Miller-Rosales Chris, Sterling Stacy A, Wood Sabrina B, Ross Thekla, Makki Mojdeh, Zamudio Cindy, Kane Irene M, Richardson Megan C, Samayoa Claudia, Charvat-Aguilar Nancy, Lu Wendy Y, Vo Michelle, Whelan Kimberly, Uratsu Connie S, Grant Richard W
University of California at Berkeley, Berkeley, CA, USA.
Division of Research, Kaiser Permanente, Oakland, CA, USA.
Contemp Clin Trials Commun. 2017 Oct 4;8:140-146. doi: 10.1016/j.conctc.2017.10.001. eCollection 2017 Dec.
BACKGROUND/AIMS: Cardiovascular disease (CVD) is the leading cause of death in the US. Many patients do not benefit from traditional disease management approaches to CVD risk reduction. Here we describe the rationale, development, and implementation of a multi-component behavioral intervention targeting patients who have persistently not met goals of CVD risk factor control.
Informed by published evidence, relevant theoretical frameworks, stakeholder advice, and patient input, we developed a group-based intervention (Changing Results: Engage and Activate to Enhance Wellness; "CREATE Wellness") to address the complex needs of patients with elevated or unmeasured CVD-related risk factors. We are testing this intervention in a randomized trial among patients with persistent (i.e > 2 years) sub-optimal risk factor control despite being enrolled in an advanced and highly successful CVD disease management program.
The CREATE Wellness intervention is designed as a 3 session, group-based intervention combining proven elements of patient activation, health system engagement skills training, shared decision making, care planning, and identification of lifestyle change barriers. Our key learnings in designing the intervention included the value of multi-level stakeholder input and the importance of pragmatic skills training to address barriers to care.
The CREATE Wellness intervention represents an evidence-based, patient-centered approach for patients not responding to traditional disease management. The trial is currently underway at three medical facilities within Kaiser Permanente Northern California and next steps include an evaluation of efficacy, adaptation for non-English speaking patient populations, and modification of the curriculum for web- or phone-based versions.
NCT02302612.
背景/目的：心血管疾病（CVD）是美国的主要死因。许多患者并未从降低CVD风险的传统疾病管理方法中获益。在此，我们描述了一种针对那些持续未达到CVD危险因素控制目标的患者的多成分行为干预措施的基本原理、开发过程及实施情况。
依据已发表的证据、相关理论框架、利益相关者的建议以及患者的意见，我们开发了一种基于小组的干预措施（改变结果：参与并行动以促进健康；“CREATE健康促进计划”），以满足CVD相关危险因素升高或未得到评估的患者的复杂需求。我们正在一项随机试验中对这一干预措施进行测试，受试患者尽管已参加了一个先进且非常成功的CVD疾病管理项目，但仍存在持续性（即>2年）的危险因素控制未达最佳情况。
CREATE健康促进计划干预措施设计为一个包含3节课程的小组干预，结合了经证实有效的患者激活、卫生系统参与技能培训、共同决策、护理计划以及识别生活方式改变障碍等要素。我们在设计该干预措施过程中的主要经验包括多层次利益相关者意见的价值以及实用技能培训对解决护理障碍的重要性。
CREATE健康促进计划干预措施代表了一种针对对传统疾病管理无反应患者的循证、以患者为中心的方法。该试验目前正在北加利福尼亚州凯撒医疗机构的三个医疗设施中进行，下一步包括疗效评估、针对非英语患者群体进行调整以及修改基于网络或电话版本的课程。
NCT02302612
