NCT00137280

Brief Summary

This project evaluates the implementation and effectiveness of a care model to improve treatment for schizophrenia within the context of diverse VA practices and priorities. The project provides information to VA clinicians and managers about Veterans with schizophrenia or schizoaffective disorder who are overweight and/or who would like to return to competitive work. The project facilitates reorganization of care practices in order to get veterans needed and desired services around wellness and work. The project creates a platform that other clinical and research interventions can build upon to improve care, and is designed to inform a national strategy for implementing evidence-based care in schizophrenia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,067

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Jun 2007

Typical duration for not_applicable schizophrenia

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 29, 2005

Completed
1.8 years until next milestone

Study Start

First participant enrolled

June 13, 2007

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2010

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2011

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

October 15, 2014

Completed
Last Updated

February 22, 2018

Status Verified

January 1, 2018

Enrollment Period

2.7 years

First QC Date

August 25, 2005

Results QC Date

October 3, 2014

Last Update Submit

January 24, 2018

Conditions

Keywords

Randomized Controlled TrialQuality of Health CareHealth Services ResearchGuidelinesMedical Informatics ComputingServices, Mental HealthMedicine, Evidenced-BasedQuality Assurance, HealthcareQuality Indicators, Health CareVeteransUnemploymentObesityQuality Improvement

Outcome Measures

Primary Outcomes (4)

  • The Effect of Care Model Implementation on Treatment Appropriateness: Weight Service Utilization

    The number of participants with one or more weight service appointments in the one year during implementation (implementation sites versus control sites) for those participants who were overweight at the baseline interview (e.g., eligible for weight services). This only includes participants who were overweight at the baseline interview (e.g., eligible for weight services).

    1 year

  • The Effect of Care Model Implementation on Treatment Appropriateness: Patient Weight Outcomes

    Analysis of Covariance (ANCOVA) was used to examine weight gained during treatment in implementation versus control groups. The dependent variable was final weight. Baseline weight, weight 6 months prior to baseline, and baseline psychotic and negative symptom subscales were included as covariates. The inclusion of weight 6 months prior to baseline served to control for subjects' weight gain/loss trajectories prior to entering the study. The two-way interactions of group by covariates were also included in the model.

    1 year

  • The Effect of Care Model Implementation on Treatment Appropriateness: Supported Employment Utilization

    The number of participants with one or more Supported Employment appointments in the one year during implementation (implementation sites versus control sites) for those participants who endorsed a desire to return to work at the baseline interview (e.g., eligible for Supported Employment services). This only includes participants who endorsed a desire to return to work at the baseline interview (e.g., eligible for Supported Employment services).

    1 year

  • The Effect of Care Model Implementation on Treatment Appropriateness: Patient Employment Outcomes

    Chi-square analysis was used to examine competitive employment gained during treatment in implementation versus control groups. The dependent variable was competitive employment. Individuals included were only those who expressed interest in returning to work at both the baseline and follow-up interview time-points.

    1 year

Study Arms (2)

Collaborative Chronic Illness Care Model

EXPERIMENTAL

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.

Behavioral: Collaborative Chronic Illness Care Model

Usual Care

NO INTERVENTION

Usual Care

Interventions

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.

Collaborative Chronic Illness Care Model

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinicians and Managers:
  • Psychiatrists, Case Managers, Nurses, Supported Employment workers Nutritionists, Local Recovery Coordinators, and Quality Improvement experts working at one of the participating VA Medical Centers
  • Patients:
  • At least 18 years old
  • Diagnosis of Schizophrenia, Schizoaffective, or schizophreniform disorder
  • At least 1 treatment visit with a clinician at the clinic during the 6 months prior to enrollment and then at least 1 treatment visit with a clinician at the clinic during the 5 months of enrollment.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

VA Long Beach Healthcare System, Long Beach, CA

Long Beach, California, 90822, United States

Location

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, 90073, United States

Location

Overton Brooks VA Medical Center, Shreveport, LA

Shreveport, Louisiana, 71101, United States

Location

VA Southern Nevada Healthcare System, North Las Vegas, NV

Las Vegas, Nevada, 89106, United States

Location

Northport VA Medical Center, Northport, NY

Northport, New York, 11768, United States

Location

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468, United States

Location

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030, United States

Location

Central Texas Veterans Health Care System, Temple, TX

Temple, Texas, 76504, United States

Location

Related Publications (7)

  • Young AS, Niv N, Cohen AN, Kessler C, McNagny K. The appropriateness of routine medication treatment for schizophrenia. Schizophr Bull. 2010 Jul;36(4):732-9. doi: 10.1093/schbul/sbn138. Epub 2008 Nov 7.

    PMID: 18997159BACKGROUND
  • Brown AH, Cohen AN, Chinman MJ, Kessler C, Young AS. EQUIP: implementing chronic care principles and applying formative evaluation methods to improve care for schizophrenia: QUERI Series. Implement Sci. 2008 Feb 15;3:9. doi: 10.1186/1748-5908-3-9.

  • Hamilton AB, Cohen AN, Young AS. Organizational readiness in specialty mental health care. J Gen Intern Med. 2010 Jan;25 Suppl 1(Suppl 1):27-31. doi: 10.1007/s11606-009-1133-3.

  • Young AS, Niv N, Chinman M, Dixon L, Eisen SV, Fischer EP, Smith J, Valenstein M, Marder SR, Owen RR. Routine outcomes monitoring to support improving care for schizophrenia: report from the VA Mental Health QUERI. Community Ment Health J. 2011 Apr;47(2):123-35. doi: 10.1007/s10597-010-9328-y. Epub 2010 Jul 25.

  • Cohen AN, Chinman MJ, Hamilton AB, Whelan F, Young AS. Using patient-facing kiosks to support quality improvement at mental health clinics. Med Care. 2013 Mar;51(3 Suppl 1):S13-20. doi: 10.1097/MLR.0b013e31827da859.

  • Hamilton AB, Cohen AN, Glover DL, Whelan F, Chemerinski E, McNagny KP, Mullins D, Reist C, Schubert M, Young AS. Implementation of evidence-based employment services in specialty mental health. Health Serv Res. 2013 Dec;48(6 Pt 2):2224-44. doi: 10.1111/1475-6773.12115. Epub 2013 Oct 21.

  • Pedersen ER, Huang W, Cohen AN, Young AS. Alcohol use and service utilization among veterans in treatment for schizophrenia. Psychol Serv. 2018 Feb;15(1):21-30. doi: 10.1037/ser0000109. Epub 2017 Mar 13.

MeSH Terms

Conditions

SchizophreniaChronic DiseaseWeight GainPsychotic DisordersPsychological Well-BeingObesity

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBody Weight ChangesBody WeightSigns and SymptomsPersonal SatisfactionBehaviorOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Results Point of Contact

Title
Dr. Alexander S. Young
Organization
Greater Los Angeles Veterans Healthcare Center

Study Officials

  • Alexander Stehle Young, MD MSHS

    VA Greater Los Angeles Healthcare System, West Los Angeles, CA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
research assessors had minimal contact with staff involved in implementation
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
FACTORIAL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2005

First Posted

August 29, 2005

Study Start

June 13, 2007

Primary Completion

March 5, 2010

Study Completion

May 31, 2011

Last Updated

February 22, 2018

Results First Posted

October 15, 2014

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations