EFFICACY OF WRITTEN TREATMENT PLANS IN ASTHMA

描述(申请人提供)：哮喘的有效自我管理要求患者或他们的照顾者认识到病情恶化的早期症状，并启动旨在防止症状恶化的适当干预措施。大多数哮喘临床指南建议，如果患者要对哮喘状态的变化做出适当的反应，纳入书面的自我管理计划是患者必须拥有、能够理解并遵循的基本工具。然而，目前还没有检验书面计划本身有效性的对照试验。此外，即使书面计划是成功自我管理的必要和有效组成部分，数据也表明很少有患者收到这些计划。如果患者和医生要增加使用书面计划的障碍，就需要进行更多的研究。此外，还需要研究来检验书面计划在不同患者群体中的有效性。这项研究的总体目标是在随机对照试验(RCT)中评估模型、书面治疗计划的有效性，并与由一组成人和儿童肺科医生和过敏症专家在其执业环境中提供的常规护理进行比较。示范计划是一种形式，允许向患者传达符合NHLBI指南的治疗方案。另一个目标是评估来自不同种族/民族背景的患者如何利用治疗计划。具体目标：1)确定使用书面计划的障碍，并确定这些障碍在不同种族/民族之间是否有所不同；2)开发、验证和试点测试书面治疗计划表范本，并向医生提供使用说明；以及3)对非裔美国人、拉丁裔和非拉丁裔白人患者进行计划表范本的随机对照试验，以：a)评估计划在患者群体中的有效性，以及b)确定使用书面计划是否可以减少哮喘结果中的种族/民族差异。我们假设，与对照组的患者相比，接受范本书面计划表的哮喘患者将在3个主要结果指标方面有明显更大的改善：1.1)哮喘症状频率的减少；1.2)紧急医疗服务的使用；以及1.3)生活质量的提高。我们还将检查4个次要结果指标：1.4)哮喘住院；1.5)活动限制天数；1.6)干预组患者在首次就诊期间接受该计划的比例；以及1.7)患者对该计划的使用情况。

DESCRIPTION (provided by applicant): Effective self-management of asthma requires that patients or their caregivers recognize the early symptoms of an exacerbation and initiate appropriate interventions aimed at preventing the progression of symptoms. Most asthma clinical guidelines suggest that the incorporation of a written self-management plan is an essential tool that patients must possess, be able to understand, and follow if they are to respond appropriately to changes in asthma status. Nevertheless, there are no controlled trials examining the efficacy of the written plan itself. Furthermore, even if written plans are an essential and an effective component of successful self-management, the data suggest that few patients receive them. Barriers to the use of written plans need more study if patients and physicians are to increase their use of this tool. Additionally, studies are needed to examine the efficacy of written plans across different patient populations. The overall goal of this study is to assess the efficacy of a model, written treatment plan in a randomized, controlled trial (RCT) compared with the usual care that is provided by a group of adult and pediatric pulmonologists and allergists in their practice settings. The model plan is a form that allows a treatment regimen consistent with NHLBI guidelines to be conveyed to patients. An additional goal is to assess how patients from different racial/ethnic backgrounds utilize treatments plans. Specific aims: 1) to identify barriers to the use of written plans and determine whether these barriers differ across racial/ethnic groups; 2) to develop, validate, and pilot test a model written treatment plan form plus instructions to doctors for its use; and 3) to conduct a RCT of the model plan form with African-American, Latino, and non-Latino white patients to: a) assess the efficacy of the plan across patient populations and b) determine if using written plans reduce racial/ethnic disparities in asthma outcomes. We hypothesize that patients with asthma who receive the model written plan form will have, relative to patients in the control group, significantly greater improvement in 3 primary outcome measures: 1.1) reduction in asthma symptom frequency; 1.2) reduction in emergency use of health care services; and 1.3) improved quality of life. We will also examine 4 secondary outcome measures: 1.4) asthma hospitalizations; 1.5) days with activity restriction; 1.6) the proportion of patients in the intervention group who receive the plan during the initial visit; and 1.7) use of the plans by patients.