Clinical trial NCT03677089: Extension for Community Healthcare Outcomes Autism Replication Evaluation
Official title: ECHO Autism Replication: Step Wedge Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Keywords: ASD
Autism
Telehealth
Primary Care Providers
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: University of Toronto
name: Children's Hospital of Philadelphia
name: University of Pittsburgh
name: University of Rochester
name: Children's Hospital Medical Center, Cincinnati
name: University of Arkansas
name: Nationwide Children's Hospital
name: Vanderbilt University Medical Center
name: University of California, Irvine
name: University of Missouri-Columbia
First posted: 2018-09-19
Enrollment: 148
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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)

Primary outcomes:
measure: Longitudinal Pattern of ASD Screening in PCP Charts
timeFrame: Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9)
measure: Longitudinal Pattern of Reported Co-occurring Medical Conditions Correctly Treated in PCP Charts
timeFrame: Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9)
Secondary outcomes:
measure: Longitudinal Pattern of Scores on Provider ASD Knowledge Assessment
timeFrame: Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9)
measure: Longitudinal Pattern of Scores on Provider ASD Self-Efficacy Assessment
timeFrame: Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9)
measure: Longitudinal Pattern of the Number of Perceived Barriers to Care
timeFrame: Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9)
measure: Participant Satisfaction With ECHO Autism Program
timeFrame: At end of intervention (Month 6)
measure: PCP ECHO Program Attendance
timeFrame: At end of intervention (Month 6)
measure: Number of Co-morbidities in Children With ASD
timeFrame: Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9)
Other outcomes:
Locations:
Study officials:
affiliation: University of Missouri Health Care, Thompson Center for Autism
name: Kristin Sohl, MD, FAAP
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Virginia, Curry School of Education
name: Micah Mazurek, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.