BETTER-BP (Behavioral Economics Trial To Enhance Regulation of Blood Pressure)

BETTER-BP（加强血压调节的行为经济学试验）

• 批准号: 10678781
• 负责人: John A Dodson
• 金额: $ 70.24万
• 依托单位: NEW YORK UNIVERSITY SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-17 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10678781
• 关键词: Address; Adherence; Age; Antihypertensive Agents; Behavior; Behavioral; Blood Pressure; Cardiovascular Diseases; Categories; Cellular Phone; Clinic; Clinical Trials; Counseling; Deterioration; Disparity population; Drug Prescriptions; Electronics; Ethnic Origin; Event; Health; Health Care Costs; Health Status; Health behavior; Health system; Hospitalization; Hospitals; Human; Hypertension; Incentives; Institution; Intervention; Link; Measures; Medicaid; Minority; Motivation; Myocardial Infarction; New York City; Outcome; Outpatients; Participant; Patient Education; Patient Recruitments; Patients; Pattern; Persons; Pharmaceutical Preparations; Population Heterogeneity; Prevention strategy; Public Hospitals; Race; Randomized; Regrets; Reporting; Research; Research Personnel; Resources; Scientist; Self Efficacy; Stroke; System; Testing; Translating; Vulnerable Populations; Work; arm; behavior change; behavioral economics; blood pressure control; blood pressure reduction; blood pressure regulation; cardiovascular disorder epidemiology; cardiovascular disorder risk; clinical practice; comorbidity; cost; depressive symptoms; design; experience; financial incentive; group intervention; improved; incentive program; medication compliance; medication nonadherence; monitoring device; mortality; novel strategies; patient engagement; pill; pragmatic randomized trial; pragmatic trial; programs; recruit; sex; smartphone application; socioeconomic disadvantage; socioeconomics; success; treatment arm

PROJECT SUMMARY Adherence to antihypertensive medications remains unacceptably low despite decades of research. This is especially true in vulnerable populations (socioeconomically disadvantaged and/or minority) who simultaneously experience the highest rates of adverse hypertension-related sequelae (e.g. myocardial infarction, stroke), and have the lowest levels of adherence. Studies to date targeted at improving adherence, such as patient education and counseling, have yielded some success but are often resource-intensive and not scalable across institutions. Behavioral economic approaches have recently been developed to enhance medication adherence; these strategies aim to leverage innately human tendencies (such as overweighting of immediate benefits) in order to improve health behaviors. To date, several behavioral economic-based studies using a lottery incentive program (“regret lottery”) approach, whereby participants are encouraged to undertake healthy behaviors through the desire to avoid regret over losing financial incentives, have been promising. However, whether these incentives translate to sustainable behavior change in vulnerable populations is unclear. In this context we propose BETTER-BP (Behavioral Economics Trial To Enhance Regulation of Blood Pressure), a pragmatic randomized trial within the New York City Health and Hospitals (NYC-H+H) system, which is the largest public hospital system in the U.S. and serves a diverse and disadvantaged population. Our trial will recruit from 3 NYC-H+H ambulatory clinics, and will use a lottery incentive program to promote adherence to antihypertensive medication that will be delivered via smartphone for 6 months. Participants will be followed for a total of 12 months to examine durable effects. We will randomize 435 patients with hypertension determined to have poor adherence (<80% adherence with antihypertensive medication), in a 2:1 (intervention:control) ratio. In Aim 1 we will evaluate the effects of the incentive lottery on ambulatory systolic blood pressure (SBP) and adherence (good adherence defined by ≥80% days adherent) between intervention and control arms at 6 months. We hypothesize that the incentive lottery will reduce SBP by ≥10 mmHg compared with control, and that more participants receiving the lottery will be adherent. In Aim 2 we will examine durable effects of the lottery on SBP and adherence at 12 months. In Aim 3, we will analyze trajectories of adherence among participants assigned to the intervention group, as well as predictors of category membership. The PI for this project (Dr. Dodson) is a cardiologist and Early Stage Investigator with experience in cardiovascular epidemiology and clinical trials. Co-I’s are Dr. Troxel, a biostatistician and expert in behavioral economic clinical trials, and Dr. Schoenthaler, a behavioral scientist with expertise in adherence and patient engagement. The results could lead to sustainable and scalable strategies to improve antihypertensive adherence and BP control among socioeconomically vulnerable patients.

项目总结 尽管进行了数十年的研究，但抗高血压药物的依从性仍然低得令人无法接受。这是 尤其是在弱势群体(社会经济上处于不利地位的和/或少数群体) 同时经历最高比率的不良高血压相关后遗症(如心肌梗塞 脑梗塞、中风)，并且依从性最低。到目前为止，针对提高依从性的研究， 如耐心教育和咨询，已经取得了一些成功，但往往是资源密集型和不 可跨机构扩展。行为经济学方法最近被开发出来，以增强 坚持用药；这些策略旨在利用人类天生的倾向(如超重 立竿见影的好处)，以改善健康行为。到目前为止，一些基于行为经济学的研究 采用彩票奖励方案(“后悔彩票”)方法，鼓励参与者进行 通过渴望避免因失去经济奖励而后悔的健康行为，一直是有希望的。 然而，这些激励措施是否会转化为弱势群体的可持续行为改变，目前还不得而知。 不清楚。在这种背景下，我们提出了更好的-BP(行为经济学试验)来加强血液调节 压力)，这是纽约市卫生和医院(NYC-H+H)系统内的一项务实的随机试验， 这是美国最大的公立医院系统，为多元化和弱势群体提供服务。我们的 试验将从3个NYC-H+H门诊诊所招募，并将使用抽奖激励计划来推广 坚持通过智能手机服用降压药，为期6个月。参与者将 总共随访12个月，以检查持久效果。我们将随机选择435名患者 高血压被确定为依从性差(80%的降压药依从性)，比例为2：1 (干预：对照)比。在目标1中，我们将评估奖励彩票对动态收缩压的影响 两次干预之间的血压和依从性(良好依从性由≥定义为80%的依从性) 并在6个月时控制武器。我们假设奖励彩票将使收缩压降低10毫米汞柱(≥ 与对照组相比，更多的参与者接受彩票将得到遵守。在《目标2》中我们将 检查抽奖对SBP和12个月后依从性的持久影响。在目标3中，我们将分析 被分配到干预组的参与者的依从性轨迹以及 类别成员资格。这个项目的PI(Dodson博士)是一名心脏病专家和早期研究员， 有心血管流行病学和临床试验经验。我的同事是生物统计学家和专家特罗克塞尔博士 在行为经济学临床试验中，舍恩塔勒博士，一位在坚持方面有专长的行为科学家 和耐心的参与。结果可能导致可持续和可扩展的战略，以改善 社会经济脆弱患者的降压依从性和血压控制。