Barber-Pharmacist Coordination to Improve Blood Pressure Management in Black Men

理发师与药剂师协调改善黑人血压管理

基本信息

批准号：
8870419
负责人：
Ronald G Victor
金额：
$ 304.91万
依托单位：
CEDARS-SINAI MEDICAL CENTER
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-06-15 至 2019-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8870419
关键词：
Address Adult Affect Agreement Appointment Authorization documentation Blood Pressure Businesses California Caring Cessation of life Clinical Pharmacists Clinical Trials Cluster randomized trial Collaborations Communities Country Data Effectiveness Enrollment Ensure Epidemic Federally Qualified Health Center Funding Gender Generic Drugs Health Health Care Costs Health Care Reform Health Promotion Health Services Research Health system Healthcare Heart failure High Prevalence Hybrids Hypertension Hypotension Intervention Intervention Trial Kidney Failure Laws Left Link Los Angeles Medical Methodology Modeling Myocardial Infarction National Heart, Lung, and Blood Institute Not Hispanic or Latino Outcome Pamphlets Patients Persons Pharmaceutical Preparations Pharmacists Pharmacotherapy Pharmacy facility Physicians Pilot Projects Play Policies Population Prevalence Primary Health Care Provider Public Health Race Randomized Reading Resources Risk Factors Role Safety Services Stroke System Telephone Testing Training Translating Translations Trust Woman Work arm base blood pressure reduction blood pressure regulation care delivery cohort combat comparison group cost cost effectiveness design disability follow-up group intervention hypertension control hypertension treatment improved innovation intervention effect male medical specialties meetings member men novel outreach peer policy implication primary outcome programs prospective role model

项目摘要

DESCRIPTION (provided by applicant): Hypertension (HTN) is devastating to non-Hispanic black men, who have a higher HTN prevalence than other groups but less physician contact and less participation in intervention trials. We previously conducted the first cluster-randomized tril of a HTN intervention in black-owned barbershops. Shops were randomized to a control arm (HTN pamphlets) or an intervention arm in which barbers (trusted peers) offered blood pressure (BP) checks to adult black male patrons and motivated those with high BP to make doctor appointments. After 10 months, we found a small intervention effect. Under-treatment of HTN by primary care providers limited the ability of the barber-based intervention to lower BP. Thus, we now have linked the barber-based intervention to pharmacist-based team care to optimize HTN management. In collaboration with Kaiser Permanente (KP) and Walgreens, we propose a new trial with the following specific aims: 1. To evaluate the efficacy of the enhanced intervention on systolic BP by conducting a cluster-randomized trial. The clientele of 20 Los Angeles (LA) barbershops will be screened to collect a cohort of 25 patrons per shop with uncontrolled HTN. Ten shops (250 patrons) will be randomized to a comparator group (HTN pamphlets) and 10 shops (250 patrons) to an intervention group in which barbers frequently check and transmit BP readings of enrolled patrons and motivate them to follow-up with pharmacists. With physicians' permission and oversight, pharmacists will promote patient activation, intensify drug therapy under a collaborative practice agreement, send progress notes to physicians, and follow up after each medication change. The primary endpoint is the change in systolic BP assessed after 6 months. We hypothesize that barbershop patrons who receive the barber- pharmacist intervention will have a greater reduction in systolic BP than patrons in the comparison group who receive standard HTN pamphlets and usual medical care. 2. To evaluate sustainability and safety with a 6- month extension study. The intervention will continue with more phone than in-person encounters with pharmacists. We hypothesize that the intervention effect on systolic BP can be sustained safely for at least 6 more months. 3. To evaluate real-world effectiveness and adoptability in an implementation pilot study. If the trial's 6-month primary outcome is met, we will: A) analyze qualitative data to inform implementation; B) evaluate effectiveness under real-world conditions with a pilot implementation study (n=300 men) in three states that involves referral to KP for their members, and to Walgreens stores for non-KP patients; C) model cost-effectiveness from a generic health care payer perspective to translate observed BP reductions into cost- offset projections; and D) modify these projections using internal corporate-specific cost data to determine if viable business models can be developed. Implementation would support Affordable Care Act initiatives promoting systems in which providers are fiscally responsible for cost, quality and outcomes. Sustained reductions in systolic BP of even 5 mmHg would reduce the disparity in HTN control affecting black men.

描述（由申请人提供）：高血压（HTN）对非西班牙裔黑人男性来说是毁灭性的，他们的高血压患病率高于其他群体，但与医生接触较少，参与干预试验也较少。我们之前对黑人拥有的理发店进行了首次集群随机 HTN 干预试验。商店被随机分配到对照组（HTN 小册子）或干预组，其中理发师（值得信赖的同行）为成年黑人男性顾客提供血压 (BP) 检查，并鼓励高血压患者预约医生。 10个月后，我们发现干预效果很小。初级保健提供者对高血压的治疗不足限制了理发师干预降低血压的能力。因此，我们现在将基于理发师的干预与基于药剂师的团队护理联系起来，以优化 HTN 管理。我们与 Kaiser Permanente (KP) 和 Walgreens 合作，提出了一项新试验，其具体目标如下： 1. 评估强化干预措施的有效性通过进行整群随机试验来测量收缩压。将对 20 家洛杉矶 (LA) 理发店的顾客进行筛查，收集每家理发店 25 名不受控制的 HTN 顾客。 10 家商店（250 名顾客）将被随机分配到比较组（HTN 小册子），10 家商店（250 名顾客）将被随机分配到干预组，其中理发师经常检查和传输登记顾客的血压读数，并激励他们与药剂师进行跟进。在医生的许可和监督下，药剂师将促进患者的激活，根据合作实践协议加强药物治疗，向医生发送进度说明，并在每次药物变化后进行跟进。主要终点是 6 个月后评估的收缩压变化。我们假设接受理发师-药剂师干预的理发店顾客比接受标准 HTN 小册子和常规医疗护理的对照组顾客的收缩压降低幅度更大。 2. 通过 6 个月的扩展研究评估可持续性和安全性。干预措施将继续进行，与药剂师的电话接触将多于面对面的接触。我们假设对收缩压的干预效果可以安全地持续至少 6 个月。 3. 评估实施试点研究的实际有效性和可采用性。如果试验的 6 个月主要结果得到满足，我们将： A) 分析定性数据以指导实施； B) 在三个州进行试点实施研究（n=300 名男性），评估现实条件下的有效性，其中包括将其会员转介至 KP，将非 KP 患者转介至沃尔格林商店； C) 从一般医疗保健支付者的角度建立成本效益模型，将观察到的血压降低转化为成本抵消预测； D) 使用企业内部特定成本数据修改这些预测，以确定是否可以开发可行的商业模式。实施将支持《平价医疗法案》倡议，促进医疗服务提供者对成本、质量和结果承担财政责任的制度。即使收缩压持续降低 5 毫米汞柱，也会减少影响黑人的高血压控制差异。