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）

基本信息

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
项目类别：
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

项目摘要

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.

项目概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。对于弱势群体（社会经济弱势群体和/或少数群体）尤其如此，他们同时经历高血压相关不良后遗症（例如心肌梗塞）的发生率最高梗塞、中风），并且具有迄今为止最低水平的旨在提高依从性的研究，例如患者教育和咨询等，已经取得了一些成功，但往往是资源密集型的，而不是最近开发了可跨机构扩展的行为经济学方法。药物依从性；这些策略旨在利用人类固有的倾向（例如超重）迄今为止，已有一些基于行为经济学的研究。采用彩票奖励计划（“后悔彩票”）方法，鼓励参与者进行通过避免因失去经济激励而后悔的健康行为是有希望的。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尚不清楚。在这种情况下，我们提出 BETTER-BP（加强血液调节的行为经济学试验）。压力），纽约市健康和医院 (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，为多元化和弱势群体提供服务。试验将从 3 个 NYC-H+H 门诊诊所招募患者，并将采用抽奖激励计划来促进参与者将坚持服用通过智能手机提供的抗高血压药物 6 个月。我们将随机对 435 名患者进行为期 12 个月的随访，以检查持久效果。高血压患者依从性较差（抗高血压药物的依从性<80%），比例为 2:1 （干预：控制）比率在目标 1 中，我们将评估激励抽奖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 ≥80% 的依从天数）和对照组在 6 个月时我们追求激励抽签将使 SBP 降低 ≥10 mmHg。与对照组相比，我们将在目标 2 中坚持更多的参与者。检查抽签对 12 个月时 SBP 和依从性的持久影响。在目标 3 中，我们将进行分析。分配到干预组的参与者的依从轨迹，以及预测因素该项目的 PI（Dodson 博士）是一位心脏病专家和早期研究员。 Troxel 博士是一位生物统计学家和专家，在心血管流行病学和临床试验方面拥有丰富的经验。行为经济学临床试验博士，以及具有依从性专业知识的行为科学家 Schoenthaler 博士和患者参与的结果可能会导致可持续和可扩展的改进策略。社会经济弱势患者的抗高血压依从性和血压控制。