NCT02271386

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
895

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 13, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 22, 2014

Completed
10 days until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2016

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

March 18, 2019

Completed
Last Updated

March 18, 2019

Status Verified

March 1, 2019

Enrollment Period

1.7 years

First QC Date

October 13, 2014

Results QC Date

November 3, 2017

Last Update Submit

March 15, 2019

Conditions

Keywords

Evidence-Based PracticeProvider Education

Outcome Measures

Primary Outcomes (8)

  • 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

    Baseline Period (8 months)

  • 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

    Baseline Period (8 months)

  • 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

    Baseline Period (8 months)

  • 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

    Baseline Period (8 months)

  • 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

    Intervention Period (8 months)

  • 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

    Intervention Period (8 months)

  • 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

    Intervention Period (8 months)

  • 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

    Intervention Period (8 months)

Secondary Outcomes (20)

  • Number of Patients Who Were Sent the Parent Rating Scale - by MOC Status

    Baseline Period (8 months)

  • Number of Patients Whose Parent Rating Scale Was Returned- by MOC Status

    Baseline Period (8 months)

  • Number of Patients Who Were Sent the Teacher Rating Scale- by MOC Status

    Baseline Period (8 months)

  • Number of Patients Whose Teacher Rating Scale Was Returned- by MOC Status

    Baseline Period (8 months)

  • Number of Patients Who Were Sent the Parent Rating Scale- by MOC Status

    Intervention Period (8 months)

  • +15 more secondary outcomes

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: Supporting Practice for ADHD (SPA)

Control

OTHER

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.

Behavioral: Supporting Practice for ADHD (SPA)

Interventions

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.

ControlIntervention

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Residents
  • Secondary Subjects: Families
  • Children aged 5-12 years receiving care from a clinician enrolled in the study for ADHD and their parents
  • Autism spectrum disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19103, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Limitations and Caveats

Enrollment occurred within 1 health system among clinicians who were interested in participating in the project and worked in practices that agreed to participate, which may limit generalizability of results.

Results Point of Contact

Title
Alexander Fiks, MD, MSCE
Organization
The Children's Hospital of Philadelphia

Study Officials

  • Alexander G Fiks, MD, MSCE

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR
  • Thomas Power, PhD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2014

First Posted

October 22, 2014

Study Start

November 1, 2014

Primary Completion

July 31, 2016

Study Completion

July 31, 2016

Last Updated

March 18, 2019

Results First Posted

March 18, 2019

Record last verified: 2019-03

Locations