Evaluation of a novel vital sign device to reduce maternal mortality and morbidity in low-resource settings: a mixed method feasibility study for the CRADLE-3 trial
Nicola Vousden,Elodie Lawley,Hannah L. Nathan,Paul T. Seed,Adrian Brown,Tafadzwa Muchengwa,Umesh Charantimath,Mrutyunjaya B Bellad,Muchabayiwa Francis Gidiri,Shivaprasad S. Goudar,Lucy C Chappell,Jane Sandall,Andrew Shennan +12 more
TLDR
A three-month mixed-methodology feasibility study demonstrates that the components of the intervention were acceptable, methods of implementing were successful and the main trial design would be feasible.Abstract:
The CRADLE-3 trial is a stepped-wedge randomised controlled trial aiming to reduce maternal mortality and morbidity by implementing a novel vital sign device (CRADLE Vital Sign Alert) and training package into routine maternity care in 10 low-income sites. The MRC Guidance on complex interventions proposes that interventions and implementation strategies be shaped by early phase piloting and development work. We present the findings of a three-month mixed-methodology feasibility study for this trial, describe how this was informed by the MRC guidance and the study design was refined. The fidelity, dose, feasibility and acceptability of implementation and training materials were assessed in three representative non-trial sites (Zimbabwe, Ethiopia, India) using multiple-choice questionnaires, evaluation of clinical management (action log), healthcare provider (HCP) semi-structured interviews and focus groups 4–10 weeks after implementation. Simultaneously, the 10 sites included in the main trial (eight countries) collected primary outcome data to inform the power calculation and randomisation allocation and assess the feasibility of data collection. The package was implemented with high fidelity (85% of HCP trained, n = 204). The questionnaires indicated a good understanding of device use with 75% of participants scoring > 75% (n = 97; 90% of those distributed). Action logs were inconsistently completed but indicated that the majority of HCP responded appropriately to abnormal results. From 18 HCP interviews and two focus groups it was widely reported that the intervention improved capacity to make clinical decisions, escalate care and make appropriate referrals. Nine of the ten main trial sites achieved ethical approval for pilot data collection. Intensive care was an inconsistent marker of morbidity and stroke an infrequent outcome and therefore they were removed from the main trial composite outcome. Tools and methods of data collection were optimized and event rates used to inform randomisation. This feasibility study demonstrates that the components of the intervention were acceptable, methods of implementing were successful and the main trial design would be feasible. Qualitative work identified key moderators that informed the main trial process evaluation. Changes to the training package, implementation strategy, study design and processes were identified to refine the implementation in the main trial. ISRCTN41244132
; Registered 24/11/2015.read more
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Effect of a novel vital sign device on maternal mortality and morbidity in low-resource settings: a pragmatic, stepped-wedge, cluster-randomised controlled trial.
Nicola Vousden,Elodie Lawley,Hannah L. Nathan,Paul T. Seed,Muchabayiwa Francis Gidiri,Shivaprasad S. Goudar,Jane Sandall,Lucy C Chappell,Andrew Shennan +8 more
TL;DR: The primary aim of this trial was to determine whether implementation of the CRADLE Vital Sign Alert and an education package into community and facility maternity care in low-resource settings could reduce a composite of all-cause maternal mortality or major morbidity (eclampsia and hysterectomy).
Journal ArticleDOI
Clinical Decision Support and Implications for the Clinician Burnout Crisis.
Ivana Jankovic,Jonathan H. Chen +1 more
TL;DR: Using the techniques of improving relevance, soliciting feedback, customization, measurement of outcomes and metrics, and iteration, the effects of CDS on burnout can be ameliorated.
Journal ArticleDOI
Development and evaluation of a novel Vital Signs Alert device for use in pregnancy in low-resource settings
Hannah L. Nathan,Nicola Vousden,Elodie Lawley,Annemarie de Greeff,Natasha L. Hezelgrave,Nicola Sloan,Nina Tanna,Shivaprasad S. Goudar,Muchabayiwa Francis Gidiri,Muchabayiwa Francis Gidiri,Jane Sandall,Lucy C Chappell,Andrew Shennan +12 more
TL;DR: The CRADLE Vital Signs Alert is an accurate device incorporating an evidence-based traffic light early warning system designed to ensure suitability for healthcare providers with limited training and may improve care for women in pregnancy, childbirth and in the postnatal period.
Journal ArticleDOI
Implementation science in maternity care: a scoping review.
TL;DR: In this paper, the authors present a systematic review of evidence-based interventions in maternity care, focusing on the use of theories, models and frameworks to promote evidence based population health.
Journal ArticleDOI
Cardiometabolic Risk Factors in Pregnancy and Implications for Long-Term Health: Identifying the Research Priorities for Low-Resource Settings.
Shobhana Nagraj,Shobhana Nagraj,Stephen Kennedy,Robyn Norton,Vivekananda Jha,Vivekananda Jha,Vivekananda Jha,Devarsetty Praveen,Lisa Hinton,Lisa Hinton,Jane E. Hirst,Jane E. Hirst +11 more
TL;DR: This mini-review paper presents an overview of the key challenges faced in the early identification, referral and management of pregnant women at increased risk of CMDs, in low-resource settings worldwide.
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