Title: Variations in the organisation of Early Pregnancy Assessment Units (EPAUs) in the UK and their effects on clinical, service and patient-centred outcomes (VESPA)
Funder: Department of Health and Social Care

Abstract: A recent NICE guideline on “Ectopic pregnancy and miscarriage” (CG154) recommended a national evaluation of Early Pregnancy Assessment Unit (EPAU) service provision in an attempt to identify factors (e.g. staffing configuration, opening hours) affecting service outcomes, pregnancy-related outcomes as well as women’s experiences of care. Data should also be used to analyse the cost effectiveness of different configurations of EPAUs. DESIGN: Prospective observational cohort study with health economic evaluation, patient survey and a qualitative arm to evaluate outcomes, cost effectiveness and to capture patient and staff experience of different models of EPAUs. SETTING: Stratified random selection of EPAUs to ensure representation of different configuration units from all areas of the UK. TARGET POPULATION: All women attending EPAUs with suspected first trimester pregnancy complications. HEALTH TECHNOLOGY BEING ASSESSED: EPAUs provide a specialised clinical service for women with suspected early pregnancy complications. Despite EPAUs being the main providers of early pregnancy care, there are significant variations in their organisational structure, size and staffing levels. OUTCOMES: Primary Outcome emergency hospital admissions as a proportion of women attending EPUs. SECONDARY OUTCOMES: Ratio of new to follow-up visits, rate of non-diagnostic ultrasound scans (pregnancy of unknown location), total number of emergency admissions of women presenting with early pregnancy complications, proportion of laparoscopies negative for ectopic pregnancy, ruptured ectopic pregnancies requiring blood transfusion, patient satisfaction with the quality of care received, staff experience of providing care. RESOUCE USE OUTCOMES: A&E visits, ITU admissions, duration of admissions, waiting times from referral to assessment. HEALTH ECONOMICS OUTCOMES: Quality of Life measures before and after assessment of women at the EPAU, cost-effectiveness of different staffing models. HEALTH ECONOMIC EVALUATION: We will examine resource use, costs and outcomes associated with different EPAU staffing models. Results will be presented in terms of the expected net benefit for each staffing model as well as in incremental cost per QALY and the incremental cost for an emergency admission averted. SAMPLE SIZE: Pilot study results showed an association between the number of dedicated consultant sessions within the EPAU and improved clinical and service outcomes. Recruiting 44 units will give us 90% power to detect a difference in admission rates between units with low and high consultant presence respectively. This calculation assumes a 5% absolute difference (3.5% vs. 8.5%) in emergency hospital admission rates between units with high and low consultant presence, a moderate degree of clustering (ICC = 0.04), and at least 150 patients per unit. ANALYSIS: The primary analysis will investigate whether admission rate is associated with the level of consultant presence. A patient-level analysis will be performed and a hierarchical logistic regression model will be used to adjust for confounding and allow for patient clustering within EPAUs. The results of this analysis will be reported in terms of odds ratios (with corresponding confidence intervals and P-values) to indicate the degree of association. PROJECT TIMETABLE: Total study duration of 2 years (study set up: 6 months; recruitment - including follow-up: 12 months; analysis and health economics: 6 months)

Lay abstract: A recent NICE guideline(1) on “Ectopic pregnancy and miscarriage” (CG154) published in December 2012 emphasises the need for good quality research to establish the effectiveness of Early Pregnancy Assessment Units (EPAUs). EPAUs are dedicated units within NHS hospitals that provide specialist care to women in the first three months of pregnancy. Women who experience pain or bleeding in the first weeks of pregnancy or women with a previous miscarriage or ectopic pregnancy are routinely seen in EPAUs. While most NHS hospitals in the UK have an EPAU, there are considerable variations between EPAUs in the levels of care they provide and their accessibility to women. In addition, staffing levels vary considerably between the units. The most cost-effective organisational model for an EPAU is unknown. Early pregnancy problems are very common with 20% of recognised pregnancies ending in miscarriage(2) and 2% of pregnancies being complicated by an ectopic pregnancy(3). Given the variation amongst units, women are likely to have different experiences of the services and the care provided. We recently completed a pilot study of 7 EPAUs across London to compare several clinical and service outcomes in units with different organisational structures, staffing levels and ease of access. The study showed significant differences in several important clinical outcomes between different units. We used these findings to plan a larger study which is described in this proposal. We propose to collect information for all women who present to EPAUs over a defined period of time with suspected complications of early pregnancy. The main outcome of interest is the number of women who require emergency admission and stay in hospital either because a diagnosis cannot be made with certainty or because of the need for treatment. We will also examine the number of follow up visits and ultrasound scans that are required to reach a diagnosis. We will look at the number of surgical keyhole procedures that were performed for suspected ectopic pregnancy and the number of procedures which did not confirm this diagnosis. We will record all women who suffered a burst ectopic pregnancy and required a blood transfusion. We will also collect and analyse information about women’s experiences of the care they received in an EPAU. We will interview both patients and members of staff in order to identify the factors affecting their satisfaction with the care they received/provided. Finally, we will use these to assess the economic performance of EPAUs. We have estimated that we need to include 44 EPAUs nationwide. We based our calculations on our findings from the smaller study, which showed that quality of care appears to be better in the units where senior doctors (consultants) tend to spend more time working with other staff members who are looking after pregnant women. We will ensure that the units included in the study represent a good mixture of units located within both different type of hospitals and different geographic areas within the UK. The study will last for 2 years, allowing 6 months for set-up, 12 months for data collection, and 6 months for analysis. The research team includes clinicians, academics, and lay members and the conduct of the study will be overseen by a Study Advisory Group. The information obtained from this study will help to better organise EPAUs nationwide in order to ensure optimal clinical outcomes in the most cost effective way.

Research activity codes: 8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH