CHAMPION
Research type
Research Study
Full title
Chronic Hypertenion in pregnAncy iMPlementatION study (CHAMPION)
IRAS ID
234256
Contact name
L Chappell
Contact email
Sponsor organisation
King's College London
Duration of Study in the UK
2 years, 8 months, 1 days
Research summary
Summary of Research
Approximately 1-2% of all pregnant women will have high blood pressure at the start of pregnancy (Chronic hypertension). High blood pressure in pregnancy can cause significant health problems for both the mother and the new-born. Women therefore require specialist care during pregnancy to prevent complications.Whilst national guidance has been available since 2010, the uptake of this guidance regionally and nationally has not been established. The first two phases of the project will investigate the way in which care for women with chronic hypertension is delivered, including whether evidence based care is being offered. The opinions of women and of their clinician will be sought to understand why it is or isn’t being offered.
Phase three of the project aims to support clinicians to share information with women about the treatment that they recommend and for women to shared their views openly with the health professional. A decision about care is reached together and is known as shared decision-making (SDM). Tools to support SDM have been tested in some areas of maternity and in people with high blood pressure who are not pregnant. In both cased the woman or patient felt better about the decision they made when the interventions were applied. SDM tools/ aids have also, in some cases, been shown to improve outcomes because clinicians and women make more evidence based choices when tools are used.
The feasibility of an SDM tool/aid will be tested in during the care of women with chronic high blood pressure in up to three NHS Trusts to see if it is acceptable to women (and clinicians). The study will also explore if it's use potentially improves women’s experience of her antenatal care, decision-making ability and outcomes for her and her new-born.
Summary of Results
: I explored the implementation of national antenatal hypertension guidelines (2018/2019) at three different NHS Trusts. I found clinical variation in the management of chronic hypertension in pregnancy across the different hospitals. Women’s experience of the management of hypertension in pregnancy was variable, with three-quarters of women experiencing conflict regarding their antihypertensive prescription which was mediated by concerns about the safety of the medication, side-effects of medication and health beliefs about hypertension. Just under half of these women were non-adherent to their antihypertensive medication. Women reported wanting better information about antihypertensive medication and better support from their healthcare professionals when making decisions about the management of their hypertension in pregnancy.
I performed a systematic review and meta-analysis of all randomised controlled trials comparing patient decision aids to usual care in women with pre-existing morbidity who were making pregnancy-related decisions. I demonstrated that patient decision aids were most effective when used to support women with pre-existing medical conditions making decisions about medication uptake in pregnancy, but that there was a paucity of evidence regarding in-consultation shared decision-making support tools.
I codesigned, implemented and evaluated a novel shared decision making (SDM) intervention for use with pregnant women with chronic hypertension. The SDM intervention that included a patient decision aid and in-consultation infographics was effective at reducing decisional conflict. In most women the reduction was of clinical importance. Almost half of the fifty women recruited to the study were uncertain about or planned not to take antihypertensives prior to the SDM intervention, compared to two women after the intervention. The SDM intervention was acceptable to both women and healthcare professionals. I considered the importance of recruiting a sample of women representative of the chronic hypertension population at every stage. The inclusion of Black and Asian women throughout the studies has meant the findings are applicable to those who, on average, experience the poorest health outcomes. This study provides evidence that the co-designed SDM intervention is effective at reducing decisional conflict and increases women’s intention to take antihypertensives. Future research should evaluate the potential impact this might have on adherence to antihypertensive medication throughout pregnancy, episodes of severe hypertension and associated health outcomes.REC name
London - South East Research Ethics Committee
REC reference
17/LO/2041
Date of REC Opinion
2 Jan 2018
REC opinion
Favourable Opinion