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

South East Wales Trials Unit, Cardiff University

Dr Julia SandersConsultant Midwife / Senior Project Manager

Family Nurse Partnership Programme

Who are Family Nurses?

• Registered Nurses or Midwives

• Health Visitors• School Nurses

• Additional training programme

• Central team at Department of Health

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

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

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 GOALS1. Improve pregnancy

outcomes

2. Improve child health and development and future school readiness and achievement

3. Improve parents’ economic self-sufficiency

8

FNP Structure1. Small teams of

Family Nurses (max 6)

2. A FNP supervisor to each team

3. Training and supervision provided directly by DoH

US trials of NFP

N = 400

Low-income whites

Semi-rural

N = 1,138

Low-income blacks

Urban

Elmira, NY

1977

Memphis, TN

1987

Denver, CO

1994

N = 735

Large portion of Hispanics

Nurse v para-professional

visitors

• 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

Consistent positive effects across at least two trials

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

Developing the Family Nurse Partnership In England

Family Nurse PartnershipAn introductory DVD

Overview of Trial Design

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

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

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

Outcome domain

•Changes in prenatal tobacco use (maternal measure)

•Birth weight (child measure)

Pregnancy & birth

Child health & development

Maternal life course and economic self-sufficiency

•Emergency attendances / admissions within two years of birth

•Proportion of women with a second pregnancy within two years of first birth

•Intention to breastfeed•Prenatal attachment

•Injuries & ingestions•Breast feeding (initiation & duration)

•Language development

•Education•Employment•Health status•Social supportPaternal involvement

Primary Secondary

Overview of the TrialStudy Outcomes

Executive Management Group

Lead applicant: Mike RoblingSnr Project Mgr: Julia SandersCo-applicants: Chris Butler

Alison KempJoyce KenkreAlan MontgomeryKate PickettDavid Torgerson

WP managers: Eleri Owen-JonesRia PooleEconomist (tbc)

Dir, SEWTU: Kerry Hood

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

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

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

Research team details