Effective Care Management of Depressed Diabetes Patients

描述（由申请人提供）： 合并抑郁症（DM/D）的糖尿病患者代表了一个庞大且特别脆弱的人群，他们可能无法从血糖控制和体力活动增强的重要性方面的知识进步中获益。这项随机有效性试验将评估以患者为中心的干预措施，旨在通过方案驱动的、基于电话的护理管理模式改善DM/D患者的糖尿病结局。该干预措施基于流行病学证据和随机试验，证明：抑郁症管理对抑郁症和糖尿病治疗结果的影响;电话护理对糖尿病患者和抑郁症患者的疗效;促进体力活动对糖尿病和抑郁症患者结局的影响;以及改善糖尿病患者与临床医生沟通技巧的疗效。382例DM/D患者将随机接受：（1）强化常规护理，包括有关抑郁症、糖尿病自我护理和促进体力活动的简短教育;或（2）基于电话的分阶段护理管理，包括抗抑郁药物治疗管理（MCM）和/或认知行为治疗（CBT）。MCM和CBT模块都是基于已证明有效的干预措施。MCM模块将使用广泛接受的算法来识别有效的抗抑郁药，确定适当的剂量，并促进依从性。MCM患者还将接受简短的身体活动咨询。CBT模块将解决患者的抑郁症状，身体活动水平和患者与提供者的沟通技巧。护理经理和患者医生之间的结构化沟通将确保干预与患者的整体护理计划相结合。为了最大限度地提高普遍性，参与者将从三个地理位置接近的医疗保健系统中抽取。强化干预阶段将包括由护士作为护理经理频繁进行电话联系，并使用手动MCM和CBT协议。维持阶段将包括每月电话随访，以监测患者的进展，加强教育信息，并促进持续的治疗依从性。结果将在4个月和12个月时进行衡量。主要终点为HbA 1c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、身体活动水平、药物依从性和提供者-患者沟通）、生活质量、治疗满意度和资源使用。该评价基于有效性试验的RE-AIM框架进行构建。

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.