Extension for Community Healthcare Outcomes Autism Replication Evaluation

NCT ID: NCT03677089

Last Updated: 2020-04-30

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-01

Study Completion Date

2018-11-27

Brief Summary

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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

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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.

Conditions

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Autism Spectrum Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

12 ECHO Autism telehealth clinics

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Toronto

OTHER

Sponsor Role collaborator

Children's Hospital of Philadelphia

OTHER

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role collaborator

University of Arkansas

OTHER

Sponsor Role collaborator

Nationwide Children's Hospital

OTHER

Sponsor Role collaborator

Vanderbilt University Medical Center

OTHER

Sponsor Role collaborator

University of California, Irvine

OTHER

Sponsor Role collaborator

University of Missouri-Columbia

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Karen Kuhlthau

Associate Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kristin Sohl, MD, FAAP

Role: PRINCIPAL_INVESTIGATOR

University of Missouri Health Care, Thompson Center for Autism

Micah Mazurek, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia, Curry School of Education

References

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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.

Reference Type DERIVED
PMID: 32150229 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan: Original

View Document

Document Type: Statistical Analysis Plan: Amendment 1

View Document

Document Type: Statistical Analysis Plan: Amendment 2

View Document

Other Identifiers

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UA3MC11054

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2016P000415

Identifier Type: -

Identifier Source: org_study_id

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