- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00137280
Implementing Effective, Collaborative Care for Schizophrenia (EQUIP-2) (EQUIP-2)
Implementing Effective, Collaborative Care for Schizophrenia
Study Overview
Status
Intervention / Treatment
Detailed Description
Objectives:
EQUIP-2 is a clinic-level controlled trial. From the four participating Veterans Integrated Services Networks (VISNs), eight specialty mental health programs were enrolled and assigned to care as usual or to receive an intervention supporting evidence-based quality improvement and use of a chronic illness care model. Participants are VISN 3 (James J. Peters VA; Northport VA); VISN 16 (Houston VA; Shreveport VA); VISN 17 (Waco VA; Temple VA); and VISN 22 (Long Beach VA; Greater Los Angeles VA). The objectives of this VA Quality Enhancement Research Initiative (QUERI) Service Directed Project are 1) assist in identifying and making available recovery-oriented services to veterans with schizophrenia; 2) implement information systems that efficiently and accurately identify patient status and who would be appropriate for these services; 3) implement a care model to support recovery-oriented care delivery; 4) evaluate, in a controlled trial, the effect of implementation on treatment delivery and patient outcomes; and 5) identify facilitators and barriers to wellness program participation in an effort to strengthen the weight management services available to patients with schizophrenia. The project studies intervention feasibility, acceptability, and impact on outcomes; performs qualitative analyses examining processes and variation in care model implementation and impact. Research includes a controlled trial of the impact of implementation, relative to usual care, on treatment quality. Participants include clinic staff and patients with schizophrenia. Data sources include interviews with participants, focus groups with a sub-set of patients, implementation documentation, the project informatics system, and VistA.
Methods:
The care model targets two clinical domains selected by the VISNs from the following: Supported Employment (SE), caregiver support, wellness programs, or clozapine. All 4 VISNs chose the same two targets: SE and wellness. The care model includes: 1) at each visit, routine collection of patient outcomes data and provision of decision support using a self-assessment kiosk; 2) provision of "psychiatric vital signs" to patients and clinicians at the time of the clinical encounter via report that prints from the kiosk; 3) education and activation of both clinicians and patients around the clinical targets; 4) regular reports identifying patients appropriate for services associated with these targets; and 5) facilitation of problem-solving and evidence-based quality improvement addressing any barriers to utilization of these services.
To inform future wellness implementation, in-depth, semi-structured interviews are conducted with patients who participated in wellness groups ("participants"), and with patients who were referred (because they were overweight or obese) but did not participate ("non-participants"). Participants consist of all enrolled patients who attended the wellness program with special attention to those patients who completed at least half of the wellness program. Non-participants consist of patients who were referred to the wellness program but did not attend. Clinicians were interviewed specifically regarding wellness implementation.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Long Beach, California, United States, 90822
- VA Long Beach Healthcare System, Long Beach, CA
-
West Los Angeles, California, United States, 90073
- VA Greater Los Angeles Healthcare System, West Los Angeles, CA
-
-
Louisiana
-
Shreveport, Louisiana, United States, 71101
- Overton Brooks VA Medical Center, Shreveport, LA
-
-
Nevada
-
Las Vegas, Nevada, United States, 89106
- VA Southern Nevada Healthcare System, North Las Vegas, NV
-
-
New York
-
Bronx, New York, United States, 10468
- James J. Peters VA Medical Center, Bronx, NY
-
Northport, New York, United States, 11768
- Northport VA Medical Center, Northport, NY
-
-
Texas
-
Houston, Texas, United States, 77030
- Michael E. DeBakey VA Medical Center, Houston, TX
-
Temple, Texas, United States, 76504
- Central Texas Veterans Health Care System, Temple, TX
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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.
Exclusion Criteria:
None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual Care
|
|
Experimental: Collaborative Chronic Illness Care Model
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Effect of Care Model Implementation on Treatment Appropriateness: Weight Service Utilization
Time Frame: 1 year
|
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
Time Frame: 1 year
|
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
Time Frame: 1 year
|
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
Time Frame: 1 year
|
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
|
Collaborators and Investigators
Investigators
- Principal Investigator: Alexander Stehle Young, MD MSHS, VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MNT 03-213
- P30MH082760 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Schizophrenia
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Organon and CoCompletedSchizophrenia, Paranoid | Schizophrenia, Disorganized | Schizophrenia, Undifferentiated
-
Bradley LegaRecruiting
-
All India Institute of Medical Sciences, BhubaneswarRecruitingTreatment Resistant SchizophreniaIndia
-
King's College LondonSouth London and Maudsley NHS Foundation TrustRecruitingTreatment-resistant Schizophrenia | Healthy Controls | Treatment-responsive SchizophreniaUnited Kingdom
-
University of Sao PauloUnknownRefractory Schizophrenia | Super Refractory SchizophreniaBrazil
-
Rakitzi, StavroulaActive, not recruiting
-
Ohio State UniversityRecruitingTreatment-resistant SchizophreniaUnited States
-
University Hospital, BrestRecruitingSchizophrenia | Schizophrenia Prodromal | Schizophrenia, ChildhoodFrance
-
NYU Langone HealthNot yet recruitingTreatment-resistant SchizophreniaUnited States
Clinical Trials on Collaborative Chronic Illness Care Model
-
US Department of Veterans AffairsUniversity of California, Los Angeles; asdCompletedSchizoaffective Disorder | Weight Gain | Chronic Illness | Schizophrenia DisordersUnited States
-
University of MichiganCompletedDepression | Bipolar DisorderUnited States
-
Chulalongkorn UniversityamfAR, The Foundation for AIDS ResearchCompleted
-
McMaster UniversityUnknown
-
C. T. Lamont Primary Care Research CentreCompletedQuality of Life | Chronic IllnessCanada
-
Massachusetts General HospitalActive, not recruitingType 1 Diabetes | Type 2 DiabetesUnited States
-
US Department of Veterans AffairsCompletedDepression | Stress Disorders, PosttraumaticUnited States
-
Trillium Health CentreCentre for Addiction and Mental Health; Medical Psychiatry AllianceCompletedDepression | AnxietyCanada
-
Harvard Vanguard Medical AssociatesBrigham and Women's Hospital; Harvard UniversityCompleted
-
Santa Clara Valley Health & Hospital SystemCompleted