Effect of the Growth Assessment Protocol on the DEtection of Small for GestatioNal age fetus: process evaluation from the DESiGN cluster randomised trial

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

Effect of the Growth Assessment Protocol on the DEtection of Small for GestatioNal age fetus: process evaluation from the DESiGN cluster randomised trial

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

Encouraging brisk walking with the free Active10 app in postnatal women who had a hypertensive pregnancy: “Just Walk It” feasibility study

Objective To explore the feasibility of a future trial to investigate whether encouraging use of the free NHS smartphone app Active10 increases brisk walking and reduces blood pressure (BP) in postnatal mothers who had hypertensive disorders of pregnancy (HDP). Design 3-month feasibility study. Setting London maternity unit. Population 21 women with HDP. Methods At recruitment we recorded initial (booking) clinic BP and asked participants to complete a questionnaire. Two months after delivery all participants were sent (by post/email/WhatsApp) a “Just Walk It” leaflet encouraging them to download the Active10 app and walk briskly for at least 10 minutes/day. This was backed by a telephone call after 2-weeks. Assessments were repeated 3-months later, and included telephone interviews about the acceptability and use of Active10. Main outcome measures Were recruitment rate, follow-up rate and acceptability/use of Active10. Results Of 28 women approached, 21 (75%, 95% CI 55.1–89.3%) agreed to participate. Age range was 21–46 years and five (24%) self-identified as black ethnicity. One woman dropped out of the study, and one became ill. The remaining participants (90%, 19/21, 95% CI 69.6–98.8%) were followed up after 3-months. Ninety-five percent (18/19) downloaded the Active10 app and 74% (14/19) continued using it at 3-months, averaging 27-minutes brisk walking/day according to Active10 weekly screenshots. Comments included: “Brilliant app”, “Really motivates me”. Mean BP was 130/81mmHg at booking and 124/80mmHg at 3-months follow-up. Conclusions The Active10 app was acceptable to postnatal women after HDP and may have increased minutes of brisk walking. A future trial could explore whether this simple, low-cost intervention could reduce long-term BP in this vulnerable group

Encouraging brisk walking with the free Active10 app in postnatal women who had a hypertensive pregnancy: "Just Walk It" feasibility study.

ObjectiveTo explore the feasibility of a future trial to investigate whether encouraging use of the free NHS smartphone app Active10 increases brisk walking and reduces blood pressure (BP) in postnatal mothers who had hypertensive disorders of pregnancy (HDP).Design3-month feasibility study.SettingLondon maternity unit.Population21 women with HDP.MethodsAt recruitment we recorded initial (booking) clinic BP and asked participants to complete a questionnaire. Two months after delivery all participants were sent (by post/email/WhatsApp) a "Just Walk It" leaflet encouraging them to download the Active10 app and walk briskly for at least 10 minutes/day. This was backed by a telephone call after 2-weeks. Assessments were repeated 3-months later, and included telephone interviews about the acceptability and use of Active10.Main outcome measuresWere recruitment rate, follow-up rate and acceptability/use of Active10.ResultsOf 28 women approached, 21 (75%, 95% CI 55.1-89.3%) agreed to participate. Age range was 21-46 years and five (24%) self-identified as black ethnicity. One woman dropped out of the study, and one became ill. The remaining participants (90%, 19/21, 95% CI 69.6-98.8%) were followed up after 3-months. Ninety-five percent (18/19) downloaded the Active10 app and 74% (14/19) continued using it at 3-months, averaging 27-minutes brisk walking/day according to Active10 weekly screenshots. Comments included: "Brilliant app", "Really motivates me". Mean BP was 130/81mmHg at booking and 124/80mmHg at 3-months follow-up.ConclusionsThe Active10 app was acceptable to postnatal women after HDP and may have increased minutes of brisk walking. A future trial could explore whether this simple, low-cost intervention could reduce long-term BP in this vulnerable group