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 尽管经过数十年的研究，抗高血压药物的依从性仍然低得令人无法接受。这是 特别是在弱势群体（社会经济弱势群体和/或少数群体）中， 同时经历高血压相关后遗症（如心肌梗死）的发生率最高 梗塞、中风），并且具有最低水平的依从性。迄今为止的研究旨在提高依从性， 例如病人教育和咨询，取得了一些成功，但往往是资源密集型， 可跨机构扩展。行为经济学的方法最近已经发展起来，以提高 药物依从性;这些策略旨在利用人类固有的倾向（如过度强调药物依从性）。 （三）改善健康行为。到目前为止，一些基于行为经济学的研究 采用彩票激励计划（“后悔彩票”）的方法，鼓励参与者 通过避免因失去经济激励而后悔的愿望，健康的行为是有希望的。 然而，这些激励措施能否转化为弱势群体可持续的行为改变， 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，以加强血液调节 压力），纽约市卫生和医院（NYC-H+H）系统内的一项实用随机试验， 这是美国最大的公立医院系统，为多样化和弱势群体提供服务。我们 试验将从3个NYC-H+H门诊诊所招募人员，并将使用彩票激励计划来推广 将通过智能手机提供6个月的抗高血压药物依从性。参与者将 随访12个月，以检查持久影响。我们将随机分配435名患者， 确定高血压依从性差（抗高血压药物依从性<80%），以2：1的比例 （干预：对照）比率。在目标1中，我们将评估激励彩票对动态收缩压的影响。 干预之间的血压（SBP）和依从性（良好依从性定义为依从天数≥80%） 6个月时控制武器。我们假设奖励抽奖将使SBP降低≥10 mmHg 与对照组相比，更多的参与者将接受抽奖。在目标2中， 检查彩票对SBP和12个月时的依从性的持久影响。在第三章中，我们将分析 分配到干预组的参与者之间的依从性轨迹，以及 类别成员。本项目的PI（Dodson博士）是一名心脏病专家和早期研究者， 心血管流行病学和临床试验经验。我的助手是Troxel博士，生物统计学家和专家 行为经济学临床试验的专家，以及行为科学家， 和患者参与度。研究结果可能会导致可持续和可扩展的战略，以改善 社会经济脆弱患者的抗高血压药物依从性和血压控制。