A Realist Evaluation of Autism ServiCe Delivery (RE-ASCeD)

NCT04422483 | Unknown DMC

• 1 other identifier: Re-ASCed Protocol IM 17-4-20
• Study Type: observational
• Target: 520
• Locations: 1 country
• Sites: 1

Brief Summary

Diagnostic pathways for children with possible autism. Which work best, for whom, when, and at what cost? Autism is a complex neuro-behaviour condition. People with autism have difficulty with social interaction and in communication with others. They may struggle with change, and repeat actions over and over. Life may be very anxious or stressful. The signs of autism can occur at any age but often appear in the first two years of life. There is no one type of autism, but many, so the condition is now called autism spectrum disorder (ASD). Autism is lifelong but this study is only about children. Caring for a child with autism can be difficult and can sometimes be tough on the whole family. This project aims to guide the people who plan services for families and children. Different teams and services that do autism assessments will help us. The investigators will ask teams and services: What speeds up diagnosis? What delays diagnosis? The study will be in four work packages:

1. 1.The investigators will review research in the UK and abroad to find evidence and ideas that will help speed up diagnosis.
2. 2.The investigators will survey professionals who work for the specialist teams who diagnose autism. The survey will be about each step in the process and ask which professionals get involved. The investigators will ask about the number of children they see and the time it usually takes to reach a diagnosis. This will give us a picture of the national situation.
3. 3.After the national survey, the investigators will select around six or eight teams. These teams will be using different and innovative approaches. The investigators will study those approaches. The investigators will talk to clinical staff, managers, referrers, parents and young people. Parents and young people will have gone through the diagnostic process. The investigators will ask parents and young people about their experiences and views. The investigators will review the steps in the diagnosis process for about 70 children in each service. The investigators will find out how long each assessment takes, how much clinical time it takes, and how much it costs. The investigators will compare findings across teams and services.
4. 4.The investigators will have national meetings with autism experts and patient groups. The investigators will show them our findings. These groups will agree recommendations for practice. Clinical teams, service managers, commissioners, parents' groups, and NHS England will receive recommendations.

Conditions

Autism; Children; Family; Diagnoses, Syndromes, and Conditions; Patient Satisfaction

Outcome Measures

Primary Outcomes (1)

• Case Study: Case Note Review - Pathway completion time taken

  Research team monitor steps in the diagnostic pathway. Access child's clinical care records for pathway completion: Time taken from referral to diagnosis/discharge (in days).

  Up to 24 months

Secondary Outcomes (19)

• Questionnaire: Reported Challenges

  Up to 6 months

• Questionnaire: Reported Type of Service

  Up to 6 months

• Questionnaire: Reported New Models of Services

  Up to 6 months

• Questionnaire: Reported Geographical Area

  Up to 6 months

• Questionnaire: Reported Activity Levels

  Up to 6 months

Other Outcomes (6)

• Realist Evaluation Outcomes

  Up to 32 months

• Realist Evaluation Contexts

  Up to 32 months

• Realist Evaluation Mechanisms

  Up to 32 months

Study Arms (4)

Service Model Level Case Studies

Realist Interviews. MONTHS 9-30 (N=6-8 sites, 12 people per site, 96 interviewees)

Other: Realist evaluation

Individual/family level interviews

Child Interviews. MONTHS 9-30 (N=6-8 sites, 6 people per site, max. 48 interviewees)

Other: Realist evaluation

Individual child/family Level Case Studies:

MONTHS 10-30 (N=6-8 sites, 78 people per model (x4), 312 participants, 156 per NU/SCFT depending on distribution of sites)

Other: Realist evaluation

Focus groups:

MONTHS 9-30 (N=6-8 sites, 6-8 focus groups of up to 8 parents) N= 64

Other: Realist evaluation

Interventions

Realist evaluation OTHER

In-depth exploration of individual service models will be carried out to determine the interrelationship of context, intervention, mechanisms and outcomes as they occur in their natural setting. Data will be gathered within case studies using mixed methods at two levels: (i) service model and (ii) individual child/ family. Methods will include semi structured realist Interviews, focus groups, and document reviews to assemble a comprehensive description of the service and model. Interviewees will include commissioners, service managers, clinicians, referrers, parents and young people. Interviews will be recorded and transcribed, proceeding to qualitative analysis based on components of the programme theory. Regular team meetings will discuss coding, address inconsistencies, and refine collective understanding of coding framework. Coded data will be collated using NVivo software.

Also known as: focus group, health economic questionnaire, survey, Interview, Case note data

Focus groups:; Individual child/family Level Case Studies:; Individual/family level interviews; Service Model Level Case Studies

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Members of staff. referrers, and users of Autism diagnostic services for children.

You may qualify if:

• Lead clinicians for childhood autism diagnostic assessment teams (children age 1-18 years), or someone who they nominate.

You may not qualify if:

• Members of staff not involved in Autism diagnostic services.
• Parents of young people who have been through the diagnostic pathway
• Young people who have been through the diagnostic pathways
• Clinicians working in centres involved in the autism diagnostic process
• Commissioners and managers of autism services; professionals who refer in to the autism pathways
• Adults on the autism pathway
• Professionals involved in the adult autism pathway

Sponsors & Collaborators

• Sussex Community NHS Foundation Trust: lead
• University of Kent: collaborator
• University of Surrey: collaborator
• Newcastle University: collaborator
• Council for Disabled Children: collaborator
• Autistica: collaborator
• West Sussex Parent Carer Forum: collaborator
• Northumberland, Tyne and Wear NHS Foundation Trust: collaborator
• Cambridgeshire and Peterborough NHS Foundation Trust: collaborator
• Brighton & Sussex Medical School: collaborator
• National Health Service, United Kingdom: collaborator

Study Sites (1)

Nightingale Primary Care Centre

Haywards Heath, West Sussex, RH16 4BN, United Kingdom

RECRUITING

Related Publications (2)

• Abrahamson V, Zhang W, Wilson PM, Farr W, Reddy V, Parr J, Peckham A, Male I. Realist evaluation of Autism ServiCe Delivery (RE-ASCeD): which diagnostic pathways work best, for whom and in what context? Findings from a rapid realist review. BMJ Open. 2021 Dec 14;11(12):e051241. doi: 10.1136/bmjopen-2021-051241.

  PMID: 34907053 DERIVED

• Abrahamson V, Zhang W, Wilson P, Farr W, Male I. Realist Evaluation of Autism ServiCe Delivery (RE-ASCeD): which diagnostic pathways work best, for whom and in what context? Protocol for a rapid realist review. BMJ Open. 2020 Jul 6;10(7):e037846. doi: 10.1136/bmjopen-2020-037846.

  PMID: 32636288 DERIVED

MeSH Terms

Conditions

Autistic Disorder; Disease; Patient Satisfaction

Interventions

Focus Groups; Surveys and Questionnaires; Interviews as Topic

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Ian Male, Msc MRCP MBBCh

  Sussex Community NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Will Senior Research Fellow, PhD

CONTACT

UK 01444 475804; will.farr@nhs.net

Helen Vaughan

CONTACT

01273 696011; helenvaughan@nhs.net

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 18, 2020
• First Posted: June 9, 2020
• Study Start: November 30, 2019
• Primary Completion: June 30, 2022
• Study Completion: December 30, 2022
• Last Updated: May 6, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Starting September 2023
• Access Criteria: Anonymised IPD will be shared if the applicant writes to the project steering committee who will review the request. Access will only be allowed once the study is complete and all publications are complete.

Locations

GB (1)