Coxon, K., Relph, S., Matias, V., Sergio A, S., Khalil, A., Pasupathy, D. and Sandall, J. (2021) Implementation of Growth Assessment Protocol (GAP) for early detection and management of Small for Gestational Age (SGA) babies during the DESiGN trial : a process evaluation. In: 32nd ICM Virtual Triennial Congress; 2, 9, 16, 23 & 30 Jun 2021, Bali (Held online). (Unpublished)

Abstract

BACKGROUND The Growth Assessment Protocol (GAP) intervention was designed to improve detection and clinical management of ‘small for gestational age’ (SGA) babies. The DESiGN trial aimed to test the GAP approach using a cluster RCT design. We conducted a process evaluation to examine the implementation of GAP during the DESiGN RCT. OBJECTIVES GAP is a complex intervention, involving training of staff, generation of customised antenatal growth charts, standardised fetal growth assessments and a protocol to manage detection of suspected SGA. The DESiGN trial process evaluation aimed to understand the barriers and facilitators to implementing GAP, and compare this to care designed to increase detection of SGA provided by ‘control arm’ hospitals during the DESiGN trial. METHODS Following Steckler and Linnen’s framework, this mixed methods evaluation examined the following aspects of implementation: Process, Fidelity, Adaptations, Dose and Reach. The evaluation involved the thirteen NHS maternity care units in England which were participating in the DESiGN trial. We used quantitative measures to examine number of staff trained, proportion of women who received the intervention and fidelity to the GAP protocol. Qualitative interviews with staff (midwives, doctors, ultrasonographers, managers) and women explored feasibility and acceptability of the GAP approach. Ethical approval was obtained through the HRA (Ref. 15/LO/1632). RESULTS Adherence to the GAP protocol varied at intervention sites; different teams used a range of approaches to train staff and introduce the new ways of measuring and detecting SGA. Staff valued elements of the GAP approach, but thought it may increase ultrasound scanning, and were not always persuaded this was a good or effective use of resources. CONCLUSIONS Implementation of new approaches can vary considerably across organisations, and this may impact upon the effectiveness of clinical interventions. KEY MESSAGE Process evaluations are a valuable way of documenting variations in implementation of a complex intervention, and can help interpret findings from RCTs.

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