Scale-up of a novel vital signs alert device to improve maternity care in Sierra Leone: a mixed methods evaluation of adoption.

BACKGROUND: The CRADLE (Community blood pressure monitoring in Rural Africa: Detection of underLying pre-Eclampsia) Vital Signs Alert device-designed specifically to improve maternity care in low resource settings-had varying impact when trialled in different countries. To better understand the contextual factors that may contribute to this variation, this study retrospectively evaluated the adoption of CRADLE, during scale-up in Sierra Leone. METHODS: This was a mixed methods study. A quantitative indicator of adoption (the proportion of facilities trained per district) was calculated from existing training records, then focus groups were held with 'CRADLE Champions' in each district (n = 32), to explore adoption qualitatively. Template Analysis was used to deductively interpret qualitative data, guided by the NASSS (non-adoption, abandonment, scale-up, spread, sustainability) Framework. FINDINGS: Substantial but non-significant variation was found in the proportion of facilities trained in each district (range 59-90%) [X2 (7, N = 8) = 10.419, p = 0.166]. Qualitative data identified complexity in two NASSS domains that may have contributed to this variation: 'the technology' (for example, charging issues, difficulty interpreting device output and concerns about ongoing procurement) and 'the organisation' (for example, logistical barriers to implementing training, infighting and high staff turnover). Key strategies mentioned to mitigate against these issues included: transparent communication at all levels; encouraging localised adaptations during implementation (including the involvement of community leaders); and selecting Champions with strong soft skills (particularly conflict resolution and problem solving). CONCLUSIONS: Complexity related to the technology and the organisational context were found to influence the adoption of CRADLE in Sierra Leone, with substantial inter-district variation. These findings emphasise the importance of gaining an in-depth understanding of the specific system and context in which a new healthcare technology is being implemented. This study has implications for the ongoing scale-up of CRADLE, and for those implementing or evaluating other health technologies in similar contexts.

Many women die during pregnancy and childbirth from causes that could be prevented, and the vast majority of these deaths occur in low-resource settings. The 'CRADLE Vital Signs Alert' is a medical device that helps identify problems during pregnancy­designed specifically for healthcare professionals in low-resource settings. However, for unknown reasons, the device appears to have varying impact according to the country or setting in which it is used. This study aimed to explore in depth whether, and why, healthcare professionals in Sierra Leone adopted the device and engaged in training (or not). Between March 2020 and January 2021, the CRADLE device and training package was disseminated across 8 districts in Sierra Leone. This relied on a few healthcare workers (nominated 'CRADLE Champions') to voluntarily distribute the devices and training in their local areas. Group discussions were held with CRADLE Champions in each district after the rollout to gather their feedback. In addition, the proportion of facilities trained in each district was recorded. The study found differences in how well the device and training was adopted in each district. Common challenges reported across districts related to technological difficulties (such as issues charging the devices) and organisational barriers (such as high levels of staff turnover at facilities). These findings will help to inform future rollout of the CRADLE device and training in Sierra Leone and highlight factors that may need to be considered by those implementing other health technologies in similar settings.

An observational cohort study of health outcomes and costs associated with early pregnancy assessment units in the UK.

BACKGROUND: The objective of this study was to assess the impact of consultant presence, volume of patients seen and weekend opening on the health and cost-related outcomes associated with different Early Pregnancy Assessment Unit (EPAU) configurations. METHODS: This was an observational study with a prospective cohort design. Six thousand six hundred six pregnant women (16 years of age and over) attending EPAUs because of suspected early pregnancy complications were recruited from 44 EPAUs across the UK. The main outcome measures were quality of life, costs, and anxiety. RESULTS: Costs, quality of life and anxiety scores were similar across configurations with little evidence to suggest an impact of consultant presence, weekend opening or volume of patients seen. Mean overall costs varied from £92 (95% CI £85 - £98) for a diagnosis of normally developing pregnancy to £1793 (95% CI £1346 - £2240) for a molar pregnancy. EQ-5D-5L score increased from 0.85 (95% CI 0.84-0.86) at baseline to 0.91 (95% CI 0.90-0.92) at 4 weeks for the 573 women who completed questionnaires at both time points, largely due to improvements in the pain/discomfort and anxiety/depression dimensions. 78% of women reported a decrease in their anxiety score immediately following their EPAU appointment. CONCLUSIONS: EPAU configuration, as specified in this study, had limited impact on any of the outcomes examined. However, it is clear that care provided in the EPAU has a positive overall effect on women's health and emotional wellbeing, with significant improvements in EQ-5D and anxiety shown following an EPAU visit.

Women's experiences of early pregnancy loss services during the pandemic: A qualitative investigation.

PROBLEM: Early pregnancy losses [EPL] are common, varied, and require different courses of management and care. BACKGROUND: In the UK, women who suspect or suffer a pregnancy loss are usually provided specialist care in early pregnancy assessment units [EPAUs]. Their configuration has recently been evaluated, but recommendations for change in-line with best practice for optimum outcomes were unable to be implemented due to the COVID-19 pandemic health system shock. AIM: To compare women's experiences of EPAUs during the pandemic to themes previously found in qualitative work undertaken with women who utilised EPAUs before the pandemic. METHODS: We conducted semi-structured virtual interviews, with women (N = 32) who suffered an early pregnancy loss during the pandemic; analysing transcripts using Template Analysis, based on findings about women's (pre-pandemic) experiences of EPAU from The VESPA Study. FINDINGS: We report on seven key themes: Barriers to Accessing Services; Communication & Information; Retention of Relational Care; Involvement in Care Decisions; Staffs' Attitude or Approach; Efficiency of Service Delivery; Sensitive Patient Management. DISCUSSION: Sensitive patient management and woman-staff interactions in EPAU settings remain a fundamental issue. Women also reported their experiences of EPAUs were comparatively worse during the pandemic. CONCLUSIONS: Women valued the care provided by EPAUs and found services to be efficient, despite pandemic-related restrictions. However, psychological recognition surrounding EPL and appropriate, sensitive, relational care and support continue to be areas in need of improvement. Our recommendation is to implement the improvements suggested by VESPA as a priority to ameliorate present sub-optimal experiences and prevent further deterioration.

CRADLE-5: a stepped-wedge type 2 hybrid implementation-effectiveness cluster randomised controlled trial to evaluate the real-world scale-up of the CRADLE Vital Signs Alert intervention into routine maternity care in Sierra Leone-study protocol.

BACKGROUND: The CRADLE Vital Signs Alert intervention (an accurate easy-to-use device that measures blood pressure and pulse with inbuilt traffic-light early warning system, and focused training package) was associated with reduced rates of eclampsia and maternal death when trialled in urban areas in Sierra Leone. Subsequently, implementation was successfully piloted as evidenced by measures of fidelity, feasibility and adoption. The CRADLE-5 trial will examine whether national scale-up, including in the most rural areas, will reduce a composite outcome of maternal and fetal mortality and maternal morbidity and will evaluate how the CRADLE package can be embedded sustainably into routine clinical pathways. METHODS: CRADLE-5 is a stepped-wedge cluster-randomised controlled trial of the CRADLE intervention compared to routine maternity care across eight rural districts in Sierra Leone (Bonthe, Falaba, Karene, Kailahun, Koinadugu, Kono, Moyamba, Tonkolili). Each district will cross from control to intervention at six-weekly intervals over the course of 1 year (May 2022 to June 2023). All women identified as pregnant or within six-weeks postpartum presenting for maternity care in the district are included. Primary outcome data (composite rate of maternal death, stillbirth, eclampsia and emergency hysterectomy) will be collected. A mixed-methods process and scale-up evaluation (informed by Medical Research Council guidance for complex interventions and the World Health Organization ExpandNet tools) will explore implementation outcomes of fidelity, adoption, adaptation and scale-up outcomes of reach, maintenance, sustainability and integration. Mechanisms of change and contextual factors (barriers and facilitators) will be assessed. A concurrent cost-effectiveness analysis will be undertaken. DISCUSSION: International guidance recommends that all pregnant and postpartum women have regular blood pressure assessment, and healthcare staff are adequately trained to respond to abnormalities. Clinical effectiveness to improve maternal and perinatal health in more rural areas, and ease of integration and sustainability of the CRADLE intervention at scale has yet to be investigated. This trial will explore whether national scale-up of the CRADLE intervention reduces maternal and fetal mortality and severe maternal adverse outcomes and understand the strategies for adoption, integration and sustainability in low-resource settings. If successful, the aim is to develop an adaptable, evidence-based scale-up roadmap to improve maternal and infant outcomes. TRIAL REGISTRATION: ISRCTN 94429427. Registered on 20 April 2022.

Emotional experiences of women who access early pregnancy assessment units: a qualitative investigation.

Purpose: Early pregnancy complications are common and often result in pregnancy loss, which can be emotionally challenging for women. Research on the emotional experiences of those attending Early Pregnancy Assessment Units [EPAUs] is scarce. This analysis explored the emotions which women spontaneously reported when being interviewed about their experiences of using EPAU services.Materials and methods: Semi-structured telephone interviews were conducted with a purposive sample of 38 women. Using Thematic Framework Analysis, we identified six unique emotional typologies which mapped onto women's clinical journeys.Results: Women with ongoing pregnancies were characterized as having: "Anxious Presentation" or "Sustained Anxiety due to Diagnostic Uncertainty", dependent on whether their initial scan result was inconclusive. Women with pregnancy loss had one of four emotional typologies, varying by diagnostic timing and required interventions: "Anxious-Upset"; "Anxious-Upset after Diagnostic Uncertainty"; "Anxious-Upset with Procedural Uncertainty"; "Anxious with Sustained Uncertainty".Conclusions: We provide insights into the distinct emotions associated with different clinical pathways through EPAU services. Our findings could be used to facilitate wider recognition of women's emotional journeys through early pregnancy complications and stimulate research into how best to support women and their partners, in these difficult times.

Differences in the organisation of early pregnancy units and the effect of senior clinician presence, volume of patients and weekend opening on emergency hospital admissions: Findings from the VESPA Study.

OBJECTIVE: To determine whether the participation of consultant gynaecologists in delivering early pregnancy care results in a lower rate of acute hospital admissions. DESIGN: Prospective cohort study and emergency hospital care audit; data were collected as part of the national prospective mixed-methods VESPA study on the "Variations in the organization of EPAUs in the UK and their effects on clinical, Service and PAtient-centred outcomes". SETTING: 44 Early Pregnancy Assessment Units (EPAUs) across the UK randomly selected in balanced numbers from eight pre-defined mutually exclusive strata. PARTICIPANTS: 6606 pregnant women (≥16 years old) with suspected first trimester pregnancy complications attending the participating EPAUs or Emergency Departments (ED) from December 2016 to July 2017. EXPOSURES: Planned and actual senior clinician presence, unit size, and weekend opening. MAIN OUTCOME MEASURES: Unplanned admissions to hospital following any visit for investigations or treatment for first trimester complications as a proportion of women attending EPAUs. RESULTS: 205/6397 (3.2%; 95% CI 2.8-3.7) women were admitted following their EPAU attendance. The admission rate among 44 units ranged from 0% to 13.7% (median 2.8). Neither planned senior clinician presence (p = 0.874) nor unit volume (p = 0.247) were associated with lower admission rates from EPAU, whilst EPAU opening over the weekend resulted in lower admission rates (p = 0.027). 1445/5464 (26.4%; 95%CI 25.3 to 27.6) women were admitted from ED. There was little evidence of an association with planned senior clinician time (p = 0.280) or unit volume (p = 0.647). Keeping an EPAU open over the weekend for an additional hour was associated with 2.4% (95% CI 0.1% to 4.7%) lower odds of an emergency admission from ED. CONCLUSIONS: Involvement of senior clinicians in delivering early pregnancy care has no significant impact on emergency hospital admissions for early pregnancy complications. Weekend opening, however, may be an effective way of reducing emergency admissions from ED.

The prevalence of incidental uterine venous plexus thrombosis in women attending a gynecology clinic.

BACKGROUND: The uterine venous plexus (UVP) is an unusual site for venous thrombosis (VT). Our aim was to determine the prevalence of UVP thrombosis (UVPT) and identify associated risk factors. METHODS: We conducted a cross-sectional study on consecutive nonpregnant women attending our general gynecology clinic with a wide variety of presenting symptoms over a 16-month period. All women underwent a transvaginal ultrasound scan which involved detailed examination of the uterine venous plexus. Women diagnosed with incidental UVPT had thrombophilia screening, lower limb venous duplex imaging, and specialist hematological review. Logistic regression was used to examine associations between various risk factors and UVPT. RESULTS: We screened 1383 women, 39 of whom had an incidental UVPT, giving a prevalence of 3.0% (95% confidence interval [CI], 2.1%-4.1%). Multivariate analysis showed positive associations between multiparity (odds ratio [OR] 5.75 [95% CI 2.10, 15.7]), recent surgery (OR 3.10 [95% CI 1.19, 8.07]), presence of leg varicose veins (OR 3.15 [95% CI 1.32, 7.49]), and a family history of venous thromboembolism (OR 8.74 [1.65, 46.4]) and negative associations between postmenopausal status (OR 0.36 [95% CI 0.13, 0.95]) and the development of UVPT. Thrombophilia was detected in 12.8% women diagnosed with UVPT. CONCLUSIONS: The prevalence of incidental UVPT in a general gynecology population was 3.0%. Several demographic and clinical factors were found to be associated with UVPT. This could help to identify women at risk of this condition, and facilitate its early detection and development of evidence-based management strategies.