survey, you will receive $15.  

 
 
 
 
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2. In the last 3 months, have you seen a doctor about your blood pressure? (varname:  
SeenDr) 
a. Yes 
b. No {GO TO QUESTION 4} 
c. DON’T KNOW {GO TO QUESTION 4} 
d. REFUSED {GO TO QUESTION 4} 
 
3. In the last 3 months, how many times did you see a doctor about your blood pressure? 
______________ (varname:  SeenDrTimes) 
DON’T KNOW 
REFUSED 
 
4. [IF DOCTOR AVAILABLE FROM PREVIOUS SURVEY] In the last 3 months, have you 
changed the doctor who is responsible for managing your blood pressure?  The 
Doctor's name we have on file is [NAME OF DOCTOR FROM PREVIOUS 
INTERVIEW]: 
[IF NO DOCTOR AVAILABLE FROM PREVIOUS SURVEY] Do you have a doctor 
who is responsible for managing your blood pressure?  (varname:  VerifyDr) 
a. Yes 
b. No {GO TO QUESTION 6} 
c. DON’T KNOW {GO TO QUESTION 6} 
d. REFUSED {GO TO QUESTION 6} 
 
5.  What is this doctor's name? (SubjectProtected) 
Doctor’s Name _____________  
Phone ____________________  
Fax # _____________________  
E-mail ____________________  
 
6. [IF INSURANCE INFO AVAILABLE FROM PREVIOUS SURVEY] In the last 3 months, 
have you changed your medical insurance plan?  The insurance information I have on 
file is: [NAME OF INSURANCE PLAN FROM PREVIOUS INTERVIEW] (varname:  
InsuranceCard) 
a. Yes 
 
 
b. No 
c. DON’T KNOW 
d. REFUSED 
 
[IF NO INSURANCE INFO AVAILABLE FROM PREVIOUS SURVEY] Do you have 
medical insurance? 
 
7. What is the insurance carrier? 
Insurance Carrier:  _____________________ (varname:  InsuranceCarrier) 
Plan Type: (HMO, PPO, EPO, POS) ___________________ (varname:  
InsurancePlanType) 
 
8. Now I would like to confirm contact information we have for you. 
[IF ADDRESS IN SMS] Do you have a new mailing address? The address(es) we 
have on file is [(ADDRESSES) IN SMS] 

 
 
 
 
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[IF NO ADDRESS IN SMS] Can I get a mailing address we could use to contact you if 
necessary? (varname:  VerifyAddress) 
a. Yes 
b. No [GO TO QUESTION 9a] 
 
9. What is your mailing address? (SubjectProtected) 
Address_________________________  
Apt/Suite ________________________ 
City ______________________ 
State _________________________ 
Zip ____________________________ 
 
9a. [INTERVIEWER: FOR EACH PHONE LISTED BELOW: 
 
READ THE STATEMENT WITH PHONE NUMBER 
IF PHONE NUMBER NO LONGER CURRENT, SELECT EDIT, SET PHONE 
STATUS TO INACTIVE, AND SELECT UPDATE.]  
 
[HOME/WORK/CELL] Can you still be reached at ________? 
 
[FRIEND/RELATIVE] I have ___________ as a friend/relative’s number who 
will know how to contact you. Is this still current? 
 
[INTERVIEWER: AFTER VERIFYING EACH PHONE ASK:] 
Other than the phone numbers I just asked about, are there any other phone 
numbers you can be reached at?  
 
[INTERVIEWER: IF YES: CLICK NEW PHONE, ENTER INFORMATION, AND 
CLICK ADD.] (SubjectProtected) 
  
10. [IF E-MAIL ADDRESS IN SMS] Do you have a new e-mail address? The e-mail 
address I have on file is: [E-MAIL ADDRESS IN SMS]? 
[IF NO E-MAIL ADDRESS in SMS] Do you have an e-mail address we could use to 
contact you? (varname:  VerifyEmail) 
a. Yes 
b. No {GO TO QUESTION 12} 
c. REFUSED 
 
11. What is your e-mail address? ____________________________ (SubjectProtected) 
 
12.   Now I have a few questions about your health. 
In the past 3 months, have you needed to go to the Emergency Room or been 
hospitalized? (varname:  ER3Mos) 
a. Yes 
b. No {GO TO QUESTION 16} 
c. DON’T KNOW {GO TO QUESTION 16} 
d. REFUSED {GO TO QUESTION 16} 
 
 

 
 
 
 
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13. For what reason? ____________________ (varname:  ERReason) 
 
14. What date were you in the hospital or emergency room?   Month __ Day ___ Year  
(varname:  ERDate) 
 
15. What hospital or emergency room did you visit? ____________(varname:  ERName) 
 
16. In the past 3 months, have you experienced any of the following? (CHECK ALL THAT 
APPLY) 
□ swollen ankles (varname: (a) AR_SwollenAnkles, RS_AR_SwollenAnkles) 
□ swollen gums (varname: (b) AR_SwollenGums, RS_SwollenGums) 
□ swelling of the lips, throat, and/or tongue (varname: (c) AR_SwelingLips, 
RS_SwelingLips) 
□ hair loss (varname: (d) AR_HairLoss, RS_HairLoss) 
□ erectile dysfunction (varname: (e) AR_ErectileDisfunction, 
RS_ErectileDisfunction) 
□ gout (varname: (f) AR_Gout, RS_Gout) 
□ difficulty breathing or wheezing (varname: (g) AR_DifficultyBreathing, 
RS_DifficultyBreathing) 
□ dry cough (varname: (h) AR_DryCough, RS_DryCough) 
□ depression (varname: (i) AR_Depression, RS_Depression) 
□ headache (varname: (j) AR_Headache, RS_Headache) 
□ palpitations (feeling that your heart is pounding or racing) (varname: (k) 
AR_Palpitations, RS_Palpitations) 
□ breast tenderness or enlargement (varname: (l) AR_BreastTenderness, 
RS_BreastTenderness) 
□ excessive sleepiness during the day (varname: (m) AR_ExcessiveSleepiness, 
RS_ExcessiveSleepiness) 
□ dizziness (varname: (n) AR_Dizziness, RS_Dizziness) 
□ skin rash (varname: (o) AR_SkinRash, RS_SkinRash) 
□ NONE OF THE ABOVE (varname: (p) AR_None) 
□ DON’T KNOW (varname: (q) AR_DK) 
□ REFUSED (varname: (r) AR_RF) 
 
16-30. IF YES FOR ANY ITEM IN 16, ASK ABOUT IT: 
Think about your… 
[NAME OF CONDITION MENTIONED IN 16] How severe was the reaction?  Was it? 
□ Mild (I did not need to see my doctor about the reaction) 
□ Moderate (I needed to see my doctor about the reaction) 
□ Severe (I was hospitalized) 
□ Life-threatening (I was hospitalized in the intensive care unit (ICU)) 
□ DON’T KNOW 
□ REFUSED 
 
32. 
Do you have any additional comments? (varname:  M3_EndComment) 
 
_____________________________________________________________________ 
 
Thank you for your time. I will be calling you again in 3 months to schedule your six-month in-
person visit with me or one of my fellow research coordinators. 

 
 
 
 
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Appendix 6B.4: 6-Month Visit Survey 
 
CUT YOUR PRESSURE TOO: 
The Nashville Barbershop Blood Pressure Study 
Health Questionnaire  
(6-Month Follow-up) 
 
Thank you for coming today. First, I need to bring up our information from your last visit and 
then I have a few questions. We can start now. 
 
CHECK ID AND NAME ON DATABASE TO ENSURE YOU HAVE PULLED UP THE 
CORRECT PERSON  
 
INTERVIEWER:  PLEASE VERIFY THAT YOU HAVE SELECTED THE CORRECT 
SUBJECT  
 
SUBJECT NAME ____________________________ 
 
SUBJECT ID ________________________________ 
 
DATE OF BIRTH _____________________________ 
 
BARBERSHOP ______________________________  
 
[INSTRUCT PARTICIPANT TO USE THE RESTROOM BEFORE YOU GET STARTED] 
 
Blood Pressure Measurement  
 
Now, I will take your blood pressure readings. 
 
[POPULATE CUFF SIZE USED IN SCREENING VISIT 1] 
 
The machine will automatically take readings over the next few minutes.  
• 
[INTERVIEWER: PLEASE HAVE PARTICIPANT SIT COMFORTABLY IN THE CHAIR 
• 
WITH FEET FLAT ON THE FLOOR,  
• 
RIGHT ARM SUPPORTED AT HEART LEVEL, 
• 
WAIT 5 MINUTES FOR PARTICIPANT TO REST BEFORE TAKING BP READINGS,  
• 
TURN MACHINE AWAY FROM SUBJECT’S VIEW, 
• 
INSTRUCT SUBJECT NOT TO TALK DURING BP’S, AND 
• 
DO NOT SPEAK TO SUBJECT DURING BP. 
• 
AFTER STARTING BP READINGS, WALK AWAY FOR A FEW MINUTES, AND 
THEN CHECK TO SEE IF 5 READINGS HAVE BEEN COMPLETED.] 
 
[INTERVIEWER: PROCEED TO CARETRENDS BLOOD PRESSURE PROCEDURE.] 
THE SUBJECT ID IS ________ 
 
1. INTERVIEWER: HOW MANY BLOOD PRESSURE READINGS WERE TAKEN?] 
______ 
 
 

 
 
 
 
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[INTERVIEWER: WAIT UNTIL BP MEASUREMENTS ARE COMPLETE, REMOVE BP 
CUFF, THEN CLICK NEXT TO RETRIEVE BP READINGS...] 
 
NOW TRYING TO RETRIEVE PRESSURE READINGS FROM THE SERVER. 
 
Systolic  
 
Diastolic 
a. ___________ 
 
 
___________ 
 
b. ___________ 
 
 
___________ 
 
c. ___________ 
 
 
___________ 
 
d. ___________ 
 
 
___________ 
 
e. ___________ 
 
 
___________ 
 
f. ___________ 
 
 
___________ 
 
g. ___________ 
 
 
___________ 
 
h. ___________ 
 
 
___________ 
 
i. 
___________ 
 
 
___________ 
 
j. 
___________ 
 
 
___________ 
 
 
[INTERVIEWER: IF BP MEASUREMENTS ARE NOT DISPLAYED CLICK THE BUTTON 
BELOW. IF NO MEASURMENTS ARE RETURNED, CLICK NEXT TO PROCEED TO 
MANUAL BP ENTRY.] 
INTERVIEWER:  CHECK HERE TO FORCE MANUAL BP SCREEN TO DISPLAY ____ 
(NOTE THIS IS NEEDED IN CASE ALL OF CARETRENDS READINGS DO NOT 
TRANSMIT] 
 
IT WAS NOT POSSIBLE TO RETRIEVE THE READINGS FROM THE SERVIER.  PLEASE  
ENTER MANUALLY. 
 
[INTERVIEWER: ENTER BP READINGS IN THE ORDER TAKEN. NOTE: BP READINGS 
ARE LISTED IN REVERSE ORDER ON THE CARE TRENDS SCREEN.] 
 
REASONS FOR MANUAL BP ENTRY 
_____________________________________________ 
 
READING DATE 
______________________________________________________________ 
 
 
 
 
 
 
 

 
 
 
 
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Systolic 
 
 
Diastolic 
 
 
Time 
1. ___________  
 
___________  
 
______________ 
 
2. __________  
 
___________  
 
______________ 
 
3. ___________  
 
___________  
 
______________ 
 
4. ___________  
 
___________  
 
______________ 
 
5. ___________  
 
___________  
 
______________ 
 
6. ___________  
 
___________  
 
______________ 
 
7. ___________  
 
___________  
 
______________ 
 
8. ___________  
 
___________  
 
______________ 
 
9. ___________  
 
___________  
 
______________ 
 
10. ___________  
 
___________  
 
______________ 
 
Compute average of BP Readings 
 Systolic _______ 
 
Diastolic ________ 
(varname: SysAvg, DiaAvg) 
 
On the participant’s blood pressure card, record the following: 
• 
Participant name (from question 2) (CONFIRM NAME AND SPELLING) 
• 
Today’s date: ________________ 
• 
Average blood pressure readings [BASED ON READINGS 3, 4, AND 5 (IF 5 OR 
MORE READINGS); BASED ON READINGS 3 AND 4 (IF 4 READINGS); MINIMUM 
OF 4 TOTAL READINGS] 
• 
IF LESS THAN 4 READINGS, DISPLAY INSUFFICIENT READINGS AND TRY TO 
CONDUCT ANOTHER SESSION 
 
If the BP is 200/120 or higher, say the following: 
 
 
Your blood pressure is dangerously high today and you need to seek medical attention 
without delay. Please call 911 to go to the nearest emergency room. Take this card with you 
to show to the emergency room doctor.  If they have any questions, the doctor may call the 
number listed on your card. 
• 
Statement was read to participant: Check YES. 
 
If the BP is 180/110 – 199/119, say the following: 
 
Your blood pressure is very high today.  Please see a doctor within the next 3 days.  Take this 
card with you to your doctor.  If they have any questions, the doctor may call the number listed 
on your card. 
 

 
 
 
 
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• 
Statement was read to participant: Check YES  
 
 
• 
 Part 1: Health and Healthcare Questions 
 
Patient Satisfaction with Chronic Disease Care Scale  
 
For the past 6 months, you have had a pharmacist bring medical care to your barbershop 
working with you and your doctor or the study doctor to control your blood pressure.  This is a 
new program and we appreciate your confidential feedback on how it’s working. 
Patient Assessment of Chronic Illness Care (PACIC). (Glasgow RE et al. Med Care 2005; 
43(5): 436-44) 
 
INTRO: Staying healthy can be difficult when you have a chronic condition. We would like to 
learn about the type of help with your condition you get from your health care team. This might 
include your regular doctor, his or her nurse, or a physician’s assistant who treats your illness.  
Your answers will be kept confidential and will not be shared with your physician or clinic. 
INTERVIEWER:  USE SHOWCARD 3 
 
Think about the following statement: 
 
Over the past 6 months, when I received care for my chronic conditions, I was: 
 
2. Asked for my ideas when we made a treatment plan.  (varname: CDIdeas) 
a. None of the time  
b. A little of the time 
c. Some of the time 
d. Most of the time 
e. Always 
f. DON’T KNOW 
g. REFUSED 
 
3. Given choices about treatment to think about. (varname: CDChoices) 
a.  None of the time  
b.  A little of the time 
c.  Some of the time 
d.  Most of the time 
e.  Always 
f.  DON’T KNOW 
h. REFUSED 
 
4. Asked to talk about any problems with my medicines or their effects. (varname: 
CDProblems) 
a. None of the time  
b. A little of the time 
c. Some of the time 
d. Most of the time 
e. Always  
f. DON’T KNOW 
g. REFUSED 
 

 
 
 
 
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5. 
Given a written list of things I should do to improve my health. (varname: CDImprove) 
a. None of the time  
b.  little of the time 
c. Some of the time 
d. Most of the time 
e. Always  
f. DON’T KNOW 
g. REFUSED 
 
6. 
Satisfied that my care was well-organized. (varname: CDOrganized) 
a. None of the time  
b. A little of the time 
c. Some of the time 
d. Most of the time 
e. Always  
f. DON’T KNOW 
g. REFUSED 
 
7. Shown how what I did to take care of myself influenced my condition. (varname: 
CDInfluenced) 
a. None of the time  
b. A little of the time 
c. Some of the time 
d. Most of the time 
e. Always 
f. DON’T KNOW 
g. REFUSED 
 
8. Asked to talk about my goals in caring for my condition. (varname: CDGoals) 
a. None of the time  
b. A little of the time 
c. Some of the time 
d. Most of the time 
e. Always 
f. DON’T KNOW 
g. REFUSED 
 
9. Helped to set specific goals to improve my eating or exercise. (varname: CDEating) 
a. None of the time  
b. A little of the time 
c. Some of the time 
d. Most of the time 
e. Always 
f. DON’T KNOW 
g. REFUSED 
 
 
 
 

 
 
 
 
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10. Given a copy of my treatment plan. (varname: CDWritten) 
a. None of the time  
b. A little of the time 
c. Some of the time 
d. Most of the time 
e. Always 
f. 
DON’T KNOW 
g. REFUSED 
 
11. Encouraged to go to a specific group or class to help me cope with my chronic condition. 
(varname: CDCope) 
a. 
None of the time  
b. 
A little of the time 
c. 
Some of the time 
d. 
Most of the time 
e. 
Always 
f. 
DON’T KNOW 
g. 
REFUSED 
 
12. Asked questions, either directly or on a survey, about my health habits. (varname: 
CDQuestions) 
a. 
None of the time  
b. 
A little of the time 
c. 
Some of the time 
d. 
Most of the time 
e. 
Always 
f. 
DON’T KNOW 
g. 
REFUSED 
 
13. Sure that my doctor or, nurse thought about my values, beliefs, and traditions when they 
recommended treatments to me? (varname: CDValues) 
a. None of the time  
b. 
A little of the time 
c. 
Some of the time 
d. 
Most of the time 
e. 
Always 
f. 
DON’T KNOW 
g. 
REFUSED 
 
14. Helped to make a treatment plan that I could carry out in my daily life. (varname: CDDaily) 
a. 
None of the time  
b. 
A little of the time 
c. 
Some of the time 
d. 
Most of the time 
e. 
Always 
f. 
DON’T KNOW 
g. 
REFUSED 
 
 
 

 
 
 
 
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15. Helped to plan ahead so I could take care of my condition even in hard times. (varname: 
CDHardTimes) 
a. 
None of the time  
b. 
A little of the time 
c. 
Some of the time 
d. 
Most of the time 
e. 
Always 
f. 
DON’T KNOW 
g. 
REFUSED 
 
16. Asked how my chronic condition affects my life. (varname: CDAffects) 
a. 
None of the time  
b. 
A little of the time 
c. 
Some of the time 
d. 
Most of the time 
e. 
Always 
f. 
DON’T KNOW 
g. 
REFUSED 
 
17. Contacted after a visit to see how things were going. (varname: CDContacted) 
a. 
None of the time  
b. 
A little of the time 
c. 
Some of the time 
d. 
Most of the time 
e. 
Always 
f. 
DON’T KNOW 
g. 
REFUSED 
 
18. Encouraged to attend programs in the community that could help me. (varname: 
CDPrograms) 
a. 
None of the time  
b. 
A little of the time 
c. 
Some of the time 
d. 
Most of the time 
e. 
Always 
f. 
DON’T KNOW 
g. 
REFUSED 
 
19. Referred to a dietitian, health educator, or counselor. (varname: CDReferred) 
a. 
None of the time  
b. 
A little of the time 
c. 
Some of the time 
d. 
Most of the time 
e. 
Always 
f. 
DON’T KNOW 
g. 
REFUSED 
 
 
 
 
 

 
 
 
 
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20. Told how my visits with other types of doctors, like an eye doctor or other specialist helped 
my treatment. (varname: CDDoctors) 
a. 
None of the time  
b. 
A little of the time 
c. 
Some of the time 
d. 
Most of the time 
e. 
Always 
f. 
DON’T KNOW 
g. 
REFUSED 
 
21. Asked how my visits with other doctors were going. (varname: CDVisits) 
 
a. 
None of the time  
b. 
A little of the time 
c. 
Some of the time 
d. 
Most of the time 
e. 
Always 
f. 
DON’T KNOW 
g. 
REFUSED 
 
DEMOGRPAHICS 
 
CV DISEASE AND RISK 
 
INTERVIEWER: We asked you similar questions when you entered the study, and we very 
much appreciate you answering again even if your answers have not changed. 
 
22.1) Have you smoked at least 100 cigarettes or cigars in your lifetime? (varname: 
Smoke100) 
a. YES 
b.  NO 
 
(SKIP TO QUESTION 23) 
c. DON’T KNOW 
(SKIP TO QUESTION 23) 
d. REFUSED 
(SKIP TO QUESTION 23) 
 
22.2) Have you smoked at all in the last year? (varname: SmokeLastYear) 
a. YES 
b.  NO  
 
(SKIP TO QUESTION 22.5) 
c. DON’T KNOW  
(SKIP TO QUESTION 22.5) 
d. REFUSED  
(SKIP TO QUESTION 22.5) 
 
22.3) Have you smoked at all in the last 30 days? (varname: SmokeLast30Days) 
a. YES 
b. NO (SKIP TO QUESTION 22.5) 
c. DON’T KNOW (SKIP TO QUESTION 22.5) 
d. REFUSED (SKIP TO QUESTION 22.5) 
 
22.4) During the past 30 days, on average, about how many cigarettes did you smoke in a 
day? (varname: SmokeNumPerDay30)  
______  (SKIP TO QUESTION 23) 
            DON’T KNOW (SKIP TO QUESTION 23) 
REFUSED (SKIP TO QUESTION 23) 

 
 
 
 
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22.5) On average, over the entire time you have smoked, how many cigarettes have you 
usually smoked per day? (varname: SmokeNumPerDayLifetime) 
_______ 
DON’T KNOW 
REFUSED 
 
22.6) How old were you when you quit smoking? (varname: SmokeQuitAge) 
____________   
DON’T KNOW 
REFUSED 
 
Perceived Health 
 
23. Overall, how would you rate your health?  Would you say… (varname: OverallHealth) 
a. Excellent 
b. Very Good 
c. Good 
d. Fair 
e. Poor 
f. Very Poor 
g.   DON’T KNOW 
h. REFUSED 
 
BP Medication Adherence Adherence to Refills and Medications (ARMS) Scale; (Adherence to 
Refills and Medications (ARMS) Scale; Kripalani, Risser, Gatti, & Jacobson, 2009) 
 
It is common for people to miss taking their medicine from time to time, or to take it differently 
than prescribed. I would like to ask you about how you actually take your blood pressure 
medicines. There are no right or wrong answers. For each question, please answer “none of 
the time,” “some of the time,” “most of the time,” or “all of the time.” 
 
24. How often do you forget to take your medicine? (varname: forgetmed) 
(1) None 
(2) Some 
(3) Most 
(4) All 
DON’T KNOW 
REFUSED 
 
25. How often do you decide not to take your medicine? (varname: decidenottakemed) 
(1) None 
(2) Some 
(3) Most 
(4) All 
DON’T KNOW 
REFUSED 
 
 
 
 
 

 
 
 
 
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26. How often do you forget to get prescriptions filled? (varname: prescrip_fill) 
(1) None 
(2) Some 
(3) Most 
(4) All 
DON’T KNOW 
REFUSED 
 
27. How often do you run out of medicine? (varname: medrunout)  
(1) None 
(2) Some 
(3) Most 
(4) All 
DON’T KNOW 
REFUSED 
 
28. How often do you skip a dose of your medicine before you go to the doctor? 
(varname_doseskip) 
(1) None 
(2) Some 
(3) Most 
(4) All 
DON’T KNOW 
REFUSED 
 
29. How often do you miss taking your medicine when you feel better? (varname: 
medfeelbetter) 
(1) None 
(2) Some 
(3) Most 
(4) All 
DON’T KNOW 
REFUSED 
 
30. How often do you miss taking your medicine when you feel sick?  (varname: medfeelsick)  
(1) None 
(2) Some 
(3) Most 
(4) All 
DON’T KNOW 
REFUSED 
 
31. How often do you miss taking your medicine when you are careless? (varname: 
medcareless)   
(1) None 
(2) Some 
(3) Most 
(4) All 
DON’T KNOW 
REFUSED 
 

 
 
 
 
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32. How often do you change the dose of your medicines to suit your needs (like when you take 
more or less pills than you’re supposed to)?  (varname: medchange) 
(1) None 
(2) Some 
(3) Most 
(4) All 
DON’T KNOW 
REFUSED 
 
33. How often do you forget to take your medicine when you are supposed to take it more than 
once a day? (varname: forget_med_multiple)   
(1) None 
(2) Some 
(3) Most 
(4) All 
DON’T KNOW 
REFUSED 
 
34. How often do you put off refilling your medicines because they cost too much money?  
(varname: medrefillmoney) 
(1) None 
(2) Some 
(3) Most 
(4) All 
DON’T KNOW 
REFUSED 
 
35. How often do you plan ahead and refill your medicines before they run out? (varname: 
medrefillplan) [PROGRAMMING:  THESE ANSWERS ARE NUMBERED IN REVERSE 
ON PURPOSE]   
(4) None 
(3) Some 
(2) Most 
(1) All 
DON’T KNOW 
REFUSED 
 
Frequency of MEDICAL APPOINTMENTS FOR HYPERTENSION 
 
36.  In the last 6 months, have you had a medical appointment for your blood pressure?  This 
could have been with your personal doctor, heart specialist, nurse, or pharmacist. 
(varname:  SeenDr) 
a. YES 
b. NO {GO TO QUESTION 38} 
c. DON’T KNOW {GO TO QUESTION 38} 
d. REFUSED {GO TO QUESTION 38} 
 
37.  In the last 6 months, how many of these appointments have you had? ______________ 
(varname:  SeenDrTimes) 
  DON’T KNOW 
  REFUSED 

 
 
 
 
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Nocturia 
 
38.  During the past 30 days, how many times per night did you typically get up to urinate, 
from the time you went to bed at night until the time you got up in the morning? 
(varname: Nocturnia) 
 
[SHOWCARD 1 - PROBE FOR AN AVERAGE OR TYPICAL NIGHT] 
 
a. 0  
 
 
(GO TO QUESTION 40) 
b. 1 
c. 2 
d. 3 
e. 4 
f. 5 OR MORE 
g. DON’T KNOW 
(GO TO QUESTION 40) 
h. REFUSED  
(GO TO QUESTION 40) 
 
39. Now using a scale from 0 to 10, with 0 indicating ‘not at all’ and 10 being ‘a great deal, 
please tell me how much does it bother you? (REPEAT QUESTION IF NEEDED: to get 
up to urinate, from the time you went to bed at night until the time you got up in the 
morning?) (varname: Nocturnia2) 
 
  
[SHOW CARD 2] 
 
☐     ☐     ☐     ☐     ☐     ☐    ☐    ☐     ☐     ☐     ☐        ☐     ☐    
0      1       2      3       4      5     6      7      8       9   10       DK   REF 
              Not at all  
 
 
 
 
 
       A great 
                                                                                                       deal  
 
40. In the last 3 months, how many times have you visited a doctor or clinic for any type of 
medical care? _____ (varname: VisitDr3Mos) 
 
ADVERSE EVENTS 
41. Have you needed to go to the Emergency Room or been hospitalized in the past 3 
months? (varname: ER3Mos) 
a. YES 
b. NO  
(SKIP TO QUESTION 45) 
c. DON’T KNOW 
(SKIP TO QUESTION 45) 
d. REFUSED (SKIP TO QUESTION 45) 
42.  For what reason? ____________________________________ 
      (varname: ERReason) 
43. What date were you in the hospital or emergency room?   Month __ Day ___ Year     
      (varname: ERDate) 
 
44. What hospital or emergency room did you visit? _______________________  
     (varname: ERName) 
 
 
 

 
 
 
 
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45. Have you experienced any of the following in the past 3 months? (CHECK ALL THAT 
APPLY) [INTERVIEWER: USE SHOWCARD 6] 
□ A) swollen ankles (varname: AR_SwollenAnkles, RS_SwollenAnkles) 
□ B) swollen gums (varname: AR_SwollenGums, RS_SwollenGums) 
□ C) swelling of the lips, throat, and/or tongue (varname: AR_SwelingLips, 
RS_SwelingLips) 
□ D) hair loss (varname: AR_HairLoss, RS_HairLoss) 
□ E) erectile dysfunction (varname: AR_ErectileDisfunction, RS_ErectileDisfunction) 
□ F) gout (varname: AR_Gout, RS_Gout) 
□ G) difficulty breathing or wheezing (varname: AR_DifficultyBreathing, 
RS_DifficultyBreathing) 
□ H) dry cough (varname: AR_DryCough, RS_DryCough) 
□ I) depression (varname: AR_Depression, RS_Depression) 
□ J) headache (varname: AR_Headache, RS_Headache) 
□ K) palpitations (feeling that your heart is pounding or racing) (varname: AR_Palpitations, 
RS_Palpitations) 
□ L) breast tenderness or enlargement (varname: AR_BreastTenderness, 
RS_BreastTenderness) 
□ M) excessive sleepiness during the day  (varname: AR_ExcessiveSleepiness, 
RS_ExcessiveSleepiness) 
□ N) dizziness (varname: AR_Dizziness, RS_Dizziness) 
□ O) skin rash (varname: AR_SkinRash, RS_SkinRash) 
□ NONE OF THE ABOVE (SKIP TO QUESTION 60) (varname: AR_None) 
□ DON’T KNOW 
 
(SKIP TO QUESTION 60) (varname: AR_DK) 
□ REFUSED 
 
(SKIP TO QUESTION 60) (varname: AR_RF) 
 
45-59. 
[NOTE:  ONE QUESTION FOR EACH ITEM IDENTIFIED IN 45]   Was it… [FOR EACH ITEM 
FOR 45, THIS QUESTION SHOULD INCLUDE BOTH THE ITEM AND THE LETTER, SO 
THAT WE CAN REFER TO SHOWCARD IF NEEDED] 
□ Mild (I did not need to see my doctor) 
□ Moderate (I needed to see my doctor) 
□ Severe (I was hospitalized) 
□ Life-threatening (I was hospitalized in the intensive care unit (ICU)) 
□ DON’T KNOW 
□ REFUSED 
AFTER ALL ITEMS ARE ASKED GO TO QUESTION 60 
 
Current Medications 
 
60. Are you taking any prescription medication for any medical condition? (varname: 
AnyMeds) 
e. Yes 
f. No 
 
 
(GO TO QUESTION 78) 
g. DON’T KNOW 
(GO TO QUESTION 78) 
 
h. REFUSED 
 
(GO TO QUESTION 78) 
 
 
62. Did you bring the medication with you today?  (varname: BringMeds) 
a. YES 
 
 
b. NO 
 
 
(GO TO QUESTION 78)  

 
 
 
 
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63-76. Now I will record the name, dose, how often you are to take the medication(s) you 
brought in today and prescriber information.  
 
ALLOW FOR DROP DOWN LIST FOR BP MEDICATIONS.  OTHER NON-BP 
MEDICATIONS JUST ALLOW FOR ENTERING NAME OF MEDICINE (OTHER NON-
BP MEDS IS FIRST OPTION ON LIST). 
 
FOR EACH BP MED: [CAN PUT IN UP TO 15 MEDS—QUESTIONS 62-76] 
 
(varname: DrugMed01 – DrugMed15) 
(varname: NonBPMed01– NonBPMed15) 
 
DOSE ________________ (varname: DoseMed01 – DoseMed15) 
 
DOSE PER DAY (response options = ½, 1, 2, 3, weekly, every night    
(varname: DosePerDayMed01– DosePerDayMed15) 
 
PRESCRIBER FIRST NAME ______________________  
(varname: PrescriberFirstMed01– PrescriberFirstMed15) 
 
PRESCRIBER LAST NAME _______________________ 
(varname: PrescriberLastMed01– PrescriberLastMed15) 
 
 
77. MEDICATION COMMENTS (varname: MedComment) 
 
 
The following questions refer to your experiences as a barbershop patron in this 
Barber-Physician-Pharmacist Program.  In answering these questions, please consider 
your barber measuring your blood pressure as well as your pharmacist meeting with 
you as part of this program. 
 
78. What impressed you most about the Program? (varname: ProgImpressed) 
 
79. What did you like least about the Program? (varname: ProgLeastLiked) 
 
80. What recommendations would you offer to improve the Program? (varname: 
ProgRecommend) 
 
81. Do you know of any other barbershops that would be interested in participating in the 
program?  [INTERVIEWER, IF YES, RECORD THE NAMES AND LOCATIONS OF 
BARBERSHOPS] (varname: ProgOthShops) 
 
Gift card 
 
Thank you for taking the time to participate in the 6 Month Follow-up. 
 
(CHECK SMS TO SEE IF PARTICIPANT HAS BEEN ISSUED A RELOADABLE DEBIT 
CARD.  IF HE HAS A DEBIT CARD TELL HIM THAT $100 WILL BE ADDED TO HIS CARD 
BY THE NEXT BUSINESS DAY.) 
 

 
 
 
 
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Here is a $100 gift card ($100 will be added to your study debit card) for completing the 6-
month Interview and for bringing your prescription pill bottles. 
 
[IF PARTICIPANT HAS debit card, ENTER NONE FOR GIFTCARD NUMBER] 
 
GIFTCARD #______________________________ (varname: GiftCardNum) 
 
[INTERVIEWER, PLEASE FOLLOW CONSENT PROCEDURES FOR FUTURE STUDIES] 
 
[INTERVIEWER: DID CUSTOMER CONSENT TO BEING IN FUTURE STUDIES AND FILL 
OUT CONTACT INFORMATION?] 
(varname: FutureStudiesS1)  
 
YES 
NO 
 
[INTERVIEWER, IF PARTICIPANT ASKS ABOUT STUDY RESULTS, YOU CAN MENTION 
THAT WE WILL BE SENDING PARTICIPANTS RESULTS AT THE END OF THE STUDY 
(LIKELY NOT UNTIL THE END OF 2020 AT THE EARLIEST)  
 
Thank you for your time.  We greatly appreciate your participation in the study. 
 
[INTERVIEWER:  ENTER COMMENTS, CORRECTIONS, OR ANY OTHER RELEVANT 
INFORMATION ABOUT THE RESPONDENT] (varname Comment) (varname 6 month: 
Comment6m) 
 
 
 
 
 
IMPORTANT--AFTER EXITING INTERVIEW VERIFY CONTACT INFORMATION IN SMS 
AND TRY TO OBTAIN ANY MISSING INFORMATION (FOR EXAMPLE, ADDRESS, PHONE 
NUMBERS) 
 
 
 
 
 

 
 
 
 
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Appendix 6B.5: Barber Exit Interview 
 
Barber Exit Interview 
Study ID: _____________ 
 
 
Barbershop: ______________________________ 
Below is a list of questions to determine your overall satisfaction in participating in the Nashville 
Implementation of the LA Barbershop Hypertension Study-Pilot trial. We appreciate your 
participation and value your feedback. Please select one of the options per question as your 
answer. Thank you. 
Please choose one of the following: 
Not at 
all 
A little 
bit 
Somewhat 
Quite a 
bit 
Very 
much 
1. How satisfied were you working with the 
VUMC staff throughout the Nashville 
Barbershop study? 
 
1 
2 
3 
4 
5 
2. Did you find that this study has brought 
positive community engagement to your 
barbershop? 
 
1 
2 
3 
4 
5 
3. Do you feel that this study strengthened 
the relationship between you and your 
clientele? 
 
1 
2 
3 
4 
5 
4. With the provided training, how confident 
were you as a Barber participating in the 
Nashville Barbershop study? 
 
1 
2 
3 
4 
5 
5. Did you find that using the blood pressure 
machine interrupted your workflow 
providing haircuts? 
 
1 
2 
3 
4 
5 
6. Did you find that using the blood pressure 
machine was bothersome? 
 
1 
2 
3 
4 
5 
7. Overall, how satisfied were you 
participating in the Nashville Barbershop 
study? 
 
1 
2 
3 
4 
5 
 
If you have additional comments or further explanation of the questions above, please provide your 
response below: 
____________________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________
____________________________________________________________________________________ 

 
 
 
 
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Appendix 6C: Blood Pressure Information Card  
 
                                         “Cut Your Pressure Too” Blood Pressure Card 
 
Participant’s Name: ____________________________________________ 
 
Your blood pressure on: _______________________ was 
/
 
                                                              Date                                (Systolic/Diastolic) 
If your blood pressure is: 
 Below 120 / 80, it is within the normal range Please SEE A DOCTOR AT LEAST 
ONCE A YEAR TO MAINTAIN GOOD HEALTH. 
 
 120/80 - 139/89, it is in the high normal range Please SEE A DOCTOR WITHIN  
6 MONTHS.  
 140/90 - 159/99, it is elevated Please SEE A DOCTOR WITHIN THE NEXT 1 MONTH.  
 160/100 — 179/109, it is very elevated Please SEE A DOCTOR WITHIN THE NEXT  
2 WEEKS. 
 
 180/110 – 199/119 or higher, it is extremely elevated Please SEE A DOCTOR  
WITHIN THE NEXT 3 DAYS. 
 
 200/120 or higher, it is DANGEROUSLY elevated Please GO TO THE  
NEAREST EMERGENCY ROOM IMMEDIATELY. If you have further questions,  
please call (615) 322-5000. 
 
If you are having chest pain, difficulty breathing, blurry vision, confusion, dizziness, or 
headache, you should seek immediate medical attention. Please see the Provider referral list 
for information on where to find a doctor. 
 
Thank you for participating in the Cut Your Pressure Too: The Nashville Barbershop 
Blood Pressure Study. 
 
 
 
 
 
 
 
 
 
Medical Director 
 
 
 
 
 
 
Clinical Pharmacist 
Cut Your Pressure Too project-Nashville 
 
 
 
 
 

 
 
 
 
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Appendix 6D: Template Pharmacist Note  
Patient Information 
Patient Name: ____________ ID #: ___ DOB: ____Patient Contact Info: phone ___ email: ___ 
Treating Physician: _______Physician Contact Information: phone:  _____ fax: ____email: ______ 
Date of Today’s Visit: ______________    Appointment Start Time: ________ 
Location of Today’s Visit:  
☐ 
Pharmacy → Pharmacy Name_____________________________                        
☐ 
Barbershop → Location ___________________________________ 
☐ 
Other→ Location Name_____________________________________ 
S/  
☐ 
Patient reports tolerating antihypertensive medication well without side effects. 
☐ 
Patient complains of experiencing an adverse drug reaction to antihypertensive 
medication.  
☐ 
Patient complains of intolerance to antihypertensive medication regimen.  
☐ 
Patient states there has been a significant interval change in health status. 
☐ 
Other: 
 
Comments: 
O/Medication Allergies:      
Medication 
Reaction 
Severity 
1) 
 
 
2) 
 
 
3) 
 
 
Current Medications: 
 
Medication 
Dosage 
Form 
 Dose 
Frequency 
Date Last 
Filled 
1) 
 
 
 
 
2) 
 
 
 
 
3) 
 
 
 
 
4) 
 
 
 
 
5) 
 
 
 
 
6) 
 
 
 
 
7) 
 
 
 
 
8) 
 
 
 
 
9) 
 
 
 
 
10) 
 
 
 
 
Associated Medical Problems: 
☐ 
DM 
☐ 
CAD 
☐ 
Stroke 
☐ 
Heart Failure 
☐ 
Hypercholesterolemia 
☐ 
CKD 
☐ 
Asthma / COPD 
☐ 
Heart Block 

 
 
 
 
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☐ 
Other/Comments: Click here to enter text. 
Patient’s BP in Barbershop on: Click here to enter a date. Patient’s BP today (only if no interval 
Barber-BP): 
 
BP 1  
HR 1 
 
BP 2  
HR 2 
 
BP 3  
HR 3 
 
BP 4  
HR 4 
 
BP 5  
HR 5 
 
BP 6  
HR 6 
 
BP 7  
HR 7 
 
BP 8  
HR 8 
 
Cuff Size:  
☐ Medium 
☐ Large 
☐ Extra-large 
 
 
 
Labs on: Click here to enter a date.    Source of Labs: ❑ POC or ❑ Laboratory 
Na  
K 
 
SCr  
eGFR  
Glu  
Targeted PE:  
Angioedema:   ❑ No  ❑ Yes                Gingival hyperplasia:  ❑ No  ❑ Yes 
Peripheral Edema  ❑ No  ❑ Yes 
   Skin Rash ❑ No  ❑ Yes 
A/ 
☐ 
BP at goal at barbershop or today (if no interval barbershop BP); no changes in 
therapy warranted 
☐ 
BP above goal at barbershop or today (if no interval barbershop BP); possible 
reasons for BP elevation include (check all that apply): 
 
☐ 
Patient’s HTN is being undertreated   
 
☐ 
Patient prescribed non-protocol medication 
 
☐ 
Patient non-adherence 
 
☐ 
Other/Comments: Click here to enter text. 
Antihypertensive Medication-Related Problems Identified: 
☐ 
Medication regimen not per protocol (not optimal based on current 
evidence/guidelines) 
☐ 
Medication regimen insufficient to reach treatment goals (dose, interval, # of 
medications) 
☐ 
Patient on short acting medication 
☐ 
Contraindication 
☐ 
Adverse Drug Reaction 
☐ 
Drug interaction 
☐ 
Drug therapy duplication 
☐ 
Medication misuse/ poor adherence 
☐ 
Abnormal lab result not addressed 
BP 1 
 
HR 1 
 
BP 2 
 
HR 2 
 
BP 3 
 
HR 3 
 
BP 4 
 
HR 4 
 
BP 5 
 
HR 5 
 
BP 6 
 
HR 6 
 
BP 7 
 
HR 7 
 
BP 8 
 
HR 8 
 

 
 
 
 
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Appendix 6E: Adverse Event Form 
 
PATIENT ID: 
 DATE FORM COMPLETED: 
 
HAS SUBJECT EXPERIENCED ANY ADVERSE 
EVENTS SINCE LAST VISIT? 
 YES 
 NO 
 
 
 
 
 
 
 
IF YES, DESCRIPTION OF THE EVENT: 
_______________________________________________________ 
EVENT ONSET DATE: _____/_____/_____ 
 OR CHECK IF CONTINUING FROM LAST VISIT 
EVENT END DATE: _____/_____/_____ 
 OR CHECK IF PRESENT AT THIS VISIT 
HAS PARTICIPANT GONE TO ER OR HOSPITAL 
SINCE THE LAST VISIT OR PHONE CALL? 
 YES 
 NO 
IF YES, DESCRIPTION OF EVENT:  
REASON FOR HOSPITALIZATION/ER VISIT: ___________________________________ 
WHAT WAS THE DATE: _________________________________ 
WHAT HOSPITAL OR ER: ________________________________ 
 
DRUG 
INTERVAL DRUG REACTIONS 
 CCB (CALCIUM CHANNEL BLOCKER) 
 ANKLE EDEMA      HYPOTENSION 
 BRADYCARDIA      GINGIVAL HYPERPLASIA 
 ACE-INHIBITOR 
 COUGH                  ACUTE KIDNEY INJURY 
 ANGIOEDEMA       HYPERKALEMIA 
 ARB (ANGIOTENSIN RECEPTOR BLOCKER) 
 ALOPECIA             ACUTE KIDNEY INJURY 
 THIAZIDE 
 ERECTILE DYSFUNCTION      GOUT 
 HYPERGLYCEMIA                    HYPOKALEMIA 
 HYPONATREMIA 
 BETA BLOCKER 
 WHEEZING                                HEART BLOCK    
 ERECTILE DYSFUNCTION           
 DEPRESSION 
 ALPHA BLOCKER 
 DIZZINESS 
 ANKLE EDEMA 
 HEART FAILURE 
 LOOP DIURETIC 
 ACUTE KIDNEY INJURY 
 HYPOKALEMIA 
 CLONIDINE (CENTRAL SYMPATHOLYTIC) 
 REBOUND HYPERTENSION 
 DRY MOUTH 
 SOMNOLENCE 
 DIRECT VASODILATORS 
 HEADACHE                             PALPITATIONS 
 SHORTNESS OF BREATH           
 LUPUS (hydralazine)             
 PERICARDITIS (hydralazine) 
 ALDOSTERONE BLOCKER 
 BREAST TENDERNESS/ ENLARGEMENT         
HYPERKALEMIA        ACUTE KIDNEY INJURY 
 ERECTILE DYSFUNCTION 
 
 
PHARMACIST SIGNATURE 
PRINT NAME 
DATE 

 
 
 
 
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SEVERITY GRADE (PLEASE CIRCLE ONE): 
1 = Grade 1: Mild AE (minor; no specific medical intervention; asymptomatic laboratory 
findings only, radiographic findings only; marginal clinical relevance) 
2 = Grade 2: Moderate AE (minimal intervention; local intervention; noninvasive intervention 
[packing, cautery])  
3 = Grade 3: Severe and undesirable AE (significant symptoms requiring hospitalization or 
invasive intervention; transfusion; elective interventional radiological procedure; therapeutic 
endoscopy or operation)  
4 = Grade 4: Life-threatening or disabling AE (complicated by acute, life-threatening 
metabolic or cardiovascular complications such as circulatory failure, hemorrhage, sepsis. 
Life-threatening physiologic consequences; need for intensive care or emergent invasive 
procedure; emergent interventional radiological procedure, therapeutic endoscopy or 
operation) 
5 = Grade 5: Fatal AE  
 
RELATIONSHIP TO STUDY DRUG (PLEASE CIRCLE ONE): 
1 = Probably Related. This category applies to those adverse events that are considered 
with a high degree of certainty to be related to the test drug.  
2= Possibly Related. This category applies to those adverse events for which a cause and 
effect relationship between the study drug and the AE has not been previously demonstrated 
and it appears unlikely from the known effects of the drug but cannot be ruled out with 
certainty.  
3= Unlikely Related. In general, this category is applicable to adverse events that does not 
follow a reasonable temporal sequence related to drug administration or it is likely to be 
explained by other known characteristics of the participant or their treatment for other 
conditions; or t does not follow a pattern/manner known or suspected to be related to study 
drug  
 
EVENT PATTERN (PLEASE CIRCLE ONE): 
1 = Continuous  
2 = Intermittent  
3 = Unknown 
 
ACTION TAKEN WITH STUDY DRUG (PLEASE CIRCLE ONE): 
1 =   No action, continued on study drug without interruption  
2 =   No change, was not on study drug at the time of AE 
3 = Temporary discontinuation of study drug 4 = Permanently Discontinued of study drug  
 
HOSPITALIZATION REQUIRED (PLEASE CIRCLE ONE): 
0 = No  
1 = Yes  
 
MEDICATIONS REQUIRED (PLEASE CIRCLE ONE): 
0 = No  
1 = Yes 
 
1/17/2012 
 

 
 
 
 
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Appendix 6F: Example Study Pharmacist to Non-Study Physician Letters 
DATE 
 
Dear Dr.  NAME, 
As you know your patient, Mr. FIRST AND LAST NAME is participating in the Barbershop Study 
conducted by Vanderbilt University Medical Center in order to determine the effectiveness of a 
novel community-partnered approach to help control hypertension.  We are writing you today to 
inform you of your patient’s progress and to share forthcoming treatment recommendations with 
you.  
Unfortunately, Mr. LAST NAME’s BP was not at goal and was most recently XXX/XX when 
measured at his barbershop on DATE.   
The following changes were made to his medication regimen [EXAMPLE]:  
1. Amlodipine 5 mg once daily was added 
 
2. Benazepril 10 mg once daily was increased to Benazepril 20 mg once daily  
His current medication regimen is: 
1. Amlodipine 5 mg once daily  
 
2. Benazepril 20 mg once daily  
 
Attached is a note detailing the pharmacist-patient visit for your review.  The barber will 
continue to monitor Mr. LAST NAME’s blood pressure on a monthly basis and report the 
readings to the study pharmacist, who will continue to work closely with Mr. LAST NAME for 
the remainder of his participation in the project and will continually update you on his 
progress.   
Please do not hesitate to call us if you have any questions or concerns. 
Sincerely, 
 
 
 
 
 
 
 
 
 
Clinical Pharmacist 
Phone: XXX-XXX-XXXX 

 
 
 
 
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Date of Visit: XX/XX/XXXX 
Patient: FIRST AND LAST NAME, DOB: XX/XX/XXXX 
Treating Physician: Dr. LAST NAME 
Location of Visit: ADDRESS 
Associated Medical Problems: (i.e. Diabetes Mellitus Type II, Lupus) 
S:  This is a 41-year-old African American man presenting for a first visit with study 
pharmacist in the Barbershop research study.  Mr. LAST NAME reports tolerating his current 
antihypertensive regimen (Benazepril 10 mg once a day) well without side effects (denies 
cough, signs/symptoms of angioedema).       
O: Patient’s blood pressure in the barbershop (BP average of the final 3 of 5 BP readings):  
X/XX/XX 169/94 
X/XX/XX 152/88 
X/XX/XX 139/79 
 
BP Cuff Size: Medium 
Labs on DATE: 
A: 
Patient’s antihypertensive medication regimen requires intensification and continued 
monitoring. Current antihypertensive regimen:  
 
P: 
Mr. LAST NAME may benefit from the addition of Amlodipine 5 mg once daily and increasing 
his benazepril dosage.  Unfortunately, Lotrel (amlodipine/benazepril) is not covered by his 
insurance formulary.   
New Regimen (per study algorithm): 
Benazepril 
20 mg daily 
Amlodipine 5 mg daily 
 
Prescription called into PHARMACY (XXX-XXX-XXXX, spoke with Janet).  We will monitor Mr. 
LAST NAME’s BP and I will call him in a few days to see how he is tolerating his new 
medication regimen.  
Jane Doe, PharmD  
Clinical Pharmacist 
Phone: XXX-XXX-XXXX  
Na 138 K 4.4 
SCr 0.82 eGFR 127 
Glu 209 
Benazepril 10 mg once 
daily 

 
 
 
 
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Appendix 6G: Participant Treatment Report Example Template 
 

 
 
 
 
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APPENDIX 7: DATA SAFETY MONITORING COMMITTEE PLAN/ SAE FORMS 
 
Preamble 
The monitoring of SAE/UPs is an important process for ensuring the safety of subjects 
participating in clinical research. This document establishes a set of procedures for collecting, 
evaluating, and reporting SAE/UPs in the study. 
  There will be two sources of safety data in this community-level intervention trial: 
(1) Research coordinators will obtain patient-reported adverse events/unanticipated problems 
on emergency department visits, hospitalizations, death, and specific blood pressure 
medication side-effects at baseline, 3 months and 6 months. They will obtain baseline data 
and 6-month data during in-person interviews with participants in their barbershops or 
through listed contact information. They will obtain 3- data as part of scheduled phone calls 
to collect data on interval changes in health. 
 
(2) The study’s Lead Clinical Pharmacist will obtain additional data on adverse events and 
unanticipated problems.  He/she will collect data on patient-reported adverse events from 
monthly scheduled in-person or phone encounters plus additional follow up phone calls 
after every BP medication change. He/she also will collect safety data from Laboratory 
tests ordered when indicated during the intervention period.        
Key Components of the Safety Monitoring Plan 
Definitions of Adverse Events and Unanticipated Problems are presented in Appendix 8. 
  
A flow diagram for expedited reporting of Serious Adverse Events/Serious Unanticipated 
Problems is presented in Appendix 9. A summary of the key components of the monitoring 
process to be undertaken to detect and report SAE/UPs for the study is presented below: 
1. The UCLA Data Coordinating Center (DCC): The DCC receives submitted electronic 
reports of AE/UPs from research coordinators and from the Lead Clinical Pharmacist. 
If AE/UP is marked as serious on the electronic case report form and thus meets the 
criteria for expedited reporting, an automatic e-mail notification is sent immediately to 
both Physician Monitors and the PI; their roles are described later.  For non-serious 
AE/UPs, the DCC will provide blinded quarterly safety reports to the DSMB, and PI who 
will forward the reports to the IRB (Vanderbilt University). As the DCC only receives de-
identified information, the local VUMC study team will link any collected data also in 
real time with the affected participant. This will be acted upon immediately as described 
here. 
 
2. Physician Monitors: The Physician Monitors serve two major roles in the evaluation of 
SAE/UPs for the trial: 1) ongoing, real-time reviews of all individual SAE/UPs from the 
research assistant or clinical pharmacist (VUMC), review the medical records, make a 
rapid determination if the event indeed is serious and is related to research participation, 
and complete and forward to the PI the Physician Monitor Report of SAE/UPs shown in 
Appendix 12; and 2) monthly reviews of cumulative SAE data to judge whether there are 
concerning trends in the occurrence of events. 
 
 
 

 
 
 
 
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3. DSMB: The DSMB is responsible for safeguarding the interests of study participants by 
assessing the safety and efficacy of study procedures, and by periodic monitoring of 
safety data and the overall conduct of the study. The DSMB reviews the following types 
of safety data: 1) quarterly reports from the UCLA DCC; 2) annual reports from DSMB 
meetings; and 3) expedited reports from the PI on individual SAE/UPs or concerning 
trends identified by the Physician Monitors. After reviewing pertinent reports, the DSMB 
determines whether any trend that may be identified is related to the trial. After each 
DSMB meeting, the study team will prepare a draft report for the DSMB Chair to review 
and sign. The VUMC PI will transmit it to the VUMC IRB. The report summarizes the 
recommendations of the DSMB regarding the safety and continuance of the study and 
should be sent to the PI within 60 days after a DSMB meeting. The DSMB serves in an 
advisory role to Vanderbilt University Medical Center. If the DSMB identifies a 
concerning safety trend related to the trial, the Board makes a recommendation to 
NCATS through the Project Officer, and to the PI, who will transmit the 
recommendations to the participating VUMC IRB. This recommendation includes 
actions that should be taken to protect current and potential participants. 
 
4. PI: For expedited reporting of any individual SAE/UP, the PI will forward the report from 
the Physician Monitors to the NCATS or NHLBI and the participating IRBs within 7 
days of its detection along with an appropriate plan to address it, if feasible. After 
each scheduled DSMB meeting, the PI receives a summary report from the DSMB 
Chair that summarizes the DSMB deliberations and recommendations.  
 
Definition of Serious Adverse Events (SAEs) See also Appendix 8 
As defined by NHLBI (http://www.nhlbi.nih.gov/crg/glossary.php#serious), serious adverse 
events (SAEs) are considered to be those events that result in at least one of the following 
outcomes: 
1. Death 
2. Life-threatening 
3. Inpatient hospitalization or prolongation of an existing hospitalization 
4. Persistent or significant disability/incapacity 
5. A congenital anomaly/birth defect 
6. Other events that might jeopardize the subject and may require medical or 
surgical intervention to prevent one of the outcomes listed above 
 
Definition of Unanticipated Problems See Also Appendix 8 
As specified by NHLBI policy (http://www.nhlbi.nih.gov/funding/policies/adverse.htm) an 
unanticipated problem (UP) is considered to be any event or problem that is: 
 
1. unexpected; and 
2. possibly, probably, or definitely related to study participation; and 
3. suggests greater risk of harm to study participant(s) than was previously 
known or recognized. 
 
An unanticipated problem is classified as serious if the event results in an emergency department 
visit, hospitalization, or death. 
 
 
 

 
 
 
 
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Procedures for Reviewing and Reporting SAE/Ups 
The Study personnel, in previous consultation with NHLBI, have established the following 
procedures for reviewing and reporting SAE/UPs. 
1. Reporting of SAE/UPS by the Principal Investigator (PI) 
The PI is responsible for prompt reporting of all SAE/UPs, as described below. 
2. Submission of the Case Report Form for SAE/Ups (see Appendices 10-12) 
Adverse events forms will be electronically entered into the study database by research 
coordinators or by the Lead Study Pharmacist as well as maintained in the VUMC hard copy 
research charts. Pharmacist documents will also be maintained in the VUMC REDCap study 
database. 
Detection and Initial Processing of SAE/Ups 
1. The electronic database is updated every 24 hours and is programmed to automatically 
send immediate e-mail notification of any new SAE/UP to both Physician Monitors and 
the PI. The report contains all information on the SAE/UP that was entered into the 
database. 
 
2. The DCC Database Manager sends summary cumulative reports of SAE/UPs to the 
Physician Monitors monthly. The Physician Monitor who has been assigned to that 
quarter reviews the summary report to determine if any concerning trends are noted. 
 
3. If a serious problem or trend is suspected, the Physician Monitors would request that 
the PI forward the information to the DSMB.  
Physician Monitors 
 will serve as Physician Monitors for this study. If neither is 
available another study MD will be designated in their absence as needed. 
 as Cedars 
Sinai will also serve in this oversight role. The Physician Monitors are assigned the responsibility 
of serving as lead Physician Monitor during alternating calendar quarters. The Lead Physician 
Monitor completes the form but reviews it together with the other Physician Monitor. The 
Physician Monitors are given limited access to the study database only to enter a Physician 
Monitor SAE/UP Report Form (see Appendix 12) for each reported SAE/UP. The form serves 
as the monitor’s evaluation of each reported SAE/UP. A description of the process for Physician 
Monitor evaluation of UPs/SAEs is presented below. 
 
1. The Physician Monitor evaluates each SAE/UP to determine if it is unexpected and 
possibly, probably, or definitely related to the study intervention, and completes the 
Physician Monitor SAE/UP Report Form (Appendix 12) online within three (3) business 
days of receipt.  Physician Monitors use the Comments section of the form when 
needed to clarify the context or assumptions used in answering form questions. 
 
2. If the participant went to the emergency department, was hospitalized, or died, the 
Physician Monitor will need to request and review the medical records. The Study 
Coordinator will facilitate this process by obtaining a signed HIPAA waiver and request 
for release of medical records from the participant or his designee.  
 
 
 

 
 
 
 
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3. The DCC Database Manager prepares quarterly SAE/UP reports that include: 1) all 
SAE/UPs; 2) all SAE/UPs related to study participation; and 3) a summary of the SAE 
monitoring process. The monthly report is emailed to both Physician Monitors, who 
review the SAE/UP reports for any concerning trends. Should any concerns arise due 
to observed trends, the lead Physician Monitor for that quarter sends a written 
recommendation to the PI requesting that the report be forwarded to the DSMB. 
 
Procedure for Expedited Reporting of SAE/Ups (see Appendix 9) 
1. Expedited SAE/UP reports from the PI should include the following: 
▪ 
Study title, grant number, PI name 
▪ 
Description and date of the event or problem, including why it merits 
expedited reporting 
▪ 
When it becomes available, date(s) on which the SAE/UP was detected by 
the DCC and e-mail alerts sent to the Physician Monitors and PI, and the 
date on which the PI sent his report to the NCATS, and applicable 
oversight bodies (relevant IRBs, the DSMB, Office for Human Research 
Protections). 
▪ 
Any corrective action planned or taken in response to the SAE/UP (e.g., 
study suspension, consent or protocol changes, additional training or 
security measures).  
▪ 
Signature of the PI 
 
2. All communications from the relevant oversight bodies regarding any expedited 
UP/SAE must be reported to NCATS. 
 
3. The PI is responsible for forwarding any IRB decisions regarding UPs/SAEs to the 
DSMB, as noted above. 
 
Quarterly Reporting of SAE/Ups to the DSMB 
Each quarter, the study biostatistician sends cumulative summary tables of all SAEs, all 
related SAE/UPs to the DSMB.  
Interim Monitoring Plan 
There will be no interim analyses for futility.  
SAE/UPs Reports 
Each quarter, the UCLA DCC prepares cumulative SAE/UPs reports for review by the Physician 
Monitors. Cumulative SAE/UPs reports are transmitted to the DSMB for review each quarter, 
and cumulative summary reports are prepared for each teleconference or in-person closed 
session meeting of the DSMB. 
 
SAE/UP tables are included in the monthly cumulative reports from the DCC to the Physician 
Monitors: 
▪ Summary data on all SAE/UPs  
▪ Summary of SAE/UPs Related to the Research  
▪ Summary of Serious Adverse Event Monitoring Process 
▪ Listing of individual SAE/UPs  
 
 

 
 
 
 
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APPENDIX 8 RELEVANT DEFINITIONS OF SAFETY TERMS PER NIH NHLBI POLICY 
 
Adverse Event - Any untoward medical occurrence associated with the use of a drug in 
humans, whether or not considered drug related. An adverse event (also referred to as an 
adverse experience) can also be any unfavorable and unintended sign (e.g., an abnormal 
laboratory finding), symptom, or disease temporally associated with the use of a drug, without 
any judgment about causality. An adverse event can arise from any use of a drug (e.g., off label 
use, use in combination with another drug) and from any route of administration, formulation or 
dose, including overdose. 
 
Serious Adverse Event (SAE) – An adverse event or suspected adverse reaction is considered 
"serious" if, in the view of either the investigator or sponsor, it results in any of the following 
outcomes: Death, a life-threatening adverse reaction, inpatient hospitalization or prolongation of 
existing hospitalization, a persistent or significant incapacity or substantial disruption of the 
ability to conduct normal life functions, or a congenital anomaly/birth defect. Important medical 
events that may not result in death, be life-threatening, or require hospitalization may be 
considered serious when, based upon appropriate medical judgment, they may jeopardize the 
patient or subject and may require medical or surgical intervention to prevent one of the 
outcomes listed above. 
 
Unanticipated Problem - any incident, experience, or outcome that meets all of the following 
criteria: 1) unexpected 2) related or possibly related to participation in the research; and 3) 
suggests that the research places subjects or others at a greater risk of harm than was 
previously known or recognized. 
 
OHRP considers unanticipated problems, in general, to include any incident, experience, or 
outcome that meets all of the following criteria: 
(1) unexpected (in terms of nature, severity, or frequency) given (a) the research procedures 
that are described in the protocol-related documents, such as the IRB- approved research 
protocol and informed consent document; and (b) the characteristics of the subject 
population being studied; 
 
(2) related or possibly related to participation in the research (in this guidance document, 
possibly related means there is a reasonable possibility that the incident, experience, or 
outcome may have been caused by the procedures involved in the research); and 
 
(3) suggests that the research places subjects or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or recognized. 
 
 
 
 

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APPENDIX 9 FLOW DIAGRAM FOR EXPEDITED REPORTING OF SERIOUS ADVERSE
EVENTS AND SERIOUS UNANTICIPATED PROBLEMS (SAE/UP)

 
 
 
 
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APPENDIX 10 RESEARCH ASSISTANT AE/UP FORM 
(Completed at Baseline and 3, 6-month follow up – embedded within those forms also) 
Interviewer/Research Assistant AE/UP Form 
1. In the past 3 months, have you gone to the Emergency Room or been hospitalized? 
a. Yes 
b. No 
 
2. If yes to #1, please ask the following questions: 
a.  For what reason were you hospitalized or in the emergency room? 
____________________ 
b. What date were you in the hospital or emergency room?  ___/____/____ 
c. What hospital or emergency room did you visit? _____________________ 
 
3. In the past 3 months, have you experienced any of the following? (check all that apply) 
□ swollen ankles 
□ swollen gums 
□ swelling of the lips, throat, and/or tongue 
□ hair loss 
□ erectile dysfunction 
□ gout 
□ difficulty breathing or wheezing 
□ dry cough 
□ depression 
□ headache 
□ palpitations (feeling that your heart is pounding or racing) 
□ breast tenderness or enlargement 
□ excessive sleepiness during the day  
□ dizziness 
□ skin rash 
 
4. If yes for any #3, rate severity: How severe was the reaction? 
□ Mild (I did not need to see my doctor about the reaction) 
□ Moderate (I needed to see my doctor about the reaction) 
□ Severe (I was hospitalized) 
□ Life-threatening (I was hospitalized in the intensive care unit (ICU) 
 
 
 
 
 

 
 
 
 
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APPENDIX 11 CLINICAL PHARMACIST AE/UP FORM – SEE APPENDIX 6E

 
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APPENDIX 12 PHYSICIAN MONITOR SAE/UP REPORT FORM 
 
Physician Monitor Report of a SAE/UP 
 
1. Date of SAE: __ __/__ __/__ __ __ __ (mm/dd/yyyy)  
 
2. Date site became aware of SAE: __ __/__ __/__ __ __ __ (mm/dd/yyyy)  
 
3. Description of SAE: _____________________________________________________  
 
4. Check the outcomes that are attributed to the SAE in the medical record or reported by the 
subject (check all that apply):  
 a. Death  
a.1 Death Date: __ __/__ __/__ __ __ __ (mm/dd/yyyy)  
 
 b. Life-threatening condition  
 
 c. Hospitalization – initial or prolonged  
 
 d. Disability  
 
 e. Congenital anomaly  
 
 f. Required intervention to prevent permanent impairment/damage  
 
Option 4.f should be used for an event that does not result in death, a life-threatening 
condition, hospitalization, disability or congenital deformity, but that did jeopardize the 
subject and that required a specific medical intervention to prevent one or more of 
outcomes 4.a – 4.e from occurring.  
 
 g. Important medical event as determined by the site PI or designee  
 
Option 4.g should only be chosen when a site judges the event to represent significant 
hazard or harm to a research subject.  
OR  
 
 h. None of the above  
 
 
 
 
 
 
 
 
*** If you checked one or more of items 4.a – 4.g, continue to complete the remaining sections.  
 
If you checked 4h (None of the above), this is not a serious event. You do not need to complete the rest 
of this form.   

 
 
 
 
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6. Was the SAE an exacerbation of a pre-existing condition (i.e. existing prior to enrollment)?  
 Yes     No  
 
7. Was the SAE related or might it have been related to an antihypertensive medication?  
 Yes     No  
 
If yes, please list the medication(s) that might have been related to the event:  
 
 Medication:  
Stopped because of Adverse Event?  
 
a. _______________________ 
 
 Yes    
  No  
 
b. _______________________  
 
 Yes    
  No  
 
c. _______________________  
 
 Yes    
  No  
 
8. Do you believe the SAE was unexpected in terms of severity or frequency?  
 Yes     No  
 
If yes, why? 
________________________________________________________________________ 
 
9. Do you believe the SAE was possibly related to participation in the research? 
 Yes     No  
 
If yes, why? 
________________________________________________________________________ 
 
10.  Do you believe the SAE suggests that the research places subjects or others at greater risk 
of harm than was previously known or recognized? 
 Yes     No  
 
If yes, why? 
_________________________________________________________________________ 
 
11. Describe relevant scans/tests/laboratory data related to the SAE, including dates.  
 
 
12. Describe other relevant history, including pre-existing medical conditions (e.g. 
allergies, smoking and alcohol use, hepatic/renal dysfunction). 
_________________________________________________________________________