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

Primary Purpose

ADHD

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Shared Care
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for ADHD focused on measuring ADHD, Primary Care, Pediatrics, Health services, shared care, care manager, screening

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Long Island City Community Practice
  • New York Presbyterina Hospital- Weill Cornell Medcial College HT5 Pediatrics ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

TAU

shared care

Arm Description

Treatment as usual. These subjects and their providers were told to pursue treatment services as they normally would do.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Co-located services will increase the number of ADHD patients accessing specialized mental health treatment services
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.
Parents will be more satisfied with care in the shared care model than in usual care

Full Information

First Posted
March 19, 2008
Last Updated
November 4, 2010
Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Mental Health (NIMH), New York State Psychiatric Institute, Research Foundation for Mental Hygiene, Inc., Columbia University
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1. Study Identification

Unique Protocol Identification Number
NCT00644566
Brief Title
Pilot Study of Shared Care of ADHD in a Pediatric Clinic:Colocation of a Psychologist as an ADHD Care Manager
Acronym
shared care
Official Title
Pilot Study of Shared Care of ADHD in a Pediatric Clinic:Colocation of a Psychologist as an ADHD Care Manager
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
August 2006 (undefined)
Primary Completion Date
June 2008 (Anticipated)
Study Completion Date
June 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
National Institute of Mental Health (NIMH), New York State Psychiatric Institute, Research Foundation for Mental Hygiene, Inc., Columbia University

4. Oversight

5. Study Description

Brief Summary
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.
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. Patients treated by the pediatricians with the added co-located services will have clinical outcomes that are superior to those that receive usual care Co-located services will increase the number of ADHD patients accessing specialized mental health treatment services 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 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. 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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD
Keywords
ADHD, Primary Care, Pediatrics, Health services, shared care, care manager, screening

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TAU
Arm Type
No Intervention
Arm Description
Treatment as usual. These subjects and their providers were told to pursue treatment services as they normally would do.
Arm Title
shared care
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Shared Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Co-located services will increase the number of ADHD patients accessing specialized mental health treatment services
Time Frame
six months
Title
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
Title
Parents will be more satisfied with care in the shared care model than in usual care
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rachel A Zuckerbrot, MD
Phone
212-543-2628
Email
zuckerbr@childpsych.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Hyman, MD
Organizational Affiliation
New York Presbyterian Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Rachel Zuckerbrot, MD
Organizational Affiliation
Columbia University/New York State Psychiatric Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Olfson, MD
Organizational Affiliation
Columbia University/New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Long Island City Community Practice
City
Long Island City
State/Province
New York
ZIP/Postal Code
11106
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
New York Presbyterina Hospital- Weill Cornell Medcial College HT5 Pediatrics Clinic
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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