Disseminating a Model Intervention to Promote Improved Attention-deficit Hyperactivity Disorder (ADHD) Care in the Community

• Sponsor: Children's Hospital Medical Center, Cincinnati (Other)
• Overall Status: Completed
• CT.gov ID: NCT01056016
• Collaborator: (none)
• Enrollment: 49
• Location: 1
• Arms: 2
• Duration (Months): 17
• Patients Per Site Per Month: 2.9

Study Details

Study Description

Brief Summary

The American Academy of Pediatrics (AAP) has established a set of consensus guidelines for pediatricians to follow. These guidelines can be challenging to implement in typical community-based practices. Cincinnati Children's Hospital Medical Center (CCHMC) has developed a program called the ADHD Collaborative to promote the adoption of these guidelines among community pediatricians. The program focuses on modifying the office system using academic detailing and quality improvement (QI) methodology to accommodate prescribed practice changes. The ADHD Collaborative has been very successful at recruiting practices in the Greater Cincinnati area, changing practice behaviors, and sustaining these practice behaviors over time at minimal cost to the project and to the office practice. Now that sustainability and effectiveness have been established, the next step is to modify the ADHD Collaborative model to make it amenable to widespread dissemination. The primary goal of the proposed study is to modify the ADHD Collaborative intervention to make it transportable and then evaluate this version in terms of effectiveness, consumer satisfaction, and costs.. A transportable intervention is described that utilizes telehealth videoconferencing, a web portal, and long-distance data collection. Initially, three pediatric practices will be recruited to test and refine the distal intervention delivery methodology. Then, eight new pediatric practices will be randomly assigned to receive the distal intervention or to a control group (treatment as usual). Information about pediatric practice behavior will be collected at baseline, 6-months, and 1-year post-baseline. The study design will allow for a preliminary assessment of the feasibility and effectiveness of the distal intervention in terms of rates of evidence-based practice behaviors to patients, change in pediatrician attitudes, consumer satisfaction, and costs.

Condition or Disease	Intervention/Treatment	Phase
Attention Deficit Hyperactivity Disorder	Other: ADHD Collaborative	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 49 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Disseminating a Model Intervention to Promote Improved ADHD Care in the Community
• Study Start Date: Jul 1, 2009
• Actual Primary Completion Date: Jul 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Wait-list control Wait-list control group
Experimental: ADHD Collaborative Intervention This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial assessment for ADHD and during follow-up after initiating medication treatment and making a Diagnostic and Statistical Manual-IV (DSM-IV) based ADHD diagnosis. Practices are given a web-based ADHD portal to assist them in creating a patient registry and to help in obtaining parent and teacher ratings scales. The intervention lasts for 6 months.	Other: ADHD Collaborative; This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial assessment for ADHD and during follow-up after initiating medication treatment and making a DSM-IV based ADHD diagnosis. Practices are given a web-based ADHD portal to assist them in creating a patient registry and to help in obtaining parent and teacher ratings scales.

Outcome Measures

Primary Outcome Measures

1. Physician ADHD Practice Behavior [Baseline and 6 months]

   Percentage of patients across pediatricians in each randomized group for whom the pediatrician collected teacher ratings to monitor treatment response

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• pediatric practice with at least 2 physicians

Exclusion Criteria:

• no electronic billing system

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cincinnati Childrens Hospital Medical Center	Cincinnati	Ohio	United States	45229

Sponsors and Collaborators

• Children's Hospital Medical Center, Cincinnati

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Epstein JN, Langberg JM, Lichtenstein PK, Mainwaring BA, Luzader CP, Stark LJ. Community-wide intervention to improve the attention-deficit/hyperactivity disorder assessment and treatment practices of community physicians. Pediatrics. 2008 Jul;122(1):19-27. doi: 10.1542/peds.2007-2704.

• Responsible Party: Jeff Epstein, Principal Investigator, Children's Hospital Medical Center, Cincinnati
• ClinicalTrials.gov Identifier: NCT01056016
• Other Study ID Numbers: R21MH082714
• First Posted: Jan 26, 2010
• Last Update Posted: Dec 23, 2016
• Last Verified: Sep 1, 2016

• Keywords provided by Jeff Epstein, Principal Investigator, Children's Hospital Medical Center, Cincinnati: ADHD
• Additional relevant MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity

Study Results

Participant Flow

Arm/Group Title	Wait-list Control	ADHD Collaborative Intervention
Arm/Group Description	Wait-list control group	This intervention includes mapping and redesign of office flow to facilitate adherence to American Academy of Pediatrics (AAP) ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics include the importance of obtaining parent and teacher behavioral ratings at the time of the initial assessment for ADHD and during follow-up after initiating medication treatment and making a DSM-IV based ADHD diagnosis. Practices are given a web-based ADHD portal to assist them in creating a patient registry and to help in obtaining parent and teacher ratings scales. The intervention lasts for 6 months. ADHD Collaborative: This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial
Period Title: Overall Study
STARTED	22	27
COMPLETED	20	26
NOT COMPLETED	2	1

Baseline Characteristics

Arm/Group Title	Wait-list Control	ADHD Collaborative Intervention	Total
Arm/Group Description	Wait-list control group	This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial assessment for ADHD and during follow-up after initiating medication treatment and making a DSM-IV based ADHD diagnosis. Practices are given a web-based ADHD portal to assist them in creating a patient registry and to help in obtaining parent and teacher ratings scales. The intervention lasts for 6 months. ADHD Collaborative: This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial	Total of all reporting groups
Overall Participants	22	27	49
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	47.0 (10.3)	46.6 (11.3)	46.8 (10.7)
Gender (Count of Participants)
Female	15 68.2%	14 51.9%	29 59.2%
Male	7 31.8%	13 48.1%	20 40.8%
Region of Enrollment (participants) [Number]
United States	22 100%	27 100%	49 100%

Outcome Measures

1. Primary Outcome

Title	Physician ADHD Practice Behavior
Description	Percentage of patients across pediatricians in each randomized group for whom the pediatrician collected teacher ratings to monitor treatment response
Time Frame	Baseline and 6 months

Outcome Measure Data

Analysis Population Description

Patient chart reviews were conducted with 174 patients in the ADHD Collaborative Intervention group and 64 patients in the Wait-list control group

Arm/Group Title	Wait-list Control	ADHD Collaborative Intervention
Arm/Group Description	Wait-list control group	This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial assessment for ADHD and during follow-up after initiating medication treatment and making a DSM-IV based ADHD diagnosis. Practices are given a web-based ADHD portal to assist them in creating a patient registry and to help in obtaining parent and teacher ratings scales. The intervention lasts for 6 months. ADHD Collaborative: This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial
Measure Participants	22	27
Baseline	0 (0)	0 (0)
6-months	6.3 (25.0)	38.7 (36.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Wait-list Control, ADHD Collaborative Intervention
	Comments	The percentage of patients with whom pediatrician in each group utilized each practice behavior at baseline and 6-months was computed. The reported statistical analysis did not account potential clustering due to the small number of practices in this study.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	=.003
	Comments
	Method	t-test, 2 sided
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	32.4
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Adverse Event Reporting Description	Participants in each Arm/Group were not monitored for adverse events.
Arm/Group Title	Wait-list Control		ADHD Collaborative Intervention
Arm/Group Description	Wait-list control group		This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial assessment for ADHD and during follow-up after initiating medication treatment and making a DSM-IV based ADHD diagnosis. Practices are given a web-based ADHD portal to assist them in creating a patient registry and to help in obtaining parent and teacher ratings scales. The intervention lasts for 6 months. ADHD Collaborative: This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial
All Cause Mortality
	Wait-list Control		ADHD Collaborative Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Wait-list Control		ADHD Collaborative Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Wait-list Control		ADHD Collaborative Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.