Impact of the Mobile HealthPROMISE Platform on the Quality of Care and Quality of Life in Patients With Inflammatory Bowel Disease: Study Protocol of a Pragmatic Randomized Controlled Trial.
Impact of the Mobile HealthPROMISE Platform on the Quality of Care and Quality of Life in Patients With Inflammatory Bowel Disease: Study Protocol of a Pragmatic Randomized Controlled Trial.
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DOI：
10.2196/resprot.4042
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发表时间：
2015-02-18
影响因子：
1.7
通讯作者：
HealthPROMISE Consortium Group
中科院分区：
文献类型：
--
作者：
Atreja A;Khan S;Rogers JD;Otobo E;Patel NP;Ullman T;Colombel JF;Moore S;Sands BE;HealthPROMISE Consortium Group
炎症性肠病(IBD)是一种慢性肠道疾病，在美国影响着100多万人。疾病的反复发作使IBD患者成为患者参与护理的理想对象，这种护理以增强自我管理和改善医患沟通为中心。在IBD中，对于不同表型、疾病程度和既往手术史的患者，最佳的治疗方法各不相同。因此，与高血压和糖尿病不同，单一的质量指标不能定义IBD这样的异质性疾病。通过像HealthPROMISE这样的应用程序，通过测量患者的生活质量(QOL)来补充传统的质量指标，可以提供更全面的评估。这项务实的随机对照试验的目的是确定HealthPROMISE APP与患者教育APP相比，在改善结果(护理质量[QOC]、QOL、患者依从性、疾病控制和资源利用)方面的影响。我们的假设是，一个以患者为中心的自我监测和协作决策支持平台将导致IBD患者总体生活质量的持续改善。参与者将在面对面的访问中被招募，并被随机分配到干预组(即HealthPROMISE)或对照组(即教育应用程序)。HealthPROMISE ARM中的患者将能够更新他们的信息，并收到疾病摘要、质量指标以及显示一段时间内QOL(SIBDQ)评分和资源利用趋势的图表。提供者将在护理时使用这些数据进行协作决策和质量改进干预。对照组的患者将在基线、办公室访问期间和研究结束时输入数据，但不会获得任何决策支持(生活质量趋势、警报或仪表板视图)。该试验将于2015年第一季度开始招募。计划招募多达300名IBD患者参加研究(分配比例为1：1)。主要终点是HealthPROMISE与控制臂中满足的质量指标的数量。次要终点包括因IBD而急诊的次数减少，因IBD而住院的次数减少，与基线相比一般生活质量评分的变化，每组符合所有合格门诊质量指标的患者的比例，以及每组的疾病控制患者的比例。此外，我们计划对具有足够的HealthPROMISE利用率的干预患者(超过6个登录，从0周到52周输入数据)进行方案分析，以实现上述主要和次要终点。HealthPROMISE是一款独特的基于云的患者报告结果(PRO)和决策支持工具，可为患者和提供商提供支持。患者跟踪他们的生活质量和症状，提供者可以实时使用可视数据(与电子健康记录[EHR]集成)，为他们的整个患者群体提供更好的护理。使用务实的试验设计，我们希望表明，与不参与护理和参与决策的患者相比，参与自己护理和参与决策的IBD患者的结果有明显改善。ClinicalTrials.gov NCT02322307；https://clinicaltrials.gov/ct2/show/NCT02322307(由网站http://www.webcitation.org/6W8PoYThr).存档
Inflammatory bowel disease (IBD) is a chronic condition of the bowel that affects over 1 million people in the United States. The recurring nature of disease makes IBD patients ideal candidates for patient-engaged care that is centered on enhanced self-management and improved doctor-patient communication. In IBD, optimal approaches to management vary for patients with different phenotypes and extent of disease and past surgical history. Hence, a single quality metric cannot define a heterogeneous disease such as IBD, unlike hypertension and diabetes. A more comprehensive assessment may be provided by complementing traditional quality metrics with measures of the patient’s quality of life (QOL) through an application like HealthPROMISE. The objective of this pragmatic randomized controlled trial is to determine the impact of the HealthPROMISE app in improving outcomes (quality of care [QOC], QOL, patient adherence, disease control, and resource utilization) as compared to a patient education app. Our hypothesis is that a patient-centric self-monitoring and collaborative decision support platform will lead to sustainable improvement in overall QOL for IBD patients. Participants will be recruited during face-to-face visits and randomized to either an interventional (ie, HealthPROMISE) or control (ie, education app). Patients in the HealthPROMISE arm will be able to update their information and receive disease summary, quality metrics, and a graph showing the trend of QOL (SIBDQ) scores and resource utilization over time. Providers will use the data for collaborative decision making and quality improvement interventions at the point of care. Patients in the control arm will enter data at baseline, during office visits, and at the end of the study but will not receive any decision support (trend of QOL, alert, or dashboard views). Enrollment in the trial will be starting in first quarter of 2015. It is intended that up to 300 patients with IBD will be recruited into the study (with 1:1 allocation ratio). The primary endpoint is number of quality indicators met in HealthPROMISE versus control arm. Secondary endpoints include decrease in number of emergency visits due to IBD, decrease in number of hospitalization due to IBD, change in generic QOL score from baseline, proportion of patients in each group who meet all eligible outpatient quality metrics, and proportion of patients in disease control in each group. In addition, we plan to conduct protocol analysis of intervention patients with adequate HealthPROMISE utilization (more than 6 log-ins with data entry from week 0 through week 52) achieving above mentioned primary and secondary endpoints. HealthPROMISE is a unique cloud-based patient-reported outcome (PRO) and decision support tool that empowers both patients and providers. Patients track their QOL and symptoms, and providers can use the visual data in real time (integrated with electronic health records [EHRs]) to provide better care to their entire patient population. Using pragmatic trial design, we hope to show that IBD patients who participate in their own care and share in decision making have appreciably improved outcomes when compared to patients who do not. ClinicalTrials.gov NCT02322307; https://clinicaltrials.gov/ct2/show/NCT02322307 (Archived by WebCite at http://www.webcitation.org/6W8PoYThr).