A continuity of care programme for women at risk of preterm birth in the UK: Process evaluation of a hybrid randomised controlled pilot trial

• Published in: PloS one 2023-01, Vol.18 (1), p.e0279695-e0279695
• Main Authors: Fernandez Turienzo, Cristina, Hull, Louise H, Coxon, Kirstie, Bollard, Mary, Cross, Pauline, Seed, Paul T, Shennan, Andrew H, Sandall, Jane
• Format: Article
• Language: English
• Subjects: Acceptability; Accuracy; Adoption; Archives & records; Birth; Care and treatment; Cervix; Childbirth & labor; Clinical trials; Continuity (mathematics); Continuity of care; Continuity of Patient Care; Data; Data systems; Documents; Domestic violence; Evaluation; Feasibility; Female; Health aspects; Health care access; Health care industry; Health risks; Health services; Hospitals; Humans; Implementation; Infant, Newborn; Infants (Premature); Intervention; Maternal child nursing; Maternal Health Services; Mathematical models; Medical records; Medicine; Medicine and Health Sciences; Midwifery; Midwives; Modelling; Obstetrics; Patients; People and Places; Pilot Projects; Pragmatism; Pregnancy; Pregnant women; Premature birth; Premature Birth - prevention & control; Premature labor; Prenatal Care; Primary groups; Public health; Qualitative analysis; Research and Analysis Methods; Risk analysis; Risk factors; Smoking; Surveys; Sustainability; Triangulation; Women; Womens health
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0279695

The development and evaluation of specific maternity care packages designed to address preterm birth remains a public health priority. We aim to evaluate the implementation, context, and potential mechanisms of action, of a new care pathway that combined midwifery continuity of care with a specialist obstetric clinic for women at risk of preterm birth (POPPIE) in London (UK). We did a multiphase mixed method triangulation evaluation nested within a hybrid type 2, randomised controlled trial in London (United Kingdom). Pregnant women with identified risk factors for preterm birth were eligible for trial participation and randomly assigned (1:1) to either midwifery continuity of care linked to a specialist obstetric clinic (POPPIE group) or standard maternity care. The primary outcome was a composite of appropriate and timely interventions for the prevention and/or management of preterm labour and birth, analysed according to intention to treat. Clinical and process outcome data were abstracted from medical records and electronic data systems, and coded by study team members, who were masked to study group allocation. Implementation data were collected from meeting records and key documents, postnatal surveys (n = 164), semi-structured interviews with women (n = 30), healthcare providers and stakeholders (n = 24) pre-, mid and post implementation. Qualitative and quantitative data from meeting records and key documents were examined narratively. Qualitative data from interviews were analysed using three thematic frameworks: Proctor's (for implementation outcomes: appropriateness, adoption, feasibility, acceptability, fidelity, penetration, sustainability), the Consolidated Framework for Implementation Research (for determinants of implementation), and published program theories of continuity models (for potential mechanisms). Data triangulation followed a convergent parallel and pragmatic approach which brought quantitative and qualitative data together at the interpretation stage. We averaged individual implementation measures across all domains to give a single composite implementation strength score which was compared to the primary outcome. Between May 9, 2017, and Sep 30, 2018, 553 women were assessed for eligibility and 334 were enrolled with less than 6% of loss to follow up (169 were assigned to the POPPIE group; 165 were to the standard group). There was no difference in the primary outcome (POPPIE group 83·3% versus standard group 84·7%; risk ratio