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CYPHP Evelina London Evaluation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03461848
Recruitment Status : Unknown
Verified April 2018 by Guy's and St Thomas' NHS Foundation Trust.
Recruitment status was:  Recruiting
First Posted : March 12, 2018
Last Update Posted : April 10, 2018
Sponsor:
Collaborators:
King's College London
Newcastle University
London School of Hygiene and Tropical Medicine
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Asthma Epilepsy Eczema Constipation Other: CYPHP Evelina London Model of care Other: Enhanced Usual Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
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.
Actual Study Start Date : April 9, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CYPHP Evelina London Model
Practice clusters across Lambeth and Southwark have been randomised to introduce either the CYPHP Evelina London model of care, or Enhanced Usual Care.
Other: CYPHP Evelina London Model of care
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.

Active Comparator: Enhanced Usual Care Model
Practice clusters across Lambeth and Southwark have been randomised to introduce either the CYPHP Evelina London model of care, or Enhanced Usual Care.
Other: Enhanced Usual Care
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.




Primary Outcome Measures :
  1. Secondary Care service use [ Time Frame: Baseline and up to 2 years after ]
    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.

  2. Health-related Quality of Life, measured by PEDSQL [ Time Frame: Baseline, 1 year and 2 years ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03461848


Contacts
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Contact: Mohamed Elsherbiny 02078486668 mohamed.elsherbiny@kcl.ac.uk
Contact: James Newham 02078486668 James.newham@kcl.ac.uk

Locations
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United Kingdom
Guy's and St Thomas' NHS Foundation Trust Recruiting
London, United Kingdom, SE1 9RT
Contact: Mohamed Elsherbiny    0207 848 6668    mohamed.elsherbiny@kcl.ac.uk   
Contact: James Newham    0207 848 6668    james.newham@kcl.ac.uk   
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
King's College London
Newcastle University
London School of Hygiene and Tropical Medicine
Investigators
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Principal Investigator: Ingrid Wolfe King's College London
Principal Investigator: Raghu Lingam University of New South Wales
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03461848    
Other Study ID Numbers: Version 1.1 26-07-2017
First Posted: March 12, 2018    Key Record Dates
Last Update Posted: April 10, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive