Recruitment and retention
Recruitment log data were used to assess the willingness of women and partners to participate and continue in the research (Table 2). Participant flow for the study is summarised in Fig. 2. In site 2, initial recruitment was below target due to fewer eligible participants being available than anticipated, mainly due to language issues. By the end of Phase 1, 16 women (80% of the planned sample) and 10 partners were recruited. This was judged sufficient to meet the objectives therefore, Phase 2 recruitment commenced as planned. In Phase 2, unexpectedly low numbers of eligible women were identified across both sites in November and December 2018, therefore recruitment was extended until November 2019 (14 months vs. 12 months planned). In Phase 2, 38 women (95% of the planned sample) and 14 partners were recruited.
Of 284 women initially identified as potentially eligible, 118 (42%) were confirmed to meet the inclusion criteria. The main reasons for ineligibility were gestation over 20 weeks at identification (N = 59; 21% of total identified), a further 49 women (17%) were judged to lack sufficient command of English to complete data collection without a translation of materials or interpretation. Of the 118 women given study information, 54 (46%) agreed to participate, site 1 had a higher recruitment rate than site 2 (51% vs. 40%, respectively). Women declining to participate were invited to supply reasons to the research midwife. Most provided nonspecific responses; commonly that they did not want to commit to the research (80%), several women approached in both phases mentioned reluctance to attend research follow-up visits. A few women approached in the intervention phase did not want to engage with the study intervention. In both phases, a small number of women specifically expressed unwillingness to complete the required questionnaires (20%). Partners and birth partners were recruited via the women. All partners and birth partners who gave consent to be contacted, agreed to participate in the study. Where a partner or birth partner was not identified or did not wish to be contacted specific reasons were not sought.
The characteristics of the women and partners/birth partners participating in the study are summarised in Tables 3 and 4. For women, age, body mass index, employment, and relationship status did not differ notably across the sites and phases, around 15% of women were current cigarette or e-cigarette smokers. A minority had degree-level (typically university Bachelors’ degree; 6) education (Phase 1: 31% vs Phase 2: 29%) and reflecting the diversity of the communities in the settings, 41% of women described their ethnicity as Asian or Black. Regarding obstetric history, the number of previous pregnancies was similar; however, there were differences in the distribution of stillbirths versus neonatal deaths across phases. In Phase 1, 13 (81%) of included women had previously experienced a stillbirth, and 3 (19%) a neonatal death, whilst in Phase 2, 21 (55%) and 18 (47%) women had prior stillbirths and neonatal deaths, respectively. One woman (Phase 2) had experienced both a stillbirth and a neonatal death, previously. In Phase 1, 10 partners and one birth partner participated, in phase 2, 14 partners participated. Of 54 women recruited, 42 (77%) completed the study and similar rates were observed in both phases. Eight women (15%) withdrew from the study before the end of data collection; 5 indicated unwillingness to complete further questionnaires, and one moved out of the area. Two women withdrew after adverse outcomes, including a second trimester miscarriage and extremely pre-term birth followed by neonatal death and two women (7%) were lost to follow up in the postnatal period.
To minimise contamination across phases midwife care coordinators were identified, and commenced training, immediately prior to Phase 2. Different approaches were taken in the two sites, to accommodate variations in service configuration. In Site 1, interest was sought across both hospital and existing community case-holding midwifery teams, 8 midwives attended 3 initial 2-h training sessions with the Chief Investigator (CI) and research midwife. In Site 2, midwives were identified in consultation with an antenatal service manager from the clinic teams, which covered 2 hospital locations. To accommodate service demands and leave, 4 midwives (2 per hospital) were trained one-to-one in Site 2. All care coordinators received a study manual and were invited to separate training sessions for the ‘Coping Strategies’ toolkit (included in the manual), facilitated by the study health psychologist [DS], which was attended by 5 care coordinators. All women recruited in Phase 2 were allocated a named care coordinator and ‘buddy’. To avoid overburden; no more than 3 women were assigned to each care-coordinator at any one time. In Site 1, it was recognised that several women had existing relationships with midwives not currently acting as care coordinators in the study. In agreement with service managers, additional one to one study training permitted these midwives to take on the role of care coordinator for the woman, if willing. An additional 8 midwives at Site 1, were trained during the period. Nine of the 17 midwives trained in Site 1 and all 4 midwives trained in Site 2 were allocated to women, and all successfully initiated contact after recruitment.
The pattern of antenatal contacts during participant’s entire pregnancies and data for continuity of midwifery carer for women in both phases are summarised in Table 5. The total number of planned antenatal visits and midwife visits for women were similar across both phases. In Phase 2, the number of direct contacts between women and care coordinators (or ‘buddies’) was variable; the median was 2 visits (range: 0–14), equating to 24% (0–74%; median and range) of total planned midwife visits. To enable comparison across both phases, the number of individual midwives seen, per woman, was defined and the midwife seen most frequently identified as ‘lead midwife’. In both phases, the median number of visits with the ‘lead’ midwife was 4, (% median [range]) Phase 1; 37 [18–100] % vs Phase 2 40 [14–84] %). The total number of individual midwives seen by each woman was also similar in both phases. Although data for ‘midwife seen’ was missing for 9% of visits, these findings suggest that the study intervention did not increase continuity of carer, assessed by direct contacts at visits. Intervention logs, supplied at allocation and completed by the care coordinators in Phase 2, captured other implementation data. Of 38 logs issued, 33 were returned (87%), 3 were returned blank and one had no antenatal entries. A median of 3 contacts per woman, (range 1–13) were entered, per log, including face to face, telephone, SMS, and email. Fourteen logs (46%) recorded an explanation of the care coordinator’s role and 12 (40%) a discussion of antenatal and birth care plans; a few reported liaising with multidisciplinary professionals where women required input outside the maternity care team during pregnancy. In logs with entries, 14 women (42%) were documented to have received contact (in-person or by phone) from the care coordinator or buddy after the birth (range 1–4 occasions). Interviews and the research midwife study logs suggest that the intervention logs were often not completed contemporaneously or consistently and may have under-reported intervention-related activities in some cases. The study ‘WhatsApp’ group included 21 women (55%), during Phase 2. Initially, some participants used the group to introduce themselves and interact with others and the research team. As the study progressed interaction declined, a few users posted regularly, particularly to share information about local support, media reports and websites of interest. The research team also used the group to publicise details of the support sessions, held monthly until December 2019. Despite regular publicity via the research teams and care coordinators the support sessions were not well attended, only 5 (13%) women accessed these in total during Phase 2.
Outcomes and acceptability
Clinical outcomes for women participants and their babies are summarised in Table 6. Of the 5 women who withdrew from questionnaire completion before birth, 4 agreed to outcome data being collected from hospital records. Fifty women (96%) had a live birth, one participant experienced a second-trimester fetal death and one baby, born extremely preterm, died in the neonatal period. All adverse events and outcomes affecting participants were reviewed by the Chief Investigator and reported to the Technical Advisory Group, none were related to the research or study intervention. Gestation at birth, labour onset, mode of birth, baby birth weight and length of hospital stay were similar between participants in both phases. Only one participant was still pregnant at the time of the first national lockdown during the COVID-19 pandemic in March 2020, in her postnatal interview limited impacts on care were described (partner was unable to attend hospital appointments and some were held remotely), therefore these data were included in the analysis.
Psychological outcome data for women and partners are presented in supplementary material Figs. S1 and S2, utility values and QALYs are summarised Table S1. The psychological and health status questionnaires and EQ-5D-5L were completed by all women participants at recruitment and those remaining in the study at follow-up. A small number of missing responses to individual questions were identified, but no required question was repeatedly omitted. Two participants did not complete the postnatal questionnaires. None of the psychological outcomes for women, or accrual of QALYs differed notably between phases. Based on the intervention logs, the estimated cost of providing the intervention (including training midwives) was £132/participant. Qualitative interviews explored experiences of care, the intervention, and the research process with 20 women (6 in Phase 1 and 14 in Phase 2, 5 partners and birth partners (1 in Phase 1 and 4 in Phase 2) at 5–6 weeks after birth, and 8 health workers (all were midwives directly or indirectly involved in delivering the intervention, including 7 care coordinators and ‘buddies’ and one specialist midwife with service management responsibility) following completion of Phase 2.
In Phase 2, two main themes were identified from the women’s interviews. Women perceived the intervention as a ‘good idea, but variable practice’ implying delivery was not consistent, and research participation was seen as ‘a worthwhile experience’. Subthemes and example supportive quotes are presented in Table 7. Seeing the same midwife as often as possible during their subsequent pregnancy was consistently identified as important to women, whether they received the study intervention or not. Notably, amongst the women participating pre-intervention, one was offered, and another actively sought antenatal continuity. In both cases women had existing relationships with community midwives from previous pregnancies, who facilitated flexible and additional appointments. Women’s experiences of the intervention were variable; those who had substantial contacts overwhelmingly described positive supportive relationships with their care coordinator or buddy. These were perceived as improving the overall experience of care during the pregnancy (Table 7). Opportunities to build trust with the care coordinator and empathy demonstrated by communicating understanding of emotions and needs during pregnancy were considered key facilitators of a good relationships by women. For others, direct contacts were described as sporadic or few.Several women described follow-up calls and messages received when the care coordinator or buddy was unable to attend appointments which were highly appreciated. Women recognised services pressures, including busy and over-running clinics as important barriers to providing continuity of care.
Views on the additional components of the intervention offered were more mixed. In Phase 2, all women recalled receiving information about the support group, but most had not attended. Timing and transport were mentioned as barriers by some women. Several women also highlighted concerns around including women at different stages of pregnancy in the same group and others had past negative experiences with pregnancy loss support groups. Overall, women and partners were extremely positive about involvement in research around improving care after stillbirth or neonatal death. Most considered the study questionnaires acceptable, and interviews were particularly welcomed as an opportunity to explore experiences and areas for improvement in care.
The midwives interviewed also recognised the value of continuity, and the potential of the intervention to improve care for women. However, despite considerable efforts care coordinators described difficulties in maintaining the level of contact they wished with their allocated women. Service pressures, shift and roster changes, leave and part-time working were identified as having negative impacts on the midwives’ ability to exert control over their working activities. Telephone calls and text messages were found to be useful and not excessively time consuming by several of the care coordinators, however frustration with inability to maintain direct contact was expressed. Several midwives felt that current organisation of services tended to prioritise completion of care ‘tasks’ and perceived that more radical change in working practices was needed to improve relational care. Changes in service management across both sites occurred during the research and not all managers were perceived to be supportive of the research. Despite the challenges, several midwives felt they had gained personally through involvement in the study. They valued training particularly for improving understanding of women’s and families needed and expressed satisfaction from their enhanced role:
‘I really enjoyed it.…just job satisfaction as well and it’s like, er, just to make sure they’re alright and like port of call for contact, and to make sure they’ve got follow up appointments…’ (Care Coordinator).
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