Barnes, Jacqueline and Stuart, Jane and Allen, Elizabeth and Petrou, Stavros and Sturgess ...

243 Pages·2017·3.68 MB·English

by  Christine Middleton

Results of the FIRST STEPS study: a randomised controlled trial and economic
evaluation of the Group Family Nurse Partnership (gFNP) programme compared to
routine care in improving outcomes for high-risk mothers and their children and
preventing abuse
Jacqueline Barnes1*
Jane Stuart1
Elizabeth Allen2
Stavros Petrou3
Joanna Sturgess2
Jane Barlow3
Geraldine Macdonald4
Helen Spiby5
Dipti Aistrop6
Edward Melhuish1
Sung Wook Kim3
Joshua Pink3
Jessica Datta7
Diana Elbourne2
1. Department of Psychological Sciences, Birkbeck University of London, Malet Street,
London WC1E 7HX, UK. * [email protected]; 02070790837
2. Department of Medical Statistics, London School of Hygiene and Tropical Medicine,
Keppel Street, London, WC1E 7HT, UK
3. Warwick Medical School, University of Warwick, Coventry CV4 7AL, UK
4. School for Policy Studies, University of Bristol, Social Science Complex, 8 Priory
Road, Bristol BS8 1TZ, UK
5. Faculty of Medicine & Health Sciences, University of Nottingham, 12th Floor, Tower
Building, University Park, Nottingham, NG7 2RD, UK
6. Sheffield Children’s NHS Foundation Trust, Flockton House, 18 & 20 Union Road
Sheffield, S11 9EF, UK
7. Department of Social and Environmental Health Research, London School of
Hygiene and Tropical Medicine, Keppel Street, London, WC1E 7HT,UK

1
Conflicts of interest
E. Allen, J. Sturgess and D. Elbourne report grants from NHS National Institute for Health
Research Public Health Programme to the London School of Hygiene and Tropical Medicine
during the conduct of the study.
G Macdonald reports: I am in the process of completing a Cochrane Review of home visiting
programmes that will include studies of Nurse Family Partnership. Two predecessor reviews
were withdrawn in response to a criticism by David Olds. The criticism did not materially
affect the results or conclusions of the reviews, but it was deemed appropriate to correct these
and republish. This work is in hand, but the results are not yet available
Key words: group support, parenting attitudes, maternal sensitivity, mental health
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Table of contents Page
Tables and figures 4
Abbreviations 8
Abstract 10
Scientific summary 12
Plain English summary 19
Chapter 1. Introduction 20
Chapter 2. Methods 26
Chapter 3. Results – main study 41
Chapter 4. Economic evaluation 79
Chapter 5. Process Evaluation 130
Chapter 6. Looked after children (LAC) nested study 177
Chapter 7. Discussion and conclusions 199
Acknowledgements 213
References 216
Appendices 230
1. Sensitivity analyses 231
2. Reliability of CARE index maternal sensitivity 238
3. Demographics updates at each time point 239

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Tables and Figures
Table Page
1 Data collection timetable 36
2 a Baseline participant’s demographic characteristics 43
2 b Baseline partner’s demographic characteristics 46
2 c Baseline smoking, alcohol and drug use 47
2 d Baseline Adult Adolescent Parenting Inventory (parenting attitudes), 49
depression symptoms (EPDS), social networks and relationship scores
3 a Attendance at group sessions – all sessions – including trial and buffer clients 51
3 b Attendance at group sessions – all sessions – trial participants (in the 52
intervention arm) only
3 c Attendance at group sessions – pregnancy sessions – trial participants (in the 53
intervention arm) only
3 d Attendance at group sessions – infancy sessions – trial participants (in the 54
intervention arm) only
3 e Baseline demographic characteristics for the intervention arm participants and 55
for those attending at least one group session
4 a Primary outcomes and estimated intervention effects at 12 months 59
4 b Primary outcomes and estimated intervention effects at 12 months – Complier 60
average causal effect estimates
5 Secondary outcomes and estimated intervention effects 61
6 Baby demographics at two months 63
7 a Infant feeding at two months 64
7 b Infant feeding at six months 64
8 a Immunisations at two months 65
8 b Immunisations at 12 months 66
9 a Smoking, alcohol and drug use at two months 70
9 b Smoking, alcohol and drug use at 12 months 72
10 a Depression scores, parenting sense of competence scores and parental stress 74
index at two months
10 b Depression scores at six months 75
10 c Adult Adolescent Parenting Inventory, depression scores, social networks and 75
relationship scores at 12 months
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11 CARE index scores (12 months) 76
12 Harms/Severe Adverse Events 77
13 DCE attributes and levels 87
14 Total cost of delivery of intervention by site and by group (£, 2014-15 prices) 92
15 Average intervention cost per participant per gFNP session (£, 2014-15 93
prices)
16 Resource use values for cases with complete data by trial allocation, study 95
period and resource category
17 Unit costs for resource items (£, 2014-15 prices) 100
18 Economic costs for cases with complete data by trial allocation, study period 103
and cost category (£, 2014-15 prices)
19 EQ-5D descriptive measurements by trial allocation, study period and 108
dimension
20 Bivariate regression of incremental total costs and incremental health 111
outcomes associated with the gFNP programme; complete cases
21 Baseline cost-effectiveness results based upon the QALY and primary trial 114
outcomes: Imputed data, NHS and PSS perspective (£, 2014-2015 prices)
22 Cost-effectiveness results based upon the QALY and primary trial outcomes: 119
Imputed data, societal perspective (£, 2014-2015 prices)
23 Cost-effectiveness results based upon the QALY and primary trial outcomes: 120
Complete case analysis, NHS and PSS perspective (£, 2014-2015 prices)
24 Sensitivity analysis that varied gFNP session attendance and group size: 122
Complete case analysis, NHS and PSS perspective (£, 2014-2015 prices)
25 Sub-group analyses: Incremental cost-effectiveness of gFNP intervention in 124
pre-specified sub-groups (£, 2014-2015 prices)
26 Consistency check within DCE design 126
27 DCE results based on conditional logit model: Expectant mothers 127
28 DCE results based on conditional logit model: General population 127
29 DCE results based on conditional logit model: Full population 128
30 Mean number of sessions attended by intervention participants, in pregnancy, 135
in infancy and in total
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31 Average FN ratings of clients’ behaviour during group sessions in feasibility 137
studies and the First Steps trial based on the UK001G forms using scales from
one (low) to five (high) or seven (high)
32 Average percentage of time per session spent on each of the six content 138
domains when delivering gFNP in pregnancy and in infancy, and variation
between sites
33 Themes derived from client and practitioner qualitative interviews 144
34 FN interview participants, LAC study 184
35 All participants. Primary outcomes and estimated intervention effects at 12 231
months
36 All participants. Secondary outcomes and estimated intervention effects 231
37 Groups with intervention delivered. Primary outcomes and estimated 233
intervention effects at 12 months
38 Groups with intervention delivered. Secondary outcomes and estimated 233
intervention effects
39 Impact of premature birth. Primary outcomes and estimated intervention 235
effects at 12 months
40 Impact of premature birth. Secondary outcomes and estimated intervention 235
effects
41 Two month demographic updates 239
42 Six month demographic updates 239
43 Twelve month demographic updates 240

Figure Page
1 First Steps CONSORT diagram 42
2 Cost-effectiveness plane and cost-effectiveness acceptability curve based 116
upon the QALY outcome: Imputed data, NHS and PSS perspective (£, 2014-
2015 prices)
3 Cost-effectiveness plane and cost-effectiveness acceptability curve based 117
upon the AAPI -2 outcome: Imputed data, NHS and PSS perspective (£,
2014-2015 prices)
6
4 Cost-effectiveness plane and cost-effectiveness acceptability curve based 118
upon the Care Index outcome: Imputed data, NHS and PSS perspective (£,
2014-2015 prices)
5 Bland-Altman plot: maternal sensitivity 238
Abbreviations
AAPI-2 Revised Adult Adolescent Parenting Index
A&E Accident and emergency unit in hospital
AES Advanced encryption standard
ANCOVA Analysis of covariance
ASQ Ages and Stages Questionnaire
BNF British national formulary
BNDC British national formulary for children
CACE Complier average causal effect
CI Confidence interval
CEA Cost effectiveness analysis
CEAC Cost effectiveness acceptability curve
CLRN Clinical Local Research Network
CQC Care Quality Commission
CRB Criminal Records Bureau
CTU Clinical Trials Unit
CUA Cost utility analysis
DCE Discrete choice experiment
DfE Department for Education
DH Department of Health
DMC Data monitoring committee
EDD Expected delivery date
EPDS Edinburgh Postnatal Depression Scale
EQ-5D-5L EuroQol five dimensions questionnaire with five-level response scale
EuroQol The EuroQol Group Association ("The EuroQol Group") comprises a network
of international, multilingual, multidisciplinary researchers,
supporting/instigating/performing scientific research and development of
instruments that describe and value health.
FN Family Nurse, trained to deliver FNP according to USA NFP guidelines
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FNMW Family Nurse who has notified their intention to practice as a midwife
FNP Family Nurse Partnership; UK name for NFP
FNP NU Family Nurse Partnership National Unit
GBP British pound
GCP Good clinical practice
GCSE General Certificate of Secondary Education qualification
gFNP Group-based Family Nurse Partnership programme
GP General practitioner
HCP Healthy Child Programme
HES Hospital Episode Statistics
HHS US Department of Health and Human Services
HRQoL Maternal health related quality of life
HSRU Health Services Research Unit
ICER Incremental cost-effectiveness ratio
ID Identification number
ISRCTN International standard randomised controlled trial number
IT Information technology
LAC Looked after child, in the care of Social Services
LMP Last menstrual period
LSHTM London School of Hygiene and Tropical Medicine
MOS Medical Outcomes Study
MRC Medical Research Council
NFP Nurse Family Partnership, the original USA developed home visiting
programme, renamed FNP in the UK
NHS National Health Service
NICE National Institute for Health and Care Excellence
NIHR NHS National Institute for Health Research
NPEU National Perinatal Epidemiology Unit
NRES National research ethics service
OR Odds ratio
PI Principal Investigator
PMM Predicted mean matching
PSOC Perceived sense of competence scale
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PSS Personal social services
PSSRU Personal social services research unit
QALY Quality-adjusted life-year
RCT Randomised controlled trial
REC Research ethics committee
RUT Random utility theory
SE Standard error
SD Standard deviation
SES Socioeconomic status
SOP Standard operating procedure
TMG Trial management group
TSC Trial steering committee
UID Unique identifier
UK United Kingdom
USA United States of America
VAS Visual analogue scale

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Abstract
Background: Family Nurse Partnership (FNP) is a home-based nurse home-visiting
programme to support vulnerable parents. Group FNP (gFNP) has similar aims and materials
and was demonstrated to be feasible in implementation evaluations.
Objectives: To determine whether gFNP, compared to usual care, could reduce risk factors
for maltreatment in a vulnerable group and be cost effective.
Design: A multi-site randomised controlled parallel-group trial and prospective economic
evaluation, with eligible women allocated (minimised by site and maternal age group) to
gFNP or usual care.
Setting: Community locations in the UK.
Participants: Expectant mothers aged <20 with one or more previous live births, or 20–24
with no previous live births and with low educational qualifications, defined as neither
Mathematics nor English Language General Certificate of Education (GCSE) at grade C or
higher or, if both, no more than four GCSEs at grade C or higher.
Intervention: Groups offered from early pregnancy until infants are 12 months old with 44
sessions (14 pregnancy, 30 infancy), delivered to 8-12 women with similar expected delivery
dates (EDDs; range 8-10 weeks) by two Family Nurses (FNs), one of whom has notified their
intention to practise as a midwife.
Main outcome measures: Parenting was assessed by a self-report measure of parenting
opinions, the revised Adolescent Adult Parenting Index (AAPI-2) and an objective measure
of maternal sensitivity, the CARE index. Cost-effectiveness was primarily expressed in
terms of incremental cost per quality-adjusted life year (QALY) gained.
Data sources: Interviews with participants at baseline and when infants were two, six and 12
months. Cost information from nurse weekly logs and other service delivery data.
Results: 166 women were enrolled (99 to intervention and 66 to control). Adjusting for site
and maternal age group the intention to treat analysis found no effect of gFNP on either of the
primary outcomes; AAPI-2 total was 7·5/10 (SE 0·1) in both arms (difference also adjusted
for baseline 0·08; 95% CI -0·15 to 0·28, p=0·50); CARE Index maternal sensitivity mean:
intervention 4·0 (SE 0·3); control 4·7(SE 0·4); (difference -0·76; 95% CI -1·67 to 0·13,
p=0·21). Sensitivity analyses supported the primary analyses. The probability that the gFNP
intervention was cost-effective based on the QALY measure did not exceed 3%. However in
terms of change in AAPI-2 score (baseline to 12 months) the probability that gFNP was cost-
effective reached 25.1%. A separate discrete choice experiment highlighted the value placed
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