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

描述(申请人提供)：高血压(HTN)对非西班牙裔黑人男性是毁灭性的，他们的HTN患病率高于其他群体，但较少与医生接触，也较少参与干预试验。我们之前在黑人拥有的理发店中进行了HTN干预的第一个整群随机试验。商店被随机分配到控制组(HTN小册子)或干预组，在控制组中，理发师(受信任的同龄人)为成年黑人男性顾客提供血压(BP)检查，并激励那些血压偏高的人预约医生。10个月后，我们发现了一种小的干预效果。初级保健提供者对HTN的治疗不足限制了以理发师为基础的干预降低BP的能力。因此，我们现在已经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。在Kaiser Permanente(KP)和Walgreens的合作下，我们提出了一项新的试验，具体目标如下：1.评估加强干预措施的疗效 通过进行一项整群随机试验来控制收缩压。洛杉矶(LA)20家理发店的客户将被筛选，以收集每个不受控制的HTN店25名顾客的队列。10家商店(250名顾客)将被随机分成对照组(HTN小册子)，10家商店(250名顾客)被随机分成干预组，在干预组中，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跟进。在医生的允许和监督下，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，并在每次用药变化后进行跟踪。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将比接受标准HTN宣传册和常规医疗护理的对照组顾客的收缩血压下降更大。2.进行为期6个月的延展研究，评价其可持续性和安全性。干预将继续通过更多的电话，而不是与药剂师的面对面接触。我们假设，对收缩压的干预效果可以安全地维持至少6个月以上。3.在实施试点研究中评估现实世界的有效性和可采纳性。如果试验的6个月主要结果得到满足，我们将：a)分析质量数据，为实施提供信息；b)在三个州进行试点实施研究(n=300人)，评估真实世界条件下的疗效，其中成员转诊至KP，非KP患者转至Walgreens门店；C)从通用医疗支付方的角度建立成本效益模型，将观察到的BP降低转化为成本抵销预测；以及D)使用内部企业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型。实施将支持《平价医疗法案》的倡议，促进提供者对成本、质量和结果承担财政责任的制度。持续降低收缩压，哪怕只有5毫米汞，就会缩小影响黑人男性的HTN控制差距。

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.