- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT01773629
Care Managers for Perinatal Depression (CMPD) (CMPD)
The investigators will evaluate effects of introducing the care manager on:
- 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
- Patient continuity of care for depression across the transition of care from pregnancy to postpartum (within 4 months postpartum).
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
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:
- 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
- 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:
- Employ econometric techniques to quantify the costs of implementing and maintaining the IMPLICIT collaborative care maternal depression intervention; and
- 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.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
-
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Pennsylvania
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Lancaster, Pennsylvania, Соединенные Штаты, 17604
- Downtown Family Medicine
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Lancaster, Pennsylvania, Соединенные Штаты, 17608
- Southeast Lancaster Health Services
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Philadelphia, Pennsylvania, Соединенные Штаты, 19122
- Broad Street Health Center
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Philadelphia, Pennsylvania, Соединенные Штаты, 19139
- Haddington Health Center
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-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Исследования в области здравоохранения
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
---|---|
Экспериментальный: 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.
|
Другой: 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.
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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.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Diagnosis of major depression within 2 weeks of screening
Временное ограничение: 2 weeks after screening
|
Patient receipt of timely diagnosis for major depression during perinatal period.
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2 weeks after screening
|
Treatment of major depression within 1 month of diagnosis
Временное ограничение: 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
Временное ограничение: 4 months
|
Patient continuity of care for depression across the transition of care from pregnancy to postpartum within 4 months postpartum.
|
4 months
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Quantify the costs of implementing a care manager
Временное ограничение: 3 years
|
Employ econometric techniques to quantify the costs of implementing and maintaining the care manager for managing perinatal depression.
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3 years
|
Qualitative assessment of success in implementation of perinatal depression care management process.
Временное ограничение: 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
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Stephen Ratcliffe, MD, MSPH, Lancaster General Hospital
- Главный следователь: Ian M Bennett, MD, PhD, University of Pennsylvania
- Главный следователь: Donna Cohen, MD, MS, Lancaster General Hospital
- Главный следователь: Michael A Horst, PhD, MPHS, MS, Lancaster General Hospital
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Оценивать)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2010-38-LGH
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
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