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Care Managers for Perinatal Depression (CMPD) (CMPD)

2014年1月29日 更新者:Lancaster General Hospital

The investigators will evaluate effects of introducing the care manager on:

  1. Patient receipt of timely diagnosis and initiation of treatment for major depression (diagnosis within 2 weeks of screening and treatment within 1 month of diagnosis); and
  2. Patient continuity of care for depression across the transition of care from pregnancy to postpartum (within 4 months postpartum).

研究概览

地位

完全的

条件

详细说明

The first two specific research aims of this proposed randomized study will evaluate the benefits of introducing site specific care managers into established multi-component enhancements of perinatal depression care. The four study sites are members of the IMPLICIT perinatal quality improvement network and provide prenatal care to a diverse population of low income minority women using a common set of care processes within diverse practice models including Obstetric, Family Medicine, and Nurse Practitioner/Midwifery settings. The established processes of care include evidence based screening, diagnosis, treatment protocols and quality improvement care teams.

The investigators will evaluate effects of introducing the care manager on:

  1. Patient receipt of timely diagnosis and initiation of treatment for major depression (diagnosis within 2 weeks of screening and treatment within 1 month of diagnosis); and
  2. Patient continuity of care for depression across the transition of care from pregnancy to postpartum (within 4 months postpartum).

For the third and fourth specific research aims we will conduct supplementary econometric and qualitative analyses to aid in understanding the provider and system context in which this intervention is implemented across the four study sites. Results of this evaluation will be used to understand for whom and in which systems of care this model is most successful as well as the costs of delivering this intervention.

Specifically the investigators will:

  1. Employ econometric techniques to quantify the costs of implementing and maintaining the IMPLICIT collaborative care maternal depression intervention; and
  2. Develop institutional ethnographies of the four study sites and identify factors associated with relative success in implementing perinatal depression care managers and improving timely diagnosis, initiation, and continuity of depression care.

Achieving these aims will provide the foundation for dissemination of this innovative approach to perinatal depression care delivery throughout the entire growing IMPLICIT network which now extends across the northeast and mid-Atlantic regions of the US; sites which provide perinatal care for low income minority women in urban, rural, and suburban communities. These sites include prenatal practices in the Robert Wood Johnson Foundation Aligning Forces for Quality initiative, the Healthy York County Coalition which is partnering with us to disseminate this work in their region.

研究类型

介入性

注册 (实际的)

194

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

    • Pennsylvania
      • Lancaster、Pennsylvania、美国、17604
        • Downtown Family Medicine
      • Lancaster、Pennsylvania、美国、17608
        • Southeast Lancaster Health Services
      • Philadelphia、Pennsylvania、美国、19122
        • Broad Street Health Center
      • Philadelphia、Pennsylvania、美国、19139
        • Haddington Health Center

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

13年 及以上 (孩子、成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

描述

Inclusion Criteria:

  • Female
  • Current pregnancy or experienced pregnancy in the past 6 weeks
  • Score >= 12 on PHQ9

Exclusion Criteria:

  • < age 13
  • Mental illness
  • Primary language other than English or Spanish

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:卫生服务研究
  • 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
实验性的:Intervention
Participants in the intervention arm will receive standard care plus the addition of a care manager. Care managers will function to provide culturally competent and linguistically appropriate support for the care of women identified as being at high risk for depression in pregnancy. Working with both the care providers and these study participants care managers will serve as connectors, coaches, collaborators, and negotiators working to overcome barriers to depression care delivery.
Participants in the intervention arm will receive standard care plus the addition of a care manager. Care managers will function to provide culturally competent and linguistically appropriate support for the care of women identified as being at high risk for depression in pregnancy. Working with both the care providers and these study participants care managers will serve as connectors, coaches, collaborators, and negotiators working to overcome barriers to depression care delivery.
其他:Control
Standard of care: within the current care processes, a woman initiating prenatal care completes a depression risk assessment using a two-step approach. Women with high risk of depression are then scheduled for a separate visit with a member of the care team (a physician, psychologist, or other mental health provider) referred to as a "perinatal depression champion" for a timely formal diagnostic interview.
Standard of care: within the current care processes, a woman initiating prenatal care completes a depression risk assessment using a two-step approach. Women with high risk of depression are then scheduled for a separate visit with a member of the care team (a physician, psychologist, or other mental health provider) referred to as a "perinatal depression champion" for a timely formal diagnostic interview.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Diagnosis of major depression within 2 weeks of screening
大体时间:2 weeks after screening
Patient receipt of timely diagnosis for major depression during perinatal period.
2 weeks after screening
Treatment of major depression within 1 month of diagnosis
大体时间:1 month
Patient receipt of timely initiation of treatment for major depression during the perinatal period.
1 month
Transition of care from pregnancy to postpartum
大体时间:4 months
Patient continuity of care for depression across the transition of care from pregnancy to postpartum within 4 months postpartum.
4 months

次要结果测量

结果测量
措施说明
大体时间
Quantify the costs of implementing a care manager
大体时间:3 years
Employ econometric techniques to quantify the costs of implementing and maintaining the care manager for managing perinatal depression.
3 years
Qualitative assessment of success in implementation of perinatal depression care management process.
大体时间:3 years
Develop institutional ethnographies of the study sites and identify factors associated with relative success in implementing perinatal depression care managers and improving timely diagnosis, initiation, and continuity of depression care. Qualitative measures include efficacy of core implementation group, commitment of implementation group, commitment of user group and readiness to change.
3 years

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

  • 首席研究员:Stephen Ratcliffe, MD, MSPH、Lancaster General Hospital
  • 首席研究员:Ian M Bennett, MD, PhD、University of Pennsylvania
  • 首席研究员:Donna Cohen, MD, MS、Lancaster General Hospital
  • 首席研究员:Michael A Horst, PhD, MPHS, MS、Lancaster General Hospital

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

2010年9月1日

初级完成 (实际的)

2013年12月1日

研究完成 (实际的)

2013年12月1日

研究注册日期

首次提交

2013年1月16日

首先提交符合 QC 标准的

2013年1月18日

首次发布 (估计)

2013年1月23日

研究记录更新

最后更新发布 (估计)

2014年1月30日

上次提交的符合 QC 标准的更新

2014年1月29日

最后验证

2014年1月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 2010-38-LGH

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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