Extension for Community Healthcare Outcomes Autism Replication Evaluation

Autism Spectrum Disorder Clinical Trial

— ECHO Autism  

Official title:

ECHO Autism Replication: Step Wedge Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03677089
• Other study ID #: 2016P000415
• Secondary ID: UA3MC11054
• Status: Completed
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: November 27, 2018

Study information

• Verified date: April 2020
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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".

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: November 27, 2018
• Est. primary completion date: November 27, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (11)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Children's Hospital Medical Center, Cincinnati, Children's Hospital of Philadelphia, Nationwide Children's Hospital, University of Arkansas, University of California, Irvine, University of Missouri-Columbia, University of Pittsburgh, University of Rochester, University of Toronto, Vanderbilt University Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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.	Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9)
Secondary	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.	Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9)
Secondary	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.	Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9)
Secondary	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").	At end of intervention (Month 6)
Secondary	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.	At end of intervention (Month 6)
Secondary	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.	Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9)