Clinical trial NCT00137280: Implementing Effective, Collaborative Care for Schizophrenia (EQUIP-2)
Official title: Implementing Effective, Collaborative Care for Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Chronic Illness
Weight Gain
Psychotic Disorder
Keywords: Randomized Controlled Trial
Quality of Health Care
Health Services Research
Guidelines
Medical Informatics Computing
Services, Mental Health
Medicine, Evidenced-Based
Quality Assurance, Healthcare
Quality Indicators, Health Care
Veterans
Unemployment
Obesity
Quality Improvement
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: University of California, Los Angeles
name: National Institute of Mental Health (NIMH)
First posted: 2005-08-29
Enrollment: 1067
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Effect of Care Model Implementation on Treatment Appropriateness: Weight Service Utilization
timeFrame: 1 year
measure: The Effect of Care Model Implementation on Treatment Appropriateness: Patient Weight Outcomes
timeFrame: 1 year
measure: The Effect of Care Model Implementation on Treatment Appropriateness: Supported Employment Utilization
timeFrame: 1 year
measure: The Effect of Care Model Implementation on Treatment Appropriateness: Patient Employment Outcomes
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: VA Long Beach Healthcare System, Long Beach, CA
state: California
city: West Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
state: California
city: Shreveport
country: United States
facility: Overton Brooks VA Medical Center, Shreveport, LA
state: Louisiana
city: Las Vegas
country: United States
facility: VA Southern Nevada Healthcare System, North Las Vegas, NV
state: Nevada
city: Bronx
country: United States
facility: James J. Peters VA Medical Center, Bronx, NY
state: New York
city: Northport
country: United States
facility: Northport VA Medical Center, Northport, NY
state: New York
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center, Houston, TX
state: Texas
city: Temple
country: United States
facility: Central Texas Veterans Health Care System, Temple, TX
state: Texas
Study officials:
affiliation: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
name: Alexander Stehle Young, MD MSHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.