Effect of the Growth Assessment Protocol on the DEtection of Small for GestatioNal age fetus: process evaluation from the DESiGN cluster randomised trial
Authors: Relph Sophie , Coxon Kirstie , Vieira Matias C. , Copas Andrew , Healey Andrew , Alagna Alessandro , Briley Annette , Johnson Mark , Lawlor Deborah A. , Lees Christoph , Marlow Neil , McCowan Lesley , McMicking Jessica , Page Louise , Peebles Donald , Shennan Andrew , Thilaganathan Baskaran , Khalil Asma , Pasupathy Dharmintra , Sandall Jane ,   on behalf of the DESiGN Collaborative Group, Bakalis Spyros , Rozette Claire , Canda Marcelo , Cicero Simona , Akinfenwa Olayinka , Cox Philippa , Giacometti Lisa , Peregrine Elisabeth , Smith Lyndsey , Page Sam , Janga Deepa , Essien Sandra , Hutt Renata , Acheampong Yaa , Trinder Bonnie , Rimell Louise , Cresswell Janet , Petty Sarah , Ajay Bini , O’Donnell Hannah , Wayman Emma , Dhanjal Mandish , Noori Muna , Iaschi Elisa , Napolitano Raffaele , Tsikimi Iris , Das Rachel , Ghalustians Fiona , Hanks Francesca , Camarasa Laura , Samarage Hiran , Hiles Stephen , David Anna , Howe David , Seward Nadine , Allen Elizabeth , Francis Jillian 
Published: September 2022

Abstract
Background
Reducing the rate of stillbirth is an international priority. At least half of babies stillborn in high-income countries are small for gestational-age (SGA). The Growth Assessment Protocol (GAP), a complex antenatal intervention that aims to increase the rate of antenatal detection of SGA, was evaluated in the DESiGN type 2 hybrid effectiveness-implementation cluster randomised trial (n = 13 clusters). In this paper, we present the trial process evaluation.

Methods
A mixed-methods process evaluation was conducted. Clinical leads and frontline healthcare professionals were interviewed to inform understanding of context (implementing and standard care sites) and GAP implementation (implementing sites). Thematic analysis of interview text used the context and implementation of complex interventions framework to understand acceptability, feasibility, and the impact of context. A review of implementing cluster clinical guidelines, training and maternity records was conducted to assess fidelity, dose and reach.

Results
Interviews were conducted with 28 clinical leads and 27 frontline healthcare professionals across 11 sites. Staff at implementing sites generally found GAP to be acceptable but raised issues of feasibility, caused by conflicting demands on resource, and variable beliefs among clinical leaders regarding the intervention value. GAP was implemented with variable fidelity (concordance of local guidelines to GAP was high at two sites, moderate at two and low at one site), all sites achieved the target to train > 75% staff using face-to-face methods, but only one site trained > 75% staff using e-learning methods; a median of 84% (range 78–87%) of women were correctly risk stratified at the five implementing sites. Most sites achieved high scores for reach (median 94%, range 62–98% of women had a customised growth chart), but generally, low scores for dose (median 31%, range 8–53% of low-risk women and median 5%, range 0–17% of high-risk women) were monitored for SGA as recommended.

Conclusions
Implementation of GAP was generally acceptable to staff but with issues of feasibility that are likely to have contributed to variation in implementation strength. Leadership and resourcing are fundamental to effective implementation of clinical service changes, even when such changes are well aligned to policy mandated service-change priorities.

Trial registration
Primary registry and trial identifying number: ISRCTN 67698474. Registered 02/11/16. https://doi.org/10.1186/ISRCTN67698474.