Pilot Study of Shared Care of ADHD in a Pediatric Clinic:Colocation of a Psychologist as an ADHD Care Manager (shared care)

November 4, 2010 updated by: Weill Medical College of Cornell University
Due to the shortage of child psychiatrists and the high prevalence of child mental health disorder, pediatricians and other pediatric primary care providers often assume responsibility for the management of various psychiatric disorders, including ADHD, Attention Deficit Hyperactivity Disorder. However, pediatricians have not been well-trained during residency to deal with the complexities of ADHD management. In addition, the system of care under which pediatricians practice do not afford the time availability that is required to properly manage a child with ADHD. On the other hand, if a pediatrician wishes to refer a patient to a child mental health specialist, many obstacles, including but not limited to stigma, insurance issues, and long waiting lists, often interfere with the patient actually receiving services for his/her ADHD. This research project seeks to examine an innovative model of care in which a child psychologist is located on the premises of a pediatric office and is available to share the care of patients with the pediatrician in order to address ADHD. We hypothesize that parents as well as pediatricians will be more satisfied with this model of care and that patients will ultimately have better outcomes. The beginning of our pilot has shown under-identification to be a barrier to care as well, and thus we propose to implement a quality improvement initiative to screen children for psychosocial issues as well. As we have had trouble with recruitment and unfortunately have had more children randomized to TAU than shared care, we propose in December 2007 a phase 2 of our study where all subjects, instead of randomization, are entered into shared care.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Study Goals:

A. To compare patients with ADHD (Attention Deficit Hyperactivity Disorder) treated by a pediatric provider in collaboration with a co-located psychologist/ADHD care manager available for evaluation/assessment and ongoing shared-care consultation to patients with ADHD in a pediatric primary care clinic treated as usual.

  1. Patients treated by the pediatricians with the added co-located services will have clinical outcomes that are superior to those that receive usual care

    1. Co-located services will increase the number of ADHD patients accessing specialized mental health treatment services
    2. A higher proportion of patients treated by the pediatric providers and psychologists than those in usual care receive doses of medication that are consistent with AAP (American Academy of Pediatrics) recommendations
  2. Patients whose providers are offered to receive the aid of the co-located psychologists will be more likely to be co-managed by the pediatrician than referred out to the community.
  3. Parents will be more satisfied with care in the shared care model than in usual care

B. Pediatricians' morale and attitudes to the treatment of ADHD will improve with the addition of a co-located psychologist.

C. ADDITIONAL AIMS:

  1. To assist a pediatric primary care clinic in implementing a quality improvement initiative to help pediatric providers better identify ADHD by implementing the PSC-17, a general psychosocial checklist.
  2. Study the usefulness of using the PSC 17 screen as a clinical tool to identify ADHD in the primary care office by obtaining results and tracking physician disposition planning based on results.

D. Operationalize Shared Care by examining what happens in such an arrangement, and see if patient recruitment and provider buy-in improves when shared care is assured.

Study Type

Interventional

Enrollment (Anticipated)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • New York
      • Long Island City, New York, United States, 11106
        • Active, not recruiting
        • Long Island City Community Practice
      • New York, New York, United States, 10021
        • Recruiting
        • New York Presbyterina Hospital- Weill Cornell Medcial College HT5 Pediatrics Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria (Patient subjects):

  • Age 6-17
  • Suspected diagnosis of ADHD, inattentive type, hyperactive type, combined type, NOS
  • Living with Guardian for at least 6 months
  • English-speaking child
  • English-speaking guardian
  • Telephone Access to Guardian
  • Inclusion for Randomization or Phase 2 shared care:
  • Diagnosis of ADHD

Exclusion Criteria:

  • Mental Retardation
  • Co-morbid psychotic disorder
  • Suicidal
  • Homicidal
  • Dangerous behavior
  • Foster care
  • Impairing co-morbid psychiatric disorder that would make ADHD treatment in a pediatric clinic unsafe or inappropriate (in the judgment of the PI based on the case review of the findings of the clinical psychologist.)
  • Allergic or contraindication to stimulant medications

Inclusion Criteria (Provider subjects):

  • Provider at Cornell Campus Helmsley Tower 5/ Long Island City Campus

Exclusion Criteria:

  • None

Inclusion for screening:

  • Age 6-17
  • Child is to be seen by pediatric provider at HT5
  • Parent or guardian reads English or Spanish

Exclusion Criteria:

  • Parent/Guardian has received screen within the year
  • Patient is too sick for parent to spend time on form

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: TAU
Treatment as usual. These subjects and their providers were told to pursue treatment services as they normally would do.
EXPERIMENTAL: shared care
A psychologist co-located in the pediatric primary care clinic shared care with the subject's pediatrician. The psychologist offered regular appointments and psychoeducation. On an individual basis, parent management training, behavioral management training, individual psychotherapy, educational intervention assistance, teacher communication, and medication education were provided as needed.
A psychologist co-located in the pediatric primary care clinic shared care with the subject's pediatrician. The psychologist offered regular appointments and psychoeducation. On an individual basis, parent management training, behavioral management training, individual psychotherapy, educational intervention assistance, teacher communication, and medication education were provided as needed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
A higher proportion of patients treated by the pediatric providers and psychologists than those in usual care receive doses of medication that are consistent with AAP (American Academy of Pediatrics) recommendations
Time Frame: six months
six months

Secondary Outcome Measures

Outcome Measure
Time Frame
Co-located services will increase the number of ADHD patients accessing specialized mental health treatment services
Time Frame: six months
six months
2. Patients whose providers are offered to receive the aid of the co-located psychologists will be more likely to be co-managed by the pediatrician than referred out to the community.
Time Frame: six months
six months
Parents will be more satisfied with care in the shared care model than in usual care
Time Frame: six months
six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Daniel Hyman, MD, New York Presbyterian Hospital
  • Principal Investigator: Rachel Zuckerbrot, MD, Columbia University/New York State Psychiatric Institute
  • Principal Investigator: Mark Olfson, MD, Columbia University/New York State Psychiatric Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (ANTICIPATED)

June 1, 2008

Study Completion (ANTICIPATED)

June 1, 2008

Study Registration Dates

First Submitted

March 19, 2008

First Submitted That Met QC Criteria

March 25, 2008

First Posted (ESTIMATE)

March 27, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

November 5, 2010

Last Update Submitted That Met QC Criteria

November 4, 2010

Last Verified

November 1, 2010

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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