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

TY - JOUR

T1 - A continuity of care programme for women at risk of preterm birth in the UK

T2 - process evaluation of a hybrid randomised controlled pilot trial

AU - Fernandez Turienzo, Cristina

AU - Hull, Louise H

AU - Coxon, Kirstie

AU - Bollard, Mary

AU - Cross, Pauline

AU - Seed, Paul T

AU - Shennan, Andrew H

AU - Sandall, Jane

N1 - Funding Information: This study was funded by the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research South London (CLAHRC) South London, now recommissioned as NIHR Applied Research Collaboration (ARC) South London. NHS Lewisham Clinical Commissioning Group (CCG) provided funding for the midwife leader post to lead organisational change. CFT, JS, LMH and KC are supported by the NIHR CLAHRC and ARC South London. JS is also an NIHR Senior Investigator, and CFT is also supported by Iolanthe Midwifery Trust and a NIHR Development and Skills Award (NIHR301603). PTS is partly funded by Tommy's (Registered charity no. 1060508). LMH is a member of King's Improvement Science, which offers co-funding to the NIHR ARC South London and comprises a specialist team of improvement scientists and senior researchers based at King's College London; her work is funded by King's Health Partners (Guy's and St Thomas' NHS Foundation Trust, King's College Hospital NHS Foundation Trust, King's College London and South London and Maudsley NHS Foundation Trust), Guy's and St Thomas' Charity and the Maudsley Charity. The views expressed in this publication are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. We thank the POPPIE Pilot co-investigators and collaborators including Debra Bick (University of Warwick); Annette L Briley (Flinders University); Andy Healey (King's College London); Haode Wang (York University); Lia Brigante, Sergio A Silverio, Claire Singh, Rachel Tribe (King's College London); Helen Knower, Jackie Moulla, Mahishee Mehta, Chloe Saad and the POPPIE midwifery team (Lewisham and Greenwich NHS Trust). We also thank the independent trial steering committee, Nigel Simpson (chair, University of Leeds and Leeds Teaching Hospital NHS Trust), Julia Sanders (Cardiff University), Soo Downe (University of Central Lancashire), and David Edwards (King's College London, Evelina London Children's Hospital), and the lay advisor contributing to patient and public involvement and engagement, Mary Newburn. We thank Lia Brigante and Chloe Saad for collecting some of the qualitative and survey data, and all women, healthcare providers and stakeholders for participating in the study. Funding Information: Stakeholder, localauthority,033: “...most babiesdied becauseof poor outcomesof pregnancy,and mostpoor outcomesof pregnancy whichresultedinchildren’sdeathswerearoundprematurity...Sowebegantothinkverycarefullyaboutwhatwemightrecommendin terms of reducingthe levelsof prematurity....” Stakeholder,localauthority,024:“IthinkPOPPIEwasn’ttheonlypossibilitybutthatwastheonethatwasavailable,so,itseemedlikeitwas worthapunt”. Stakeholder, clinicalcommissioning group,025: “...wemanagedtocobble togethersome moneyto support,obviouslylargely supported by CLAHRC...Ithink£50ktosupportsomeofthe,oh,Ithinktheleadmidwife,erIcan’trememberexactlywhatit’scovering,butthe midwife.Um,andsowesortofagreedthatwedidn’tgoany,throughanymassivedecisiontreeassuch.Itwasmorethat,sortofagood thing todo. It linked withthe STP[Sustainability Transformation Partnership] work we weredoing anyway...” Stakeholder,hospital,022:“Wewerereallyexcitedtobeapproachedandatthatpointtherewasn’tverymuchmidwiferyresearchgoingon intheTrust.Therewasquitealotofobstetric,butnotsomuchmidwifery,soitwasgoodtogetamidwiferyfocusedresearch.And,um,the seniormidwiveswerealsokeen,becausetherewassomucharoundofferingcontinuity,and,andhowtodoit.But,hugeconcernsabout whetherwecoulddoit.Becauseinthat,intheTrusttherehadn’tbeenanycontinuitymodels” Stakeholder,clinicalcommissioninggroup,026:“Imustadmit,itwasum,ImeanImightbestrayingoutsideofthequestion,butitwassuch an uphill battleinitially, gettingit startedat [Trust].They’dnot reallyhad anythingon that scalebefore....” Stakeholder,localauthority,024:“ButIthinkitwasareallygoodlearning,becauseitwasanexampleofhow,ifyouhavelotsofdifferent peoplewho,whoallwantittohappen,youcan,withthelevers,it’snotoneparticularthingthateventuallymakesithappen,it’sallthese differentthingseverywhere”. Stakeholder,hospital,031:“Itwasquitedifficulttobeginwith,andthe,itwasallbeingsetupastohowitcouldhappen,andwehadtosort ofreleasesomeofyourwhole-timeequivalentsfromyourteamstomakethenewteam,and,andthentohave,youknow,women,sosetting upthewholesystemhere,itwas,itwasdifficulttobeginwith,but,verysoonitjustbecamethenorm”. Publisher Copyright: Copyright: © 2023 Fernandez Turienzo et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

PY - 2023/1

Y1 - 2023/1

N2 - Background 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). Methods 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. Results 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 0.98 [95% CI 0.90 to 1.08]). Appropriateness and adoption: The introduction of the POPPIE model was perceived as a positive fundamental change for local maternity services. Partnership working and additional funding were crucial for adoption. Fidelity: More than 75% of antenatal and postnatal visits were provided by a named or partner midwife, and a POPPIE midwife was present in more than 80% of births. Acceptability: Nearly 98% of women who responded to the postnatal survey were very satisfied with POPPIE model. Quantitative fidelity and acceptability results were supported by the qualitative findings. Penetration and sustainability: Despite delays (likely associated with lack of existing continuity models at the hospital), the model was embedded within established services and a joint decision was made to sustain and adapt the model after the trial (strongly facilitated by national maternal policy on continuity pathways). Potential mechanisms of impact identified included e.g. access to care, advocacy and perceptions of safety and trust. There was no association between implementation measures and the primary outcome. Conclusions The POPPIE model of care was a feasible and acceptable model of care that was implemented with high fidelity and sustained in maternity services. Larger powered trials are feasible and needed in other settings, to evaluate the impact and implementation of continuity programmes in other communities affected by preterm birth and women who experience social disadvantage and vulnerability.

AB - Background 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). Methods 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. Results 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 0.98 [95% CI 0.90 to 1.08]). Appropriateness and adoption: The introduction of the POPPIE model was perceived as a positive fundamental change for local maternity services. Partnership working and additional funding were crucial for adoption. Fidelity: More than 75% of antenatal and postnatal visits were provided by a named or partner midwife, and a POPPIE midwife was present in more than 80% of births. Acceptability: Nearly 98% of women who responded to the postnatal survey were very satisfied with POPPIE model. Quantitative fidelity and acceptability results were supported by the qualitative findings. Penetration and sustainability: Despite delays (likely associated with lack of existing continuity models at the hospital), the model was embedded within established services and a joint decision was made to sustain and adapt the model after the trial (strongly facilitated by national maternal policy on continuity pathways). Potential mechanisms of impact identified included e.g. access to care, advocacy and perceptions of safety and trust. There was no association between implementation measures and the primary outcome. Conclusions The POPPIE model of care was a feasible and acceptable model of care that was implemented with high fidelity and sustained in maternity services. Larger powered trials are feasible and needed in other settings, to evaluate the impact and implementation of continuity programmes in other communities affected by preterm birth and women who experience social disadvantage and vulnerability.

UR - http://www.scopus.com/inward/record.url?scp=85146171409&partnerID=8YFLogxK

U2 - 10.1371/journal.pone.0279695

DO - 10.1371/journal.pone.0279695

M3 - Article

C2 - 36634125

SN - 1932-6203

VL - 18

SP - e0279695

JO - PLoS ONE

JF - PLoS ONE

IS - 1 January

M1 - e0279695

ER -