- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00928863
Haemorrhagia Postpartum: an Implementation Study on the NVOG Guidelines and MOET Instructions (Fluxim)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
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Nijmegen, Olanda, 6500 HB
- Radboud University Nijmegen Medical Centre
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- woman with a high risk for haemorrhagia post partum
Exclusion Criteria:
- woman who refuses to participate
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Modelli osservazionali: Solo caso
- Prospettive temporali: Prospettiva
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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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
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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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).
Lasso di tempo: 1 year
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1 year
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feasibility study: the primary outcome measure regarding effectiveness is the adherence to developed quality indicators.
Lasso di tempo: 1 years
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1 years
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barrier analysis
Lasso di tempo: 1 year
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the primary outcomes in the barrier analysis are the barriers and facilitators among patients and professional regarding adherence to the quality indicators
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1 year
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
actual care study: the secondary outcome measure is the outcome (e.g. the incidence of HPP) of care.
Lasso di tempo: 1 year
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1 year
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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.
Lasso di tempo: 1 year
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1 year
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Rosella Hermens, PhD, IQ healthcare, Radboud University Nijmegen Medical Centre
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 80-82315-98-09003
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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