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

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: NCT03677089
Recruitment Status : Completed
First Posted : September 19, 2018
Results First Posted : April 30, 2020
Last Update Posted : April 30, 2020
Sponsor:
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
Information provided by (Responsible Party):
Karen Kuhlthau, Massachusetts General Hospital

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".

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Behavioral: 12 ECHO Autism telehealth clinics Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Health Services Research
Official Title: ECHO Autism Replication: Step Wedge Randomized Trial
Actual Study Start Date : September 1, 2016
Actual Primary Completion Date : November 27, 2018
Actual Study Completion Date : November 27, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ECHO Cohort
Sites undergo 12 ECHO Autism telehealth clinics. Clusters of two sites each will initiate intervention with 3 months between the start of each cluster.
Behavioral: 12 ECHO Autism telehealth clinics
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 Measures :
  1. Longitudinal Pattern of ASD Screening in PCP Charts [ Time Frame: Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9) ]
    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.

  2. Longitudinal Pattern of Reported Co-occurring Medical Conditions Correctly Treated in PCP Charts [ Time Frame: Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9) ]
    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 :
  1. Longitudinal Pattern of Scores on Provider ASD Knowledge Assessment [ Time Frame: Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9) ]

    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.


  2. Longitudinal Pattern of Scores on Provider ASD Self-Efficacy Assessment [ Time Frame: Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9) ]

    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.


  3. Longitudinal Pattern of the Number of Perceived Barriers to Care [ Time Frame: Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9) ]
    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.

  4. Participant Satisfaction With ECHO Autism Program [ Time Frame: At end of intervention (Month 6) ]
    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").

  5. PCP ECHO Program Attendance [ Time Frame: At end of intervention (Month 6) ]
    Percentage of the average number of sessions (out of 12) that the participant attended, of those who have completed the program.

  6. Number of Co-morbidities in Children With ASD [ Time Frame: Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9) ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

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): NCT03677089


Sponsors and Collaborators
Massachusetts General Hospital
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
Investigators
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Principal Investigator: Kristin Sohl, MD, FAAP University of Missouri Health Care, Thompson Center for Autism
Principal Investigator: Micah Mazurek, PhD University of Virginia, Curry School of Education
  Study Documents (Full-Text)

Documents provided by Karen Kuhlthau, Massachusetts General Hospital:
Study Protocol  [PDF] May 9, 2017
Statistical Analysis Plan: Original  [PDF] October 29, 2018
Statistical Analysis Plan: Amendment 1  [PDF] January 30, 2019
Statistical Analysis Plan: Amendment 2  [PDF] November 25, 2019

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Karen Kuhlthau, Associate Professor of Pediatrics, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03677089    
Other Study ID Numbers: 2016P000415
UA3MC11054 ( Other Grant/Funding Number: Health Resources and Services Administration )
First Posted: September 19, 2018    Key Record Dates
Results First Posted: April 30, 2020
Last Update Posted: April 30, 2020
Last Verified: April 2020
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
Keywords provided by Karen Kuhlthau, Massachusetts General Hospital:
ASD
Autism
Telehealth
Primary Care Providers
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders