Trial Outcomes & Findings for Extension for Community Healthcare Outcomes Autism Replication Evaluation (NCT NCT03677089)
NCT ID: NCT03677089
Last Updated: 2020-04-30
Results Overview
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.
COMPLETED
NA
148 participants
Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9)
2020-04-30
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
148
|
|
Overall Study
Baseline/Pre-Intervention
|
137
|
|
Overall Study
Mid-Intervention
|
120
|
|
Overall Study
Post-Intervention
|
117
|
|
Overall Study
Follow-Up
|
114
|
|
Overall Study
COMPLETED
|
114
|
|
Overall Study
NOT COMPLETED
|
34
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Extension for Community Healthcare Outcomes Autism Replication Evaluation
Baseline characteristics by cohort
| Measure |
ECHO Cohort
n=132 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
124 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
|
Age, Continuous
|
46.8 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
108 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
124 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black / African-American
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other/Multiracial
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White or Caucasian
|
100 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
114 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9)Population: Participants were not included if they were at the Canadian site because Canadian screening practices are different from the AAP recommendations used in the study. In addition, participants can be included in this outcome measure only if they have children with a well-child visit at 18 or 24 months in the 30 days prior to the chart review.
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.
Outcome measures
| Measure |
Baseline
n=86 Participants
Month 0
|
Mid-Intervention
n=86 Participants
Month 3
|
Post-Intervention
n=87 Participants
Month 6
|
End of Follow-Up
n=86 Participants
Month 9
|
|---|---|---|---|---|
|
Longitudinal Pattern of ASD Screening in PCP Charts
|
61 percentage of children screened
Standard Deviation 41
|
64 percentage of children screened
Standard Deviation 41
|
66 percentage of children screened
Standard Deviation 40
|
64 percentage of children screened
Standard Deviation 39
|
PRIMARY outcome
Timeframe: Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9)Population: 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.
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.
Outcome measures
| Measure |
Baseline
n=69 Participants
Month 0
|
Mid-Intervention
n=74 Participants
Month 3
|
Post-Intervention
n=72 Participants
Month 6
|
End of Follow-Up
n=72 Participants
Month 9
|
|---|---|---|---|---|
|
Longitudinal Pattern of Reported Co-occurring Medical Conditions Correctly Treated in PCP Charts
|
81 percentage of co-morbid medical problems
Standard Deviation 27
|
76 percentage of co-morbid medical problems
Standard Deviation 30
|
78 percentage of co-morbid medical problems
Standard Deviation 31
|
86 percentage of co-morbid medical problems
Standard Deviation 25
|
SECONDARY outcome
Timeframe: Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9)Population: Participant numbers are based on the number of participants completing the appropriate form at the time point.
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.
Outcome measures
| Measure |
Baseline
n=104 Participants
Month 0
|
Mid-Intervention
n=98 Participants
Month 3
|
Post-Intervention
n=103 Participants
Month 6
|
End of Follow-Up
n=98 Participants
Month 9
|
|---|---|---|---|---|
|
Longitudinal Pattern of Scores on Provider ASD Knowledge Assessment
|
49 score on a scale (0-100)
Standard Deviation 22
|
53 score on a scale (0-100)
Standard Deviation 24
|
56 score on a scale (0-100)
Standard Deviation 25
|
57 score on a scale (0-100)
Standard Deviation 26
|
SECONDARY outcome
Timeframe: Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9)Population: Participant numbers are based on the number of participants completing the appropriate form at the time points.
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.
Outcome measures
| Measure |
Baseline
n=104 Participants
Month 0
|
Mid-Intervention
n=100 Participants
Month 3
|
Post-Intervention
n=103 Participants
Month 6
|
End of Follow-Up
n=98 Participants
Month 9
|
|---|---|---|---|---|
|
Longitudinal Pattern of Scores on Provider ASD Self-Efficacy Assessment
|
43 score on a scale (0-100)
Standard Deviation 12
|
61 score on a scale (0-100)
Standard Deviation 11
|
70 score on a scale (0-100)
Standard Deviation 12
|
71 score on a scale (0-100)
Standard Deviation 12
|
SECONDARY outcome
Timeframe: Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9)Population: Participant numbers are based on the number of participants completing the appropriate form at the time points.
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.
Outcome measures
| Measure |
Baseline
n=104 Participants
Month 0
|
Mid-Intervention
n=100 Participants
Month 3
|
Post-Intervention
n=104 Participants
Month 6
|
End of Follow-Up
n=98 Participants
Month 9
|
|---|---|---|---|---|
|
Longitudinal Pattern of the Number of Perceived Barriers to Care
|
4.8 reported barriers (count out of 10)
Standard Deviation 1.6
|
3.7 reported barriers (count out of 10)
Standard Deviation 1.9
|
2.6 reported barriers (count out of 10)
Standard Deviation 1.4
|
2.6 reported barriers (count out of 10)
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: At end of intervention (Month 6)Population: Participant numbers are based on the number of participants completing the appropriate form at the time point.
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").
Outcome measures
| Measure |
Baseline
n=102 Participants
Month 0
|
Mid-Intervention
Month 3
|
Post-Intervention
Month 6
|
End of Follow-Up
Month 9
|
|---|---|---|---|---|
|
Participant Satisfaction With ECHO Autism Program
|
96 percentage of of satisfied participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Baseline
n=104 Participants
Month 0
|
Mid-Intervention
Month 3
|
Post-Intervention
Month 6
|
End of Follow-Up
Month 9
|
|---|---|---|---|---|
|
PCP ECHO Program Attendance
|
83 percentage of sessions attended
Standard Deviation 17
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9)Population: Participant numbers are based on the number of participants completing the appropriate form at the time points.
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.
Outcome measures
| Measure |
Baseline
n=91 Participants
Month 0
|
Mid-Intervention
n=88 Participants
Month 3
|
Post-Intervention
n=92 Participants
Month 6
|
End of Follow-Up
n=95 Participants
Month 9
|
|---|---|---|---|---|
|
Number of Co-morbidities in Children With ASD
|
0.67 number of co-morbid conditions per child
Standard Deviation 0.64
|
0.76 number of co-morbid conditions per child
Standard Deviation 0.63
|
0.59 number of co-morbid conditions per child
Standard Deviation 0.55
|
0.68 number of co-morbid conditions per child
Standard Deviation 0.74
|
Adverse Events
ECHO Cohort
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Karen Kuhlthau
Massachusetts General Hospital - Clinical Coordinating Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place