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: 10019587
• 负责人: John A Dodson
• 金额: $ 75.6万
• 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/10019587
• 关键词: Address; Adherence; Age; Antihypertensive Agents; Behavior; Behavioral; Blood Pressure; Cardiovascular Diseases; Categories; Cellular Phone; Clinic; Clinical Trials; Counseling; Ethnic Origin; Event; Foundations; Health; Health Care Costs; Health Status; Health behavior; Health system; Hospitalization; Hospitals; Human; Hypertension; Incentives; Institution; Intervention; Lead; Link; Measures; Medicaid; Minority; Motivation; Myocardial Infarction; New York City; Outcome; Outpatients; Overweight; Participant; Patient Education; Patient Recruitments; Patients; Pattern; 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; base; behavior change; behavioral economics; blood pressure reduction; blood pressure regulation; cardiovascular disorder epidemiology; cardiovascular disorder risk; clinical practice; comorbidity; cost; depressive symptoms; design; disadvantaged population; experience; financial incentive; group intervention; improved; incentive program; incentive strategies; medication compliance; medication nonadherence; monitoring device; mortality; novel strategies; patient engagement; pill; pragmatic trial; programs; randomized trial; 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.

项目摘要 遵守降压药的研究需求仍然是不可接受的。这是 在弱势群体（社会经济处于不利和/或少数民族）中尤其如此 类似地体验不良高血压相关后遗症的最高率（例如，心肌 梗塞，中风），并且粘附水平最低。迄今为止针对提高依从性的研究， 例如患者的教育和咨询，取得了一些成功，但通常是资源密集的，而不是 跨机构可扩展。最近已经开发出行为经济方法来增强 药物依从性；这些策略旨在利用天生的人类趋势（例如超重 立即的好处），以改善健康行为。迄今为止，一些基于行为经济的研究 使用彩票激励计划（“遗憾彩票”）方法，鼓励参与者进行 通过承诺避免因失去经济激励措施而遗憾的愿望，健康的行为已得到承诺。 但是，这些激励措施是否转化为脆弱人群的可持续行为变化是 不清楚。在这种情况下，我们提出了更好的BP（行为经济学试验以增强血液调节 压力），纽约市健康与医院（NYC-H+H）系统中的务实随机试验， 这是美国最大的公立医院系统，为转移和灾难人口提供服务。我们的 审判将从3个NYC-H+H卧床诊所招募，并将使用彩票激励计划来促进 坚持将通过智能手机提供6个月的降压药。参与者会 遵循总共12个月的时间检查持久效果。我们将随机435例患者 在2：1中，高血压确定依从性差（<80％遵守降压药） （干预：控制）比率。在AIM 1中，我们将评估激励彩票对卧床收缩期的影响 干预之间的血压（SBP）和依从性（由≥80％天数定义） 并在6个月时控制武器。我们假设激励彩票将SBP降低≥10mmHg 与对照相比，越来越多的参加彩票的参与者会遵守。在目标2中，我们将 检查彩票对SBP和12个月时依从性的持久影响。在AIM 3中，我们将分析 分配给干预组的参与者之间依从性的轨迹，以及 类别会员资格。该项目的PI（Dodson博士）是心脏病专家和早期调查员 心血管流行病学和临床试验的经验。 Co-I是Troxel博士，他是生物统计学家和专家 在行为经济临床试验中，以及具有依从性专业知识的行为科学家Schoenthaler博士 和患者参与。结果可能会导致可持续和可扩展的策略来改善 社会经济脆弱的患者中的降压性依从性和BP控制。