Effect of the Children and Young People's Health Partnership model of paediatric integrated care on health service use and child health outcomes: a pragmatic two-arm cluster randomised controlled trial.

BACKGROUND: Paediatric health systems across high-income countries are facing avoidable adverse outcomes and increasing demands and costs. The aim of this study was to compare the effect of an enhanced usual care model with that of an integrated health-care model that offers local health clinics for general paediatric problems and early intervention and care for children and young people with tracer conditions. METHODS: In this pragmatic two-arm cluster randomised controlled trial, we compared the Children and Young People's Health Partnership (CYPHP) model of care versus enhanced usual care (EUC) among children registered at general practices in south London, UK. The CYPHP trial intervention was delivered between April 1, 2018, and June 30, 2021, and children younger than 16 years during the intervention period and registered at study practices on June 30, 2021, were included in the analysis. A restricted randomisation (1:1) following a computer-generated sequence was done by a masked independent statistician at the level of general practice cluster, stratified by borough (Lambeth or Southwark). Cluster allocation and data collection were masked, with unmasking of trial statisticians before analysis. The CYPHP model comprised all elements of EUC (electronic decision support, a primary care hotline, health checks, self-management support and health promotion, and resilience building and mental health first aid) plus local child health clinics delivered by paediatricians and general practitioners, and a nurse-led early intervention service for children with tracer conditions (asthma, eczema, and constipation). Primary outcomes were non-elective admissions (NELA; admissions coded as an emergency) among the whole trial population up to June 30, 2021, and paediatric quality of life (Pediatric Quality of Life Inventory [PedsQL]) among participants with tracer conditions at 6 months after recruitment. Secondary outcomes were primary and secondary care use, child mental health, parental wellbeing, standardised symptom scores for asthma, eczema, and constipation, health-care quality, and child absences from school and parent absences from work. The trial was registered on ClinicalTrials.gov, NCT03461848, and is complete. FINDINGS: The trial was conducted between April 1, 2018, and Dec 31, 2021. In total, 23 general practice clusters, consisting of 70 practices with 97 970 registered children, were randomised to CYPHP (n=11) or EUC (n=12). We found no effect, at the population level, of CYPHP versus EUC on non-elective admissions during the intervention period (adjusted mean incidence rate ratio [IRR] 1·00 [95% CI 0·91 to 1·10], p=0·99). Among children with tracer conditions, we found no difference in paediatric quality of life (PedsQL score) at 6 months (adjusted mean difference -0·033 [95% CI -0·122 to 0·055], p=0·46). As a secondary outcome, among children with tracer conditions and requiring care, NELA rates at 12 months did not differ between the CYPHP and EUC groups (66·1 per 1000 person-years vs 75·3 per 1000 person-years; adjusted mean IRR 0·87 [0·61-1·22], p=0·42). In children requiring care, a statistically significant improvement was observed in eczema symptoms at 6 months from baseline in the CYPHP group versus the EUC group (adjusted mean difference -1·370 [-2·630 to -0·122], p=0·032). Quality of asthma care significantly improved among children in the CYPHP group compared with children in the EUC group. No significant improvement was seen for all other secondary outcomes. INTERPRETATION: Although the CYPHP trial found a null effect for the primary outcomes, we found clinically important improvements in some secondary outcomes including care quality. Previous research has shown that large-scale system change requires time to observe a potential positive effect. FUNDING: Guy's and St Thomas Charity, the Lambeth and Southwark Clinical Commissioning Groups, and Evelina London Children's Hospital.

Effect of digital health, biomarker feedback and nurse or midwife-led counselling interventions to assist pregnant smokers quit: a systematic review and meta-analysis.

OBJECTIVE: To assess the effect of digital health (DH), biomarker feedback (BF) and nurse or midwife-led counselling (NoMC) interventions on abstinence in pregnant smokers during pregnancy and postpartum. SETTINGS: Any healthcare setting servicing pregnant women, including any country globally. PARTICIPANTS: Pregnant women of any social, ethnic or geographical background who smoke. METHODS: We searched Embase, Medline, Web Of Science, Google Scholar, PsychINFO, CINAHL and PubMed between 2007 and November 2021. We included published original intervention studies in English with comparators (usual care or placebo). Two independent assessors screened and abstracted data. We performed a random-effects meta-analysis, assessed risk of bias with the Cochrane Tool and used Grading of Recommendations Assessment, Development and Evaluation to assess the quality of evidence. RESULTS: We identified 57 studies and included 54 in the meta-analysis. Sixteen studies assessed DH (n=3961), 6 BF (n=1643), 32 NoMC (n=60 251), 1 assessed NoMC with BF (n=1120) and 2 NoMC with DH interventions (n=2107). DH interventions had moderate certainty evidence to achieve continuous abstinence (CA) at late pregnancy (4 studies; 2049 women; RR=1.98, 95% CI 1.08 to 3.64, p=0.03) and low certainty evidence to achieve point prevalence abstinence (PPA) postpartum (5 studies; 2238 women; RR=1.46, 95% CI 1.05 to 2.02, p=0.02). NoMC interventions had moderate certainty evidence to achieve PPA in late pregnancy (15 studies; 16 234 women; RR=1.54, 95% CI 1.16 to 2.06, p<0.01) and low certainty evidence to achieve PPA postpartum (13 studies; 5466 women; RR=1.79, 95% CI 1.14 to 2.83, p=0.01). Both DH and BF interventions did not achieve PPA at late pregnancy, nor NoMC interventions achieve CA postpartum. The certainty was reduced due to risk of bias, heterogeneity, inconsistency and/or imprecision. CONCLUSION: NoMC interventions can assist pregnant smokers achieve PPA and DH interventions achieve CA in late pregnancy. These interventions may achieve other outcomes.

Study protocol for a real-world evaluation of an integrated child and family health hub for migrant and refugee women.

INTRODUCTION: Continuity of child and family healthcare is vital for optimal child health and development for developmentally vulnerable children. Migrant and refugee communities are often at-risk of poor health outcomes, facing barriers to health service attendance including cultural, language, limited health literacy, discrimination and unmet psychosocial needs. 'Integrated health-social care hubs' are physical hubs where health and social services are co-located, with shared referral pathways and care navigation. AIM: Our study will evaluate the impact, implementation and cost-benefit of the First 2000 Days Care Connect (FDCC) integrated hub model for pregnant migrant and refugee women and their infants. MATERIALS AND METHODS: This study has three components. Component 1 is a non-randomised controlled trial to compare the FDCC model of care with usual care. This trial will allocate eligible women to intervention and control groups based on their proximity to the Hub sites. Outcome measures include: the proportion of children attending child and family health (CFH) nurse services and completing their CFH checks to 12 months of age; improved surveillance of growth and development in children up to 12 months, post partum; improved breastfeeding rates; reduced emergency department presentations; and improved maternal well-being. These will be measured using linked medical record data and surveys. Component 2 will involve a mixed-method implementation evaluation to clarify how and why FDCC was implemented within the sites to inform future roll-out. Component 3 is a within-trial economic evaluation from a healthcare perspective to assess the cost-effectiveness of the Hubs relative to usual care and the implementation costs if Hubs were scaled and replicated. ETHICS AND DISSEMINATION: Ethical approval was granted by the South Eastern Sydney Local Health District Human Research Ethics Committee in July 2021 (Project ID: 020/ETH03295). Results will be submitted for publication in peer-reviewed journals and presented at relevant conferences. TRIAL REGISTRATION NUMBER: ACTRN12621001088831.

Delivering paediatric precision medicine: Genomic and environmental considerations along the causal pathway of childhood neurodevelopmental disorders.

Precision medicine refers to treatments that are targeted to an individual's unique characteristics. Precision medicine for neurodevelopmental disorders (such as cerebral palsy, attention-deficit/hyperactivity disorder, obsessive-compulsive disorder, Tourette syndrome, and autism spectrum disorder) in children has predominantly focused on advances in genomic sequencing technologies to increase our ability to identify single gene mutations, diagnose a multitude of rare neurodevelopmental disorders, and gain insights into pathogenesis. Although targeting specific gene variants with high penetrance will help some children with rare disease, this approach will not help most children with neurodevelopmental disorders. A 'pathway' driven approach targeting the cumulative influence of psychosocial, epigenetic, or cellular factors is likely to be more effective. To optimize the therapeutic potential of precision medicine, we present a biopsychosocial integrated framework to examine the 'gene-environment neuroscience interaction'. Such an approach would be supported through harnessing the power of big data, transdiagnostic assessment, impact and implementation evaluation, and a bench-to-bedside scientific discovery agenda with ongoing clinician and patient engagement. WHAT THIS PAPER ADDS: Precision medicine has predominantly focused on genetic risk factors. The impact of environmental risk factors, particularly inflammatory, metabolic, and psychosocial risks, is understudied. A holistic biopsychosocial model of neurodevelopmental disorder causal pathways is presented. The model will provide precision medicine across the full spectrum of neurodevelopmental disorders.

The COVID-19 System Shock Framework: Capturing Health System Innovation During the COVID-19 Pandemic.

BACKGROUND: Coronavirus disease 2019 (COVID-19) has resulted in over 2 million deaths globally. The experience in Australia presents an opportunity to study contrasting responses to the COVID-19 health system shock. We adapted the Hanefeld et al framework for health systems shocks to create the COVID-19 System Shock Framework (CSSF). This framework enabled us to assess innovations and changes created through COVID-19 at the Sydney Children's Hospitals Network (SCHN), the largest provider of children's health services in the Southern hemisphere. METHODS: We used ethnographic methods, guided by the CSSF, to map innovations and initiatives implemented across SCHN during the pandemic. An embedded field researcher shadowed members of the emergency operations centre (EOC) for nine months. We also reviewed clinic and policy documents pertinent to SCHN's response to COVID-19 and conducted interviews and focus groups with stakeholders, including clinical directors, project managers, frontline clinicians, and other personnel involved in implementing innovations across SCHN. RESULTS: The CSSF captured SCHN's complex response to the pandemic. Responses included a COVID-19 assessment clinic, inpatient and infectious disease management services, redeploying and managing a workforce working from home, cohesive communication initiatives, and remote delivery of care, all enabled by a dedicated COVID-19 fund. The health system values that shaped SCHN's response to the pandemic included principles of equity of healthcare delivery, holistic and integrated models of care, and supporting workforce wellbeing. SCHN's resilience was enabled by innovation fostered through a non-hierarchical governance structure and responsiveness to emerging challenges balanced with a singular vision. CONCLUSION: Using the CSSF, we found that SCHN's ability to innovate was key to ensuring its resilience during the pandemic.

Integrated health Services for Children: a qualitative study of family perspectives.

BACKGROUND: There is increasing evidence that integrated care improves child related quality of life and reduces health service use. However, there is limited evidence on family perspectives about the quality of integrated care for children's services. This study aimed to understand children, young people, and caregivers' perceptions of a new integrated care service, and to identify essential components of integrated care for children and young people with ongoing conditions. METHODS: A qualitative analysis of in-depth interviews with caregivers and children included families (N = 37) with children with one of four ongoing conditions (asthma, eczema, epilepsy, constipation) who had experienced a new integrated care service delivered in South London, UK. RESULTS: Four key components of integrated services identified were: that the key health-worker understood the health needs of the family in context; that professionals involved children and caregivers in treatment; that holistic care that supported the family unit was provided; and that families experienced coordination across health, social, and education systems. CONCLUSIONS: Children and families identify care navigation and a holistic approach as key components that make high quality integrated care services. Service developments strengthening these aspects will align well with family perspectives on what works and what matters.

Brief evidence-based interventions for universal child health services: a restricted evidence assessment of the literature.

BACKGROUND: Universal child health services (UCHS) provide an important pragmatic platform for the delivery of universal and targeted interventions to support families and optimize child health outcomes. We aimed to identify brief, evidence-based interventions for common health and developmental problems that could be potentially implemented in UCHS. METHODS: A restricted evidence assessment (REA) of electronic databases and grey literature was undertaken covering January 2006 to August 2019. Studies were eligible if (i) outcomes related to one or more of four areas: child social and emotional wellbeing (SEWB), infant sleep, home learning environment or parent mental health, (ii) a comparison group was used, (iii) universal or targeted intervention were delivered in non-tertiary settings, (iv) interventions did not last more than 4 sessions, and (v) children were aged between 2 weeks postpartum and 5 years at baseline. RESULTS: Seventeen studies met the eligibility criteria. Of these, three interventions could possibly be implemented at scale within UCHS platforms: (1) a universal child behavioural intervention which did not affect its primary outcome of infant sleep but improved parental mental health, (2) a universal screening programme which improved maternal mental health, and (3) a targeted child behavioural intervention which improved parent-reported infant sleep problems and parental mental health. Key lessons learnt include: (1) Interventions should impart the maximal amount of information within an initial session with future sessions reinforcing key messages, (2) Interventions should see the family as a holistic unit by considering the needs of parents with an emphasis on identification, triage and referral, and (3) Brief interventions may be more acceptable for stigmatized topics, but still entail considerable barriers that deter the most vulnerable. CONCLUSIONS: Delivery and evaluation of brief evidence-based interventions from a UCHS could lead to improved maternal and child health outcomes through a more responsive and equitable service. We recommend three interventions that meet our criteria of "best bet" interventions.

Integrated Care Models and Child Health: A Meta-analysis.

CONTEXT: Integrated care models may improve health care for children and young people (CYP) with ongoing conditions. OBJECTIVE: To assess the effects of integrated care on child health, health service use, health care quality, school absenteeism, and costs for CYP with ongoing conditions. DATA SOURCES: Medline, Embase, PsycINFO, Cumulative Index to Nursing and Allied Health Literature, and the Cochrane Library databases (1996-2018). STUDY SELECTION: Inclusion criteria consisted of (1) randomized controlled trials, (2) evaluating an integrated care intervention, (3) for CYP (0-18 years) with an ongoing health condition, and (4) including at least 1 health-related outcome. DATA EXTRACTION: Descriptive data were synthesized. Data for quality of life (QoL) and emergency department (ED) visits allowed meta-analyses to explore the effects of integrated care compared to usual care. RESULTS: Twenty-three trials were identified, describing 18 interventions. Compared with usual care, integrated care reported greater cost savings (3/4 studies). Meta-analyses found that integrated care improved QoL over usual care (standard mean difference = 0.24; 95% confidence interval = 0.03-0.44; P = .02), but no significant difference was found between groups for ED visits (odds ratio = 0.88; 95% confidence interval = 0.57-1.37; P = .57). LIMITATIONS: Included studies had variable quality of intervention, trial design, and reporting. Randomized controlled trials only were included, but valuable data from other study designs may exist. CONCLUSIONS: Integrated care for CYP with ongoing conditions may deliver improved QoL and cost savings. The effects of integrated care on outcomes including ED visits is unclear.

The Children and Young People's Health Partnership Evelina London Model of Care: process evaluation protocol.

INTRODUCTION: Children and young people (CYP) in the UK have poor health outcomes, and there is increasing emergency department and hospital outpatient use. To address these problems in Lambeth and Southwark (two boroughs of London, UK), the local Clinical Commissioning Groups, Local Authorities and Healthcare Providers formed The Children and Young People's Health Partnership (CYPHP), a clinical-academic programme for improving child health. The Partnership has developed the CYPHP Evelina London model, an integrated healthcare model that aims to deliver effective, coordinated care in primary and community settings and promote better self-management to over approximately 90 000 CYP in Lambeth and Southwark. This protocol is for the process evaluation of this model of care. METHODS AND ANALYSIS: Alongside an impact evaluation, an in-depth, mixed-methods process evaluation will be used to understand the barriers and facilitators to implementing the model of care. The data collected mapped onto a logic model of how CYPHP is expected to improve child health outcomes. Data collection and analysis include qualitative interviews and focus groups with stakeholders, a policy review and a quantitative analysis of routine clinical and administrative data and questionnaire data. Information relating to the context of the trial that may affect implementation and/or outcomes of the CYPHP model of care will be documented. ETHICS AND DISSEMINATION: The study has been reviewed by NHS REC Cornwall & Plymouth (17/SW/0275). The findings of this process evaluation will guide the scaling up and implementation of the CYPHP Evelina London Model of Care across the UK. Findings will be disseminated through publications and conferences, and implementation manuals and guidance for others working to improve child health through strengthening health systems. TRIAL REGISTRATION NUMBER: NCT03461848.

Evaluating the effect of innovative motivation and supervision approaches on community health worker performance and retention in Uganda and Mozambique: study protocol for a randomised controlled trial.

BACKGROUND: If trained, equipped and utilised, community health workers (CHWs) delivering integrated community case management for sick children can potentially reduce child deaths by 60%. However, it is essential to maintain CHW motivation and performance. The inSCALE project aims to evaluate, using a cluster randomised controlled trial, the effect of interventions to increase CHW supervision and performance on the coverage of appropriate treatment for children with diarrhoea, pneumonia and malaria. METHODS/DESIGN: Participatory methods were used to identify best practices and innovative solutions. Quantitative community based baseline surveys were conducted to allow restricted randomisation of clusters into intervention and control arms. Individual informed consent was obtained from all respondents. Following formative research and stakeholder consultations, two intervention packages were developed in Uganda and one in Mozambique. In Uganda, approximately 3,500 CHWs in 39 clusters were randomised into a mobile health (mHealth) arm, a participatory community engagement arm and a control arm. In Mozambique, 275 CHWs in 12 clusters were randomised into a mHealth arm and a control arm. The mHealth interventions encompass three components: 1) free phone communication between users; 2) data submission using phones with automated feedback, messages to supervisors for targeted supervision, and online data access for district statisticians; and 3) motivational messages. The community engagement arm in Uganda established village health clubs seeking to 1) improve the status and standing of CHWs, 2) increase demand for health services and 3) communicate that CHWs' work is important. Process evaluation was conducted after 10 months and end-line surveys will establish impact after 12 months in Uganda and 18 months in Mozambique. Main outcomes include proportion of sick children appropriately treated, CHW performance and motivation, and cost effectiveness of interventions. DISCUSSION: Study strengths include a user-centred design to the innovations, while weaknesses include the lack of a robust measurement of coverage of appropriate treatment. Evidence of cost-effective innovations that increase motivation and performance of CHWs can potentially increase sustainable coverage of iCCM at scale. TRIAL REGISTRATION: (identifier NCT01972321 ) on 22 April 22 2013.

Integrating maternal psychosocial well-being into a child-development intervention: the five-pillars approach.

Maternal psychosocial well-being (MPW) is a wide-ranging concept that encompasses the psychological (e.g., mental health, distress, anxiety, depression, coping, problem solving) and social (e.g., family and community support, empowerment, culture) aspects of motherhood. Evidence-based MPW interventions that can be integrated into large-scale maternal and child health programs have not been developed. Building on several years of research in Pakistan, we developed and integrated a cognitive behavioral therapy-based MPW intervention (the five-pillars approach) into a child nutrition and development program. Following formative research with community health workers (CHWs; n = 40) and families (n = 37), CHWs were trained in (1) empathic listening, (2) family engagement, (3) guided discovery using pictures, (4) behavioral activation, and (5) problem solving. A qualitative feasibility study in one area demonstrated that CHWs were able to apply these skills effectively to their work, and the approach was found to be useful by CHWs, mothers, and their families. The success of the approach can be attributed to (1) mothers being the central focus of the intervention, (2) using local CHWs whom the mothers trust, (3) simplified training and regular supervision, and (4) an approach that facilitates, not adds, to the CHWs' work.

Capacity building in the health sector to improve care for child nutrition and development.

The effectiveness of interventions promoting healthy child growth and development depends upon the capacity of the health system to deliver a high-quality intervention. However, few health workers are trained in providing integrated early child-development services. Building capacity entails not only training the frontline worker, but also mobilizing knowledge and support to promote early child development across the health system. In this paper, we present the paradigm shift required to build effective partnerships between health workers and families in order to support children's health, growth, and development, the practical skills frontline health workers require to promote optimal caregiving, and the need for knowledge mobilization across multiple institutional levels to support frontline health workers. We present case studies illustrating challenges and success stories around capacity development. There is a need to galvanize increased commitment and resources to building capacity in health systems to deliver early child-development services.