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Evaluating the Family Nurse Partnership in England – the Building Blocks Trial
British Association for Community Child Health ASM 3rd Sept 2013
Dr Mike RoblingChief Investigator, Building BlocksDirector, South East Wales Trials Unit, Cardiff University
Today …
British Association for Community Child Health ASM 3rd Sept 2013
• An intervention for first‐time pregnant teenagers in England
• What is it and how is it delivered?
• The Building Blocks Trial – determining the effectiveness and cost‐effectiveness of FNP in England
• Approach to evaluation design• Considerations when running the trial• Who have been included• What results and when available
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British Association for Community Child Health ASM 3rd Sept 2013
The Family Nurse Partnership programme
• FNP is an evidenced based, preventive, early intervention programme for vulnerable young first time mothers.
• It offers intensive and structured home visiting, delivered by specially trained nurses, from early pregnancy until age two.
• The programme developed in the US over 30 years
• Testing in England began in 2007
British Association for Community Child Health ASM 3rd Sept 2013
International replication: Four stage process
• Adaptation to local context
• Pilot testing of feasibility and acceptability
• Randomised controlled trial
• Replication and expansion
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British Association for Community Child Health ASM 3rd Sept 2013
FNP in England
• Commenced in 2007 in ten areas• In April 2013:
• 11,000 places offering personalised support• Programme expansion announced to 16,000 by 2015
• Formative evaluation of ten sites completed
• Partnership of three organisations contracted to lead FNP:• Tavistock and Portman NHS Foundation Trust • Impetus Trust• Social Research Unit at Dartington
Responsibility: national leadership, strategic development &governance, education and coaching of nurses & supervisors, site preparation, quality improvement
British Association for Community Child Health ASM 3rd Sept 2013
• Improve pregnancy outcomes
• Improve child health and development and future school readiness and achievement
• Improve parents’ economic self‐sufficiency
FNP goals & structure
• Small teams of Family Nurses (max 8)
• A FNP supervisor to each team
• Training and supervision provided directly by FNP NU
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British Association for Community Child Health ASM 3rd Sept 2013
• 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
FNP visiting schedule
British Association for Community Child Health ASM 3rd Sept 2013
• Personal health – women’s health practices and mental health
• Environmental health – 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
Visit content
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British Association for Community Child Health ASM 3rd Sept 2013
• evaluate effectiveness of FNP within 3 domains: pregnancy and birth, child health and development, and parental life course and self‐sufficiency
• assess incremental costs & consequences of FNP compared to existing child services
• estimate longer term costs & effects of FNP using data showing the link between short term outcomes and long term costs and effects
• evaluate what processes may vary the impact of the FNP
The Building Blocks Trial1: study aims
1: Trial registration number: ISRCTN23019866. Protocol paper: Owen‐Jones et al. BMC Pediatrics 2013
British Association for Community Child Health ASM 3rd Sept 2013
Overview of the TrialDesign: •Individually randomised controlled trial (RCT)
Participants: •1600 women •Aged 19 or under •Recruited to RCT by 24 weeks and expecting first child
Randomisation:•Following baseline assessment automated phone / web allocation
•Allocation 50% FNP : 50% Usual Care•Stratification by site, gestation, smoking status and language of data collection
•Intention to treat analysis
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British Association for Community Child Health ASM 3rd Sept 2013
Eligibility Criteria
Women were included if they were:
aged 19 or under in catchment area covered by the local FNP teamExpecting first child (women whose previous pregnancy ended in miscarriage, stillbirth or termination were eligible)
Recruited at no later than 24 weeks gestation Gillick competent to provide adequate informed consent to research participation (including conversational English)
But excluded if they: Planned to have their child adoptedPlanned to leave the FNP area for 3+ monthsRequired an interpreter to receive the FNP programme
British Association for Community Child Health ASM 3rd Sept 2013
Pregnancy & birth Child Health & development
Maternal life course & economic self‐
sufficiency
Change in prenatal tobacco use
Birth weight
Intention to breastfeed
Prenatal attachment
Employment
Health status
Social support
Proportion of women with second pregnancy within two years of first birth
Injuries & ingestions
Breast feeding initiation & duration
Language development
Emergency attendances & admissions within two years of birth
Primary
Secondary*
* NB Illustrative not exhaustive selection of secondary outcomes
Outcomes overview
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Woman identified and agrees to be approached
Assessed for eligibility and consented Baseline data (CAPI)
Randomisation
Intervention Control
34‐36 weeks gestation (CATI)
Maternity
6 month post partum (CATI)
1 year post partum (CATI)
2 years post partum (CAPI)
Birth
18 month post partum (CATI)
Key: CAPI: Computer Assisted Personal Interview CATI: Computer Assisted Telephone Interview
Data collection:self‐report
Participant progress
Routine antenatal careFNP visits & routine maternal care
FNP visits & usual services Usual services
Primary & secondary care
Data collection: record abstraction
Generic Recruitment Pathway
Booking appointment• Maternity / midwifery
Other sources• Children’s centres, health visitors, GPs, Connexions, self‐referral, midwifery (after booking appointment etc
Consider eligibility criteria
Health / social care professional approach• Agreement for further contact only• Guided by generic script – but approach likely to be highly variable
• Completion of response leaflet• Contact local Building Blocks researcher
Initial approach
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British Association for Community Child Health ASM 3rd Sept 2013
Who were the 1618 recruited to the trial?
Variable Mean (SD) or count (%)
Age: 17.9 (16.9 to 18.8) yearsLiving with:
Both parents 352 (21.8%)One parent 667 (41.2%)Neither 599 (37.0%)
Living with father of baby: 368 (24.9%)NEET status (Y): 581 (36.1%)Paid job (Y): 338 (20.9%)Index of Multiple Deprivation 38.2 (25.2 to 52.0)Relationship status
Separated 165 (10.2%)Closely involved (boyfriend) 1222 (75.5%)
EthnicityWhite background 1425 (88.1%)Mixed background 89 (5.5%)Asian background 27 (1.7%)Black background 71 (4.4%)
British Association for Community Child Health ASM 3rd Sept 2013
Gestational age <16/52: 59.3%Smoking (Y): 46.8%
Site variations
Ethnicity (white):All sites 88.1%Site # 100%Site # 14.3%
NEET statusAll sites 36.1%Site # 40%Site # 28.6%
Minimisation variables:
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British Association for Community Child Health ASM 3rd Sept 2013
0
20
40
60
80
100
120
140
160
Participant recruitment (n=1618) by trial site (n=18)
Recruiting to: March, May or June 2010
British Association for Community Child Health ASM 3rd Sept 2013
Sourcing outcome data in Building Blocks
ImmunisationsHES: inpatients, outpatients
A&E
Abortions
Maternity records
GP records
Self‐report
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British Association for Community Child Health ASM 3rd Sept 2013
Percentage
Baseline interviews 99+%34-36 week interviews 81%
Baseline urines collected 97%34-36 week urines 71%
Birth CRFs 99+%6 month Interview 64%
12 month Interview 67%18 month Interview 66%24 month Interview 77%Withdrawn overall 12%
Follow‐up by self‐report and birth records
British Association for Community Child Health ASM 3rd Sept 2013
• Screened by health professionals: n = 3251
• Randomised n=1645
• Reasons for non‐recruitment: not meeting criteria n=638 declined n=727 no reason provided n=36 eligibility unknown n=205
• Withdrawn: n=5 (ineligible), n=78 (mandatory), n=110 (elective)
Recruitment & retention
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British Association for Community Child Health ASM 3rd Sept 2013
• Informed by Social Exchange Theory
• Developing & maintaining contact details
• Managing withdrawals
• Incentives to stay
Retention strategies
British Association for Community Child Health ASM 3rd Sept 2013
• Love2shop High street vouchers following interview completion:
£25 (12 & 18 months) & £40 (2 years)
• Phone cards (recruitment & 34 weeks)
• Birthday Gift (Book for baby)
• Gift at 2 year interview
Incentive‐based approaches
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British Association for Community Child Health ASM 3rd Sept 2013
• Miss one interview
• Miss all interviews
• Leave study (and FNP)• Leave study and withdraw permission for data use
Retaining participants: management options available
British Association for Community Child Health ASM 3rd Sept 2013
• Review of governance and approvals• Site set up• Equality and diversity• Data collection & outcome assessment• Ensuring stakeholder involvement in all aspects of the trial
Lay involvement: Stakeholder Group
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British Association for Community Child Health ASM 3rd Sept 2013
Timeline for delivering & reporting the trial
Trial starts: October 2008Recruitment starts: June 2009First baby born: October 2009Recruitment completed: June 20102 year follow‐up starts: October 20112 year follow‐up completed: March 2013
Final data set acquired: October 2013Report to funder: April 2014
British Association for Community Child Health ASM 3rd Sept 2013
• Working within policy arena – pros & cons
• A committed workforce• Governance in a UK context• Recruitment & retention• Specific assessment and data access issues (e.g. maternal sensitivity, secondary care data, primary care data)
Challenges along the way …
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British Association for Community Child Health ASM 3rd Sept 2013
• Objective measure maltreatment: (i) referral to SSD; child protection referral; CiN referral (ii) Child protection registration (& categorisation); CiN status (& categorisation)
• Associated measures: (i) injuries & ingestions (ii) DNA rates (hospital appointments) (iii) immunisation rates
• Intermediate FNP outcomes: subsequent pregnancies
• Costs: health and social care resource use
The longer term perspective
NIHR PHR: Evaluating the long‐term effectiveness and the cost and consequences of the Family Nurse Partnership parenting support programme in reducing maltreatment in young children
British Association for Community Child Health ASM 3rd Sept 2013
This is an independent report commissioned and funded by the Policy Research Programme in the Department of Health. The views expressed are not necessarily those of the Department.
Summary
• A programme currently primarily evidenced in the US
• A major continuing policy focus in England• Developing the evidence for the UK, and internationally
• Challenges in evaluation and lessons learned• Your own questions