Extension for Community Healthcare Outcomes Autism Replication Evaluation

NCT03677089 | Completed Results DMC

• 2 other identifiers: 2016P000415UA3MC11054
• Study Type: interventional
• Target: 148
• Locations: 0 countries
• Sites: N/A

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".

Conditions

Autism Spectrum Disorder

Keywords

ASD; Autism; Telehealth; Primary Care Providers

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9)

• 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.

  Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9)

Secondary Outcomes (6)

• Longitudinal Pattern of Scores on Provider ASD Knowledge Assessment

  Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9)

• Longitudinal Pattern of Scores on Provider ASD Self-Efficacy Assessment

  Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9)

• Longitudinal Pattern of the Number of Perceived Barriers to Care

  Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9)

• Participant Satisfaction With ECHO Autism Program

  At end of intervention (Month 6)

• PCP ECHO Program Attendance

  At end of intervention (Month 6)

Study Arms (1)

ECHO Cohort

EXPERIMENTAL

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

Interventions

12 ECHO Autism telehealth clinics BEHAVIORAL

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.

ECHO Cohort

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• University of Toronto: collaborator
• Children's Hospital of Philadelphia: collaborator
• University of Pittsburgh: collaborator
• University of Rochester: collaborator
• Children's Hospital Medical Center, Cincinnati: collaborator
• University of Arkansas: collaborator
• Nationwide Children's Hospital: collaborator
• Vanderbilt University Medical Center: collaborator
• University of California, Irvine: collaborator
• University of Missouri-Columbia: collaborator

Related Publications (1)

• 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.

  PMID: 32150229 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Karen Kuhlthau
• Organization: Massachusetts General Hospital - Clinical Coordinating Center

KKUHLTHAU@PARTNERS.ORG

617-724-2842

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Model Details: 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.

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: September 19, 2018
• Study Start: September 1, 2016
• Primary Completion: November 27, 2018
• Study Completion: November 27, 2018
• Last Updated: April 30, 2020
• Results First Posted: April 30, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share