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

This study has been completed.
Sponsor:
Collaborators:
University of California, Los Angeles
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00137280
First received: August 25, 2005
Last updated: October 8, 2014
Last verified: October 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  
Number of Participants  
[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  
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 [2]
[units: units on a scale]
Mean ± Standard Deviation
  2.3  ± 1.3     2.5  ± 1.3     2.4  ± 1.3  
Negative Symptoms, Brief Psychiatric Rating Scale [3]
[units: units on a scale]
Mean ± Standard Deviation
  1.5  ± 0.8     2.0  ± 1.3     1.8  ± 0.8  
Functioning, Global Assessment of Functioning Scale [4]
[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] Participants are only counted in one category; Participants are counted in the highest weight gain potential category.
[2] 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.
[3] 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.
[4] 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
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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
None


  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: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00137280     History of Changes
Other Study ID Numbers: MNT 03-213, P30MH082760
Study First Received: August 25, 2005
Results First Received: October 3, 2014
Last Updated: October 8, 2014
Health Authority: United States: Federal Government