Fixed Dose Intervention Trial of New England Enhancing Survival in SMI Patients

新英格兰提高 SMI 患者生存率的固定剂量干预试验

• 批准号: 8919458
• 负责人: JOHN HSU
• 金额: $ 96.86万
• 依托单位: MCLEAN HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-09-03 至 2018-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8919458
• 关键词: 18 year old; Accounting; Address; Adherence; Adult; Adverse effects; Affect; Angiotensin Receptor; Angiotensins; Antipsychotic Agents; Area; Biometry; Bipolar Disorder; Boston; Cardiovascular Agents; Cardiovascular Diseases; Cardiovascular system; Caring; Cessation of life; Clinic; Clinical; Clinical Treatment; Consent; Data; Databases; Dose; Drug Combinations; Effectiveness; Electronic Health Record; Equilibrium; Evaluation; Event; Excess Mortality; General Population; Generations; Generic Drugs; Guidelines; Health; Individual; Insurance Coverage; Intention; Intervention; Intervention Trial; Interview; Life Expectancy; Lipids; Literature; Massachusetts; Mental Health; Metabolic; Monitor; New England; Outcome; Oxidoreductase; Pathway interactions; Patients; Pattern; Persons; Pharmaceutical Preparations; Pharmacy facility; Physiological; Population; Prevention; Prevention therapy; Primary Health Care; Primary Prevention; Probability; Protocols documentation; Psychiatric therapeutic procedure; Randomized; Randomized Clinical Trials; Randomized Controlled Trials; Regimen; Resources; Risk; Risk Assessment; Risk Factors; Risk Reduction; Safety; Schizoaffective Disorders; Schizophrenia; Scientist; Secondary Prevention; Site; Source; Structural Models; Structure; System; Techniques; Testing; Time; Titrations; Treatment Protocols; United Kingdom; United States; Variant; Weight; Work; arm; base; cardiovascular disorder prevention; cardiovascular risk factor; care delivery; clinical care; compliance behavior; cost; density; follow-up; improved; inhibitor/antagonist; intervention effect; mortality; open label; population based; programs; severe mental illness; time use; treatment adherence; treatment strategy; trial comparing; two-arm study

DESCRIPTION (provided by applicant): Patients with severe mental illness (SMI) die younger than persons in the general population. Much of the excess mortality for SMI patients is attributable to cardiovascular disease, and is exacerbated by treatment with second-generation antipsychotics (2GAs). Although the cardiovascular risks are well-known, and safe, efficacious therapy exists, few SMI patients receive cardiovascular prevention drugs. Care delivery fragmentation and poor patient adherence are central problems to reducing cardiovascular risks for patients with SMI. To address these problems, we propose to conduct a multi-site, open-label, randomized controlled trial comparing an initial treatment strategy of free, fixed-doses of two generic, cardiovascular prevention drugs (statins and angiotensin drugs) delivered within mental health clinics versus usual treatment. The study will include 600 adult patients (18+ years old; 300 per arm) with schizophrenia, schizoaffective disorder, or bipolar disorder who are receiving 2GAs within four mental health clinics in the Boston area. We have three aims: 1) to compare the proportions of subjects in each arm who are receiving cardiovascular drug treatment and are adherent to therapy during 12-months of follow-up; 2) to compare changes in composite (e.g., Framingham scores) and individual (e.g., lipid levels) cardiovascular risk factor levels using an intent-to-treat (ITT) approach; and 3) to compare risk factor levels, accounting for variation in adherence over time, using causal inference techniques to estimate the per-protocol effect of the intervention. Thus, our three aims examine whether this low cost, streamlined treatment strategy increases the numbers of subjects receiving cardiovascular prevention therapy and improves cardiovascular risk levels. Because patient adherence is a major concern in this clinical area, we will supplement the ITT assessment of risk levels by using techniques such as marginal structural models with inverse probability weighting to account for time-varying adherence. We will follow subjects for up to 12 months, and collect interview and biometric data at baseline, 3-, 6-, 9-, and 12-months, and supplement these data with other sources of existing information, e.g., from electronic health records and the state All Payer Claims Database. This population-based initial treatment strategy could be an effective and efficient approach for overcoming traditional barriers to cardiovascular disease prevention within the SMI population. Findings from this study will inform efforts to improve care and outcomes, and to enhance survival for patients with severe mental illness.

描述（由申请人提供）：严重精神疾病 (SMI) 患者的死亡时间比一般人群要早。 SMI 患者的超额死亡率大部分归因于心血管疾病，并且第二代抗精神病药物 (2GA) 治疗会加剧这种情况。尽管心血管风险众所周知，并且存在安全、有效的治疗方法，但很少有 SMI 患者接受心血管预防药物。护理服务分散和患者依从性差是降低 SMI 患者心血管风险的核心问题。为了解决这些问题，我们建议进行一项多中心、开放标签、随机对照试验，比较在心理健康诊所提供的两种免费固定剂量的心血管预防药物（他汀类药物和血管紧张素药物）的初始治疗策略与常规治疗相比。该研究将包括 600 名患有精神分裂症、分裂情感性障碍或双相情感障碍的成年患者（18 岁以上；每组 300 名），他们在波士顿地区的四个心理健康诊所接受 2GA。我们有三个目标：1）比较每组中正在接受心血管药物治疗并在 12 个月的随访期间坚持治疗的受试者比例； 2) 使用意向治疗（ITT）方法比较综合（例如弗雷明汉评分）和个体（例如血脂水平）心血管危险因素水平的变化； 3) 比较风险因素水平，考虑依从性随时间的变化，使用因果推理技术来估计干预措施的每个方案效果。因此，我们的三个目标是检验这种低成本、简化的治疗策略是否会增加接受心血管预防治疗的受试者数量并改善心血管风险水平。由于患者依从性是该临床领域的一个主要问题，因此我们将通过使用边缘结构模型等技术和逆概率加权来补充 ITT 风险水平评估，以解释随时间变化的依从性。我们将跟踪受试者长达 12 个月，收集基线、3、6、9 和 12 个月的访谈和生物识别数据，并用其他现有信息来源（例如电子健康记录）补充这些数据以及州所有付款人索赔数据库。这种基于人群的初始治疗策略可能是克服 SMI 人群心血管疾病预防传统障碍的有效且高效的方法。这项研究的结果将为改善护理和结果以及提高严重精神疾病患者的生存率做出努力。