Evaluating the Family Nurse Partnership in England: a randomised controlled trial

1. Evaluating the Family Nurse Partnership in England: a randomised controlled trial South East Wales Trials Unit, Cardiff University Dr Julia Sanders Consultant Midwife / Senior Project Manager

2. Family Nurse Partnership Programme

3. Who are Family Nurses? • Registered Nurses or Midwives • Health Visitors • School Nurses • Additional training programme • Central team at Department of Health

4. Family Nurse Partnership Programme • A structured, intensive home visiting programme delivered by Family Nurses to pregnant teenagers • Programme runs through pregnancy and until baby’s second birthday. • Licensed programme developed and tested in the USA with fidelity measures to ensure replication of original research

5. Visiting Schedule • 1/week first month • Every other week during pregnancy • 1/week first 6 weeks after delivery • Every other week until 21 months • Once a month until age 2

6. Content of visits 6 domains • Personal health – women’s health practices and mental health • Environmental health – adequacy of home and neighbourhood • Life course development – women’s future goals • Maternal role – skills and knowledge to promote health and development of their child • Family and friends – helping to deal with relationship issues and enhance social support • Health and human services – linking to other services

7. FNP GOALS Improve pregnancy outcomes Improve child health and development and future school readiness and achievement Improve parents’ economic self-sufficiency 7

8. FNP Structure Small teams of Family Nurses (max 6) A FNP supervisor to each team Training and supervision provided directly by DoH 8

9. US trials of NFP Elmira, NY 1977 Memphis, TN 1987 Denver, CO 1994 N = 400 Low-income whites Semi-rural N = 1,138 Low-income blacks Urban N = 735 Large portion of Hispanics Nurse v para-professional visitors

10. Consistent positive effects across at least two trials • Improvements in women’s antenatal health • Reductions in children’s injuries • Fewer subsequent pregnancies • Greater intervals between births • Increases in fathers’ involvement • Increases in employment • Reductions in welfare and food stamps • Improvements in school readiness

11. Developing the Family Nurse Partnership In England Sept 2006: Action Plan for Social Exclusion - proposal for 10 test sites of NFP £30M support allocated (2008-9 to 2010-11) Pilot running from March 2007 (10 sites): evaluation reported July 2008 US NFP adapted for English setting – Family Nurse Partnership 18 new sites invited to apply to be part of RCT – selected March 2008

12. Family Nurse PartnershipAn introductory DVD

13. Overview of Trial Design

14. Overview of the Trial • Design: • Individually randomised controlled trial • Participants: • 2400 women aged 19 or under, recruited to RCT by 24 weeks and expecting first child • Randomisation: • Following baseline assessment by automated telephone allocation • Stratification by site, gestation, smoking status and language of data collection

15. Trial Sites • Barnsley • Cornwall • Coventry • Cumbria • Derby City • Berkshire East • Hull • Lambeth • Leeds • Liverpool • Manchester • Northamptonshire • South Birmingham • Southwark • Sunderland • South East Essex • Tower Hamlets • Walsall

16. Eligibility Criteria • Women will be included if they: • Are aged 19 or under • Live within the catchment area covered by the local FNP team • Are expecting their first child (women whose previous pregnancy ended in miscarriage, stillbirth or termination are eligible for the trial) • Can be recruited at no later than 24 weeks gestation • Are Gillick competent to provide adequate informed consent to research participation (including competence in English at conversational level or higher). • But excluded if they: • Plan to have their child adopted • Plan to leave the FNP area during the time of the trial either for 3+ months • Women who would require an interpreter to receive the FNP programme

17. Overview of the Trial Study Outcomes Outcome domain Primary Secondary Pregnancy & birth • Changes in prenatal tobacco use (maternal measure) • Birth weight (child measure) • Intention to breastfeed • Prenatal attachment Child health & development • Emergency attendances / admissions within two years of birth • Injuries & ingestions • Breast feeding (initiation & duration) • Language development Maternal life course and economic self-sufficiency • Proportion of women with a second pregnancy within two years of first birth • Education • Employment • Health status • Social supportPaternal involvement

18. Executive Management Group Lead applicant: Mike Robling Snr Project Mgr: Julia SandersCo-applicants: Chris Butler Alison Kemp Joyce Kenkre Alan Montgomery Kate Pickett David Torgerson WP managers: Eleri Owen-Jones Ria Poole Economist (tbc) Dir, SEWTU: Kerry Hood

19. Progress Update Ethics MREC Approval granted Global Governance Checks completed Contracts R & D Required with 41 PCTs and NHS Trusts Eight variations have been required to cover different models of working Researchers Being employed by CLRNs, Trusts, PCTs, Joint Trusts Recruitment 500 + women recruited to date

20. Project Timetable • Train local researchers (From May 2009) • Recruit / randomise participants (June 2009 – Feb 2010) • 34 -36 urine collection • Consultation recordings (Jul 2009 – Jun 2012) • Initial Service Mapping Interviews (Oct 2008 – Jun 2009) • Focus groups (Feb 2010 – Aug 2010 / Dec 2011 – Jun 2012) • 2 year FUP interview (Aug 2011 – Jun 2012) • Reporting Jan 2013

21. Research team details Katy Addison, Study Administrator  029 2068 7617 buildingblocksinfo@cardiff.ac.uk South East Wales Trials Unit, Cardiff University, 7th Floor, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS Dr Eleri Owen-Jones, Trial Manager  029 2068 7601 Dr Julia Sanders, Midwife & Senior Project Manager  029 2068 7623 sandersj3@cf.ac.uk Dr Mike Robling, Chief Investigator  029 2068 7177  www.cf.ac.uk/medic/buildingblocks