BIG CHANGE

BOS supported implementation of guidelines on clinical hypertension and its management in gestation

Objective

Hypertension is a common complication of pregnancy. Seventeen percent of the clinical pregnancies are complicated by hypertension and 2% by preeclampsia. Severe hypertension and preeclampsia (hypertension and proteinuria) poses an increased risk for mortality and morbidity to both the mother and the fetus. The Dutch trends in maternal morbidity due to severe hypertension and preeclampsia are currently a reason for great concern. It is thought that a high degree of these maternal complications results from suboptimal or insufficient treatment. A recent study showed that in 96% of the cases of maternal death several factors of substandard care were present. In 85% of the cases, these factors were classified as insufficient treatment of hypertension. Therefore, the management of hypertension is an important part of the care of pregnant women for which improvement is necessary. The NVOG has developed evidence-based guidelines on the management of hypertension in pregnancy and chronic hypertension. However, it seems likely that these guidelines are not implemented yet. In order to reduce maternal complications, an implementation strategy to improve adherence to the guidelines on hypertension in pregnancy is necessary. The main objective of this study is to assess the cost-effectiveness of an innovative implementation strategy of the NVOG guidelines on hypertension including a computerised decision support system (BOS) and professional audit and feedback compared to a common strategy of professional audit and feedback.

Study design

A cluster randomized controlled trail with an economic evaluation alongside will be performed.

Outcome measures

The primary outcome measures for the evaluation of the effectiveness of both strategies is a combined rate of major maternal complications (maternal death, organ specific complications of hypertension, HELPP syndrome, placental abruption). Secondary outcome measures for effectiveness are guidelines’ adherence rates, fetal death rates, Caesarean delivery rates, rates of neonatal mortality and morbidity.

Time schedule

- Preparation of the study: recruitment of hospitals/gynaecologists; design of questionnaires and cost diaries; development of organizational infrastructure for trial; indicator development; development of guideline into BOS: months 0-4

- Before measurement (=audit) & feedback: months 5-8

- Implementation study (effect- and process evaluation: patient recruitment, treatment, outcome assessment): months 9-27

-Data-entry; follow-up measurements: months 28-31

- Analysis, economic evaluation and writing final report: months 32-36

Projectleaders

Prof.dr.M.W. van Tulder, EMGO Institute of the VU University Amsterdam

Dr. R.P.G.M. Hermens, senior researcher IQ Health Care UMC Nijmegen

Dr. M.G.A.J.Wouters, gynaecologist VUmc Amsterdam

Drs. S.H.E Luitjes, VUmc Amsterdam

Subsidy

ZonMw

Contact

Susanne Luitjes – s.luitjes@vumc.nl