General Internal Medicine and UCSF Center for Vulnerable Populations at San Francisco General Hospital and Trauma Center, University of California, 94110, USA.
BMC Health Serv Res. 2012 Jan 26;12:22. doi: 10.1186/1472-6963-12-22.
Health information technology can enhance self-management and quality of life for patients with chronic disease and overcome healthcare barriers for patients with limited English proficiency. After a randomized controlled trial of a multilingual automated telephone self-management support program (ATSM) improved patient-centered dimensions of diabetes care in safety net clinics, we collaborated with a nonprofit Medicaid managed care plan to translate research into practice, offering ATSM as a covered benefit and augmenting ATSM to promote medication activation. This paper describes the protocol of the Self-Management Automated and Real-Time Telephonic Support Project (SMARTSteps).
METHODS/DESIGN: This controlled quasi-experimental trial used a wait-list variant of a stepped wedge design to enroll 362 adult health plan members with diabetes who speak English, Cantonese, or Spanish and receive care at 4 publicly-funded clinics. Through language-stratified randomization, participants were assigned to four intervention statuses: SMARTSteps-ONLY, SMARTSteps-PLUS, or wait-list for either intervention. In addition to usual primary care, intervention participants received 27 weekly calls in their preferred language with rotating queries and response-triggered education about self-care, medication adherence, safety concerns, psychological issues, and preventive services. Health coaches from the health plan called patients with out-of-range responses for collaborative goal setting and action planning. SMARTSteps-PLUS also included health coach calls to promote medication activation, adherence and intensification, if triggered by ATSM-reported non-adherence, refill non-adherence from pharmacy claims, or suboptimal cardiometabolic indicators. Wait-list patients crossed-over to SMARTSteps-ONLY or -PLUS at 6 months. For participants who agreed to structured telephone interviews at baseline and 6 months (n = 252), primary outcomes will be changes in quality of life and functional status with secondary outcomes of 6-month changes in self-management behaviors/efficacy and patient-centered processes of care. We will also evaluate 6-month changes in cardiometabolic (HbA1c, blood pressure, and LDL) and utilization indicators for all participants.
Outcomes will provide evidence regarding real-world implementation of ATSM within a Medicaid managed care plan serving safety net settings. The evaluation trial will provide insight into translating and scaling up health information technology interventions for linguistically and culturally diverse vulnerable populations with chronic disease.
ClinicalTrials.gov: NCT00683020.
健康信息技术可以增强慢性病患者的自我管理能力和生活质量，克服英语水平有限的患者的医疗保健障碍。在一项多语言自动化电话自我管理支持计划（ATSM）的随机对照试验改善了安全网诊所中糖尿病患者以患者为中心的护理维度之后，我们与一家非营利性医疗补助管理式医疗计划合作，将研究转化为实践，将 ATSM 作为一项涵盖的福利，并增强 ATSM 以促进药物激活。本文介绍了自我管理自动化和实时电话支持项目（SMARTSteps）的方案。
方法/设计：本对照准实验性试验采用了一种阶梯式楔形设计的等待名单变体，招募了 362 名患有糖尿病且讲英语、粤语或西班牙语的成年医疗计划成员，并在 4 家公共资助的诊所接受护理。通过语言分层随机化，参与者被分配到四种干预状态：仅 SMARTSteps、SMARTSteps-PLUS 或两种干预的等待名单。除了常规的初级保健外，干预参与者还会根据自我保健、药物依从性、安全问题、心理问题和预防服务等方面的旋转查询和响应触发教育，每周接受 27 次电话咨询，以其首选语言进行。来自医疗保健计划的健康教练会在超出范围的响应时致电患者，以进行协作目标设定和行动计划。SMARTSteps-PLUS 还包括健康教练的电话，以在 ATSM 报告的不依从、从药房索赔中识别出的不依从或不理想的心血管代谢指标触发时，促进药物激活、依从性和强化。等待名单上的患者在 6 个月时交叉到 SMARTSteps-ONLY 或 -PLUS。对于在基线和 6 个月时同意进行结构化电话访谈的参与者（n=252），主要结果将是生活质量和功能状态的变化，次要结果将是 6 个月内自我管理行为/功效和以患者为中心的护理过程的变化。我们还将评估所有参与者的心血管代谢（HbA1c、血压和 LDL）和利用指标的 6 个月变化。
结果将为在为安全网服务的医疗补助管理式医疗计划中实施 ATSM 提供实际实施的证据。评估试验将深入了解为患有慢性病的语言和文化多样化的弱势群体翻译和扩大健康信息技术干预措施。
ClinicalTrials.gov：NCT00683020。
