ACCP Cardiology PRN Journal Clubaccpcardsprnjournalclub.pbworks.com/w/file/fetch/127014161/Barber 1...

ACCP Cardiology PRN Journal Club14 June 2018

Mentor Bio

Dr. Rob Hough completed Doctor of Pharmacy training at the University of Florida in Gainesville, Florida. He then completed a post-graduate pharmacy practice residency at the Veterans Affairs Medical Center, West Palm Beach, Florida. Dr. Hough is a board certified pharmacotherapy specialist with added qualifications in cardiology and is currently practicing at the Veterans Affairs Medical Center, West Palm Beach, Florida as a clinical pharmacy specialist in ambulatory cardiology clinic and the director of the post graduate year-2 Cardiology Pharmacy Residency Program.

Presenter Bio

Dr. Kody Merwine earned her doctorate of pharmacy from the University of Missouri-Kansas City School of Pharmacy. Kody then completed her PGY1 Pharmacy Practice Residency at Thomas Jefferson University Hospitals. She is now completing her PGY2 in cardiology at the University of Kentucky HealthCare. Kody will be practicing as a Heart Failure specialist at West Virginia University.

Effectiveness of a Barber-Based Intervention for Improving

Hypertension Control in Black Men(Barber-1)

Kody Ann Merwine, PharmD

PGY-2 Cardiology Pharmacy Resident

University of Kentucky HealthCare

Lexington, KY

Victor RG, et al. Arch Intern Med. 2011; 171 (4):342-350.

Disclosure Statement

• I have no financial relationships with commercial interests that pertain to the content presented in this program.

Background

• Black males have the highest death rate from hypertension (HTN) than any other race, ethnic, and sex group in the United States• The death rate is 3 times higher among black men than white men

• Outreach programs at community partners, such as: churches, sporting events, and barbershops, have been used to help deliver medical information and messages

• Integration of health wellness into the community, makes healthcare more accessible and improves patient engagement

Victor RG, et al. Arch Intern Med. 2011; 171 (4):342-350.Lloyd-Jones D, et al. Circulation. 2009; 119(3):480-486.

Barber-1

Objective

• To assess if high blood pressure (BP) monitoring and referral program conducted by barbers encourages black males with elevated blood pressures to pursue physician follow-up and ultimately blood pressure control


Barber-1

Methods

• Randomized Cluster Trial

• Location: Dallas County, Texas

• Time: March 2006- December 2009


Definition of HTN:BP> 135/85 mm Hg

orBP > 130/80 mm Hg for diabetic patrons

Barber-1

Methods


10 Week Baseline BP Screening

17 Barbershops

≥ 95% black male clientele

Intervention Group9 shops- 75 HTN patrons per shop

• BP checks with haircuts• Promoted physician follow-up

Comparison Group8 shops- 77 HTN patrons per shop

• BP pamphlets (Peer-based)

10 MonthsData

Collected

Intervention Group9 shops

n=539 patrons with HTN

Comparison Group8 shops

n=483 patrons with HTN

Barber-1

Methods


Compensation for Barbers

Recorded BP $3.00

Phone Call Requesting Nurse-Assisted Physician Referral

$10.00

BP card return $50.00

Compensation for Patrons

Haircut FREE for each referral card

returned to the barber

Barber-1

Outcomes

• Change in hypertension control rate for each barbershop

Primary Outcome

• Hypertension treatment rate

• Hypertension awareness rate

• Systolic blood pressure

• Diastolic blood pressure

• Number of blood pressure medication per patron

Secondary Outcome


Barber-1

Statistic Analysis• Sample size of 800 patients (8 barbershops with 100 patients each) was necessary

for a power of 80% to detect 15% absolute mean difference• Over-time correlation was intended to be 0.1→ Actually 1• Statistically significant: p<0.05

• Statistics were presented as the means

• Statistical Evaluation• Regression Models

• Cost-effectiveness simulations were determined by the Coronary Heart Disease (CHD) Policy Model• Simulate the average benefits of the observed systolic BP reduction on the number of

adverse events prevented and associated health care cost savings during a 1- year intervention


Barber-1

Baseline CharacteristicsCharacteristics Intervention (n=9 shops) Comparison (n=8 shops)

Barber per shop, mean + SD, No. 5 (3-7) 4 (3-6)

Patrons wit HTN per shop, mean (range),No. 77 (37-163) 75 (30-165)

Total No. of patrons 695 602

Age, mean (SEM),y 49.5 (2.4) 51.2 (2.6)

Married or living with a partner 388 (56.7) 431 (67.3)

Level of education≤High SchoolCollegePostgraduate

342 (46.9)239 (43.4)

59 (9.7)

241 (38.9)279 (48.0)82 (13.1)

Full-time Employment 403 (61.6) 354 (64.5)

Income, % of the poverty level≤ 100101-300301-500>500

110 (15.8)209 (29.8)237 (36.0)116 (18.4)

76 (12.0)145 (26.3)202 (33.4)170 (28.4)


Barber-1

Baseline Characteristics ContinuedCharacteristics Intervention (n=9 shops) Comparison (n=8 shops)

Primary Medial Care Health Insurance StatusAny policyHMO or privateVeterans AffairsMedicareMedicaidSafety net

587 (85.3)458 (68.6)80 (10.2)94 (11.4)47 (6.4)31 (3.9)

524 (84.6)421 (70.7)84 (12.1)88 (10.3)45 (6.7)23 (2.9)

Barbershop patronageDuration of patronage, mean (SEM), yTime between haircuts, mean (SEM), wk

7.4 (1.3)3.8 (0.4)

9.7 (1.7)3.2 (0.3)

Cardiac risk factors and historyFamily history of HTNCurrent smokerBMI, mean (SE)DiabetesHigh cholesterol levelPrior stroke, MI, and/or heart failureChronic renal failure

576 (83.3)159 (22.1)31.4 (0.5)144 (19.2)311 (44.2)103 (13.0)

11 (1.4)

505 (84.0)104 (17.5)30.7 (0.4)136 (19.1)297 (44.8)86 (12.9)14 (1.8)


Barber-1

Primary Endpoint


Characteristics Intervention Effect

Absolute Difference

% (95% CI)

P value

Adjusted P value

Control rate among all patrons with HTN

8.8(0.8 to 16.9)

.04 .03

Control rate among treated patrons with HTN

9.6(-0.3 to 19.5)

.06 .05

Barber-1

Secondary Endpoints

Characteristics Intervention Group Comparison Group Intervention Effect

Baseline Follow-Up Absolute Change, %

(95% CI)

Baseline Follow-Up Absolute Change, %

(95% CI)

Absolute Difference, % (95% CI)

P value Adjusted P value

HTN treatment rate 67.9 79.0 11.2 (7.3 to 15.0)

69.9 76.1 6.2 (2.1 to 10.3)

5.0(-0.6 to 10.6)

.10 .33

HTN awareness rate 79.5 86.3 6.8(3.3 to 10.3)

79.1 85.4 6.4 (2.5 to 10.2)

0.4 (-0.6 to 10.6)

.72 .57

Systolic BP, mm Hg 137.6 129.8 -7.8(-9.7 to -5.9)

136.4 131.1 -5.3 (-7.4 to -3.2)

-2.5 (-5.3 to 0.3)

.08 .09

Diastolic BP, mm Hg 81.5 78.7 -2.8 (-4.0 to -1.6)

80.0 78.1 -1.9 (-3.2 to -0.6)

-0.9 (-2.6 to 0.8)

.28 .18

BP medications per patron with HTN

1.4 1.8 0.5 (0.3-0.6)

1.4 1.7 0.3 (0.1 to 0.4)

0.2 (0.0 to 0.4)

.07 .09


Barber-1

Cost-effectiveness Simulation

Implement intervention at

~18,000 black-owned barbershops in US

To reduce BP by 2.5 mmHg in ~ 50% of US Black males with HTN

Decreased Major Adverse Cardiovascular Events in the

First Year:

• Reduce myocardial infarctions (MIs) by 800

• Reduce strokes by 550• Reduce death by 900

Saving $ 98 million in CHD care and $ 13 million in stroke care


Mean Total Incentive Payment:$112 per HTN patron

Barber-1

Authors’ Conclusion

• Blood pressure screening had a positive effect on controlling HTN among black male barbershop patrons when barbers:• Became health educators

• Monitored BP

• Promoted physician follow-up

• Further research is needed


Barber-1

Critique

Strengths

• Randomized

• Reduction in major adverse cardiovascular events

• Novel intervention

• Targets a traditional underrepresented patient population

Limitations

• No true control group

• Small population

• Unknown BP medications

• Extrapolation to females, other ethnicities, and geographical regions

• Hawthorne effect

• Financial Incentives

Practice Implications

• Community Outreach

• Ambulatory Care

• Opportunities for pharmacy expansion

Acknowledgements

• Dr. Rob Hough, PharmD, BCPS-AQ Cardiology

• Dr. Zachary Noel, PharmD, BCPS

• Dr. John Bucheit, PharmD, BCACP, CDE

• Dr. Tracy Macaulay, PharmD, AACC, BCPS-AQ Cardiology

Effectiveness of a Barber-Based Intervention for Improving

Hypertension Control in Black Men(Barber-1)

Kody Ann Merwine, PharmD

PGY-2 Cardiology Pharmacy Resident


Lexington, KY


Presenter Bio

Dr. Elisabeth Sulaica is a PGY2 Cardiology Pharmacy Resident at the University of Kentucky HealthCare. She received her PharmD from the University of Houston College of Pharmacy and completed her PGY1 Pharmacy Practice Residency at the Michael E. DeBakey Veterans Affairs Medical Center. Dr. Sulaica has accepted a position with the University College of Pharmacy as a clinical assistant professor.

A Cluster-Randomized Trial of Blood-Pressure Reduction in Black Barbershops

Elisabeth Sulaica, PharmD

PGY2 Cardiology Pharmacy Resident


Lexington, KY

Disclosures

I have no financial relationships with commercial interests that pertain to the content presented in this program.

Background• The BARBER-1 Study demonstrated that black-owned barbershops are promising

community-partners in combating hypertension (HTN) in an underrepresented population• Statistically significant blood pressure (BP) control in intervention group• Small change in systolic blood pressure (SBP)

• Number of BP medications similar per patron between Intervention and Comparison groups (1.8 vs. 1.7; P Value 0.07)• Types of blood pressure medications prescribed not reported

• Question of outcomes if combine HTN medication management with community-partnership

• Further defining role of clinical pharmacists in ambulatory HTN management

Arch Intern Med 2011;171(4):342-350.

Objective

• Assess if a greater reduction in SBP after 6 months in patients frequenting barbershops through a pharmacist-led intervention

New Engl J Med 2018;378:1291-301.Image: http://www.todayifoundout.com/index.php/2013c

Methods

Barbershops with 25 patients/shop with uncontrolled

HTN

Intervention Group:Barber-Pharmacist

Intervention

Control Group:Barber-Based Health

Education

Follow-up

Follow-up

6 months

6 months

New Engl J Med 2018;378:1291-301.

1:1

• Blood pressure goal <130/80 mm Hg• Both groups received:

▪ Results of blood-pressure screenings▪ Follow-up calls at 3 months▪ Vouchers for monthly haircuts

Methods (cont’d)Intervention Group:

Barber-Pharmacist InterventionControl Group:

Barber-Based Health Education

• Pharmacist to prescribe two-drug therapy• Progress notes sent to participant’s

designated community physician• $25/pharmacist visit• Review of blood-pressure trends

• Pamphlets and instruction from barber regarding BP management

• Encouraged patient to follow-up with provider

• Pharmacist training:

– 20 hours of didactic continuing education on clinical hypertension

– 8 hours interactive training by private investigators

• Barber training:

– 6 hours formal training

– Monthly booster sessions

New Engl J Med 2018;378:1291-301.

Hypertension Treatment AlgorithmOut-Of-Office BP ≥135/85 mm Hg

1st Line Drug Classes:• Step 1: Calcium-channel blocker (CCB) plus Angiotensin-converting enzyme inhibitor

(ACEI)/Angiotensin Receptor Blocker (ARB)• Step 2: add thiazide-type diuretic• Step 3: add aldosterone antagonist

Add-on Drug Classes:• Vasodilating Beta-Blocker• Central Sympatholytic• Alpha Blocker• Nitrates, Direct Vasodilators

Consider referral to hypertensive specialist

New Engl J Med 2018;378:1291-301.

Study Population

Inclusion Criteria Exclusion Criteria

Non-Hispanic black men Women

35-79 years of age Non-black men

≥1 haircut every 6 weeks for ≥6 months Receiving dialysis or chemotherapy

SBP ≥140 mm Hg at 2 screenings Cognitive impairment

Complete baseline data Incomplete baseline data

New Engl J Med 2018;378:1291-301.

Outcomes

Primary Outcome

• Change in SBP from baseline to 6 months after randomization

Secondary Outcomes

• Change in DBP from baseline to 6 months after randomization

• Rates of meeting BP goals

• Number of antihypertensive drugs

• Adverse drug reactions

• Self-rated health

• Patient engagement

New Engl J Med 2018;378:1291-301.

Statistical Analysis• Enrollment target of 10 barbershop clusters (25 participants/cluster)

• Due to low enrollment, adjusted to encompass 10 shop-clusters/group with at least 10 participants/cluster

• 90% power to detect a 6.9 mm Hg reduction in SBP in the intervention group

• Two-sided alpha level of 0.05

• Linear mixed effect model• Baseline blood pressure

• Doctor for routine medical care

• High cholesterol level

New Engl J Med 2018;378:1291-301.

Baseline CharacteristicsCharacteristic Intervention Group Control Group

BarbershopsNo. of barbershopsYears in business

2817.3±14.2

2418.1±8.3

ParticipantsAge (yr)Highest education level – no./total no. (%)No high school degreeHigh school graduate/GED equivalentSome college or associate’s degreeBachelor’s degreeGraduate or professional degree

54.4±10.2

6/131 (4.6)30/131 (22.9)67/131 (51.1)21/131 (16.0)

7/131 (5.3)

54.6±9.5

13/171 (7.6)49/171 (28.7)76/171 (44.4)23/171 (13.5)10/171 (5.8)

Annual household income – no./total no. (%)$0 - $15,999$16,000 - $24,999$25,000 - $39,999$40,000 - $49,999$50,000 - $74,999$75,000 - $99,999≥$100,000

31/123 (25.2)20/123 (16.3)

9/123 (7.3)14/123 (11.4)20/123 (16.3)16/123 (13.0)13/123 (10.6)

34/168 (20.2)15/168 (8.9)

19/168 (11.3)21/168 (12.5)34/168 (20.2)21/168 (12.5)24/168 (14.3)

New Engl J Med 2018;378:1291-301.

Baseline Characteristics (cont’d)

Characteristic Intervention Group Control Group

Any health insurance – no. (%) 112 (84.8) 150 (87.7)

Regular medical care provider – no./total no. (%) 101/131 (77.1) 134/170 (78.8)

Regular medical care provider – no./total no. (%) Any health insurance – no. (%) Barbershop patronageDuration of patronage (yr)Frequency of visits – every no. of wk

101/131 (77.1)112 (84.8)

10.2±9.62.0±0.9

134/170 (78.8)150 (87.7)

11.5±9.02.1±1.1

Cardiovascular risk factorsCurrent smoker – no./total no. (%)High cholesterol level – no. (%)

43/130 (33.1)46 (34.8)

51/171 (29.8)41 (24)

New Engl J Med 2018;378:1291-301.

Blood-Pressure OutcomesOutcome Intervention Group

(N=132)Control Group

(N=171)Intervention Effect P Value

SBP – mm HgBaseline6 moChange

152.8±10.3125.5±11.0-27.0 ±13.7

154.6±12.0145.4±15.2-9.3±16.0 -21.5 (-28.4 to -14.7) <0.001

DBP – mm HgBaseline6 moChange

92.2±11.574.7±8.3

-17.5±11.0

89.8±11.285.5±12.0-4.3±11.8 -14.9 (-19.6 to -10.3) <0.001

HTN control at 6 mo – no.(%)BP <140/90 mm HgBP <135/85 mm HgBP <130/80 mm Hg

118 (89.4)109 (82.6)84 (63.6)

55 (32.2)32 (18.7)20 (11.7)

3.4 (2.5 to 4.6)5.5 (2.6 to 11.7)5.7 (2.5 to 12.8)

<0.001<0.001<0.001

New Engl J Med 2018;378:1291-301.

Blood Pressure Medication by Group Baseline 6 months

Intervention Group (N=132)

Control Group (N = 171)


Control Group (N=171)

No. of BP medications/participant

(Mean)1.1±1.2 1.1±1.4 2.6±0.9 1.4±1.4

First Line Drugs

ACEI/ARB – no. (%) 52 (39.4) 61 (35.7) 130 (98.5) 71 (41.5)

CCB – no. (%) 43 (32.6) 37 (21.6) 125 (94.7) 56 (32.8)

Diuretic – no. (%) 25 (18.9) 47 (27.5) 61 (46.2) 49 (28.7)

Add-On Drugs

AA – no. (%) 0 (0) 2 (1.2) 14 (10.6) 2 (1.2)

Beta-blocker – no. (%) 13 (9.9) 25 (14.6) 14 (10.6) 33 (19.3)

Alpha-blocker – no. (%) 1 (0.8) 3 (1.8) 1 (0.8) 2 (1.2)

Central Sympatholytic – no. (%)

2 (1.5) 6 (3.5) 1 (0.8) 6 (3.5)

Direct Vasodilator – no. (%) 2 (1.5) 10 (5.9) 0 (0) 8 (4.7)

New Engl J Med 2018;378:1291-301.

Type of Blood Pressure MedicationBaseline 6 months





Medication Class – no. (%)

Long acting ACEI or ARB 1 (0.8) 2 (1.2) 72 (54.6) 2 (1.2)

CCBAmlodipineOther CCB-dihydropyridineNondihydropyridine

40 (30.3)0 (0)

3 (2.3)

29 (17)3 (1.8)5 (2.9)

124 (93.9)1 (0.8)0 (0)

50 (29.2)1 (0.6)5 (2.9)

Thiazide or Thiazide-typeIndapamideChlorthalidoneHydrochlorothiazide

0 (0)2 (1.5)

19 (14.4)

0 (0)5 (2.9)

33 (19.3)

42 (31.8)5 (3.8)

14 (10.6)

0 (0)5 (2.9)

37 (21.6)

Aldosterone Antagonist 0 (0) 2 (1.2) 14 (10.6) 2 (1.2)

Standard Beta-blockerVasodilating Beta-blocker

9 (6.8)4 (3)

16 (9.4)9 (5.3)

0 (0)14 (10.6)

23 (13.5)10 (5.9)

Central Sympatholytic 2 (1.5) 6 (3.5) 1 (0.8) 6 (3.5)

Direct Vasodilator 2 (1.5) 10 (5.9) 0 (0) 8 (4.7)

New Engl J Med 2018;378:1291-301.

Adverse ReactionsIntervention Group (N=132)

no. (%)Control Group (N=171)

no. (%)Odds Ratio

(95% CI)P Value

Any adverse reaction 78 (59.1) 100 (58.5) 1.1 (0.7-1.8) 0.73

Difficulty breathing 9 (6.8) 21 (12.3) 0.4 (0.3-0.7) <0.001

Erectile dysfunction 19 (14.4) 15 (8.8) 1.8 (0.9-3.6) 0.08

Dizziness 19 (14.4) 13 (7.6) 2.1 (1.0-4.6) 0.06

Swollen ankles 21 (15.9) 20 (11.7) 1.6 (0.9-2.8) 0.14

Dry cough 24 (18.2) 27 (15.8) 1.3 (0.8-2.2) 0.25

Depression 17 (12.9) 18 (10.5) 1.3 (0.6-2.5) 0.53

New Engl J Med 2018;378:1291-301.

Patient Self-Rated HealthBaseline 6 months





Rating – no. (%)

Excellent or Very Good 27 (20.6) 35 (20.6) 38 (28.8) 42 (24.6)

Good 51 (38.9) 78 (45.9) 57 (43.2) 75 (43.9)

Fair, Poor, or Very Poor 53 (40.5) 57 (33.5) 37 (28) 54 (31.6)

Statistical Analyses p-value

Intervention Group: Baseline versus 6 months 0.004

Control Group: Baseline versus 6 months 0.29

• Each patient in the intervention group • Received an average of 7 in-person pharmacists visits• Received an average of 4 follow-up telephone calls from pharmacists• Called/messaged pharmacists 6 times

New Engl J Med 2018;378:1291-301.

Author’s Conclusions

• Health promotion by barbers led to greater blood pressure reduction in black men with uncontrolled hypertension who frequented barbershops when coupled with drug-therapy adjusted by trained pharmacists.

New Engl J Med 2018;378:1291-301.

Literature Critique

Strengths Limitations

• Medication therapy tailored to black men• Benefits of community support and drug

therapy combination• Only 5% drop-out rate• More information in an under-

represented population• Closer follow-up in intervention group

• Surrogate endpoint• May have targeted different BP goals in

the control group• Feasibility of implementation

Practice implications

• Improved BP management with tailored medication therapy• TYPE of diuretic and CCB

• Additional evidence of pharmacist impact on ambulatory HTN management

• Feasibility of implementation and sustainability yet to be seen• Awaiting additional 6-month extension results

Acknowledgments

• Rob Hough, PharmD, BCPS (AQ – Cardiology)

• Zachary Noel, PharmD, BCPS

• John Bucheit, PharmD, BCACP, CDE

• Tracy E. Macaulay, PharmD, AACC, BCPS (AQ – Cardiology)

A Cluster-Randomized Trial of Blood-Pressure Reduction in Black

Barbershops

Elisabeth Sulaica, PharmD

PGY2 Cardiology Pharmacy Resident


Lexington, KY

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