Effectiveness and cost-effectiveness of a guideline-based stepped care model for patients with depression: study protocol of a cluster-randomized controlled trial in routine care.
Effectiveness and cost-effectiveness of a guideline-based stepped care model for patients with depression: study protocol of a cluster-randomized controlled trial in routine care.
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DOI：
10.1186/s12888-014-0230-y
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发表时间：
2014-08-20
期刊：
影响因子：
4.4
通讯作者：
Härter M
中科院分区：
文献类型：
--
作者：
Watzke B;Heddaeus D;Steinmann M;König HH;Wegscheider K;Schulz H;Härter M
抑郁症是一种广泛而严重的疾病，往往伴随着高度的痛苦和疾病负担。不同护理提供者之间缺乏整合，妨碍了基于指南的治疗。这对卫生保健系统构成重大挑战，也造成相当大的直接和间接费用。为了应对这些挑战，该项目的目的是实施和评估基于指南的抑郁症患者阶梯式护理模式，包括不同强度和设置的六种治疗方案，包括使用创新技术的低强度治疗。该研究是一项随机对照干预试验，对来自初级保健的抑郁症患者的连续样本进行了评估，并在一年内的四个时间标准化测量点进行了前瞻性调查。在参与的初级保健单位一级进行的群集随机化将全科医生分为两组。在干预组中，患者（n = 660）在由全科医生，心理治疗师，精神科医生和住院护理设施组成的多专业网络中接受阶梯式护理方法，而对照组患者（n = 200）接受常规护理。主要的研究问题涉及从基线到t3（12个月）的阶梯式护理模式的有效性。主要结局是通过PHQ-9测量的抑郁症状的变化;次要结局包括应答、缓解和复发、功能性生活质量（SF-12和EQ-5D-3 L）、其他临床和心理社会变量、直接和间接成本以及增量成本-效果比。此外，评估了整体模型以及单独治疗组分的可行性和可接受性。这种阶梯式护理模式整合了参与抑郁症治疗的所有初级和二级卫生保健提供者;它阐述了创新和循证治疗要素，遵循分层方法，并在常规护理中实施，而不是标准化条件。在积极的结果的情况下，其可持续实施的协作护理模式可以显着改善抑郁症患者的医疗保健状况，以及不同层次的护理提供者的互动和护理提供。本研究注册于ClinicalTrials.gov，编号NCT 01731717（注册日期：2013年6月24日）。
Depression is a widespread and serious disease often accompanied by a high degree of suffering and burden of disease. The lack of integration between different care providers impedes guideline-based treatment. This constitutes substantial challenges for the health care system and also causes considerable direct and indirect costs. To face these challenges, the aim of this project is the implementation and evaluation of a guideline-based stepped care model for depressed patients with six treatment options of varying intensity and setting, including low-intensity treatments using innovative technologies. The study is a randomized controlled intervention trial of a consecutive sample of depressive patients from primary care assessed with a prospective survey at four time-standardized measurement points within one year. A cluster randomization at the level of participating primary care units divides the general practitioners into two groups. In the intervention group patients (n = 660) are treated within the stepped care approach in a multiprofessional network consisting of general practitioners, psychotherapists, psychiatrists and inpatient care facilities, whereas patients in the control condition (n = 200) receive routine care. The main research question concerns the effectiveness of the stepped-care model from baseline to t3 (12 months). Primary outcome is the change in depressive symptoms measured by the PHQ-9; secondary outcomes include response, remission and relapse, functional quality of life (SF-12 and EQ-5D-3 L), other clinical and psychosocial variables, direct and indirect costs, and the incremental cost-effectiveness ratio. Furthermore feasibility and acceptance of the overall model as well as of the separate treatment components are assessed. This stepped care model integrates all primary and secondary health care providers involved in the treatment of depression; it elaborates innovative and evidence-based treatment elements, follows a stratified approach and is implemented in routine care as opposed to standardized conditions. In case of positive results, its sustainable implementation as a collaborative care model may significantly improve the health care situation of depressive patients as well as the interaction and care delivery of different care providers on various levels. This study is registered with ClinicalTrials.gov, number NCT01731717 (date of registration: 24 June 2013).
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影响因子：
4.4
作者：
Duhoux A;Fournier L;Gauvin L;Roberge P
通讯作者：
Roberge P
影响因子：
7.7
作者：
Haerter, Martin;Klesse, Christian;Berger, Mathias
通讯作者：
Berger, Mathias
影响因子：
0.7
作者：
Gräfe, K;Zipfel, S;Löwe, B
通讯作者：
Löwe, B
影响因子：
3
作者：
Dolan, P
通讯作者：
Dolan, P
DOI：
10.1007/s00406-012-0359-y
发表时间：
2012-11-01
影响因子：
4.7
作者：
Haerter, Martin;Kentgens, Maren;Lambert, Martin
通讯作者：
Lambert, Martin