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AsthmaNCT03461848

CYPHP Evelina London Evaluation

A study testing CYPHP Evelina London Model of care in people with Asthma and Eczema, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The Children and Young People's Health Partnership (CYPHP) Evelina London model is an innovative, evidence-based approach to reshaping healthcare services in Southwark and Lambeth. Read more about this study

Who is it for?
Ages 0 to 16 years
Conditions the study is for
Asthma, Eczema, Constipation
What is being tested?
CYPHP Evelina London Model of care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,731 participants
Where
1 siteUnited Kingdom
Study dates
9 Apr 2018to 31 Mar 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 0 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Population evaluation inclusion criteria
  • CYP<16 years (In 2011, 2 years prior to CYPHP service start)
  • Registered with a participating practice in Lambeth and Southwark.
  • Tracer condition evaluation inclusion criteria
  • Registered with a participating practice in Lambeth and Southwark.
  • CYP<16 years (In 2011, 2 years prior to CYPHP service start)
  • Diagnosed or identified as having one of the four tracer conditions by the CYPHP/EUC service, according to the service definitions

Who cannot join

  • Tracer condition evaluation exclusion criteria, participants will be excluded from the evaluation if the following applies:
  • If during the course of the evaluation period the patient diagnosis is clarified or changes to one which is no longer included within the tracer conditions studied.
  • If the patient ceases to be registered with a participating practice.
  • If the patient moves their primary residence outside of Lambeth or Southwark.
  • With regards to epilepsy only: if the patient no longer receives treatment for their epilepsy by a consultant working within the Guy's and St. Thomas' NHS Foundation Trust or King's College London NHS Trust.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Guy's and St Thomas' NHS Foundation Trust

    London, SE1 9RT

Other trials in United Kingdom

About this study

Official title: The Children and Young People's Health Partnership (CYPHP) Evelina London Model of Care: An Opportunistic Cluster Randomised Evaluation to Assess Child Health Outcomes, Healthcare Quality, and Health Service Use.

The Children and Young People's Health Partnership (CYPHP) Evelina London model is an innovative, evidence-based approach to reshaping healthcare services in Southwark and Lambeth. The model of care is a complex health services public health intervention aiming to integrate care across organisational and professional boundaries. There is a major focus on improving front line care for all children and young people, and comprehensive proactive care for those with common and long-term conditions such as asthma, epilepsy, eczema, and constipation

CYPHP Evelina London model of care is being adopted by the Clinical Commissioning Groups of Southwark and Lambeth as part of routine care. Early roll out of the model has already started. However, due to resource limitations, implementation will occur in phases. In the first phase (~two years), half of GP practices in the Lambeth and Southwark area will implement the full model while others will offer enhanced usual care (EUC). The evaluation team will utilize this staged CCG roll out to evaluate the programme using a cluster randomised controlled trial design. It is expected that all the EUC practices will also adopt the CYPHP model within the next three years.

The impact of the CYPHP Evelina London model will be assessed at two levels; at the population level ("Population evaluation") and among CYP with specific conditions ("Tracer condition evaluation"). The tracer condition evaluation will with consent, follow up CYP with tracer conditions (asthma, epilepsy, eczema, constipation) to assess the impact of the new model of care on health service use, quality of care, and child health measures including health-related quality of life. Cost-effectiveness will be assessed for population and tracer conditions.

Read the detailed description

The UK lags behind other high-income countries in several measures of child health, including mortality (Wolfe et al, 2013). The UK position relative to comparable European countries is poor in many regards, including higher all-cause mortality, especially for infants and adolescents, and a slower decline in non-communicable disease mortality (Viner and Wolfe 2018 (in press)). Approximately 20% of childhood deaths are thought to be preventable, with higher proportions in specific categories such as CYP with chronic conditions (Fraser et al, 2014). The current models of healthcare provision for children and young people in the UK do not consistently provide optimum healthcare for CYP, for example are not adequately responsive to the epidemiological transition towards long term conditions (LTCs) (Wolfe et al, 2011; Royal College of Paediatrics and Child Health, 2015). Between 60 and 70% of children who died in the UK between 2001 and 2010 had a chronic condition requiring frequent contact with the health system (Gilbert, 2015). Chronic, non-communicable disease accounts for 79% of all disability adjusted life years lost (DALYS), among young people aged 1-14 years, across Europe, with respiratory diseases (mainly asthma) and neuropsychiatric disorders including anxiety and depression, among the most common causes of morbidity (Wolfe et al, 2013). The current UK model of hospital-centred paediatric care was developed to deliver acute inpatient and high intensity specialist services rather than high quality care for CYP with long term conditions (LTCs) who need multidisciplinary, coordinated and planned care to prevent illness and disease complications and to maximize wellbeing and developmental potential (Mansfield, 2013). The current healthcare model, in the context of the wider health and social care system in the UK, has resulted in suboptimal health outcomes for both acute and chronic illness (Wolfe et al, 2011). Finally, the current service is not as responsive to families' needs as it should be, and is often inefficient with a reliance on high-cost emergency department attendance and acute admissions (Wolfe et al, 2013; Mansfield, 2013). The boroughs of Lambeth and Southwark have higher than national average rates of infant and child mortality, variable and sometimes poor outcomes for acute care and planned care for conditions including asthma, epilepsy, and mental health disorders. There are high and rising A\&E attendance rates for children, emergency hospital admissions, and hospital outpatient use.

As described in the Royal College of Paediatrics and Child Health's Facing the Future: Together for Child Health report (Royal College of Paediatrics and Child Health 2015), there is an urgent need to develop new evidence based, cost effective and sustainable health care services to meet the increasing demands caused by the rising prevalence of chronic illness across the life course (Wolfe et al, 2013; Davies, 2012; European commission health and consumers directorate-general, 2014). Countries that have developed health service models with greater continuity between primary and secondary care, delivered by teams with stronger incentives to work together, have better health outcomes (Wolfe et al, 2013). A systematic review of international peer-reviewed published evidence conducted by the CYPHP team showed that integrated primary and secondary chronic care models can be beneficial on patient experience and health outcomes, and can be cost saving (Wolfe et al, in draft). However, this review highlighted the lack of high quality evidence in this area to inform service delivery and commissioning.

The CYPHP Evelina London model is an innovative, evidence-based approach to reshaping everyday healthcare services through integrating care across four key areas: (1) vertical integration of care across primary and secondary care; (2) horizontal integration of health, education, and social care; (3) integration along the life course especially at transition points; and (4) integration across public health, healthcare, and healthy public policy. A major focus of the CYPHP Evelina London model is improving front line care for all children and young people since front line care (primary care and accident and emergency) is where the majority of healthcare is delivered, and also acts as the gateway to other services. Front line care can therefore be an enabler or barrier for the rest of the system to function well. In particular, effective and efficient urgent care is important to ensure that sufficient resources are available for the planned proactive comprehensive care that children with long-term conditions need.

The CYPHP Evelina London model of care was co-produced by local Clinical Commissioning Groups (CCG's) and Primary and Secondary Healthcare Providers using the best available evidence and extensive consultation with local children, young people, and families. The Partnership of CCGs and Providers, with support of local families, wish to implement the model across the London boroughs of Lambeth and Southwark. Components of the model have been piloted in the area to test feasibility and acceptability. However, there is a lack of comprehensive rigorous evidence about integrated models of care for CYP. This evaluation is designed to help fill that evidence gap, and determine the effectiveness and cost-effectiveness of the new model of care. The evaluation, embedded within the cluster randomised rollout of the model, aims to:

  • To evaluate the impact of the Children and Young People's Health Partnership (CYPHP) Evelina London model of care on the health, healthcare, and health service use of children and young people (CYP).
  • To understand how and why the CYPHP Evelina London model of care was effective or ineffective, and to identify contextually relevant strategies for successful implementation as well as practical difficulties in adoption, delivery, and maintenance to inform wider implementation.
  • To assess the costs of delivery and cost effectiveness of the CYPHP Evelina Model of care compared to enhanced usual care.
  • To generate rigorous evidence for local, national, and international service providers and commissioners, and contribute to the evidence base in CYP health services research.
Being tested
CYPHP Evelina London Model of care, Enhanced Usual Care
Medical subject headings
Asthma, Eczema, Constipation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CYPHP Evelina London Model of careOther

    Universal services offer, Paediatric hotlines, Education and training for health professionals, Online decision support tools and guidelines, Young people-friendly access to primary care, and Resilience training in schools, Targeted services offered dependent on need. Children with any of the tracer conditions will be offered pathway based care including early intervention for physical and related mental health needs, paediatric nursing support, care plans shared with schools, medication reviews, and peer-led parenting support. Self-management support, social support signposting, and safety-netting are offered to all.

  • Enhanced Usual CareOther

    Universal services offer, Paediatric hotlines, Education and training for health professionals, Online decision support tools and guidelines, Young people-friendly access to primary care, and Resilience training in schools, Self-management support, social support signposting, and safety-netting are offered to all.

Study groups in NCT03461848
Study groupRoleWhat they receive
CYPHP Evelina London ModelExperimentalPractice clusters across Lambeth and Southwark have been randomised to introduce either the CYPHP Evelina London model of care, or Enhanced Usual Care.
Receives: Other: CYPHP Evelina London Model of care
Enhanced Usual Care ModelActive comparatorPractice clusters across Lambeth and Southwark have been randomised to introduce either the CYPHP Evelina London model of care, or Enhanced Usual Care.
Receives: Other: Enhanced Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Secondary Care service use

    Population Evaluation: To assess differences in rates of secondary care service use among CYP from GP practices delivering the CYPHP model compared with practices delivering EUC, up to two years' post-implementation of the service.

    Measured: Baseline and up to 2 years after

  2. Health-related Quality of Life, measured by PEDSQL

    Tracer conditions evaluation: To assess differences in health-related quality of life among CYP with tracer conditions from practices delivering the CYPHP model compared with practices delivering EUC, up to two years' post-implementation of the service.

    Measured: Baseline, 1 year and 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2018
  2. Study start9 Apr 2018
  3. Primary completion31 Dec 2021
  4. Study completion31 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1,731 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03461848
Sponsor's protocol ID
Version 1.1 26-07-2017
Status last verified
Jan 2021
First submitted
27 Feb 2018
Last updated
13 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Satherley RM, Newham J, Cecil E, Forman J, Kelly C, Wolfe I, Lingam R. Implementation of the children and young people's health partnership model of paediatric integrated care: a mixed-methods process evaluation. Arch Dis Child. 2025 Jul 18;110(8):603-611. doi: 10.1136/archdischild-2024-327664.

    PubMed 39904570
  • Cecil E, Forman J, Newham J, Hu N, Lingam R, Wolfe I. Investigating a novel population health management system to increase access to healthcare for children: a nested cross-sectional study within a cluster randomised controlled trial. BMJ Qual Saf. 2024 Oct 18;33(11):694-703. doi: 10.1136/bmjqs-2024-017223.

    PubMed 38991704
  • Wolfe I, Forman J, Cecil E, Newham J, Hu N, Satherley R, Soley-Bori M, Fox-Rushby J, Cousens S, Lingam R. 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. Lancet Child Adolesc Health. 2023 Dec;7(12):830-843. doi: 10.1016/S2352-4642(23)00216-X. Epub 2023 Oct 19.

    PubMed 37866369
  • Kelly CB, Soley-Bori M, Lingam R, Forman J, Cecil L, Newham J, Wolfe I, Fox-Rushby J. Mapping PedsQL scores to CHU9D utility weights for children with chronic conditions in a multi-ethnic and deprived metropolitan population. Qual Life Res. 2023 Jul;32(7):1909-1923. doi: 10.1007/s11136-023-03359-4. Epub 2023 Feb 23.

    PubMed 36814010
  • Soley-Bori M, Lingam R, Satherley RM, Forman J, Cecil L, Fox-Rushby J, Wolfe I. Children and Young People's Health Partnership Evelina London Model of Care: economic evaluation protocol of a complex system change. BMJ Open. 2021 Nov 24;11(11):e047085. doi: 10.1136/bmjopen-2020-047085.

    PubMed 34819278
  • Satherley RM, Green J, Sevdalis N, Newham JJ, Elsherbiny M, Forman J, Wolfe I, Lingam R; CYPHP team. The Children and Young People's Health Partnership Evelina London Model of Care: process evaluation protocol. BMJ Open. 2019 Sep 3;9(8):e027302. doi: 10.1136/bmjopen-2018-027302.

    PubMed 31481367
  • Newham JJ, Forman J, Heys M, Cousens S, Lemer C, Elsherbiny M, Satherley RM, Lingam R, Wolfe I. Children and Young People's Health Partnership (CYPHP) Evelina London model of care: protocol for an opportunistic cluster randomised controlled trial (cRCT) to assess child health outcomes, healthcare quality and health service use. BMJ Open. 2019 Sep 3;9(8):e027301. doi: 10.1136/bmjopen-2018-027301.

    PubMed 31481366

Questions about this trial

What is this clinical trial studying?

A study testing CYPHP Evelina London Model of care in people with Asthma and Eczema, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Secondary Care service use (time frame: Baseline and up to 2 years after). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03461848, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2022.

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