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Implementing Effective, Collaborative Care for Schizophrenia (EQUIP-2) (EQUIP-2)

This study has been completed.
Sponsor:
Collaborators:
University of California, Los Angeles
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00137280
First received: August 25, 2005
Last updated: April 6, 2015
Last verified: July 2014
Results First Received: October 3, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Conditions: Schizophrenia
Chronic Illness
Weight Gain
Psychotic Disorder
Intervention: Behavioral: Collaborative Chronic Illness Care Model

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were selected randomly from the population of individuals with schizophrenia receiving care at VA mental health clinics. All clinicians and managers at mental health clinics were selected.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients were excluded if they did not meet inclusion criteria, refused to participate, or were not approached about participation. Staff were excluded if they refused to participate.

Reporting Groups
  Description
Collaborative Chronic Illness Care Model A care model that integrates greater availability of clinical information, reorganizes the practice system and provider roles, fosters care coordination, and focuses on evidence-based protocols--specifically supported employment and wellness services for individuals with schizophrenia.
Usual Care Continue with usual care

Participant Flow:   Overall Study
    Collaborative Chronic Illness Care Model   Usual Care
STARTED   389   412 
COMPLETED   305   357 
NOT COMPLETED   84   55 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
People with schizophrenia

Reporting Groups
  Description
Collaborative Chronic Illness Care Model A care model that integrates greater availability of clinical information, reorganizes the practice system and provider roles, fosters care coordination, and focuses on evidence-based protocols--specifically supported employment and wellness services for individuals with schizophrenia.
Usual Care Continue with usual care
Total Total of all reporting groups

Baseline Measures
   Collaborative Chronic Illness Care Model   Usual Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 389   412   801 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.0  (9.3)   54.5  (9.5)   54.3  (9.4) 
Gender 
[Units: Participants]
     
Female   30   39   69 
Male   359   373   732 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   3   10   13 
Asian   3   3   6 
Native Hawaiian or Other Pacific Islander   4   1   5 
Black or African American   160   195   355 
White   175   180   355 
More than one race   11   4   15 
Unknown or Not Reported   33   19   52 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   72   28   100 
Not Hispanic or Latino   312   380   692 
Unknown or Not Reported   5   4   9 
Region of Enrollment 
[Units: Participants]
     
United States   389   412   801 
Duration with Schizophrenia, years 
[Units: Years]
Mean (Standard Deviation)
 26.2  (11.7)   25.8  (12.7)   26.0  (12.3) 
Psychotropic medications by weight gain potential [1] 
[Units: Participants]
     
High Weight Gain Potential   70   65   135 
Moderate Weight Gain Potential   149   158   307 
Low Weight Gain Potential   96   92   188 
Unknown/Not Reported   74   97   171 
[1] Participants are only counted in one category; Participants are counted in the highest weight gain potential category.
Weight, kilograms 
[Units: Kilograms]
Mean (Standard Deviation)
 94.6  (20.4)   93.0  (20.1)   93.8  (20.2) 
Body Mass Index 
[Units: Kg/m^2]
Mean (Standard Deviation)
 30.2  (6.1)   29.9  (6.5)   30.1  (6.3) 
Diagnosis of Diabetes 
[Units: Participants]
     
Yes   120   118   238 
No   269   294   563 
Waist Circumference, centimeters 
[Units: Centimeters]
Mean (Standard Deviation)
 104.9  (16.3)   104.3  (15.7)   104.6  (16.0) 
Psychotic Symptoms, Brief Psychiatric Rating Scale [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 2.3  (1.3)   2.5  (1.3)   2.4  (1.3) 
[1] The Brief Psychiatric Rating Scale includes a number of scales that measure domains of psychopathology. Item scores and scale scores range from 1 (none) to 7 (extremely severe). The psychotic symptoms scale measures severity of psychosis.
Negative Symptoms, Brief Psychiatric Rating Scale [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 1.5  (0.8)   2.0  (1.3)   1.8  (0.8) 
[1] The Brief Psychiatric Rating Scale includes a number of scales that measure domains of psychopathology. Item scores and scale scores range from 1 (none) to 7 (extremely severe). The negative symptoms scale measures severity of negative symptoms.
Functioning, Global Assessment of Functioning Scale [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
     
Occupational Functioning   39.5  (20.6)   38.2  (16.8)   38.8  (18.8) 
Social Functioning   53.4  (14.1)   54.4  (12.9)   53.9  (13.5) 
Symptomatic Functioning   53.4  (15.1)   50.2  (13.8)   51.7  (14.5) 
[1] The Global Assessment of Functioning Scale consists of three scales: occupational functioning, social functioning, and symptomatic functioning. Each scale ranges from 1 (worst possible functioning) to 100 (superior functioning).


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Effect of Care Model Implementation on Treatment Appropriateness: Weight Service Utilization   [ Time Frame: 1 year ]

2.  Primary:   The Effect of Care Model Implementation on Treatment Appropriateness: Patient Weight Outcomes   [ Time Frame: 1 year ]

3.  Primary:   The Effect of Care Model Implementation on Treatment Appropriateness: Supported Employment Utilization   [ Time Frame: 1 year ]

4.  Primary:   The Effect of Care Model Implementation on Treatment Appropriateness: Patient Employment Outcomes   [ Time Frame: 1 year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Alexander S. Young
Organization: Greater Los Angeles Veterans Healthcare Center
phone: 310-268-3416
e-mail: alexander.young@va.gov


Publications of Results:

Other Publications:

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00137280     History of Changes
Other Study ID Numbers: MNT 03-213
P30MH082760 ( US NIH Grant/Contract Award Number )
Study First Received: August 25, 2005
Results First Received: October 3, 2014
Last Updated: April 6, 2015
Health Authority: United States: Federal Government