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临床试验/NCT01773629
NCT01773629
已完成
不适用

Care Managers for Perinatal Depression (CMPD)

Lancaster General Hospital4 个研究点 分布在 1 个国家目标入组 194 人2010年9月

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Depression
发起方
Lancaster General Hospital
入组人数
194
试验地点
4
主要终点
Diagnosis of major depression within 2 weeks of screening
状态
已完成
最后更新
12年前

概览

简要总结

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).

详细描述

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.

注册库
clinicaltrials.gov
开始日期
2010年9月
结束日期
2013年12月
最后更新
12年前
研究类型
Interventional
研究设计
Parallel
性别
Female

研究者

责任方
Sponsor

入排标准

入选标准

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

排除标准

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

结局指标

主要结局

Diagnosis of major depression within 2 weeks of screening

时间窗: 2 weeks after screening

Patient receipt of timely diagnosis for major depression during perinatal period.

Treatment of major depression within 1 month of diagnosis

时间窗: 1 month

Patient receipt of timely initiation of treatment for major depression during the perinatal period.

Transition of care from pregnancy to postpartum

时间窗: 4 months

Patient continuity of care for depression across the transition of care from pregnancy to postpartum within 4 months postpartum.

次要结局

  • Quantify the costs of implementing a care manager(3 years)
  • Qualitative assessment of success in implementation of perinatal depression care management process.(3 years)

研究点 (4)

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