The CLIP program will train Community Health Workers (CHWs) to screen and identify Black men with elevated blood pressure (BP) or stage 1 hypertension (HTN), initiate lifestyle counseling; and link them to primary care and social services.
The study will consist of: 1. An implementation phase that will use a cluster randomized cluster trial of 20 barbershops among Black men with elevated BP or Stage 1 HTN, to compare the effect of the Barbershop-based Facilitation (BF) strategy (n=10 barbershops; n=210 participants) vs. self-directed control (i.e. receipt of information for implementation of CLIP without the BF strategy; n=10 barbershops; n=210 participants), on BP reduction, HTN prevention, linkage to care, and adoption of CLIP at 12 months 2. A post-implementation phase that will use Reach Effectiveness Adoption Implementation and Maintenance (RE-AIM) to evaluate the effect of the BF strategy versus self-directed control on sustainability of CLIP 6 months after completion of the trial; and cost-effectiveness over a 10-year time horizon.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
430
Multilevel intervention designed to mitigate adverse social determinants of health (SDoH) via linkage to care, health system navigation, and referral to social services.
Trained and qualified facilitators assist community health workers (CHWs) to: 1) increase their confidence in delivering CLIP; 2) understand participants' concerns and beliefs about hypertension (HTN); and 3) develop skills in lifestyle counseling to help the men initiate lifestyle modification.
NYU Langone Health
New York, New York, United States
Change in Systolic Blood Pressure (SBP) Levels
All participants will have office blood pressure (BP) measured on their non-dominant arm with an Omron HEM-907XL BP device. 3 BP readings separated by one minute will be obtained at each visit. The 3 BP readings will be averaged to obtain mean BP. SBP Levels are classified as follows: * Normal: Below 120 millimeters of mercury (mm Hg) * Elevated: 120-129 mm Hg * Stage 1 hypertension: 130-139 mm Hg * Stage 2 hypertension: 140 mm Hg or more * Hypertensive crisis: 180 mm Hg or more
Time frame: Baseline, Month 12
Change in Diastolic Blood Pressure (DBP) Levels
All participants will have office blood pressure (BP) measured on their non-dominant arm with an Omron HEM-907XL BP device. At each visit, 3 BP readings separated by one minute will be obtained. The 3 BP readings will be averaged to obtain study BP. DBP Levels are classified as follows: * Normal: Lower than 80 millimeters of mercury (mm Hg) * Stage 1 hypertension: 80-89 mm Hg * Stage 2 hypertension: 90 mm Hg or more * Hypertensive crisis: 120 mm Hg or more.
Time frame: Baseline, Month 12
Number of Participants Presenting to Referral Clinics within 3 Months of Community Health Worker (CHW) Referral
Measurement of linkage to care. Data will be gathered via telephone interview or during barbershop visit.
Time frame: Baseline
Number of Participants Presenting to Referral Clinics within 3 Months of Community Health Worker (CHW) Referral
Measurement of linkage to care. Data will be gathered via telephone interview or during barbershop visit.
Time frame: Month 6
Number of Participants Presenting to Referral Clinics within 3 Months of Community Health Worker (CHW) Referral
Measurement of linkage to care. Data will be gathered via telephone interview or during barbershop visit.
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Time frame: Month 12
Number of Participants Presenting to Referral Clinics within 3 Months of Community Health Worker (CHW) Referral
Measurement of linkage to care. Data will be gathered via telephone interview or during barbershop visit.
Time frame: Month 18
Number of Barbershops Completing all Components of CLIP
Measurement of the rate of adoption of Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP).
Time frame: Month 12
Number of Barbershops Continuing to Use CLIP at 6 Months Post-Completion of Intervention
Measurement of the sustainability of Community-to-Clinic Linkage Implementation Program in Barbershops (CLIP).
Time frame: Month 18
Number of Participants Presenting with Incident Stage 2 HTN
Incident Stage 2 hypertension (HTN) is defined as: * Systolic Blood Pressure (SBP) of at least 140 millimeters of mercury (mm Hg)/Diastolic Blood Pressure (DBP) of at least 90 mm Hg; or * Antihypertensive medication initiation.
Time frame: Baseline
Number of Participants Presenting with Incident Stage 2 HTN
Incident Stage 2 hypertension (HTN) is defined as: * Systolic Blood Pressure (SBP) of at least 140 millimeters of mercury (mm Hg)/Diastolic Blood Pressure (DBP) of at least 90 mm Hg; or * Antihypertensive medication initiation.
Time frame: Month 6
Number of Participants Presenting with Incident Stage 2 HTN
Incident Stage 2 hypertension (HTN) is defined as: * Systolic Blood Pressure (SBP) of at least 140 millimeters of mercury (mm Hg)/Diastolic Blood Pressure (DBP) of at least 90 mm Hg; or * Antihypertensive medication initiation.
Time frame: Month 12
Number of Participants Presenting with Incident Stage 2 HTN
Incident Stage 2 hypertension (HTN) is defined as: * Systolic Blood Pressure (SBP) of at least 140 millimeters of mercury (mm Hg)/Diastolic Blood Pressure (DBP) of at least 90 mm Hg; or * Antihypertensive medication initiation.
Time frame: Month 18
12-Item Short Form Survey (SF-12) Questionnaire Score
The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality-of-life measure. SF-12 consists of 12 questions that are scored in various ways. The total score range is 12-48; the higher the score, the better the physical and mental health functioning.
Time frame: Baseline
12-Item Short Form Survey (SF-12) Questionnaire Score
The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality-of-life measure. SF-12 consists of 12 questions that are scored in various ways. The total score range is 12-48; the higher the score, the better the physical and mental health functioning.
Time frame: Month 6
12-Item Short Form Survey (SF-12) Questionnaire Score
The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality-of-life measure. SF-12 consists of 12 questions that are scored in various ways. The total score range is 12-48; the higher the score, the better the physical and mental health functioning.
Time frame: Month 12
12-Item Short Form Survey (SF-12) Questionnaire Score
The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality-of-life measure. SF-12 consists of 12 questions that are scored in various ways. The total score range is 12-48; the higher the score, the better the physical and mental health functioning.
Time frame: Month 18
Cost per Millimeters of Mercury (mm Hg) Reduction in Blood Pressure (BP)
Dollar amount associated with a 1-mm Hg reduction in BP. Lower costs are considered more desirable outcomes.
Time frame: Up to Month 18
Cost per Incident Stage 2 Hypertension (HTN) Case Prevented
Dollar amount associated with the prevention of an Incident Stage 2 HTN case. Lower costs are considered more desirable outcomes. Incident Stage 2 HTN is defined as: * Systolic Blood Pressure (SBP) of at least 140 millimeters of mercury (mm Hg)/Diastolic Blood Pressure (DBP) of at least 90 mm Hg; or * Antihypertensive medication initiation.
Time frame: Up to Month 18