Comparative Effectiveness of Two Community Based Diabetes Management Approaches

描述（由申请人提供）：拟议的随机对照试点研究将为设计一项完全有效的试验提供信息，该试验将测试护士主导的跨学科护理管理干预的全球有效性，以改善从社区免费诊所接受初级医疗护理的无保险糖尿病患者的健康状况，与接受同行主导自我管理的类似患者相比。这些方法的比较有效性尚未在随机试验中进行测试。 30例患者将在前6个月随机接受护理管理干预。护士主导护理管理模式的主要组成部分包括：1）以病人为中心的评估和目标设定，以最大限度地提高病人的自我管理技能; 2）教育，以提高自我效能和促进富有成效的临床接触; 3）通过跨学科团队获得专科护理; 4）根据病人的目标提供定制的循证治疗建议;（5）由护理经理进行护理协调。在第二个6个月，患者将返回常规诊所护理。同行领导的自我管理小组将被邀请参加每周一次的同行领导的自我管理培训，遵循斯坦福大学培训师模式，这是一个严格禁止的计划，确保统一应用。该培训将持续6周，每晚2小时，将涵盖慢性病的自我管理，制定行动计划，反馈和解决问题，处理情绪，症状管理技术，与医疗保健提供者沟通，药物和治疗决策。然后，同侪顾问将在护士的协助下，在前6个月的剩余时间内，每月进行1小时的小组会议，以审查/修订行动计划，审查自我管理技巧，并进行社会说服和建模。在第二个6个月，患者将返回常规诊所护理。 除了证明可行性，完善纳入标准，并提供样本量确定的数据外，该试点将帮助我们选择适当的测量工具，以定义用于比较各组和估计各组内变化的健康和福祉的综合概况。将在6个月和12个月时获得测量概况，并分为5个领域：1）医疗风险管理、住院天数、生活质量、医疗管理质量和自我管理质量。对于该试点，我们将不会测试任何假设，因为对于如此大量的测试，保护I型错误对于任何合理的样本量都会产生不足的功效。相反，将计算每个领域以及总体检验的效应量和置信区间，这些结果将用于功效分析。在完全把握度试验中，将使用我们其他联邦资助的慢性病管理试验中使用的多个终点的创新全球假设检验策略，完成5个领域的组比较。还将进行成本效益分析。

DESCRIPTION (provided by applicant): The proposed randomized controlled pilot study will inform the design of a fully powered trial that will test the global effectiveness of a nurse-led interdisciplinary care management intervention for improving the health profile of uninsured diabetic patients who receive their primary medical care from a community-based free clinic compared to similar patients who undergo peer-led self management. The comparative effectiveness of these approaches has not been tested in a randomized trial. Thirty patients will be randomized to the care management intervention for the first 6 months. Major components of the nurse-led care management model include: 1) patient-centered assessment and goal setting to maximize patients' self-management skills; 2) education to improve self efficacy and promote productive clinical encounters; 3) access to specialist care through an interdisciplinary team; 4) delivery of customized evidence-based treatment recommendations in response to patients' goals; and 5) care coordination by a nurse care manager. For the second 6 months patients will return to usual clinic care. The peer-led self management group will be invited to attend weekly peer-led self-management training following the Stanford Train the Trainer Model, a strictly proscribed program ensuring uniform application. The training will occur for 2 hours per night for 6 weeks and will cover self-management of chronic conditions, making action plans, feedback and problem solving, handling emotions, symptom management techniques, communication with health care providers, medications and making treatment decisions. The peer advisors will then lead, with assistance from a nurse, 1 hour monthly group sessions for the remainder of the first 6 months for review/revision of action plans, review of self management techniques and ongoing social persuasion and modeling. For the second 6 months patients will return to usual clinic care. In addition to demonstrating feasibility, refining inclusion criteria, and providing data for sample size determination, this pilot will help us select appropriate measurement tools to define a comprehensive profile of health and wellbeing to be used for comparing the groups and for estimating change within each group. The profile of measures will be obtained at six and 12 months and fall into five domains: 1)Medical risk management, hospitalization days, quality of life, quality of medical management, and quality of self- management. For this pilot, we will not test any hypotheses since protecting Type I error for such a large number of tests would yield inadequate power for any reasonable sample size. Instead, effect sizes and confidence intervals will be calculated for each domain as well as the overall test, and these results will be used for power analysis. In the fully powered trial, comparison of the groups across the 5 domains will be accomplished using an innovative global hypothesis testing strategy for multiple endpoints used in our other federally funded chronic illness management trials. A cost effectiveness analysis will also be performed.