Effective Care Management of Depressed Diabetes Patients

描述(由申请人提供)： 糖尿病伴发抑郁症(DM/D)是一个庞大且特别脆弱的人群，他们可能无法从有关血糖控制和加强体力活动重要性的知识进步中受益。这项随机有效性试验将评估一种以患者为中心的干预措施，旨在通过协议驱动的、基于电话的护理管理模式改善DM/D患者的糖尿病结果。这项干预基于流行病学证据和随机试验，证明了：抑郁症管理对抑郁症和糖尿病治疗结果的影响；对糖尿病患者和抑郁症患者进行电话护理的有效性；促进体力活动对糖尿病和抑郁症患者结果的影响；以及改善糖尿病患者与临床医生沟通技能的有效性。382名DM/D患者将被随机分为两组：(1)增强的日常护理，包括关于抑郁、糖尿病自我护理和促进体力活动的简短教育；或(2)基于电话的阶段性护理管理，包括抗抑郁药物护理管理(MCM)和/或认知行为疗法(CBT)。MCM和CBT模块都是基于经证实有效的干预措施。MCM模块将使用一种被广泛接受的算法来识别有效的抗抑郁药物，确定适当的剂量，并促进依从性。MCM患者还将接受简短的体力活动咨询。CBT模块将解决患者的抑郁症状、体力活动水平和患者与提供者的沟通技能。护理经理和患者医生之间的结构化沟通将确保干预措施与患者的整体护理计划相结合。为了最大限度地提高普适性，参与者将从三个地理位置相近的医疗保健系统中挑选出来。密集干预阶段将包括护士作为护理经理进行频繁的电话联系，并使用手动的MCM和CBT方案。维护阶段将包括每月电话随访，以监测患者的进展，强化教育信息，并促进继续坚持治疗。结果将在4个月和12个月时进行衡量。主要终点将是HbA1c水平和心血管风险指数。次要终点包括近端干预目标(例如，抑郁症状、体力活动水平、服药依从性和提供者与患者的沟通)、生活质量、治疗满意度和资源使用。评价是根据RE-AIM有效性试验框架进行的。

DESCRIPTION (provided by applicant): Diabetes patients with co-occurring depression (DM/D) represent a large and especially vulnerable population that may not benefit from advances in knowledge regarding the importance of glycemic control and physical activity enhancement. This randomized effectiveness trial will evaluate a patient-centered intervention designed to improve diabetes outcomes among DM/D patients through a protocol-driven, telephone-based care management model. The intervention is based on epidemiologic evidence and randomized trials demonstrating: the impact of depression management on depression and diabetes treatment outcomes; the efficacy of telephone care for diabetic patients and depressed patients; the impact of physical activity promotion on outcomes among diabetic and depressed patients; and the efficacy of improving diabetes patients' communication skills with their clinicians. 382 DM/D patients will be randomized to either: (1) enhanced usual care consisting of brief education regarding depression, diabetes self-care, and physical activity promotion; or (2) telephone-based, staged care management that includes antidepressant medication care management (MCM) and/or cognitive behavioral therapy (CBT). Both the MCM and CBT modules are based on interventions with proven efficacy. The MCM module will use a widely-accepted algorithm to identify efficacious antidepressant agents, determine appropriate doses, and promote adherence. MCM patients also will receive brief physical activity counseling. The CBT module will address patients' depressive symptoms, physical activity levels, and patient-provider communication skills. Structured communication between care managers and patients' physicians will insure that the intervention is integrated with patients' overall care plans. To maximize generalizability, participants will be drawn from three geographically proximate healthcare systems. The intensive intervention phase will consist of frequent telephone contacts by a nurse serving as a care manager and using manualized MCM and CBT protocols. The maintenance phase will consist of monthly telephone follow-up to monitor patients' progress, reinforce educational messages, and promote continued treatment adherence. Outcomes will be measured at four- and 12-months. Primary endpoints will be HbA1c levels and a cardiovascular risk index. Secondary endpoints include proximal intervention targets (e.g., depressive symptoms, physical activity levels, medication adherence, and provider-patient communication), quality of life, treatment satisfaction, and resource use. The evaluation has been structured based on the RE-AIM framework for effectiveness trials.