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

描述（由申请人提供）：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，但与医生接触较少，参与干预试验较少。我们之前在黑人拥有的理发店中进行了HTN干预的第一次聚类随机试验。商店被随机分为对照组（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，并激励那些血压高的人预约医生。10个月后，我们发现了一个小的干预效果。初级保健提供者对HTN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。与Kaiser Permanente（KP）和Walgreens合作，我们提出了一项新的试验，其具体目标如下：1.评估强化干预措施对以下方面的有效性： 收缩压进行随机分组试验。将对20家洛杉矶（LA）理发店的顾客进行筛选，以收集每家店25名患有不受控制的HTN的顾客。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，在干预组中，理发师经常检查并传输登记顾客的BP读数，并激励他们与药剂师进行随访。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随访。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更大。2.通过6个月的扩展研究评价可持续性和安全性。干预将继续与更多的电话比面对面的接触药剂师。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.在实施试点研究中评估现实世界的有效性和可采用性。如果试验的6个月主要结局得到满足，我们将：A）分析定性数据，为实施提供信息; B）通过试点实施研究评估真实条件下的有效性（n=300名男性）在三个州，涉及转诊到KP为他们的成员，和沃尔格林商店为非KP患者; 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BP降低转化为成本抵消预测;以及D）使用内部公司特定的成本数据来修改这些预测，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》倡议，促进提供者对成本、质量和结果负责任的制度。即使收缩压持续降低5 mmHg，也会减少影响黑人男性的HTN控制差异。

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.