bacch presentation m robling - british academy of...

11/02/2014

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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 …


• 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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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


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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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


• 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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• 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


• 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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• 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


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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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


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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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%)


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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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


Sourcing outcome data in Building Blocks

ImmunisationsHES: inpatients, outpatients

A&E

Abortions

Maternity records

GP records

Self‐report

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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


• 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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• Informed by Social Exchange Theory

• Developing & maintaining contact details

• Managing withdrawals

• Incentives to stay

Retention strategies


• 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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• Miss one interview

• Miss all interviews

• Leave study (and FNP)• Leave study and withdraw permission for data use

Retaining participants: management options available


• 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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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


• 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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• 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


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

bacch presentation m robling - british academy of...

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