My Data Choices, evaluation of effective consent strategies for patients with behavioral health conditions

 描述(申请人提供)：对有行为健康状况(BHC)患者及其代理人的数据共享偏好知之甚少，对严重精神疾病(SMI)患者的选择更是知之甚少。我们的假设是，行为健康患者和代理人不想要目前使用的广泛同意模式，而是希望有更大程度的选择，以在粒度水平上确定哪些健康信息(特别是敏感信息)应该共享用于护理和研究。拟议研究的主要目标是解决以下公开挑战：(1)确定对行为健康患者和代孕者有意义的敏感健康信息类别，(2)通过将它们与标准医学术语联系起来，以精确和统一的方式指定已识别的共享选择类别，(3)理解提供者对实施患者和代孕者驱动的数据共享选择的观点，(4)部署和测试电子知情同意管理工具，我们将其称为支持分级同意模型的“MyChoice”，(5)通过在“MyChoice”教育材料中嵌入每个数据类别中包含的信息类型以及限制护理数据访问的潜在有利和不利后果，帮助BCH患者智能地实施细粒度控制，以及(6)在行为健康信息交换(HIE)的背景下部署和测试“MyChoice”和受信任的经纪人。在研究结束时，我们将招募200名患有BHC的成年患者(70名患有SMI)和70名代理人，并将他们随机分配到：(I)干预组：招募者是参与患者护理的人；(Ii)控制组：招募者不是设施炎护理团队的一部分。我们将同意双方同意MyChoice，尽管他们的选择不会影响实际的数据共享。我们将调查(I)和(II)之间以及BHC患者、SMI患者和代孕者之间在共享选项、理解和同意程度方面是否存在差异。此外，我们将查阅参与者的电子医疗记录，并随机选择在同意MyChoice的3个月内发生的50次相遇。对于这些遭遇，我们将使用受信任的中介来确定如果尊重隐私偏好，提供商可能会被限制访问的数据。我们将使用这些情景来分析临床、伦理、政策、监管和技术影响。

 DESCRIPTION (provided by applicant): Little is known about data sharing preferences of patients with behavioral health conditions (BHCs) and their surrogates, and even less is known about the choice of patients with Serious Mental Illness (SMI). Our hypothesis is that, instead of wanting the currently used broad consent models, behavioral health patients and surrogates want a greater degree of choice to determine at a granular level which health information (in particular, sensitive information) to share for care and research. The main goals of the proposed research are to address the open challenges of: (1) identifying categories of sensitive health information that are meaningful for behavioral health patients and surrogates, (2) specifying the identified categories of sharing choices in a precise and uniform way by linking them to standard medical terminologies, (3) understanding providers perspective on implementing patients' and surrogates' driven data sharing choices, (4) deploying and testing an electronic informed consent management tool, that we call "MyChoice" that supports tiered-consent models, (5) helping BCH patients to intelligently exercise granular control by embedding into "MyChoice" educational material on the type of information contained in each data category and potential favorable and unfavorable consequences of restricting data access for care, and (6) deploying and testing "MyChoice" and the Trusted Broker in a context of a behavioral health information exchange (HIE). At the end of the study we will recruit 200 adult patients with BHCs (70 with SMI) and 70 surrogates and randomly assign them to: (i) intervention arm: the recruiter is someone involved in the patient's care; (ii) control arm: the recruiter is not part of the facilitis' care team. We will consent both arms with MyChoice, though their choices will have no effect on the actual data sharing. We will investigate if differences occur in sharing options, levels of comprehension and consent between (i) and (ii) and within the population of patients with BHCs, patients with SMI, and surrogates. Also, we will inspect the electronic medical records of the participants and randomly select 50 encounters occurred within 3 months of consenting with MyChoice. For those encounters we will retrospectively use the Trusted Broker to identify the data that providers could have been restricted to access if privacy preferences were respected. We will use those scenarios to analyze clinical, ethical, policy, regulatory and technical implications.