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Return to Work Among Patients With Stress Related Mental Disorders - An Intervention in the Swedish Primary Care (PRIMA)

2020年6月10日 更新者:Vastra Gotaland Region

Return to Work Among Patients With Stress Related Mental Disorders - An Intervention in the Swedish Primary Care (PRIMA)

The aim of this project is to develop a model for return to work (RTW) for patients sick listed due to stress related mental disorders, which takes into account each patient's specific situation; includes the workplace, and is well adapted to the Swedish primary care setting.

In late 2016, general practitioners (GPs) and rehabilitation coordinators at both public and private primary care centers will be offered a one-day training about work and workability for patients with stress related mental disorders. Also, the participants will be trained in a specific method that includes the patient's employer early in the rehabilitation process

The project has a quasi-experimental and longitudinal design. The intervention will be conducted on 15 different primary care centers, which will be matched with a comparison group. Return to work for 500 patients will be analyzed using registry data, 6, 12 and 18 months after sick-listing. The hypothesis is that patients who are sick-listed at primary care centers that completely or partially implemented the specific method on average will return earlier to work than patients sick-listed at primary care centers that did not implement the method.

Alongside studying if the intervention has an effect on the patients' RTW over time, the investigators aim to investigate the mechanisms explaining the effects and the individual and organizational level (primary care units) circumstances necessary for these mechanisms to be triggered. To gain deeper knowledge about mechanisms and context, the investigators will conduct interviews with the treatment staff and collect registry data about the primary care units.

研究概览

研究类型

介入性

注册 (实际的)

132

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Clinical diagnosis of International Classification of Diseases (ICD)10 F43
  • Has an employment
  • Good command in spoken and written Swedish

Exclusion Criteria:

  • Participants must not have been on long term sick-leave (>60 days) during the last three years, regardless of causative diagnosis.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
无干预:照常治疗
有源比较器:Work-related measures
  • One-day training for GP:s and rehabilitation coordinators
  • A treatment protocol which includes contact with the patient's employer
  • Clinical support from the Institute of Stress Medicine
After mapping the patient's psychosocial work situation using tools provided at the one-day training, the patient's employer will be contacted and involved in the rehabilitation planning.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Following sick leave data from the Swedish Social Insurance Agency's records we will measure time taken to return to work (RTW) among patients in the intervention group vs. time taken to RTW among patients in the control group.
大体时间:Three measurement time points. First measurement will occur 6 months from baseline.
Three measurement time points. First measurement will occur 6 months from baseline.
Following sick leave data from the Swedish Social Insurance Agency's records we will measure time taken to return to work (RTW) among patients in the intervention group vs. time taken to RTW among patients in the control group.
大体时间:Second measurement time point will occur at 12 months from baseline.
Second measurement time point will occur at 12 months from baseline.
Following sick leave data from the Swedish Social Insurance Agency's records we will measure time taken to return to work (RTW) among patients in the intervention group vs. time taken to RTW among patients in the control group.
大体时间:Third measurement time point will occur at 18 months from baseline.
Third measurement time point will occur at 18 months from baseline.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Lisa Björk、the Institute of Stress Medicine

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年12月1日

初级完成 (实际的)

2019年1月1日

研究完成 (实际的)

2020年5月1日

研究注册日期

首次提交

2016年11月1日

首先提交符合 QC 标准的

2017年1月11日

首次发布 (估计)

2017年1月16日

研究记录更新

最后更新发布 (实际的)

2020年6月12日

上次提交的符合 QC 标准的更新

2020年6月10日

最后验证

2020年6月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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