Improving Adherence and Intensification of Medications Among Diabetes Patients

描述(申请人提供)：良好的血压(BP)、血糖和血脂控制对于预防糖尿病并发症是必不可少的，但很难实现。血压控制可能是最困难的目标，与血糖或血脂控制不良的糖尿病患者相比，血压控制不良的糖尿病患者更多。患者对药物的依从性差以及临床医生未能启动或强化药物治疗都会导致对这些糖尿病危险因素的控制不力。我们建议评估一种基于临床药剂师的量身定制的干预措施，以改善两个综合分娩健康系统：Kaiser Permanente和退伍军人健康管理局中服药依从性较差或药物强化不足的高血压糖尿病患者的糖尿病风险因素控制。这项多地点、整群随机、对照试验的具体目的是：1)评估干预措施对血压、血糖和血脂控制的效果；2)评估干预措施对患者对BP、降血糖和降血脂方案的依从性、这些方案的强度以及对医疗保健的满意度的影响；3)评估干预措施与常规护理相比的成本效益；以及4)评估VA和Kaiser地点实施干预措施的过程，以确定不同地点的干预措施可能与干预的普适性有关。 使用电子数据，我们将主动识别8个初级保健干预小组中每个小组中血压控制不佳、再灌装依从性差或药物强化不足的所有糖尿病患者；8个非干预(对照)小组的提供者也将收到控制不良的患者的通知，并收到他们的依从性/强化信息。如果这些危险因素中的任何一个控制不佳，也将评估坚持和治疗强化模式的血糖和血脂。临床药剂师经过动机访谈(MI)技术培训，并在计算机化依从性模块的指导下，将识别BP药物和(视情况而定)降血糖和降血脂药物的服药依从性障碍，并提供依从性咨询。他们还将被授权根据特定部位的算法更改和滴定药物。结果将在12个月后进行评估，届时将有多达2000名患者接受干预。在研究结束时，我们将准备一套翻译工具包，以加强干预措施的传播。这项转化性研究旨在解决医学研究所面临的挑战，即通过系统重新设计来提高质量，方法是利用信息技术识别有风险的患者，将临床药剂师整合到基于团队的护理中以支持临床决策，并为这些药剂师提供必要的技能，以提供有效的行为咨询和用药改变。在借鉴以前有效的干预措施的同时，这项研究首次将这些基本要素结合起来，以改善糖尿病患者的预后。良好的血压(BP)、血糖和胆固醇控制是预防糖尿病并发症的关键，但实现起来非常困难。患者对药物的依从性差以及临床医生未能启动或强化药物治疗都会导致对这些糖尿病危险因素的控制不力。这项转化性研究旨在解决医学研究所面临的通过系统重新设计提高质量的挑战，方法是利用信息技术识别可能需要更具体帮助的患者，将临床药剂师整合到基于团队的护理中以支持有效的临床管理，并为这些药剂师提供帮助患者管理自己的药物所需的技能。在借鉴以前有效的干预措施的同时，这项研究首次将这些基本要素结合起来，以改善糖尿病患者的预后。

DESCRIPTION (provided by applicant): Good blood pressure (BP), glycemic, and lipid control is essential to prevent complications of diabetes mellitus but is very difficult to achieve. BP control may be the most difficult goal, with more diabetes patients having poor BP control than poor glycemic or lipid control. Both poor patient adherence to medications and clinicians' failure to initiate or intensify medications contribute to poor control of these diabetes risk factors. We propose to evaluate a tailored clinical pharmacist-based intervention to improve diabetes risk factor control among hypertensive diabetes patients with poor medication adherence or inadequate medication intensification in two integrated delivery health systems: Kaiser Permanente and the Veterans Health Administration. The Specific Aims of this multi-site, cluster randomized, controlled trial are: 1)To evaluate the effects of the intervention on BP, glycemic, and lipid control; 2)To assess the impact of the intervention on patients' adherence to BP, anti-hyperglycemic, and lipid-lowering regimens, intensity of these regimens, and satisfaction with health care; 3) To evaluate the cost-effectiveness of the intervention compared to usual care; and 4) To evaluate the process of intervention implementation in VA and Kaiser sites in order to identify similarities and differences across sites that may relate to intervention generalizability. Using electronic data, we will proactively identify all diabetes patients within each of 8 primary care intervention teams who have poor BP control and either poor refill adherence or insufficient medication intensification; providers in the 8 non-intervention (control) teams will also be notified of patients with poor control and receive their adherence/intensification information. Adherence and treatment intensification patterns will also be evaluated for glycemia and lipids if either of these risk factors is poorly controlled. Clinical pharmacists, trained in motivational interviewing (MI) techniques and guided by computerized adherence modules, will identify barriers to medication adherence for BP medications and (as appropriate) for anti-hyperglycemic and lipid medications and provide adherence counseling. They will also be authorized to change and titrate medications following site-specific algorithms. Outcomes will be measured after 12-months, at which time up to 2000 patients will have received the intervention. At the conclusion of the study, we will prepare a translation toolkit to enhance dissemination of the intervention. This translational study is designed to address the Institute of Medicine challenge to improve quality through system redesign by using information technology to identify patients at risk, integrating clinical pharmacists in team-based care to support clinical decision making, and providing those pharmacists with the skills necessary to deliver effective behavioral counseling and medication change. While drawing on previously effective interventions, this is the first study to combine these essential elements to improve outcomes for patients with diabetes. Good blood pressure (BP), glucose, and cholesterol control is essential to prevent complications of diabetes mellitus but is very difficult to achieve. Both poor patient adherence to medications and clinicians' failure to initiate or intensify medications contribute to poor control of these diabetes risk factors. This translational study is designed to address the Institute of Medicine challenge to improve quality through system redesign by using information technology to identify patients who may need more specific help, integrating clinical pharmacists in team-based care to support effective clinical management, and providing those pharmacists with the skills necessary to help patients manage their own medications. While drawing on previously effective interventions, this is the first study to combine these essential elements to improve outcomes for patients with diabetes.