<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04422483</url>
  </required_header>
  <id_info>
    <org_study_id>Re-ASCed Protocol IM 17-4-20</org_study_id>
    <nct_id>NCT04422483</nct_id>
  </id_info>
  <brief_title>A Realist Evaluation of Autism ServiCe Delivery (RE-ASCeD)</brief_title>
  <acronym>Re-ASCed</acronym>
  <official_title>A Realist Evaluation of Autism ServiCe Delivery (RE-ASCeD): Which Diagnostic Pathways Work Best, for Whom, When, and at What Cost?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sussex Community NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Kent</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Surrey</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Newcastle University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Council for Disabled Children</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Autistica</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>West Sussex Parent Carer Forum</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Northumberland, Tyne and Wear NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cambridgeshire and Peterborough NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Brighton &amp; Sussex Medical School</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Health Service, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Sussex Community NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Diagnostic pathways for children with possible autism. Which work best, for whom, when, and&#xD;
      at what cost? Autism is a complex neuro-behaviour condition. People with autism have&#xD;
      difficulty with social interaction and in communication with others. They may struggle with&#xD;
      change, and repeat actions over and over. Life may be very anxious or stressful. The signs of&#xD;
      autism can occur at any age but often appear in the first two years of life. There is no one&#xD;
      type of autism, but many, so the condition is now called autism spectrum disorder (ASD).&#xD;
      Autism is lifelong but this study is only about children. Caring for a child with autism can&#xD;
      be difficult and can sometimes be tough on the whole family.&#xD;
&#xD;
      This project aims to guide the people who plan services for families and children. Different&#xD;
      teams and services that do autism assessments will help us. The investigators will ask teams&#xD;
      and services: What speeds up diagnosis? What delays diagnosis?&#xD;
&#xD;
      The study will be in four work packages:&#xD;
&#xD;
        1. The investigators will review research in the UK and abroad to find evidence and ideas&#xD;
           that will help speed up diagnosis.&#xD;
&#xD;
        2. The investigators will survey professionals who work for the specialist teams who&#xD;
           diagnose autism. The survey will be about each step in the process and ask which&#xD;
           professionals get involved. The investigators will ask about the number of children they&#xD;
           see and the time it usually takes to reach a diagnosis. This will give us a picture of&#xD;
           the national situation.&#xD;
&#xD;
        3. After the national survey, the investigators will select around six or eight teams.&#xD;
           These teams will be using different and innovative approaches. The investigators will&#xD;
           study those approaches. The investigators will talk to clinical staff, managers,&#xD;
           referrers, parents and young people. Parents and young people will have gone through the&#xD;
           diagnostic process. The investigators will ask parents and young people about their&#xD;
           experiences and views. The investigators will review the steps in the diagnosis process&#xD;
           for about 70 children in each service. The investigators will find out how long each&#xD;
           assessment takes, how much clinical time it takes, and how much it costs. The&#xD;
           investigators will compare findings across teams and services.&#xD;
&#xD;
        4. The investigators will have national meetings with autism experts and patient groups.&#xD;
           The investigators will show them our findings. These groups will agree recommendations&#xD;
           for practice. Clinical teams, service managers, commissioners, parents' groups, and NHS&#xD;
           England will receive recommendations.&#xD;
&#xD;
      The research team has specialist expertise in autism, health services, economics, and&#xD;
      statistics. The team includes public and NHS England partners. This will ensure the&#xD;
      investigators take account of the needs of families and the investigators send the findings&#xD;
      to people who plan services.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Scientific Summary (following Rameses 2 reporting guidelines)&#xD;
&#xD;
      Study Title&#xD;
&#xD;
      A Realist Evaluation of Autism ServiCe Delivery (RE-ASCeD): Which diagnostic pathways work&#xD;
      best, for whom, when, and at what cost?&#xD;
&#xD;
      Research Question Which autism diagnostic pathways work best, for whom, in what&#xD;
      circumstances, and at what cost when providing timely and high quality diagnostic services?&#xD;
&#xD;
      Secondary Research Questions&#xD;
&#xD;
        -  What factors underpin timely diagnosis service delivery success or failure?&#xD;
&#xD;
        -  What needs to be in place to identify the needs and create individualized, holistic&#xD;
           pathways of diagnosis for the child and their family?&#xD;
&#xD;
      Background The NHS England Long Term Plan states: &quot;Children and young people with suspected&#xD;
      autism wait too long before being provided with a diagnostic assessment. Over the next three&#xD;
      years the investigators aim to test and implement the most effective ways to reduce waiting&#xD;
      times…achieving timely diagnostic assessments in line with best practice guidelines...(and)&#xD;
      to support children with autism and their families, throughout the diagnostic process.&quot; Set&#xD;
      against a background of increasing demand for diagnostic assessment, and the need, as&#xD;
      recommended by the NICE guidelines, for a multidisciplinary approach to assessment, taking at&#xD;
      least 13 hours of professional time and £800 per child, evidence is needed to identify models&#xD;
      of diagnostic assessment to achieve timely diagnoses, and how families can best be supported&#xD;
      through this process. The NHSE Long Term Plan aims to reduce the wait time for diagnosis, and&#xD;
      the aim of this project is to find ways/models to directly address that need.&#xD;
&#xD;
      Aims and Objectives This study aims to examine existing models of Autism diagnostic service&#xD;
      delivery, and to investigate which approaches offer the most timely, cost-effective, high&#xD;
      quality and child and family friendly solutions, and in line with realist thinking, to&#xD;
      identify the factors that are likely to underpin their success, or failure, if rolled out&#xD;
      more generally across providers.&#xD;
&#xD;
      Method&#xD;
&#xD;
      The study will use Realist Evaluation methodology, which enables evaluation of complex&#xD;
      interventions in health care by building on existing research, to identify &quot;what works, for&#xD;
      whom and in what circumstances&quot;. Mixed methods, including Rapid Realist (literature) Review,&#xD;
      survey of current practice, and case studies of centres delivering promising approaches, will&#xD;
      be used to build a picture in an iterative manner, to identify underlying Contexts and&#xD;
      Mechanisms that contribute to the desired Outcomes (CMO configurations) of improved Autism&#xD;
      diagnostic service delivery and user experience, that in turn can provide plausible&#xD;
      explanations of why the service models work or do not in certain circumstances. Data analysis&#xD;
      from each phase of the study will be synthesised through a realist evaluative process&#xD;
      comprising of four stages:&#xD;
&#xD;
        1. Articulation of programme theories and propositions from WP1 of the study (rapid realist&#xD;
           review). Identification of candidate CMO configurations.&#xD;
&#xD;
        2. Data collection from WP4 (case studies) of the study to test and refine propositions.&#xD;
&#xD;
        3. Map the outcomes of each model across the cases; interrogate what contexts and&#xD;
           mechanisms explain the pattern of outcomes.&#xD;
&#xD;
        4. Through stakeholder consolidation (WP5), refine explanatory CMO configurations to&#xD;
           evaluate what works best and in what circumstances to deliver timely and cost-effective&#xD;
           diagnostic services that meet the needs of children with possible Autism&#xD;
&#xD;
      Initial Programme Theory (Based on NICE principles) If there is an MDT assessment by a team&#xD;
      with competencies in child neurodevelopment and mental health (context), then Autism will be&#xD;
      recognised as a complex condition that relies on detailed history and observation across&#xD;
      settings (mechanism) to diagnose it, leading to an accurate diagnosis, recognition of&#xD;
      associated comorbidity such as ADHD and intellectual disability (outcome), and the ruling out&#xD;
      of complex differential diagnoses.&#xD;
&#xD;
      This will also create - whilst not an explicit part of this project - accurate pictures of&#xD;
      child strengths and needs to inform individualized packages of support and intervention&#xD;
      through health, education and social care (outcome).&#xD;
&#xD;
      Work Package One (months 1-7). Rapid Realist Review. Evidence will be sought from published&#xD;
      studies and evaluations of Autism diagnostic services, including controlled trials,&#xD;
      uncontrolled studies, cost-effectiveness studies, process evaluations, grey literature and&#xD;
      qualitative studies, including unpublished information about locally implemented Autism&#xD;
      services. The purpose will be to refine or develop initial programme theories.&#xD;
&#xD;
      Work Package Two (months 1-6): National/International Survey of Current Diagnostic Practice:&#xD;
      An electronic survey will be sent to UK CDCs, CAMHS teams, and tertiary centres, delivering&#xD;
      Autism diagnostic services. This will ask teams to describe current challenges to, and any&#xD;
      new models of diagnostic service delivery they are using. Analysis will use both qualitative&#xD;
      and quantitative methods, to identify common themes, and services using novel approaches.&#xD;
&#xD;
      Work Package Three (months 7-9): Purposive Sampling Frame. The findings of WP 1 &amp; 2 will be&#xD;
      used to develop a matrix of the key features of service delivery, plus other contextual&#xD;
      factors such as lower SES, rural, urban etc. This will be used as a sampling frame. It is&#xD;
      anticipated that 6-8 service delivery models will be purposefully selected as case studies&#xD;
      across the matrix to ensure the investigators have a full range of delivery models and&#xD;
      population characteristics.&#xD;
&#xD;
      Work Package Four: Case studies (months 10-29): In-depth exploration of individual service&#xD;
      models will be carried out to determine the interrelationship of context, intervention,&#xD;
      mechanisms and outcomes as they occur in their natural setting. Data will be gathered within&#xD;
      case studies using mixed methods at two levels: (i) service model and (ii) individual child/&#xD;
      family. Methods will include semi structured realist Interviews, focus groups, and document&#xD;
      reviews to assemble a comprehensive description of the service and model. Interviewees will&#xD;
      include commissioners, service managers, clinicians, referrers, parents and young people.&#xD;
      Interviews will be recorded and transcribed, proceeding to qualitative analysis based on&#xD;
      components of the programme theory. Regular team meetings will discuss coding, address&#xD;
      inconsistencies, and refine collective understanding of coding framework. Coded data will be&#xD;
      collated using NVivo software.&#xD;
&#xD;
      For each case study the journeys of at last 58 children completing the diagnostic pathway&#xD;
      will be recorded from case notes to measure pathway, hours of professional input and time to&#xD;
      diagnosis. Costs incurred by families for example travel to clinic, loss of earnings, will be&#xD;
      collected by interview. Associations between service use costs and characteristics of the&#xD;
      child and model will be assessed by regression analysis.&#xD;
&#xD;
      Work Package Five: Consolidation event, Months 27-28 : The investigators will run two&#xD;
      iterative national consensus workshops, inviting key stakeholders including NHSE and&#xD;
      parents/young people, to refine and confirm the context-mechanism-outcome configurations, and&#xD;
      salient actions required to deliver timely, reliable and costed diagnostic services that meet&#xD;
      the needs of children with possible Autism. This will lead to dissemination of models to&#xD;
      inform the ongoing development of service models within the NHSE Long-Term Plan,&#xD;
      commissioning guidelines and local service development.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 30, 2019</start_date>
  <completion_date type="Anticipated">December 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Case Study: Case Note Review - Pathway completion time taken</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>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).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Questionnaire: Reported Challenges</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>National/International Survey of Current Diagnostic Practice: Asking diagnostic service teams to describe current challenges to, and any new models of diagnostic service delivery they are using.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire: Reported Type of Service</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>National/International Survey of Current Diagnostic Practice: Asking diagnostic service teams to describe type of service, e.g. Child Adolescent Mental Health Services, Child Development Clinic, Tertiary referral, in-patient ward, finance department.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire: Reported New Models of Services</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>National/International Survey of Current Diagnostic Practice: Asking diagnostic service teams to describe any new models of diagnostic service delivery they are using.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire: Reported Geographical Area</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>National/International Survey of Current Diagnostic Practice: Asking diagnostic service teams to describe Geographical area (England), e.g. population size, ethnic background, socioeconomic status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire: Reported Activity Levels</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>National/International Survey of Current Diagnostic Practice: Asking diagnostic service teams to describe Activity levels: - Numbers of new referrals into and out of the service annually Number on current case-loads Waiting list times e.g. average Number of diagnoses (different types) per year Time taken to reach diagnosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire: Reported Resources Available</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>National/International Survey of Current Diagnostic Practice: Asking diagnostic service teams to describe resources available:- Team size Team composition Professional multidisciplinary skill mix Facilities available Equipment available</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire: Reported Age Range of Service</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>National/International Survey of Current Diagnostic Practice: Asking diagnostic service teams to describe reported age range of services</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire: Reported Clinical Remit</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>National/International Survey of Current Diagnostic Practice: Asking diagnostic service teams to describe services remit and confirm type of service assessments for children for:- Autism ADHD Early trauma Neuro-disability Mental health, Common comorbidities Differential diagnoses of Autism</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire: Reported Clinical Team Competencies for Clinical Remit</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>National/International Survey of Current Diagnostic Practice: Asking diagnostic service teams to describe services remit and confirm professional service competencies for children for:- Autism ADHD Early trauma Neuro-disability Mental health, Common comorbidities Differential diagnoses of Autism</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Case Study - Diagnostic Team Realist Interviews</measure>
    <time_frame>1 hour interview during 12 month case studies</time_frame>
    <description>Realist interviews either with between 6 and 12 team members per service to include commissioners, managers, clinicians, and referrers (GPs, SENCOs, HV, School nurse).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Case Study: Child and Family Interviews</measure>
    <time_frame>30 minutes interview during 12 month case studies</time_frame>
    <description>Convenience sample of children and families who have recently been referred for assessment and diagnosis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Case Study: Case Note Review - Dates of Meetings</measure>
    <time_frame>Up to 20 months</time_frame>
    <description>Research team monitor steps in the diagnostic pathway. Access child's clinical care records for dates of meetings to construct timeline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Case Study: Case Note Review - Duration of Meetings</measure>
    <time_frame>Up to 20 months</time_frame>
    <description>Research team monitor steps in the diagnostic pathway. Access child's clinical care records for duration of meetings to calculate time taken overall to complete pathway.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Case Study: Case Note Review - Purpose of Clinical Meeting</measure>
    <time_frame>Up to 20 months</time_frame>
    <description>Research team monitor steps in the diagnostic pathway. Access child's clinical care records for purpose of contact with family/child for health professionals.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Case Study: Case Note Review - Test results</measure>
    <time_frame>Up to 20 months</time_frame>
    <description>Research team monitor steps in the diagnostic pathway. Access child's clinical care records for test results .</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Case Study: Case Note Review Pathway completion final diagnosis</measure>
    <time_frame>Up to 20 months</time_frame>
    <description>Research team monitor steps in the diagnostic pathway. Access child's clinical care records for final diagnosis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Case Study: Case Note Review - Pathway completion time taken</measure>
    <time_frame>Up to 20 months</time_frame>
    <description>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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Case Study: Case Note Review Pathway Completion Co-Morbidities</measure>
    <time_frame>Up to 20 months</time_frame>
    <description>Research team monitor steps in the diagnostic pathway. Access child's clinical care records for any co-morbidities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Case Study: Case Note Review Pathway Completion- type of professional involved</measure>
    <time_frame>Up to 20 months</time_frame>
    <description>Research team monitor steps in the diagnostic pathway. Access child's clinical care records for type of professionals involved.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Realist Evaluation Outcomes</measure>
    <time_frame>Up to 32 months</time_frame>
    <description>Reported Outcomes of Autism diagnostic service delivery and user experience, that provide plausible explanations of why the service models work or do not in certain circumstances.</description>
  </other_outcome>
  <other_outcome>
    <measure>Realist Evaluation Contexts</measure>
    <time_frame>Up to 32 months</time_frame>
    <description>Reported Contexts of Autism diagnostic service delivery and user experience, that provide plausible explanations of why the service models work or do not in certain circumstances.</description>
  </other_outcome>
  <other_outcome>
    <measure>Realist Evaluation Mechanisms</measure>
    <time_frame>Up to 32 months</time_frame>
    <description>Reported Mechanisms of Autism diagnostic service delivery and user experience, that provide plausible explanations of why the service models work or do not in certain circumstances.</description>
  </other_outcome>
  <other_outcome>
    <measure>Rapid Realist Review</measure>
    <time_frame>Up to 7 months</time_frame>
    <description>Rapid Realist Review (RRR) will build on the systematic review undertaken in preparation of the NICE guidelines. The RRR will add to this through providing context-specific explanations for what works within a particular set of parameters. RRR is a well-established approach to synthesising evidence within a compressed time period that can identify groups of interventions or models of service delivery that relate to desired outcomes. It is also seen as consistent with the RAMESES standards for realist syntheses.</description>
  </other_outcome>
  <other_outcome>
    <measure>Novel Health Economic Evaluation Questionnaire: Parent Reported Experience</measure>
    <time_frame>Every 3 months from the date of participant consent and assessed up to a maximum of 24 months</time_frame>
    <description>Parents reported experience of the diagnostic process up to either diagnosis or discharge. Maximum values will be unknown until data set is complete. Reports from parents may be either positive or negative and will be on a Likert scale of 1-10 with 1 strong against the current diagnostic process and 10 strongly in favour.</description>
  </other_outcome>
  <other_outcome>
    <measure>Novel Health Economic Evaluation Questionnaire: Parent Reported Expenses</measure>
    <time_frame>Every 3 months from the date of participant consent and assessed up to a maximum of 24 months</time_frame>
    <description>Parents reported out of pocket expenses on travel, loss of earnings, childcare costs. Values will be in pound sterling and maximum will be unknown until data set is complete.</description>
  </other_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">520</enrollment>
  <condition>Autism</condition>
  <condition>Children</condition>
  <condition>Family</condition>
  <condition>Diagnoses, Syndromes, and Conditions</condition>
  <condition>Patient Satisfaction</condition>
  <arm_group>
    <arm_group_label>Service Model Level Case Studies</arm_group_label>
    <description>Realist Interviews. MONTHS 9-30 (N=6-8 sites, 12 people per site, 96 interviewees)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Individual/family level interviews</arm_group_label>
    <description>Child Interviews. MONTHS 9-30 (N=6-8 sites, 6 people per site, max. 48 interviewees)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Individual child/family Level Case Studies:</arm_group_label>
    <description>MONTHS 10-30 (N=6-8 sites, 78 people per model (x4), 312 participants, 156 per NU/SCFT depending on distribution of sites)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Focus groups:</arm_group_label>
    <description>MONTHS 9-30 (N=6-8 sites, 6-8 focus groups of up to 8 parents) N= 64</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Realist evaluation</intervention_name>
    <description>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.</description>
    <arm_group_label>Focus groups:</arm_group_label>
    <arm_group_label>Individual child/family Level Case Studies:</arm_group_label>
    <arm_group_label>Individual/family level interviews</arm_group_label>
    <arm_group_label>Service Model Level Case Studies</arm_group_label>
    <other_name>focus group</other_name>
    <other_name>health economic questionnaire</other_name>
    <other_name>survey</other_name>
    <other_name>Interview</other_name>
    <other_name>Case note data</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Members of staff. referrers, and users of Autism diagnostic services for children.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Survey Inclusion Criteria:&#xD;
&#xD;
        • Lead clinicians for childhood autism diagnostic assessment teams (children age 1-18&#xD;
        years), or someone who they nominate.&#xD;
&#xD;
        Survey Exclusion Criteria:&#xD;
&#xD;
        • Members of staff not involved in Autism diagnostic services.&#xD;
&#xD;
        Case Studies Inclusion Criteria :&#xD;
&#xD;
          -  Parents of young people who have been through the diagnostic pathway&#xD;
&#xD;
          -  Young people who have been through the diagnostic pathways&#xD;
&#xD;
          -  Clinicians working in centres involved in the autism diagnostic process&#xD;
&#xD;
          -  Commissioners and managers of autism services; professionals who refer in to the&#xD;
             autism pathways&#xD;
&#xD;
        Case Studies Exclusion Criteria:&#xD;
&#xD;
          -  Adults on the autism pathway&#xD;
&#xD;
          -  Professionals involved in the adult autism pathway&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ian Male, Msc MRCP MBBCh</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sussex Community NHS Foundation Trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Will Senior Research Fellow, PhD</last_name>
    <phone>UK 01444 475804</phone>
    <email>will.farr@nhs.net</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Helen Vaughan</last_name>
    <phone>01273 696011</phone>
    <email>helenvaughan@nhs.net</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Nightingale Primary Care Centre</name>
      <address>
        <city>Haywards Heath</city>
        <state>West Sussex</state>
        <zip>RH16 4BN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ian Male, MD</last_name>
      <phone>01444 414100</phone>
      <email>ian.male@nhs.net</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>May 5, 2021</last_update_submitted>
  <last_update_submitted_qc>May 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sussex Community NHS Foundation Trust</investigator_affiliation>
    <investigator_full_name>William Farr</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Disease</mesh_term>
    <mesh_term>Autistic Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD data that is anonymised, will be released by the project steering commitee,and only then, IPD data that underlie results in publication will be shared</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Starting September 2023</ipd_time_frame>
    <ipd_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.</ipd_access_criteria>
  </patient_data>
  <pending_results>
    <submitted>April 26, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04422483
org study id: Re-ASCed Protocol IM 17-4-20
nct id: NCT04422483
lead sponsor: 
collaborator: 
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has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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. The investigators will review research in the UK and abroad to find evidence and ideas
           that will help speed up diagnosis.

        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. 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. 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.

      The research team has specialist expertise in autism, health services, economics, and
      statistics. The team includes public and NHS England partners. This will ensure the
      investigators take account of the needs of families and the investigators send the findings
      to people who plan services.
Scientific Summary (following Rameses 2 reporting guidelines)

      Study Title

      A Realist Evaluation of Autism ServiCe Delivery (RE-ASCeD): Which diagnostic pathways work
      best, for whom, when, and at what cost?

      Research Question Which autism diagnostic pathways work best, for whom, in what
      circumstances, and at what cost when providing timely and high quality diagnostic services?

      Secondary Research Questions

        -  What factors underpin timely diagnosis service delivery success or failure?

        -  What needs to be in place to identify the needs and create individualized, holistic
           pathways of diagnosis for the child and their family?

      Background The NHS England Long Term Plan states: "Children and young people with suspected
      autism wait too long before being provided with a diagnostic assessment. Over the next three
      years the investigators aim to test and implement the most effective ways to reduce waiting
      times…achieving timely diagnostic assessments in line with best practice guidelines...(and)
      to support children with autism and their families, throughout the diagnostic process." Set
      against a background of increasing demand for diagnostic assessment, and the need, as
      recommended by the NICE guidelines, for a multidisciplinary approach to assessment, taking at
      least 13 hours of professional time and £800 per child, evidence is needed to identify models
      of diagnostic assessment to achieve timely diagnoses, and how families can best be supported
      through this process. The NHSE Long Term Plan aims to reduce the wait time for diagnosis, and
      the aim of this project is to find ways/models to directly address that need.

      Aims and Objectives This study aims to examine existing models of Autism diagnostic service
      delivery, and to investigate which approaches offer the most timely, cost-effective, high
      quality and child and family friendly solutions, and in line with realist thinking, to
      identify the factors that are likely to underpin their success, or failure, if rolled out
      more generally across providers.

      Method

      The study will use Realist Evaluation methodology, which enables evaluation of complex
      interventions in health care by building on existing research, to identify "what works, for
      whom and in what circumstances". Mixed methods, including Rapid Realist (literature) Review,
      survey of current practice, and case studies of centres delivering promising approaches, will
      be used to build a picture in an iterative manner, to identify underlying Contexts and
      Mechanisms that contribute to the desired Outcomes (CMO configurations) of improved Autism
      diagnostic service delivery and user experience, that in turn can provide plausible
      explanations of why the service models work or do not in certain circumstances. Data analysis
      from each phase of the study will be synthesised through a realist evaluative process
      comprising of four stages:

        1. Articulation of programme theories and propositions from WP1 of the study (rapid realist
           review). Identification of candidate CMO configurations.

        2. Data collection from WP4 (case studies) of the study to test and refine propositions.

        3. Map the outcomes of each model across the cases; interrogate what contexts and
           mechanisms explain the pattern of outcomes.

        4. Through stakeholder consolidation (WP5), refine explanatory CMO configurations to
           evaluate what works best and in what circumstances to deliver timely and cost-effective
           diagnostic services that meet the needs of children with possible Autism

      Initial Programme Theory (Based on NICE principles) If there is an MDT assessment by a team
      with competencies in child neurodevelopment and mental health (context), then Autism will be
      recognised as a complex condition that relies on detailed history and observation across
      settings (mechanism) to diagnose it, leading to an accurate diagnosis, recognition of
      associated comorbidity such as ADHD and intellectual disability (outcome), and the ruling out
      of complex differential diagnoses.

      This will also create - whilst not an explicit part of this project - accurate pictures of
      child strengths and needs to inform individualized packages of support and intervention
      through health, education and social care (outcome).

      Work Package One (months 1-7). Rapid Realist Review. Evidence will be sought from published
      studies and evaluations of Autism diagnostic services, including controlled trials,
      uncontrolled studies, cost-effectiveness studies, process evaluations, grey literature and
      qualitative studies, including unpublished information about locally implemented Autism
      services. The purpose will be to refine or develop initial programme theories.

      Work Package Two (months 1-6): National/International Survey of Current Diagnostic Practice:
      An electronic survey will be sent to UK CDCs, CAMHS teams, and tertiary centres, delivering
      Autism diagnostic services. This will ask teams to describe current challenges to, and any
      new models of diagnostic service delivery they are using. Analysis will use both qualitative
      and quantitative methods, to identify common themes, and services using novel approaches.

      Work Package Three (months 7-9): Purposive Sampling Frame. The findings of WP 1 & 2 will be
      used to develop a matrix of the key features of service delivery, plus other contextual
      factors such as lower SES, rural, urban etc. This will be used as a sampling frame. It is
      anticipated that 6-8 service delivery models will be purposefully selected as case studies
      across the matrix to ensure the investigators have a full range of delivery models and
      population characteristics.

      Work Package Four: Case studies (months 10-29): 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.

      For each case study the journeys of at last 58 children completing the diagnostic pathway
      will be recorded from case notes to measure pathway, hours of professional input and time to
      diagnosis. Costs incurred by families for example travel to clinic, loss of earnings, will be
      collected by interview. Associations between service use costs and characteristics of the
      child and model will be assessed by regression analysis.

      Work Package Five: Consolidation event, Months 27-28 : The investigators will run two
      iterative national consensus workshops, inviting key stakeholders including NHSE and
      parents/young people, to refine and confirm the context-mechanism-outcome configurations, and
      salient actions required to deliver timely, reliable and costed diagnostic services that meet
      the needs of children with possible Autism. This will lead to dissemination of models to
      inform the ongoing development of service models within the NHSE Long-Term Plan,
      commissioning guidelines and local service development.
observational model: Ecologic or Community
time perspective: Retrospective
measure: Case Study: Case Note Review - Pathway completion time taken
time frame: Up to 24 months
description: 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).
measure: Questionnaire: Reported Challenges
time frame: Up to 6 months
description: National/International Survey of Current Diagnostic Practice: Asking diagnostic service teams to describe current challenges to, and any new models of diagnostic service delivery they are using.
measure: Questionnaire: Reported Type of Service
time frame: Up to 6 months
description: National/International Survey of Current Diagnostic Practice: Asking diagnostic service teams to describe type of service, e.g. Child Adolescent Mental Health Services, Child Development Clinic, Tertiary referral, in-patient ward, finance department.
measure: Questionnaire: Reported New Models of Services
time frame: Up to 6 months
description: National/International Survey of Current Diagnostic Practice: Asking diagnostic service teams to describe any new models of diagnostic service delivery they are using.
measure: Questionnaire: Reported Geographical Area
time frame: Up to 6 months
description: National/International Survey of Current Diagnostic Practice: Asking diagnostic service teams to describe Geographical area (England), e.g. population size, ethnic background, socioeconomic status.
measure: Questionnaire: Reported Activity Levels
time frame: Up to 6 months
description: National/International Survey of Current Diagnostic Practice: Asking diagnostic service teams to describe Activity levels: - Numbers of new referrals into and out of the service annually Number on current case-loads Waiting list times e.g. average Number of diagnoses (different types) per year Time taken to reach diagnosis
measure: Questionnaire: Reported Resources Available
time frame: Up to 6 months
description: National/International Survey of Current Diagnostic Practice: Asking diagnostic service teams to describe resources available:- Team size Team composition Professional multidisciplinary skill mix Facilities available Equipment available
measure: Questionnaire: Reported Age Range of Service
time frame: Up to 6 months
description: National/International Survey of Current Diagnostic Practice: Asking diagnostic service teams to describe reported age range of services
measure: Questionnaire: Reported Clinical Remit
time frame: Up to 6 months
description: National/International Survey of Current Diagnostic Practice: Asking diagnostic service teams to describe services remit and confirm type of service assessments for children for:- Autism ADHD Early trauma Neuro-disability Mental health, Common comorbidities Differential diagnoses of Autism
measure: Questionnaire: Reported Clinical Team Competencies for Clinical Remit
time frame: Up to 6 months
description: National/International Survey of Current Diagnostic Practice: Asking diagnostic service teams to describe services remit and confirm professional service competencies for children for:- Autism ADHD Early trauma Neuro-disability Mental health, Common comorbidities Differential diagnoses of Autism
measure: Case Study - Diagnostic Team Realist Interviews
time frame: 1 hour interview during 12 month case studies
description: Realist interviews either with between 6 and 12 team members per service to include commissioners, managers, clinicians, and referrers (GPs, SENCOs, HV, School nurse).
measure: Case Study: Child and Family Interviews
time frame: 30 minutes interview during 12 month case studies
description: Convenience sample of children and families who have recently been referred for assessment and diagnosis.
measure: Case Study: Case Note Review - Dates of Meetings
time frame: Up to 20 months
description: Research team monitor steps in the diagnostic pathway. Access child's clinical care records for dates of meetings to construct timeline.
measure: Case Study: Case Note Review - Duration of Meetings
time frame: Up to 20 months
description: Research team monitor steps in the diagnostic pathway. Access child's clinical care records for duration of meetings to calculate time taken overall to complete pathway.
measure: Case Study: Case Note Review - Purpose of Clinical Meeting
time frame: Up to 20 months
description: Research team monitor steps in the diagnostic pathway. Access child's clinical care records for purpose of contact with family/child for health professionals.
measure: Case Study: Case Note Review - Test results
time frame: Up to 20 months
description: Research team monitor steps in the diagnostic pathway. Access child's clinical care records for test results .
measure: Case Study: Case Note Review Pathway completion final diagnosis
time frame: Up to 20 months
description: Research team monitor steps in the diagnostic pathway. Access child's clinical care records for final diagnosis.
measure: Case Study: Case Note Review - Pathway completion time taken
time frame: Up to 20 months
description: 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).
measure: Case Study: Case Note Review Pathway Completion Co-Morbidities
time frame: Up to 20 months
description: Research team monitor steps in the diagnostic pathway. Access child's clinical care records for any co-morbidities.
measure: Case Study: Case Note Review Pathway Completion- type of professional involved
time frame: Up to 20 months
description: Research team monitor steps in the diagnostic pathway. Access child's clinical care records for type of professionals involved.
measure: Realist Evaluation Outcomes
time frame: Up to 32 months
description: Reported Outcomes of Autism diagnostic service delivery and user experience, that provide plausible explanations of why the service models work or do not in certain circumstances.
measure: Realist Evaluation Contexts
time frame: Up to 32 months
description: Reported Contexts of Autism diagnostic service delivery and user experience, that provide plausible explanations of why the service models work or do not in certain circumstances.
measure: Realist Evaluation Mechanisms
time frame: Up to 32 months
description: Reported Mechanisms of Autism diagnostic service delivery and user experience, that provide plausible explanations of why the service models work or do not in certain circumstances.
measure: Rapid Realist Review
time frame: Up to 7 months
description: Rapid Realist Review (RRR) will build on the systematic review undertaken in preparation of the NICE guidelines. The RRR will add to this through providing context-specific explanations for what works within a particular set of parameters. RRR is a well-established approach to synthesising evidence within a compressed time period that can identify groups of interventions or models of service delivery that relate to desired outcomes. It is also seen as consistent with the RAMESES standards for realist syntheses.
measure: Novel Health Economic Evaluation Questionnaire: Parent Reported Experience
time frame: Every 3 months from the date of participant consent and assessed up to a maximum of 24 months
description: Parents reported experience of the diagnostic process up to either diagnosis or discharge. Maximum values will be unknown until data set is complete. Reports from parents may be either positive or negative and will be on a Likert scale of 1-10 with 1 strong against the current diagnostic process and 10 strongly in favour.
measure: Novel Health Economic Evaluation Questionnaire: Parent Reported Expenses
time frame: Every 3 months from the date of participant consent and assessed up to a maximum of 24 months
description: Parents reported out of pocket expenses on travel, loss of earnings, childcare costs. Values will be in pound sterling and maximum will be unknown until data set is complete.
arm group label: Service Model Level Case Studies
description: Realist Interviews. MONTHS 9-30 (N=6-8 sites, 12 people per site, 96 interviewees)
arm group label: Individual/family level interviews
description: Child Interviews. MONTHS 9-30 (N=6-8 sites, 6 people per site, max. 48 interviewees)
arm group label: Individual child/family Level Case Studies:
description: MONTHS 10-30 (N=6-8 sites, 78 people per model (x4), 312 participants, 156 per NU/SCFT depending on distribution of sites)
arm group label: Focus groups:
description: MONTHS 9-30 (N=6-8 sites, 6-8 focus groups of up to 8 parents) N= 64
intervention type: Other
intervention name: Realist evaluation
description: 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.
arm group label: Focus groups:
arm group label: Individual child/family Level Case Studies:
arm group label: Individual/family level interviews
arm group label: Service Model Level Case Studies
other name: focus group
other name: health economic questionnaire
other name: survey
other name: Interview
other name: Case note data
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ian Male, Msc MRCP MBBCh
role: Principal Investigator
affiliation: Sussex Community NHS Foundation Trust
last name: Will Senior Research Fellow, PhD
phone: UK 01444 475804
email: will.farr@nhs.net
last name: Helen Vaughan
phone: 01273 696011
email: helenvaughan@nhs.net
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Sussex Community NHS Foundation Trust
investigator full name: William Farr
investigator title: Principal Investigator
mesh term: Disease
mesh term: Autistic Disorder
sharing ipd: Yes
ipd description: IPD data that is anonymised, will be released by the project steering commitee,and only then, IPD data that underlie results in publication will be shared
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Starting September 2023
ipd 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.
submitted: April 26, 2023