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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).

調査の概要

状態

完了

条件

詳細な説明

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.

研究の種類

介入

入学 (実際)

194

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

13年歳以上 (子、大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

女性

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:ヘルスサービス研究
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.
他の: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Diagnosis of major depression within 2 weeks of screening
時間枠: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
時間枠: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
時間枠:4 months
Patient continuity of care for depression across the transition of care from pregnancy to postpartum within 4 months postpartum.
4 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Quantify the costs of implementing a care manager
時間枠: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.
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

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

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2010年9月1日

一次修了 (実際)

2013年12月1日

研究の完了 (実際)

2013年12月1日

試験登録日

最初に提出

2013年1月16日

QC基準を満たした最初の提出物

2013年1月18日

最初の投稿 (見積もり)

2013年1月23日

学習記録の更新

投稿された最後の更新 (見積もり)

2014年1月30日

QC基準を満たした最後の更新が送信されました

2014年1月29日

最終確認日

2014年1月1日

詳しくは

本研究に関する用語

キーワード

その他の研究ID番号

  • 2010-38-LGH

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

Interventionの臨床試験

3
購読する