基层医疗中抑郁症管理强化项目的评估：一项整群随机对照试验。INDI项目（改善抑郁症的干预措施）。
Assessment of an enhanced program for depression management in primary care: a cluster randomized controlled trial. The INDI project (Interventions for Depression Improvement).
作者信息
Aragonès Enric, Caballero Antonia, Piñol Josep Ll, López-Cortacans Germán, Badia Waleska, Hernández Josep M, Casaus Pilar, Folch Sílvia, Basora Josep, Labad Antonio
机构信息
Tarragona-Reus Primary Care Area, Catalan Health Institute, Spain.
出版信息
BMC Public Health. 2007 Sep 20;7:253. doi: 10.1186/1471-2458-7-253.
BACKGROUND
Most depressed patients are attended at primary care. However, there are significant shortcomings in the diagnosis, management and outcomes of these patients. The aim of this study is to determine whether the implementation of a structured programme for managing depression will provide better health outcomes than usual management.
DESIGN
A cluster-randomized controlled trial involving two groups, one of which is the control group consisting of patients who are treated for depression in the usual way and the other is the intervention group consisting of patients on a structured programme for treating depression.
SETTING
20 primary care centres in the province of Tarragona (Spain)
SAMPLE
400 patients over 18 years of age who have experienced an episode of major depression (DSM-IV) and who need to initiate antidepressant treatment
INTERVENTION
A multi-component programme with clinical, educational and organisational procedures that includes training for the health care provider and evidence-based clinical guidelines. It also includes primary care nurses working as care-managers who provide educational and emotional support for the patients and who are responsible for active and systematic clinical monitoring. The programme aims to improve the primary care/specialized level interface.
MEASUREMENTS
The patients will be monitored by telephone interviews. The interviewer will not know which group the patient belongs to (blind trial). These interviews will be given at 0, 3, 6 and 12 months.
MAIN VARIABLES
Severity of the depressive symptoms, response rate and remission rate.
ANALYSIS
Outcomes will be analyzed on an intent-to-treat basis and the unit of analysis will be the individual patient. This analysis will take into account the effect of study design on potential lack of independence between observations within the same cluster.
DISCUSSION
The effectiveness of caring for depression in primary care can be improved by various strategies. The most effective models involve organisational changes and a greater role of nurses. However, these models are almost exclusively from the USA, and this randomized clinical trial will determine if this approach could be effective to improve the outcomes of depression in primary care in the Spanish health care system.
TRIAL REGISTRATION
ISRCTN16384353.
背景
大多数抑郁症患者在基层医疗中接受治疗。然而，这些患者在诊断、管理和治疗结果方面存在显著不足。本研究的目的是确定实施一项结构化的抑郁症管理方案是否比常规管理能带来更好的健康结果。
设计
一项整群随机对照试验，分为两组，一组为对照组，由按常规方式治疗抑郁症的患者组成；另一组为干预组，由参加结构化抑郁症治疗方案的患者组成。
地点
西班牙塔拉戈纳省的20个基层医疗中心
样本
400名18岁以上经历过重度抑郁症发作（DSM-IV）且需要开始抗抑郁治疗的患者
干预措施
一个包含临床、教育和组织程序的多成分方案，包括对医护人员的培训和循证临床指南。还包括担任护理管理者的基层医疗护士，他们为患者提供教育和情感支持，并负责积极和系统的临床监测。该方案旨在改善基层医疗/专科医疗水平之间的衔接。
测量方法
通过电话访谈对患者进行监测。访谈者不知道患者属于哪一组（盲法试验）。这些访谈将在0、3、6和12个月时进行。
主要变量
抑郁症状的严重程度、缓解率和治愈率。
分析
将基于意向性分析对结果进行分析，分析单位为个体患者。该分析将考虑研究设计对同一群组内观察结果潜在缺乏独立性的影响。
讨论
通过各种策略可以提高基层医疗中抑郁症护理的有效性。最有效的模式涉及组织变革和护士发挥更大作用。然而，这些模式几乎都来自美国，这项随机临床试验将确定这种方法在西班牙医疗体系中是否能有效改善基层医疗中抑郁症的治疗结果。
试验注册号
ISRCTN16384353
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