- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT00928863
Haemorrhagia Postpartum: an Implementation Study on the NVOG Guidelines and MOET Instructions (Fluxim)
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
The most important cause of maternal morbidity in the Netherlands is Haemorrhagia post partum (HPP), with an incidence of 5% containing 10.000 women in the Netherlands a year. Introduction of an evidence-based guideline about HPP by the Dutch society of Obstetrics and Gynaecology (NVOG) and the course Management of Obstetrics Emergencies and Trauma (MOET course) did not lead to a reduction in HPP. This implies the possibility of an incomplete implementation of both the NVOG guideline and MOET-instructions.
To evaluate the implementation of the guideline and MOET instruction in the current care, measurement of the actual care will be performed in a representative sample of 20 hospitals. Before actual care can be measured, quality indicators have to be developed regarding the process, structure and outcome based on the key recommendations from the NVOG guideline on HPP and the MOET instructions. The indicator development will be performed according to the RAND-modified Delphi method .The key recommendations from the NVOG guideline on HPP and the MOET instructions will be extracted and will be tested in two rounds among an independent panel of 12-15. The selected key recommendations will be operationalized in measurable elements. In an observational multi-centre study, actual care will be measured by video monitoring the third stage of delivery and a medical record search among 320 high risk patients for HPP in 20 hospitals. Additional information for indicator adherence will be searched in the medical records of the videotaped patients. In this manner, deviations from the indicators can be outlined. This study will provide us with reliable information about current practice in the Netherlands.
A qualitative study will be performed with the aim to discover factors in detail that are "pro" or "contra" adhering to the developed HPP-indicators by focus group interviews among groups of different involved professionals and experienced patients. Subsequently, to assess the 'prevalence' of the factors mentioned in the focus group interviews, a survey with questionnaires will be performed among all Dutch gynaecologists and midwives. The data will be analyzed to assess the most frequently mentioned barriers and facilitators.
Based on the results of step 1 and 2, a tailored implementation strategy will be developed to increase the adherence to the recommendations. The different implementation elements will be tailored to the barriers and facilitators found and will probably combine interventions directed at professional and organizational level. This strategy will be implemented and evaluated in a feasibility study. The study will be performed in 3 hospitals where the effect of the implementation strategy, the adherence to the developed indicators will be measured. A process evaluation will be performed to study the experiences of the clinicians and patients with this strategy. A cost analysis of the tested implementation strategy will take place.
Тип исследования
Регистрация (Ожидаемый)
Контакты и местонахождение
Места учебы
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Nijmegen, Нидерланды, 6500 HB
- Radboud University Nijmegen Medical Centre
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
- woman with a high risk for haemorrhagia post partum
Exclusion Criteria:
- woman who refuses to participate
Учебный план
Как устроено исследование?
Детали дизайна
- Наблюдательные модели: Только для случая
- Временные перспективы: Перспективный
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
---|---|
Haemorrhagia post partum
Women with a high risk for haemorrhagia post partum.
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testing a taylor made strategy for implementation NVOG guideline and MOET instruction in 3 hospitals
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
actual care study: the primary outcome measure is the adherence to the quality indicators (derived from the NVOG guideline on HPP and the MOET instructions).
Временное ограничение: 1 year
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1 year
|
|
feasibility study: the primary outcome measure regarding effectiveness is the adherence to developed quality indicators.
Временное ограничение: 1 years
|
1 years
|
|
barrier analysis
Временное ограничение: 1 year
|
the primary outcomes in the barrier analysis are the barriers and facilitators among patients and professional regarding adherence to the quality indicators
|
1 year
|
Вторичные показатели результатов
Мера результата |
Временное ограничение |
---|---|
actual care study: the secondary outcome measure is the outcome (e.g. the incidence of HPP) of care.
Временное ограничение: 1 year
|
1 year
|
feasibility study: the secondary outcome measures are the experiences of professionals and patients with the different elements of the implementation strategy and the changed care, and the cost of the tested strategy.
Временное ограничение: 1 year
|
1 year
|
Соавторы и исследователи
Следователи
- Главный следователь: Rosella Hermens, PhD, IQ healthcare, Radboud University Nijmegen Medical Centre
Публикации и полезные ссылки
Общие публикации
- Woiski M, de Visser S, van Vugt H, Dijkman A, Schuitemaker N, van Meir C, Middeldorp J, Huisjes A, Mol BW, Molkenboer J, Moonen-Delarue D, Oudijk M, van Rheenen-Flach L, Rijnders R, Pernet P, Porath M, de Wit S, Grol R, Scheepers H, Hermens R. Evaluating Adherence to Guideline-Based Quality Indicators for Postpartum Hemorrhage Care in the Netherlands Using Video Analysis. Obstet Gynecol. 2018 Sep;132(3):656-667. doi: 10.1097/AOG.0000000000002781.
- de Visser SM, Woiski MD, Grol RP, Vandenbussche FPHA, Hulscher MEJL, Scheepers HCJ, Hermens RPMG. Development of a tailored strategy to improve postpartum hemorrhage guideline adherence. BMC Pregnancy Childbirth. 2018 Feb 8;18(1):49. doi: 10.1186/s12884-018-1676-6.
- Woiski MD, van Vugt HC, Dijkman A, Grol RP, Marcus A, Middeldorp JM, Mol BW, Mols F, Oudijk MA, Porath M, Scheepers HJ, Hermens RP. From Postpartum Haemorrhage Guideline to Local Protocol: A Study of Protocol Quality. Matern Child Health J. 2016 Oct;20(10):2160-8. doi: 10.1007/s10995-016-2050-9.
- Woiski MD, Belfroid E, Liefers J, Grol RP, Scheepers HC, Hermens RP. Influencing factors for high quality care on postpartum haemorrhage in the Netherlands: patient and professional perspectives. BMC Pregnancy Childbirth. 2015 Oct 23;15:272. doi: 10.1186/s12884-015-0707-9.
- Woiski MD, Hermens RP, Middeldorp JM, Kremer JA, Marcus MA, Wouters MG, Grol RP, Lotgering FK, Scheepers HC. Haemorrhagia post partum; an implementation study on the evidence-based guideline of the Dutch Society of Obstetrics and Gynaecology (NVOG) and the MOET (Managing Obstetric Emergencies and Trauma-course) instructions; the Fluxim study. BMC Pregnancy Childbirth. 2010 Jan 26;10:5. doi: 10.1186/1471-2393-10-5.
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Ожидаемый)
Завершение исследования (Ожидаемый)
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
- 80-82315-98-09003
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