Haemorrhagia Postpartum: an Implementation Study on the NVOG Guidelines and MOET Instructions (Fluxim)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Rosella Hermens, Radboud University
ClinicalTrials.gov Identifier:
NCT00928863
First received: June 25, 2009
Last updated: May 22, 2013
Last verified: May 2013
  Purpose

The objectives of this study is first to asses to what extent the guidelines of the Dutch Society of Obstetrics and Gynaecology (NVOG) and the MOET (Management of Obstetric and Emergencies and Trauma) instructions for haemorrhagia postpartum have been implemented in current care in the Dutch practice. Second to study barriers and facilitators for guideline adherence and to develop and test a tailored implementation strategy, based on these findings.


Condition Intervention
Hemorrhage, Postpartum
Other: implementation aids

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Haemorrhagia Postpartum: an Implementation Study on the NVOG Guidelines and MOET Instructions

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • 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). [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • feasibility study: the primary outcome measure regarding effectiveness is the adherence to developed quality indicators. [ Time Frame: 1 years ] [ Designated as safety issue: No ]
  • barrier analysis [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    the primary outcomes in the barrier analysis are the barriers and facilitators among patients and professional regarding adherence to the quality indicators


Secondary Outcome Measures:
  • actual care study: the secondary outcome measure is the outcome (e.g. the incidence of HPP) of care. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 320
Study Start Date: January 2010
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Haemorrhagia post partum
Women with a high risk for haemorrhagia post partum.
Other: implementation aids
testing a taylor made strategy for implementation NVOG guideline and MOET instruction in 3 hospitals

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

women with a high risk for haemorrhagia postpartum delivering in a hospital

Criteria

Inclusion Criteria:

  • woman with a high risk for haemorrhagia post partum

Exclusion Criteria:

  • woman who refuses to participate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00928863

Locations
Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands, 6500 HB
Sponsors and Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
Investigators
Principal Investigator: Rosella Hermens, PhD IQ healthcare, Radboud University Nijmegen Medical Centre
  More Information

No publications provided by Radboud University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rosella Hermens, Dr, Radboud University
ClinicalTrials.gov Identifier: NCT00928863     History of Changes
Other Study ID Numbers: 80-82315-98-09003
Study First Received: June 25, 2009
Last Updated: May 22, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
haemorrhagia postpartum
implementation guidelines
maternal morbidity
management of obstetrics and trauma

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage

ClinicalTrials.gov processed this record on September 16, 2014