Improving Adherence and Intensification of Medications Among Diabetes Patients

描述（由申请人提供）：良好的血压（BP）、血糖和脂质控制对预防糖尿病并发症至关重要，但很难实现。控制血压可能是最困难的目标，与血糖或脂质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和临床医生未能启动或加强药物治疗导致这些糖尿病危险因素控制不佳。我们建议在Kaiser Permanente和Veterans health Administration这两个综合医疗系统中评估一种基于临床药师的量身定制的干预措施，以改善依从性差或药物强化不足的高血压糖尿病患者的糖尿病危险因素控制。这项多地点、整群随机对照试验的具体目的是：1)评估干预对血压、血糖和血脂控制的影响；2)评估干预对患者对降压、降糖、降脂方案的依从性、方案强度以及对医疗服务满意度的影响；3)与常规护理相比，评估干预的成本效益；4)评估VA和Kaiser站点的干预实施过程，以确定可能与干预普遍性相关的站点之间的异同。

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.