Extension for Community Healthcare Outcomes Autism Replication Evaluation

ECHO Autism Replication: Step Wedge Randomized Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03677089

Acronym

ECHO Autism

Enrollment

148

Registered

2018-09-19

Start date

2016-09-01

Completion date

2018-11-27

Last updated

2020-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Keywords

ASD, Autism, Telehealth, Primary Care Providers

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.

Interventions

BEHAVIORAL12 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

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.

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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)

Design outcomes

Primary

Measure	Time frame	Description
Longitudinal Pattern of ASD Screening in PCP Charts	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.
Longitudinal Pattern of Reported Co-occurring Medical Conditions Correctly Treated in PCP Charts	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

Measure	Time frame	Description
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)	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.
Participant Satisfaction With ECHO Autism Program	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).
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)	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.
Number of Co-morbidities in Children With ASD	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.
PCP ECHO Program Attendance	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.
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)	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.

Participant flow

Recruitment details

Target enrollment was 150. 149 participants, primary care physicians, were screened from 10 ECHO Autism Hub Centers. 1 participant failed screening. 148 participants were enrolled. Screenings/enrollment occurred between September 12, 2016 and January 16, 2018. Two ECHO Autism Hub Centers were randomized to each of the 5 cohorts/clusters.

Pre-assignment details

The 10 sites were randomly assigned to cohort using SAS. Each site was assigned a random number (from a uniform distribution), and the two lowest numbers were assigned to period 1, etc. through the two highest numbers assigned period 5. No blocking or stratification was used in the randomization.

Participants by arm

Arm	Count
ECHO Cohort Cohorts are composed of 12 ECHO Autism telehealth clinics. Clusters of two sites each will initiate intervention with 3 months between the start of each cluster.	132
Total	132

Baseline characteristics

Characteristic	ECHO Cohort
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	8 Participants
Age, Categorical Between 18 and 65 years	124 Participants
Age, Continuous	46.8 years STANDARD_DEVIATION 11.6
Ethnicity (NIH/OMB) Hispanic or Latino	8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	124 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race/Ethnicity, Customized Race Asian	21 Participants
Race/Ethnicity, Customized Race Black / African-American	7 Participants
Race/Ethnicity, Customized Race Other/Multiracial	4 Participants
Race/Ethnicity, Customized Race White or Caucasian	100 Participants
Region of Enrollment Canada	18 Participants
Region of Enrollment United States	114 Participants
Sex: Female, Male Female	108 Participants
Sex: Female, Male Male	24 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 132
other Total, other adverse events	0 / 132
serious Total, serious adverse events	0 / 132

Outcome results

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.