TY - JOUR
T1 - Effect of the Growth Assessment Protocol on the DEtection of Small for GestatioNal age fetus
T2 - process evaluation from the DESiGN cluster randomised trial
AU - DESiGN Collaborative Group
AU - Relph, Sophie
AU - Coxon, Kirstie
AU - Vieira, Matias C.
AU - Copas, Andrew
AU - Healey, Andrew
AU - Alagna, Alessandro
AU - Briley, Annette
AU - Johnson, Mark
AU - Lawlor, Deborah A.
AU - Lees, Christoph
AU - Marlow, Neil
AU - McCowan, Lesley
AU - McMicking, Jessica
AU - Page, Louise
AU - Peebles, Donald
AU - Shennan, Andrew
AU - Thilaganathan, Baskaran
AU - Khalil, Asma
AU - Pasupathy, Dharmintra
AU - Sandall, Jane
N1 - Funding Information:
This study was funded by Guy’s and St Thomas’ Charity (MAJ150704), Stillbirth and Neonatal Death Charity — SANDS (RG1011/16) and Tommy’s Charity. MCV was supported by CAPES (BEX 9571/13–2). SR, KC and AH were personally supported by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care South London at King’s College Hospital NHS Foundation Trust. NM receives a proportion of funding from the Department of Health’s NIHR Biomedical Research Centres funding scheme at UCLH/UCL. DAL’s contributions were supported by the Bristol NIHR Biomedical Research Centre and her NIHR Senior Investigator Award (NF-0616-10102). JS is supported by an NIHR Senior Investigator Award and the NIHR Applied Research Collaboration South London (NIHR ARC South London) at King’s College Hospital NHS Foundation Trust. DP was funded by Tommy’s Charity during the period of the study. The views expressed are those of the author[s] and not necessarily those of the NIHR, the Department of Health and Social Care or any of the other listed funders. None of the funders influenced the design, analyses or interpretation of results.
Funding Information:
We would like to thank the members of the DESiGN Collaborative Group for their contribution to this study. The group can be contacted via the corresponding author ([email protected]) and are comprised of the following: Spyros Bakalis, Claire Rozette and Marcelo Canda (from Guy’s and St Thomas’ Hospital NHS Foundation Trust); Simona Cicero, Olayinka Akinfenwa, Philippa Cox and Lisa Giacometti (from Homerton University Hospital NHS Foundation Trust); Elisabeth Peregrine, Lyndsey Smith and Sam Page (from Kingston Hospital NHS Foundation Trust); Deepa Janga and Sandra Essien (from North Middlesex University Hospital NHS Trust); Renata Hutt (from Royal Surrey County Hospital NHS Foundation Trust), Yaa Acheampong, Bonnie Trinder and Louise Rimell (from St George’s University Hospitals NHS Foundation Trust); Janet Cresswell and Sarah Petty (from Chesterfield Royal Hospital NHS Foundation Trust); Bini Ajay, Hannah O’Donnell and Emma Wayman (from Croydon Health Services NHS Trust); Mandish Dhanjal, Muna Noori and Elisa Iaschi (from Imperial College Healthcare NHS Trust); Raffaele Napolitano, Iris Tsikimi and Rachel Das (from University College London Hospitals NHS Foundation Trust); Fiona Ghalustians and Francesca Hanks (from Chelsea and Westminster Hospital NHS Foundation Trust); Laura Camarasa (from Hillingdon Hospitals NHS Foundation Trust); and Hiran Samarage and Stephen Hiles (from London North West Healthcare NHS Trust). We would also like to thank the DESiGN Trial Steering Committee/Data Monitoring Committee members: Anna David (from University College London), David Howe (from University Hospital Southampton), Nadine Seward (from King’s College London), Elizabeth Allen (from the London School of Hygiene and Tropical Medicine), and Jillian Francis (from The University of Melbourne). At last, we wish to thank the Stillbirth Clinical Study Group and the Royal College of Obstetricians and Gynaecologists for reviewing the study protocol during development of the study.
Publisher Copyright:
© 2022, The Author(s).
PY - 2022/9/5
Y1 - 2022/9/5
N2 - 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 .
AB - 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 .
KW - Acceptability
KW - Antenatal screening
KW - Cluster-controlled trial
KW - Context
KW - Feasibility
KW - Implementation
KW - Process evaluation
KW - Small-for-gestational age foetus
UR - http://www.scopus.com/inward/record.url?scp=85137203432&partnerID=8YFLogxK
U2 - 10.1186/s13012-022-01228-1
DO - 10.1186/s13012-022-01228-1
M3 - Article
C2 - 36064428
AN - SCOPUS:85137203432
SN - 1748-5908
VL - 17
SP - 60
JO - Implementation science : IS
JF - Implementation science : IS
IS - 1
M1 - 60
ER -
