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Educating and Supporting Primary Care Providers in the Implementation of Evidence-based Practices for ADHD

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Supporting Practice for ADHD (SPA)
Sponsored by
Children's Hospital of Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring Evidence-Based Practice, Provider Education

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

Primary Subjects: Clinicians

Inclusion Criteria:

  • Non-resident clinician (physician or nurse practitioner) at participating site

Exclusion Criteria:

  • Residents

Secondary Subjects: Families

Inclusion Criteria:

  • Children aged 5-12 years receiving care from a clinician enrolled in the study for ADHD and their parents

Exclusion Criteria:

  • Autism spectrum disorder

Sites / Locations

  • Children's Hospital of Philadelphia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Intervention

Control

Arm Description

Clinicians in the intervention arm will receive the three-part intervention (Supporting Practice for ADHD, or SPA) which includes: education about ADHD management and communication training, collaborative consultation, and performance feedback, for the first 8 months of the study.

Clinicians in the control arm will receive no intervention for the first 8 months of the study, then will receive the full SPA intervention for the last 8 months of the study.

Outcomes

Primary Outcome Measures

Number of Patients Who Were Sent the Parents Rating Scale
This measure is based on chart review of patients of clinicians in each study arm (up to 4 patients per clinician) and reflects whether there is evidence that a parent rating scale was sent out during the baseline interval
Number of Patients Whose Parent Rating Scale Was Returned
This measure is based on chart review of patients of clinicians in each study arm (up to 4 patients per clinician) and reflects whether there is evidence that a parent rating scale was received by the clinician during the baseline interval
Number of Patients Who Were Sent the Teacher Rating Scale
This measure is based on chart review of patients of clinicians in each study arm (up to 4 patients per clinician) and reflects whether there is evidence that a teacher rating scale was sent out during the baseline interval
Number of Patients Whose Teacher Rating Scale Was Returned
This measure is based on chart review of patients of clinicians in each study arm (up to 4 patients per clinician) and reflects whether there is evidence that a teacher rating scale was received by the clinician during the baseline interval
Number of Patients Who Were Sent the Parents Rating Scale
This measure is based on chart review of patients of clinicians in each study arm (up to 4 patients per clinician) and reflects whether there is evidence that a parent rating scale was sent out during the intervention interval
Number of Patients Whose Parent Rating Scale Was Returned
This measure is based on chart review of patients of clinicians in each study arm (up to 4 patients per clinician) and reflects whether there is evidence that a parent rating scale was received by the clinician during the intervention interval
Number of Patients Who Were Sent the Teacher Rating Scale
This measure is based on chart review of patients of clinicians in each study arm (up to 4 patients per clinician) and reflects whether there is evidence that a teacher rating scale was sent out during the intervention interval
Number of Patients Whose Teacher Rating Scale Was Returned
This measure is based on chart review of patients of clinicians in each study arm (up to 4 patients per clinician) and reflects whether there is evidence that a teacher rating scale was received by the clinician during the intervention interval

Secondary Outcome Measures

Number of Patients Who Were Sent the Parent Rating Scale - by MOC Status
We calculated the percent of patient charts with evidence that a parent rating scale was sent out during the baseline period, separately for intervention clinicians who did and did not complete Maintenance of Certification (MOC) attestation.
Number of Patients Whose Parent Rating Scale Was Returned- by MOC Status
We calculated the percent of patient charts with evidence that a parent rating scale was received by the clinician/practice during the baseline period, separately for intervention clinicians who did and did not complete Maintenance of Certification (MOC) attestation.
Number of Patients Who Were Sent the Teacher Rating Scale- by MOC Status
We calculated the percent of patient charts with evidence that a teacher rating scale was sent out during the baseline period, separately for intervention clinicians who did and did not complete Maintenance of Certification (MOC) attestation.
Number of Patients Whose Teacher Rating Scale Was Returned- by MOC Status
We calculated the percent of patient charts with evidence that a teacher rating scale was received by the clinician/practice during the baseline period, separately for intervention clinicians who did and did not complete Maintenance of Certification (MOC) attestation.
Number of Patients Who Were Sent the Parent Rating Scale- by MOC Status
We calculated the percent of patient charts with evidence that a parent rating scale was sent out during the intervention period, separately for intervention clinicians who did and did not complete Maintenance of Certification (MOC) attestation.
Number of Patients Whose Parent Rating Scale Was Returned- by MOC Status
We calculated the percent of patient charts with evidence that a parent rating scale was received by the clinician/practice during the intervention period, separately for intervention clinicians who did and did not complete Maintenance of Certification (MOC) attestation.
Number of Patients Who Were Sent the Teacher Rating Scale- by MOC Status
We calculated the percent of patient charts with evidence that a teacher rating scale was sent out during the intervention period, separately for intervention clinicians who did and did not complete Maintenance of Certification (MOC) attestation.
Number of Patients Whose Teacher Rating Scale Was Returned- by MOC Status
We calculated the percent of patient charts with evidence that a teacher rating scale was received by the clinician/practice during the intervention period, separately for intervention clinicians who did and did not complete Maintenance of Certification (MOC) attestation.
Number of Patients Who Were Sent the Parent Rating Scale- by Feedback Call Participation
We calculated the percent of patient charts with evidence that a parent rating scale was sent out during the baseline period, separately for intervention clinicians who did and did not participate in at least one performance feedback call.
Number of Patients Whose Parent Rating Scale Was Returned- by Feedback Call Participation
We calculated the percent of patient charts with evidence that a parent rating scale was received by the clinician/practice during the baseline period, separately for intervention clinicians who did and did not participate in at least one performance feedback call.
Number of Patients Who Were Sent the Teacher Rating Scale- by Feedback Call Participation
We calculated the percent of patient charts with evidence that a teacher rating scale was sent out during the baseline period, separately for intervention clinicians who did and did not participate in at least one performance feedback call.
Number of Patients Whose Teacher Rating Scale Was Returned- by Feedback Call Participation
We calculated the percent of patient charts with evidence that a teacher rating scale was received by the clinician/practice during the baseline period, separately for intervention clinicians who did and did not participate in at least one performance feedback call.
Number of Patients Who Were Sent the Parent Rating Scale- by Feedback Call Participation
We calculated the percent of patient charts with evidence that a parent rating scale was sent out during the intervention period, separately for intervention clinicians who did and did not participate in at least one performance feedback call.
Number of Patients Whose Parent Rating Scale Was Returned- by Feedback Call Participation
We calculated the percent of patient charts with evidence that a parent rating scale was received by the clinician/practice during the intervention period, separately for intervention clinicians who did and did not participate in at least one performance feedback call.
Number of Patients Who Were Sent the Teacher Rating Scale- by Feedback Call Participation
We calculated the percent of patient charts with evidence that a teacher rating scale was sent out during the intervention period, separately for intervention clinicians who did and did not participate in at least one performance feedback call.
Number of Patients Whose Teacher Rating Scale Was Returned- by Feedback Call Participation
We calculated the percent of patient charts with evidence that a teacher rating scale was received by the clinician/practice during the intervention period, separately for intervention clinicians who did and did not participate in at least one performance feedback call.
Implementation Outcome: Number of Clinicians Who Completed All 3 Educational Presentations
We assessed the proportion of clinicians randomized to the intervention group that completed all 3 educational presentations.
Implementation Outcome: Number of Clinicians Who Used the Collaborative Consultation Component
We calculated the proportion of clinicians in the intervention group that posted in the online networking site which was used to facilitate collaborative consultation.
Implementation Outcome: Number of Clinicians Who Participated in at Least One Performance Feedback Call
We calculated the proportion of clinicians in the intervention group who participated in at least one of the four performance feedback calls that were held during the study period.
Implementation Outcome: Number of Clinicians Who Participated in All Intervention Components and Attested to Fulfilling MOC Requirements
We calculated the proportion of clinicians in the intervention group who completed all components of the intervention and attested to fulfilling MOC requirements.

Full Information

First Posted
October 13, 2014
Last Updated
March 15, 2019
Sponsor
Children's Hospital of Philadelphia
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1. Study Identification

Unique Protocol Identification Number
NCT02271386
Brief Title
Educating and Supporting Primary Care Providers in the Implementation of Evidence-based Practices for ADHD
Official Title
Educating and Supporting Primary Care Providers in the Implementation of Evidence-based Practices for ADHD
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
July 31, 2016 (Actual)
Study Completion Date
July 31, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Although numerous studies have demonstrated that a high percentage of primary care providers (PCPs) are knowledgeable about the American Academy of Pediatrics' guidelines for managing ADHD, many fail to implement these guidelines correctly. The goal of this project is to increase the use of evidence-based practices (EBP) for assessing and treating children with ADHD between 5 and 12 years in the context of primary care practice. This randomized controlled trial will evaluate the whether a 3-part intervention (education about ADHD management and communication training, collaborative consultation, and performance feedback regarding use of EBPs) is effective in improving EBP use among primary care providers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
Evidence-Based Practice, Provider Education

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
895 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Clinicians in the intervention arm will receive the three-part intervention (Supporting Practice for ADHD, or SPA) which includes: education about ADHD management and communication training, collaborative consultation, and performance feedback, for the first 8 months of the study.
Arm Title
Control
Arm Type
Other
Arm Description
Clinicians in the control arm will receive no intervention for the first 8 months of the study, then will receive the full SPA intervention for the last 8 months of the study.
Intervention Type
Behavioral
Intervention Name(s)
Supporting Practice for ADHD (SPA)
Intervention Description
The SPA intervention will last for 8 months for each study arm (first 8 months of the study for the intervention group, last 8 months for the control group). The intervention includes 3 components: 1) a series of web-based educational presentations to provide education to providers about evidence-based practice for managing ADHD and strategies for promoting effective communication with families 2) Collaborative consultation designed to address clinical issues arising in practice will be provided by members of the study team. 3) Providers will be given systematic performance feedback with regard to their use of evidence-based practices for ADHD every 2 months during the 8-month intervention period.
Primary Outcome Measure Information:
Title
Number of Patients Who Were Sent the Parents Rating Scale
Description
This measure is based on chart review of patients of clinicians in each study arm (up to 4 patients per clinician) and reflects whether there is evidence that a parent rating scale was sent out during the baseline interval
Time Frame
Baseline Period (8 months)
Title
Number of Patients Whose Parent Rating Scale Was Returned
Description
This measure is based on chart review of patients of clinicians in each study arm (up to 4 patients per clinician) and reflects whether there is evidence that a parent rating scale was received by the clinician during the baseline interval
Time Frame
Baseline Period (8 months)
Title
Number of Patients Who Were Sent the Teacher Rating Scale
Description
This measure is based on chart review of patients of clinicians in each study arm (up to 4 patients per clinician) and reflects whether there is evidence that a teacher rating scale was sent out during the baseline interval
Time Frame
Baseline Period (8 months)
Title
Number of Patients Whose Teacher Rating Scale Was Returned
Description
This measure is based on chart review of patients of clinicians in each study arm (up to 4 patients per clinician) and reflects whether there is evidence that a teacher rating scale was received by the clinician during the baseline interval
Time Frame
Baseline Period (8 months)
Title
Number of Patients Who Were Sent the Parents Rating Scale
Description
This measure is based on chart review of patients of clinicians in each study arm (up to 4 patients per clinician) and reflects whether there is evidence that a parent rating scale was sent out during the intervention interval
Time Frame
Intervention Period (8 months)
Title
Number of Patients Whose Parent Rating Scale Was Returned
Description
This measure is based on chart review of patients of clinicians in each study arm (up to 4 patients per clinician) and reflects whether there is evidence that a parent rating scale was received by the clinician during the intervention interval
Time Frame
Intervention Period (8 months)
Title
Number of Patients Who Were Sent the Teacher Rating Scale
Description
This measure is based on chart review of patients of clinicians in each study arm (up to 4 patients per clinician) and reflects whether there is evidence that a teacher rating scale was sent out during the intervention interval
Time Frame
Intervention Period (8 months)
Title
Number of Patients Whose Teacher Rating Scale Was Returned
Description
This measure is based on chart review of patients of clinicians in each study arm (up to 4 patients per clinician) and reflects whether there is evidence that a teacher rating scale was received by the clinician during the intervention interval
Time Frame
Intervention Period (8 months)
Secondary Outcome Measure Information:
Title
Number of Patients Who Were Sent the Parent Rating Scale - by MOC Status
Description
We calculated the percent of patient charts with evidence that a parent rating scale was sent out during the baseline period, separately for intervention clinicians who did and did not complete Maintenance of Certification (MOC) attestation.
Time Frame
Baseline Period (8 months)
Title
Number of Patients Whose Parent Rating Scale Was Returned- by MOC Status
Description
We calculated the percent of patient charts with evidence that a parent rating scale was received by the clinician/practice during the baseline period, separately for intervention clinicians who did and did not complete Maintenance of Certification (MOC) attestation.
Time Frame
Baseline Period (8 months)
Title
Number of Patients Who Were Sent the Teacher Rating Scale- by MOC Status
Description
We calculated the percent of patient charts with evidence that a teacher rating scale was sent out during the baseline period, separately for intervention clinicians who did and did not complete Maintenance of Certification (MOC) attestation.
Time Frame
Baseline Period (8 months)
Title
Number of Patients Whose Teacher Rating Scale Was Returned- by MOC Status
Description
We calculated the percent of patient charts with evidence that a teacher rating scale was received by the clinician/practice during the baseline period, separately for intervention clinicians who did and did not complete Maintenance of Certification (MOC) attestation.
Time Frame
Baseline Period (8 months)
Title
Number of Patients Who Were Sent the Parent Rating Scale- by MOC Status
Description
We calculated the percent of patient charts with evidence that a parent rating scale was sent out during the intervention period, separately for intervention clinicians who did and did not complete Maintenance of Certification (MOC) attestation.
Time Frame
Intervention Period (8 months)
Title
Number of Patients Whose Parent Rating Scale Was Returned- by MOC Status
Description
We calculated the percent of patient charts with evidence that a parent rating scale was received by the clinician/practice during the intervention period, separately for intervention clinicians who did and did not complete Maintenance of Certification (MOC) attestation.
Time Frame
Intervention Period (8 months)
Title
Number of Patients Who Were Sent the Teacher Rating Scale- by MOC Status
Description
We calculated the percent of patient charts with evidence that a teacher rating scale was sent out during the intervention period, separately for intervention clinicians who did and did not complete Maintenance of Certification (MOC) attestation.
Time Frame
Intervention Period (8 months)
Title
Number of Patients Whose Teacher Rating Scale Was Returned- by MOC Status
Description
We calculated the percent of patient charts with evidence that a teacher rating scale was received by the clinician/practice during the intervention period, separately for intervention clinicians who did and did not complete Maintenance of Certification (MOC) attestation.
Time Frame
Intervention Period (8 months)
Title
Number of Patients Who Were Sent the Parent Rating Scale- by Feedback Call Participation
Description
We calculated the percent of patient charts with evidence that a parent rating scale was sent out during the baseline period, separately for intervention clinicians who did and did not participate in at least one performance feedback call.
Time Frame
Baseline Period (8 months)
Title
Number of Patients Whose Parent Rating Scale Was Returned- by Feedback Call Participation
Description
We calculated the percent of patient charts with evidence that a parent rating scale was received by the clinician/practice during the baseline period, separately for intervention clinicians who did and did not participate in at least one performance feedback call.
Time Frame
Baseline Period (8 months)
Title
Number of Patients Who Were Sent the Teacher Rating Scale- by Feedback Call Participation
Description
We calculated the percent of patient charts with evidence that a teacher rating scale was sent out during the baseline period, separately for intervention clinicians who did and did not participate in at least one performance feedback call.
Time Frame
Baseline Period (8 months)
Title
Number of Patients Whose Teacher Rating Scale Was Returned- by Feedback Call Participation
Description
We calculated the percent of patient charts with evidence that a teacher rating scale was received by the clinician/practice during the baseline period, separately for intervention clinicians who did and did not participate in at least one performance feedback call.
Time Frame
Baseline Period (8 months)
Title
Number of Patients Who Were Sent the Parent Rating Scale- by Feedback Call Participation
Description
We calculated the percent of patient charts with evidence that a parent rating scale was sent out during the intervention period, separately for intervention clinicians who did and did not participate in at least one performance feedback call.
Time Frame
Intervention Period (8 months)
Title
Number of Patients Whose Parent Rating Scale Was Returned- by Feedback Call Participation
Description
We calculated the percent of patient charts with evidence that a parent rating scale was received by the clinician/practice during the intervention period, separately for intervention clinicians who did and did not participate in at least one performance feedback call.
Time Frame
Intervention Period (8 months)
Title
Number of Patients Who Were Sent the Teacher Rating Scale- by Feedback Call Participation
Description
We calculated the percent of patient charts with evidence that a teacher rating scale was sent out during the intervention period, separately for intervention clinicians who did and did not participate in at least one performance feedback call.
Time Frame
Intervention Period (8 months)
Title
Number of Patients Whose Teacher Rating Scale Was Returned- by Feedback Call Participation
Description
We calculated the percent of patient charts with evidence that a teacher rating scale was received by the clinician/practice during the intervention period, separately for intervention clinicians who did and did not participate in at least one performance feedback call.
Time Frame
Intervention Period (8 months)
Title
Implementation Outcome: Number of Clinicians Who Completed All 3 Educational Presentations
Description
We assessed the proportion of clinicians randomized to the intervention group that completed all 3 educational presentations.
Time Frame
Intervention Period (8 months)
Title
Implementation Outcome: Number of Clinicians Who Used the Collaborative Consultation Component
Description
We calculated the proportion of clinicians in the intervention group that posted in the online networking site which was used to facilitate collaborative consultation.
Time Frame
Intervention Period (8 months)
Title
Implementation Outcome: Number of Clinicians Who Participated in at Least One Performance Feedback Call
Description
We calculated the proportion of clinicians in the intervention group who participated in at least one of the four performance feedback calls that were held during the study period.
Time Frame
Intervention Period (8 months)
Title
Implementation Outcome: Number of Clinicians Who Participated in All Intervention Components and Attested to Fulfilling MOC Requirements
Description
We calculated the proportion of clinicians in the intervention group who completed all components of the intervention and attested to fulfilling MOC requirements.
Time Frame
Intervention Period (8 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Primary Subjects: Clinicians Inclusion Criteria: Non-resident clinician (physician or nurse practitioner) at participating site Exclusion Criteria: Residents Secondary Subjects: Families Inclusion Criteria: Children aged 5-12 years receiving care from a clinician enrolled in the study for ADHD and their parents Exclusion Criteria: Autism spectrum disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander G Fiks, MD, MSCE
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Thomas Power, PhD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Educating and Supporting Primary Care Providers in the Implementation of Evidence-based Practices for ADHD

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