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| ID | Type | Description | Link |
|---|---|---|---|
| UA3MC11054 | Other Grant/Funding Number | Health Resources and Services Administration |
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| Name | Class |
|---|---|
| University of Toronto | OTHER |
| Children's Hospital of Philadelphia | OTHER |
| University of Pittsburgh | OTHER |
| University of Rochester |
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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".
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ECHO Cohort | Experimental | Sites undergo 12 ECHO Autism telehealth clinics. Clusters of two sites each will initiate intervention with 3 months between the start of each cluster. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 12 ECHO Autism telehealth clinics | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kristin Sohl, MD, FAAP | University of Missouri Health Care, Thompson Center for Autism | Principal Investigator |
| Micah Mazurek, PhD | University of Virginia, Curry School of Education | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32150229 | Derived | 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. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | percentage of children screened | Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9) |
|
1 year, 9 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Karen Kuhlthau | Massachusetts General Hospital - Clinical Coordinating Center | 617-724-2842 | KKUHLTHAU@PARTNERS.ORG |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 9, 2017 | Nov 12, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Original | Oct 29, 2018 | Feb 11, 2020 | SAP_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Amendment 1 | Jan 30, 2019 | Feb 11, 2020 | SAP_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan: Amendment 2 | Nov 25, 2019 | Feb 11, 2020 | SAP_003.pdf |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D001321 | Autistic Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| OTHER |
| Children's Hospital Medical Center, Cincinnati | OTHER |
| University of Arkansas | OTHER |
| Nationwide Children's Hospital | OTHER |
| Vanderbilt University Medical Center | OTHER |
| University of California, Irvine | OTHER |
| University of Missouri-Columbia | OTHER |
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.
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|
| 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. | 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. | 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"). | 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. | 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. | Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9) |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Month 0 |
| OG001 | Mid-Intervention | Month 3 |
| OG002 | Post-Intervention | Month 6 |
| OG003 | End of Follow-Up | Month 9 |
|
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| 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. | 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. | Posted | Mean | Standard Deviation | percentage of co-morbid medical problems | Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9) |
|
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| 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. | Participant numbers are based on the number of participants completing the appropriate form at the time point. | Posted | Mean | Standard Deviation | score on a scale (0-100) | 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. | Participant numbers are based on the number of participants completing the appropriate form at the time points. | Posted | Mean | Standard Deviation | score on a scale (0-100) | Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9) |
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| 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. | Participant numbers are based on the number of participants completing the appropriate form at the time points. | Posted | Mean | Standard Deviation | reported barriers (count out of 10) | Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9) |
|
|
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| 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"). | Participant numbers are based on the number of participants completing the appropriate form at the time point. | Posted | Number | percentage of of satisfied participants | At end of intervention (Month 6) |
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| 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. | Posted | Mean | Standard Deviation | percentage of sessions attended | At end of intervention (Month 6) |
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| 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. | Participant numbers are based on the number of participants completing the appropriate form at the time points. | Posted | Mean | Standard Deviation | number of co-morbid conditions per child | Baseline (Month 0), mid-intervention (Month 3), post-intervention (Month 6), and end of follow-up (Month 9) |
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| 0 |
| 132 |
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| 132 |
| 0 |
| 132 |
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