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Extension for Community Healthcare Outcomes Autism Replication Evaluation (ECHO Autism)

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
12 ECHO Autism telehealth clinics
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Autism Spectrum Disorder focused on measuring ASD, Autism, Telehealth, Primary Care Providers

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Current practice as a primary care provider (PCP)
  • Currently providing care for children
  • Professional training in: general pediatrics, family medicine, advance practice nursing (i.e. nurse practitioner or physician assistant)
  • Active medical license in the state of practice
  • Patient population is at least 50% underserved

Exclusion Criteria:

  • Trainee status (e.g., medical student, intern, resident, or other pre-professional trainee)
  • Subspecialist (e.g., psychiatrists, neurologists, developmental and behavioral pediatricians)
  • Practicing within the same practice as another PCP participant (i.e., only one PCP participant from any given practice may be enrolled as a research participant in the study)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    ECHO Cohort

    Arm Description

    Sites undergo 12 ECHO Autism telehealth clinics. Clusters of two sites each will initiate intervention with 3 months between the start of each cluster.

    Outcomes

    Primary Outcome Measures

    Longitudinal Pattern of ASD Screening in PCP Charts
    Clinical Practice/Behavior for ASD screening will be assessed at four time points by review of a subset of charts from each Primary Care Provider's practice. Four subsets of charts will be reviewed for appropriate ASD screening occurring during well-child visits. Data will be summarized into the percent of children appropriately screened for ASD by each PCP.
    Longitudinal Pattern of Reported Co-occurring Medical Conditions Correctly Treated in PCP Charts
    Clinical Practice/Behavior for treating co-occurring medical conditions will be assessed at four time points by review of a subset of charts from each Primary Care Provider's practice. All visits with an ASD will be reviewed. Data will be summarized into the percent of co-occurring medical conditions appropriately treated by each PCP.

    Secondary Outcome Measures

    Longitudinal Pattern of Scores on Provider ASD Knowledge Assessment
    ASD knowledge will be assessed at four time points using a 33-item unpublished test developed specifically for the current study. The test assesses knowledge in the areas of ASD screening/identification, psychiatric co-morbidities, medical co-morbidities, and management of additional ASD-specific needs. This test scores are based on the total number of correct answers, among all 33 questions. Any missing answers are counted as incorrect responses. Scores range from 0-100 with higher scores showing more knowledge of ASD.
    Longitudinal Pattern of Scores on Provider ASD Self-Efficacy Assessment
    Self-Efficacy will be assessed at four time points using a 57-item unpublished questionnaire developed for a previous ECHO Autism pilot study. The questionnaire is comprised of five domains: ASD screening and identification, ASD referral and resources, assessment and treatment of medical comorbidities, assessment and treatment of psychiatric comorbidities, and other items. Primary Care Providers report the degree to which they are confident in their ability to provide effective care in each domain. Items are rated on a 6-point Likert-type scale, where 1 = "no confidence" and 6 = "highly confident/expert". Items are summed for a total score and five sub-scale scores. A subscale is marked as missing if more than 20% of responses are missing and the total score is marked as missing if any subscale is marked as missing or if 6 or more of the 57 questions have missing responses. These scores are then normalized to a percentage. Higher scores indicate greater perceived self-efficacy.
    Longitudinal Pattern of the Number of Perceived Barriers to Care
    Perceived barriers to caring for children with autism in primary care will be assessed by participant response to an unpublished 9-item checklist and an open response "other" category for a total of 10 possible barriers. A maximum of 10 barriers can be reported and a minimum of 0. More reported barriers indicate more barriers to care.
    Participant Satisfaction With ECHO Autism Program
    Participant satisfaction will be assessed using an unpublished 12-item survey developed for a previous ECHO Autism pilot study. The survey includes 10 questions assessing overall satisfaction with participation in the ECHO Autism clinic (rated on a 5-point Likert-type scale), and two questions asking for overall comments and suggestions. Participant satisfaction is defined as the percentage of participants who answer 2 = "agree" or 1 = "strongly agree" to question 1 ("Participation in ECHO Autism improved my ability to care for children with autism in my practice").
    PCP ECHO Program Attendance
    Percentage of the average number of sessions (out of 12) that the participant attended, of those who have completed the program.
    Number of Co-morbidities in Children With ASD
    The summary measure is defined as the mean number of co-morbidities reported among the four co-morbidities of interest for a child with ASD. Participants can be included in this outcome measure only if they have children with ASD seen in the 60 days prior to the chart review with an identified medical co-morbidity.

    Full Information

    First Posted
    August 14, 2018
    Last Updated
    April 29, 2020
    Sponsor
    Massachusetts General Hospital
    Collaborators
    University of Toronto, Children's Hospital of Philadelphia, University of Pittsburgh, University of Rochester, Children's Hospital Medical Center, Cincinnati, University of Arkansas, Nationwide Children's Hospital, Vanderbilt University Medical Center, University of California, Irvine, University of Missouri-Columbia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03677089
    Brief Title
    Extension for Community Healthcare Outcomes Autism Replication Evaluation
    Acronym
    ECHO Autism
    Official Title
    ECHO Autism Replication: Step Wedge Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2016 (Actual)
    Primary Completion Date
    November 27, 2018 (Actual)
    Study Completion Date
    November 27, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Massachusetts General Hospital
    Collaborators
    University of Toronto, Children's Hospital of Philadelphia, University of Pittsburgh, University of Rochester, Children's Hospital Medical Center, Cincinnati, University of Arkansas, Nationwide Children's Hospital, Vanderbilt University Medical Center, University of California, Irvine, University of Missouri-Columbia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    ECHO Autism was intended to assess rigorously the impact of a 12-session telemedicine training program on participating Primary Care Providers (PCP) knowledge, clinical behavior, and self-efficacy in the screening and care of children with Autism Spectrum Disorder (ASD). Each session is referred to as an "ECHO clinic".
    Detailed Description
    The study involved 10 sites (each referred to as an "ECHO Autism Hub"), each running a 12-session training program using a common curriculum and core lecture, with each site expected to recruit 15 PCPs. Sites were randomized in a stepped-wedge design with 5 clusters (2 sites per cluster) and a staggered start over a 1-year period. Staggering the start allowed for some control for potential temporal trends, as well as allowing the core team to focus on working with each site to ensure smooth startup of the training program at each site. Outcomes are measured at baseline (Month 0), during the intervention (approximately 3 months after the start of the intervention) and after the end of the intervention (approximately 6 months after the start of the intervention). An additional measurement was made 3 months after the end of the intervention to assess whether deterioration occurs after clinic participation ends. All participants received the intervention.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Autism Spectrum Disorder
    Keywords
    ASD, Autism, Telehealth, Primary Care Providers

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Sites were randomized in a stepped-wedge design with 5 clusters (2 sites per cluster) and a staggered start over a 1-year period. Staggering the start allowed for some control for potential temporal trends, as well as allowing the core team to focus on working with each site to ensure smooth startup of the training program at each site. All participants received the intervention.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    148 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ECHO Cohort
    Arm Type
    Experimental
    Arm Description
    Sites undergo 12 ECHO Autism telehealth clinics. Clusters of two sites each will initiate intervention with 3 months between the start of each cluster.
    Intervention Type
    Behavioral
    Intervention Name(s)
    12 ECHO Autism telehealth clinics
    Intervention Description
    Twice-monthly 2-hour ECHO Autism Clinics will be provided during a 6-month period. Each Clinic will include a didactic presentation, 2 to 3 Primary Care Provider-generated case presentations, expert feedback, and group discussion. Although the ECHO Clinic will include discussion of specific cases, no identifiable personal health information will be shared, individual patients will not be identified, and no direct patient care will be provided.
    Primary Outcome Measure Information:
    Title
    Longitudinal Pattern of ASD Screening in PCP Charts
    Description
    Clinical Practice/Behavior for ASD screening will be assessed at four time points by review of a subset of charts from each Primary Care Provider's practice. Four subsets of charts will be reviewed for appropriate ASD screening occurring during well-child visits. Data will be summarized into the percent of children appropriately screened for ASD by each PCP.
    Time Frame
    Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9)
    Title
    Longitudinal Pattern of Reported Co-occurring Medical Conditions Correctly Treated in PCP Charts
    Description
    Clinical Practice/Behavior for treating co-occurring medical conditions will be assessed at four time points by review of a subset of charts from each Primary Care Provider's practice. All visits with an ASD will be reviewed. Data will be summarized into the percent of co-occurring medical conditions appropriately treated by each PCP.
    Time Frame
    Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9)
    Secondary Outcome Measure Information:
    Title
    Longitudinal Pattern of Scores on Provider ASD Knowledge Assessment
    Description
    ASD knowledge will be assessed at four time points using a 33-item unpublished test developed specifically for the current study. The test assesses knowledge in the areas of ASD screening/identification, psychiatric co-morbidities, medical co-morbidities, and management of additional ASD-specific needs. This test scores are based on the total number of correct answers, among all 33 questions. Any missing answers are counted as incorrect responses. Scores range from 0-100 with higher scores showing more knowledge of ASD.
    Time Frame
    Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9)
    Title
    Longitudinal Pattern of Scores on Provider ASD Self-Efficacy Assessment
    Description
    Self-Efficacy will be assessed at four time points using a 57-item unpublished questionnaire developed for a previous ECHO Autism pilot study. The questionnaire is comprised of five domains: ASD screening and identification, ASD referral and resources, assessment and treatment of medical comorbidities, assessment and treatment of psychiatric comorbidities, and other items. Primary Care Providers report the degree to which they are confident in their ability to provide effective care in each domain. Items are rated on a 6-point Likert-type scale, where 1 = "no confidence" and 6 = "highly confident/expert". Items are summed for a total score and five sub-scale scores. A subscale is marked as missing if more than 20% of responses are missing and the total score is marked as missing if any subscale is marked as missing or if 6 or more of the 57 questions have missing responses. These scores are then normalized to a percentage. Higher scores indicate greater perceived self-efficacy.
    Time Frame
    Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9)
    Title
    Longitudinal Pattern of the Number of Perceived Barriers to Care
    Description
    Perceived barriers to caring for children with autism in primary care will be assessed by participant response to an unpublished 9-item checklist and an open response "other" category for a total of 10 possible barriers. A maximum of 10 barriers can be reported and a minimum of 0. More reported barriers indicate more barriers to care.
    Time Frame
    Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9)
    Title
    Participant Satisfaction With ECHO Autism Program
    Description
    Participant satisfaction will be assessed using an unpublished 12-item survey developed for a previous ECHO Autism pilot study. The survey includes 10 questions assessing overall satisfaction with participation in the ECHO Autism clinic (rated on a 5-point Likert-type scale), and two questions asking for overall comments and suggestions. Participant satisfaction is defined as the percentage of participants who answer 2 = "agree" or 1 = "strongly agree" to question 1 ("Participation in ECHO Autism improved my ability to care for children with autism in my practice").
    Time Frame
    At end of intervention (Month 6)
    Title
    PCP ECHO Program Attendance
    Description
    Percentage of the average number of sessions (out of 12) that the participant attended, of those who have completed the program.
    Time Frame
    At end of intervention (Month 6)
    Title
    Number of Co-morbidities in Children With ASD
    Description
    The summary measure is defined as the mean number of co-morbidities reported among the four co-morbidities of interest for a child with ASD. Participants can be included in this outcome measure only if they have children with ASD seen in the 60 days prior to the chart review with an identified medical co-morbidity.
    Time Frame
    Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9)

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Current practice as a primary care provider (PCP) Currently providing care for children Professional training in: general pediatrics, family medicine, advance practice nursing (i.e. nurse practitioner or physician assistant) Active medical license in the state of practice Patient population is at least 50% underserved Exclusion Criteria: Trainee status (e.g., medical student, intern, resident, or other pre-professional trainee) Subspecialist (e.g., psychiatrists, neurologists, developmental and behavioral pediatricians) Practicing within the same practice as another PCP participant (i.e., only one PCP participant from any given practice may be enrolled as a research participant in the study)
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kristin Sohl, MD, FAAP
    Organizational Affiliation
    University of Missouri Health Care, Thompson Center for Autism
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Micah Mazurek, PhD
    Organizational Affiliation
    University of Virginia, Curry School of Education
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    32150229
    Citation
    Mazurek MO, Parker RA, Chan J, Kuhlthau K, Sohl K; ECHO Autism Collaborative. Effectiveness of the Extension for Community Health Outcomes Model as Applied to Primary Care for Autism: A Partial Stepped-Wedge Randomized Clinical Trial. JAMA Pediatr. 2020 May 1;174(5):e196306. doi: 10.1001/jamapediatrics.2019.6306. Epub 2020 May 4.
    Results Reference
    derived

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