An interventional study of 12 ECHO Autism telehealth clinics in Autism Spectrum Disorder, sponsored by Massachusetts General Hospital. Completed. Per ClinicalTrials.gov, last updated 2020-04-30.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Health services research
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".
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.
1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.
This study's enrollment of 148 is above the median of 45 across 1,044 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.
Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.
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Exclusion Criteria:
Sites undergo 12 ECHO Autism telehealth clinics. Clusters of two sites each will initiate intervention with 3 months between the start of each cluster.
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.
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.
Time frame: Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9)
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.
Time frame: Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9)
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.
Time frame: Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9)
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.
Time frame: Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9)
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.
Time frame: Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9)
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").
Time frame: At end of intervention (Month 6)
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.
Time frame: At end of intervention (Month 6)
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.
Time frame: Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9)
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.
| Milestone | ECHO Cohort |
|---|---|
| Started | 148 |
| Baseline/pre-intervention | 137 |
| Mid-intervention | 120 |
| Post-intervention | 117 |
| Follow-up | 114 |
| Completed | 114 |
| Not completed | 34 |
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.
| percentage of children screened | Baseline | Mid-Intervention | Post-Intervention | End of Follow-Up |
|---|---|---|---|---|
| Longitudinal Pattern of ASD Screening in PCP Charts | 61 ± 41 | 64 ± 41 | 66 ± 40 | 64 ± 39 |
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.
| percentage of co-morbid medical problems | Baseline | Mid-Intervention | Post-Intervention | End of Follow-Up |
|---|---|---|---|---|
| Longitudinal Pattern of Reported Co-occurring Medical Conditions Correctly Treated in PCP Charts | 81 ± 27 | 76 ± 30 | 78 ± 31 | 86 ± 25 |
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.
| score on a scale (0-100) | Baseline | Mid-Intervention | Post-Intervention | End of Follow-Up |
|---|---|---|---|---|
| Longitudinal Pattern of Scores on Provider ASD Knowledge Assessment | 49 ± 22 | 53 ± 24 | 56 ± 25 | 57 ± 26 |
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.
| score on a scale (0-100) | Baseline | Mid-Intervention | Post-Intervention | End of Follow-Up |
|---|---|---|---|---|
| Longitudinal Pattern of Scores on Provider ASD Self-Efficacy Assessment | 43 ± 12 | 61 ± 11 | 70 ± 12 | 71 ± 12 |
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.
| reported barriers (count out of 10) | Baseline | Mid-Intervention | Post-Intervention | End of Follow-Up |
|---|---|---|---|---|
| Longitudinal Pattern of the Number of Perceived Barriers to Care | 4.8 ± 1.6 | 3.7 ± 1.9 | 2.6 ± 1.4 | 2.6 ± 1.5 |
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").
| percentage of of satisfied participants | ECHO Cohort |
|---|---|
| Participant Satisfaction With ECHO Autism Program | 96 |
Percentage of the average number of sessions (out of 12) that the participant attended, of those who have completed the program.
| percentage of sessions attended | ECHO Cohort |
|---|---|
| PCP ECHO Program Attendance | 83 ± 17 |
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.
| number of co-morbid conditions per child | Baseline | Mid-Intervention | Post-Intervention | End of Follow-Up |
|---|---|---|---|---|
| Number of Co-morbidities in Children With ASD | 0.67 ± 0.64 | 0.76 ± 0.63 | 0.59 ± 0.55 | 0.68 ± 0.74 |
Collected over 1 year, 9 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ECHO Cohort | 0/132 (0%) | 0/132 (0%) | 0/132 (0%) |
| Age, Categorical(Participants) | ECHO Cohort |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 124 |
| >=65 years | 8 |
| Age, Continuous(years) | ECHO Cohort |
|---|---|
| Mean | 46.8 ± 11.6 |
| Sex: Female, Male(Participants) | ECHO Cohort |
|---|---|
| Female | 108 |
| Male | 24 |
| Ethnicity (NIH/OMB)(Participants) | ECHO Cohort |
|---|---|
| Hispanic or Latino | 8 |
| Not Hispanic or Latino | 124 |
| Unknown or Not Reported | 0 |
| Race/Ethnicity, Customized(Participants) | ECHO Cohort |
|---|---|
| Race — Asian | 21 |
| Race — Black / African-American | 7 |
| Race — Other/Multiracial | 4 |
| Race — White or Caucasian | 100 |
| Region of Enrollment(Participants) | ECHO Cohort |
|---|---|
| United States | 114 |
| Canada | 18 |
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