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| Name | Class |
|---|---|
| University of California, Los Angeles | OTHER |
| Cedars-Sinai Medical Center | OTHER |
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Black men face a shorter life expectancy than white men due to poorer health outcomes associated with many chronic diseases, most notably hypertension and its cardiovascular complications. A lack of access to healthcare resources and poor engagement with healthcare providers drive these inequities. A seminal trial conducted in the Metro Los Angeles area demonstrated the effectiveness of using collaborative care partnerships between black-owned barbershops and pharmacists to reduce blood pressure in black men.
The purpose of this study is to test the feasibility and success of implementing a single-arm, smaller-scale version of the Los Angeles study in the Nashville area to provide additional empiric support for collaborative care partnerships to treat hypertension in other geographic locations.
Uncontrolled hypertension (HTN) is a significant risk factor for mortality among non-Hispanic black men, and black men have the highest incidence of death from HTN of any race, ethnic, or gender group in the United States. Sustained, trusting interactions with healthcare professionals and a lack of access to healthcare resources are both significant drivers of these disparities. A cluster, randomized controlled trial in the Metro Los Angeles area demonstrated that health promotion by black barbers resulted in greater reductions in blood pressure (BP) when combined with medication management by specialty-trained pharmacists, as compared to health promotion by barbers alone.
The purposes of this single arm, pre-test/post-test study are to a) establish an effective network of barbershop research hubs in Nashville, b) test the feasibility of engaging with a specialty-trained pharmacist in collaboration with a barbershop to treat blood pressure in black men, and c) create a local registry of potential subjects as a platform for enrolling black men in future studies. There is no central hypothesis in this pilot implementation study, but the study will evaluate the ability of the barbershop-based research methodology to recruit and retain black men in a study; the fidelity to the intervention by barbers, the pharmacist, and the hypertensive male participants; and the effectiveness of the intervention on systolic blood pressure reduction and patient satisfaction. All participants will also be offered the opportunity to participate in a separate research registry for recruitment into future studies.
Research staff will offer free BP screening to all adult black men entering each shop for approximately 4 weeks, or until recruitment targets have been met. Patrons with a systolic BP > 140 mm Hg on two separate occasions will be eligible to participate. The patrons' existing physician or the lead physician or a study physician will sign a collaborative practice agreement for a specialty-trained pharmacist to provide care and prescribe BP medications within the study protocol. All participants in this study will execute a visit with the study physician for an evaluation to establish care, supported by the funding for this proposal.
Barbers will participate in training related to skills on BP measurement and counseling performed by either collaborating researchers from the University of California, Los Angeles-Cedars Sinai or from local study personnel. Barbers will frequently check and transmit the BP readings of their enrolled patrons and motivate them to work with the clinical pharmacist, who will meet them in their barbershops to optimize BP medication. The pharmacist will promote patient activation, intensify drug therapy under a collaborative practice agreement as permitted by Tennessee state law, send progress notes to the participant's physicians, and ensure appropriate safety monitoring after each medication change.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypertension Management Model | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypertension Management Model | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Systolic and Diastolic Blood Pressure | Blood pressure changes were quantified as the baseline minus the 6 month value. | Baseline to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
Study population is black men.
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| Name | Affiliation | Role |
|---|---|---|
| David Harrison, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nash | Tennessee | 37232 | United States | ||
| Masters Barbershop |
IPD will be shared with other researchers with IRB approvals and also approved data sharing agreements contracts.
Data is currently available. It will remain available until the study is closed.
IRB approval.
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Non-Hispanic Black male clients, age 35-79 with systolic blood pressure > 140 mmHG on two screening visits. Enrolled participants were monitored closely throughout the 6-month study timeline and descriptive statistics preformed.
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| ID | Title | Description |
|---|---|---|
| FG000 | PharmD Community-based Delivery of Hypertension Management Including Medication Adjustment as Needed | 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. Hypertension Management Model: 1. Blood Pressure readings by barbers 2. Clinical Pharmacist evaluation and counseling 3. Blood pressure measurement 4. Point of care basic metabolic panel measurement |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Adults 35 - 79 years old, non-Hispanic black males, patron of one of the participating barbershops with Systolic BP > 140 on 2 screening visits.
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| ID | Title | Description |
|---|---|---|
| BG000 | Male Participants Who Received the Hypertension Management Model. | Adult Black males 39 to 79 years who were clients of one of our participating Barber Shops were screened for hypertension. Those with systolic BPs greater than 140 mmHg were asked to participate. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Systolic and Diastolic Blood Pressure | Blood pressure changes were quantified as the baseline minus the 6 month value. | Change in BP from baseline to 6 months | Posted | Mean | Standard Deviation | mmHg | Baseline to 6 months |
|
|
Baseline to 6 months
Adverse events were assessed for participants once they signed their consent form. When a serious event was reported study personnel completed an adverse event form, submitted to the physician monitor for review and then submitted it to the DSMB if required.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Male Participants Who Received the Hypertension Management Model | Adult Black males 39 to 79 years who were clients of one of our participating Barber Shops were screened for hypertension. Those with systolic BPs greater than 140 mmHg were asked to participate. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Seizure | Nervous system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Covid Pneumonia | Immune system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David G. Harrison | Vanderbilt University Medical Center | 6158753049 | david.g.harrison@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 25, 2020 | Jun 3, 2022 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 11, 2020 | Nov 5, 2021 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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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.
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| Nashville |
| Tennessee |
| 37218 |
| United States |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Systolic Blood Pressure | Systolic Blood Pressure measurement, mmHg; Sitting position, average of three sequential measurements with an automated blood pressure monitor. | Mean | Standard Deviation | mmHg |
|
| Diastolic Blood Pressure | Diastolic Blood Pressure measurement, mmHg; Sitting position, average of three sequential measurements with an automated blood pressure monitor. | Mean | Standard Deviation | mmHg |
|
|
|
| 0 |
| 30 |
| 3 |
| 30 |
| 6 |
| 30 |
| Transient Ischemic Attack | Blood and lymphatic system disorders | Systematic Assessment |
|
| hyperglycemia | Endocrine disorders | Systematic Assessment |
|
| dizziness | Product Issues | Systematic Assessment |
|
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