Uncontrolled hypertension - the role of medication adherence and clinical inertia

描述（由申请人提供）：Ian Kronish，MD，MPH是西奈山医学院医学系的普通内科医生和助理教授。候选人的长期目标是成为行为心脏病学领域独立的以患者为导向的研究人员，研究医生和患者行为影响慢性心血管疾病预后和管理的因素。更具体地说，候选人对开发，测试和传播行为干预措施感兴趣，这些干预措施可以提高对推荐心血管行为的依从性。候选人在全科医学研究期间参与了这一领域，当时他研究了急性冠状动脉综合征患者中抑郁与非依从性的关系，以及急性冠状动脉综合征后非依从性对临床结局的影响。拟议的职业发展计划将密切指导的以患者为导向的研究经验与多学科教学培训相结合，包括1）临床试验设计，2）生物统计学，3）健康行为理论和4）专门的高血压培训。普通内科医生最常遇到的心血管问题之一是无法控制的高血压。不受控制的高血压的两个重要原因与行为因素有关，包括：1）临床医生的治疗强化不足，也称为临床惰性; 2）患者不依从药物治疗。在健康心理学家Karina Davidson博士和普通内科医生托马斯麦金（医学博士，公共卫生硕士）的指导下，该候选人旨在测试是否为临床医生提供有关患者药物依从性的客观信息可以改善临床医生对不受控制的高血压的管理。为了实现这一目标，候选人将首先招募并随机分配30名初级保健临床医生。随机分配到干预组的临床医生稍后将收到总结患者对血压药物依从性的报告。随机分配至对照组的临床医生将继续接受常规治疗。然后，他将从与临床医生相同的实践中招募300名患有不受控制的高血压的患者。这些患者将接受为期一个月的血压药物电子监测。然后，这些患者将返回与之前入组研究的临床医生一起进行访视。在患者访视时，干预组的临床医生将收到一份定量报告，总结他们的患者在前一个月对血压药物的依从性。对照组的临床医生将不会收到此报告，并将根据常规护理对其患者进行治疗。然后，候选人将评估收到依从性信息的临床医生是否更有可能1）加强血压不受控制的依从性患者的治疗（即：增加药物剂量或数量）和2）建议依从性差的患者。这些数据将用于计算更大、更明确试验的把握度。拟议研究的另一个目标是评估患者相关、提供者相关和卫生系统因素，这些因素可能是1个月导入期内药物依从性差的预测因素，并使用这些因素开发一个模型来预测不依从血压药物。 公共卫生相关性：如果向临床医生提供患者电子监测的血压药物依从性报告可以改善高血压的管理，那么电子监测依从性可能是减少血压不受控制的患者比例的有用工具。此外，成功开发一种可以预测血压药物依从性差的模型可能有助于为针对依从性差的患者的干预措施设计提供信息，并有助于识别无法获得电子药物监测的依从性差的患者。

DESCRIPTION (provided by applicant): Ian Kronish, MD, MPH is a general internist and Assistant Professor in the Department of Medicine at the Mount Sinai School of Medicine. The candidate's long-term goal is to become and independent patient- oriented researcher in the field of behavioral cardiology, examining factors by which physician and patient behavior impact the prognosis and management of chronic cardiovascular illnesses. More specifically, the candidate is interested in developing, testing, and disseminating behavioral interventions that can improve adherence to recommended cardiovascular behaviors. The candidate became involved in this area during his fellowship in general medicine when he studied the association of depression with non-adherence among patients after acute coronary syndromes as well as the impact of non-adherence on clinical outcomes after acute coronary syndromes. The proposed career development plan combines a closely mentored patient- oriented research experience with multidisciplinary, didactic training in 1) clinical trial design, 2) biostatistics, 3) health behavior theory, and 4) specialized hypertension training. One of the most commonly encountered cardiovascular problems encountered by general internists is uncontrolled hypertension. Two important causes of uncontrolled hypertension relate to behavioral factors and include: 1) inadequate therapy intensification by clinicians, also known as clinical inertia and 2) patient non-adherence to medications. Under the mentorship of health psychologist Karina Davidson, PhD, and general internist Thomas McGinn, MD, MPH, the candidate aims to test whether providing clinicians with objective information about their patients' adherence to medications can improve clinician management of uncontrolled hypertension. To achieve this aim, the candidate will first enroll and randomize 30 primary care clinicians. Clinicians randomized to the intervention will later receive reports that summarize their patients' adherence to blood pressure medications. Clinicians randomized to the control arm will continue with usual care. He will then enroll 300 patients with uncontrolled hypertension from the same practice as the clinicians. These patients will have their adherence to blood pressure medications electronically monitored for one month. These patients will then return for visits with their clinicians who were previously enrolled in the study. At the time of the patient visit, clinicians in the intervention group will receive a quantitative report summarizing their patients' adherence to blood pressure medications in the prior month. Clinicians in the control arm will not receive this report and will treat their patients according to usual care. The candidate will then assess whether clinicians who receive the adherence information are more likely to 1) intensify treatment in adherent patients with uncontrolled blood pressure (i.e: increase dose or number of medications) and 2) counsel poorly adherent patients. These data will be used to calculate power for a larger, more definitive trial. Another goal of the proposed research will be to assess patient-related, provider-related, and health system factors that may be predictors of poor adherence to medication during the 1-month run-in period and to use these factors to develop a model for predicting non-adherence to blood pressure medications. PUBLIC HEALTH RELEVANCE: If providing clinicians with reports of their patients' electronically monitored adherence to blood pressure medications improves the management of hypertension, then electronically monitoring adherence may be a useful tool to reduce the proportion of patients with uncontrolled blood pressure. Further, the successful development of a model that can predict poor adherence to blood pressure medications may be helpful for informing the design of interventions targeted at patients with poor adherence and for identifying poorly adherent patients who do not have access to electronic medication monitoring.