Cradle 5

CRADLE 5: Evaluation of the introduction of the CRADLE Vital Signs Alert device in the management of hypertension and shock in pregnancy in Sierra Leone

Sierra Leone (SL) has one of the highest maternal mortality rates in the world (770 deaths per 100,000 live births)1, with high rates of neonatal mortality (35 per 1000 live births)2. 1 in 17 women will die during their lifetime in childbirth; risks are 40-60% higher for teenage mothers3. Infants of mothers who die are up to 10 times more likely to die within the first 2 years of life4. We have determined that 76% of maternal deaths in SL are caused by pre-eclampsia/ eclampsia, bleeding and infection5,6. All cause abnormalities in blood pressure (BP) and heart rate (HR) (vital signs). Unfortunately, there are often disparities in access and availability of blood pressure devices to measure vital signs and understanding around how to respond, leading to delays in management and escalation of care. 19% of health facilities in SL don’t have a single BP device and 82% of maternal deaths in SL occur in a health facility, linked to poor quality of care6.

The CRADLE Vital Signs Alert (VSA) device – a validated, portable and easy-to-use BP and HR monitor with inbuilt traffic light early warning system – alerts users to act promptly, enabling timely life-saving intervention.

There are a number of mechanisms whereby the CRADLE intervention could lead to improved health outcomes for mothers and their babies. These included:

  • The CRADLE traffic light engages women in their own health during pregnancy and is a motivating factor for women to attend antenatal care
  • The CRADLE traffic light and CRADLE training empowers staff to communicate clearly with women and have confidence to deliver appropriate care
  • The CRADLE traffic light and training helps HCPs to confidently reassure women when all is well
  • The CRADLE traffic light alerts and training ensures healthcare providers act in a timely manner when there is a need to offer additional management at the health facility, therefore reducing inappropriate referrals
  • The CRADLE traffic light and training aids junior staff ability to communicate and escalate to senior staff or within the multi-disciplinary team i.e. to senior midwives or doctors
  • The CRADLE traffic light alerts and training ensures healthcare providers act in a timely manner when there is a need to referral a woman to a higher level of healthcare facility
  • The CRADLE traffic light is a communication tool for community stakeholders and decision makers, helping them to understand if a pregnant woman needs additional treatment and they are more able to support the woman in accepting treatment and ongoing referral

The CRADLE VSA and training package (CRADLE VSA intervention) was introduced in ten urban clusters across sub-Saharan Africa, India and Haiti5. The device was recognised in the PATH-led award for the top 30 high-impact global health innovations7, and won the prestigious Newton Prize in 2017, recognizing excellent research and innovation in support of economic development and social welfare.

Results from Sierra Leone reported a 60% reduction in maternal death (RR 0.37 [95% CI 0.25 to 0.55], p<0.0001) and a 40% reduction in primary outcome (one or more of eclampsia, hysterectomy or maternal death) (OR 0.60 [95% CI 0.50 – 0.72], p<0.001). This evidence confirms that deaths and associated morbidity are avoidable through simple interventions already widely available in SL, provided abnormal vital signs are detected early and prompt action taken. Implementation analysis showed high levels of fidelity, acceptability and reach8.

This evidence produced political and organisational buy-in from the SL Ministry of Health and Sanitation (MoHS), who strongly advocated for VSA devices and training to be distributed within the country. In collaboration with KCL and Welbodi Partnership (SL implementation partner), the MoHS have distributed 2800 devices, and trained 2851 healthcare workers (training-of-trainers model) in 8 of SL’s 16 districts. The MoHS have strongly advocated for continuity of this programme during COVID-19 in response to falling rates of ANC attendance, evidence that this programme is a priority to stakeholders and policymakers in country.

We have carried out a retrospective evaluation of the CRADLE intervention within the 8 districts that have already received the CRADLE intervention. As well as measuring the intervention’s effect, we have explored the feasibility of adoption, fidelity and reach measurements, and identify key district implementation adaptations, to understand reasons for inter-district variability within this initial rollout.

Research aims and Study Design:

Using the MRC Framework for developing and evaluating complex interventions9, we propose a two-stage design:

  • Phase 1 (feasibility): January – March 2022: We will prospectively explore and co-design the process measures to be used for evaluation in the 8 new districts during this feasibility phase. We will optimise data collection strategies (both process measures and clinical outcome data) for Phase 2, to ensure elegant implementation design and ensure sites are not overburdened with data collection during the trial.
  • Phase 2 (CRADLE 5 trial): March 2022 – August 2023: We will undertake a type 2 hybrid implementation-effectiveness randomised controlled trial (RCT) in a stepped wedge design, rolling out the adapted intervention and prospectively evaluating both the implementation of this complex intervention and its impact on significant maternal and neonatal morbidity and mortality. We will used mixed methods to explore implementation outcomes.

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