Department of Women and Children's Health, Faculty of Life Sciences and Medicine, School of Life Course Sciences, Women's Health Academic Centre KHP, King's College London, 10th Floor North Wing, St. Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH, UK.
Department of Midwifery, Faculty of Health, Social Care and Education, Kingston and St. George's Universities, Kenry House, Kingston Hill, London, KT2 7LB, UK.
Implement Sci. 2022 Sep 5;17(1):60. doi: 10.1186/s13012-022-01228-1.
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.
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.
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.
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.
Primary registry and trial identifying number: ISRCTN 67698474. Registered 02/11/16. https://doi.org/10.1186/ISRCTN67698474 .
降低死产率是一个国际优先事项。在高收入国家，至少有一半的死产婴儿是小于胎龄儿（SGA）。生长评估方案（GAP）是一种复杂的产前干预措施，旨在提高产前发现 SGA 的比率，该方案已在 DESiGN 2 型混合有效性实施群组随机试验（n = 13 个群组）中进行了评估。在本文中，我们介绍了试验过程评估。
进行了混合方法的过程评估。对临床负责人和一线医疗保健专业人员进行了访谈，以了解背景（实施和标准护理地点）和 GAP 实施（实施地点）。使用复杂干预措施的背景和实施情况框架对访谈文本进行了主题分析，以了解可接受性、可行性以及背景的影响。对实施群组临床指南、培训和产妇记录进行了审查，以评估忠实性、剂量和范围。
在 11 个地点对 28 名临床负责人和 27 名一线医疗保健专业人员进行了访谈。实施点的工作人员普遍认为 GAP 是可以接受的，但由于资源需求之间存在冲突以及临床负责人对干预价值的不同看法，导致实施的可行性存在问题。GAP 的实施忠实度存在差异（两个地点的本地指南与 GAP 的一致性很高，两个地点中等，一个地点较低），所有地点均按照目标通过面对面的方法培训了 > 75%的员工，但只有一个地点通过电子学习方法培训了 > 75%的员工；五个实施点中有 84%（范围为 78%-87%）的女性正确进行了风险分层。大多数地点的覆盖率得分较高（中位数为 94%，范围为 62%-98%的女性有定制的生长图表），但一般来说，SGA 的剂量监测得分较低（中位数为 31%，范围为 8%-53%的低风险女性和中位数为 5%，范围为 0%-17%的高风险女性），这与推荐的做法一致。
GAP 的实施对工作人员来说总体上是可以接受的，但存在可行性问题，这可能导致实施力度的差异。领导力和资源对于有效实施临床服务变革至关重要，即使这些变革与政策规定的服务变革重点非常一致。
主要注册处和试验识别号：ISRCTN67698474。注册日期：2016 年 11 月 2 日。https://doi.org/10.1186/ISRCTN67698474。
