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

Schizophrenia Clinical Trial

— EQUIP-2  

Official title:

Implementing Effective, Collaborative Care for Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00137280
• Other study ID #: MNT 03-213
• Secondary ID: P30MH082760
• Status: Completed
• Phase: N/A
• First received: August 25, 2005
• Last updated: January 24, 2018
• Start date: June 13, 2007
• Est. completion date: May 31, 2011

Study information

• Verified date: January 2018
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1067
• Est. completion date: May 31, 2011
• Est. primary completion date: March 5, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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:

Related Conditions & MeSH terms

• Chronic Disease
• Chronic Illness
• Mental Disorders
• Psychotic Disorder
• Psychotic Disorders
• Schizophrenia
• Weight Gain

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	James J. Peters VA Medical Center, Bronx, NY	Bronx	New York
United States	Michael E. DeBakey VA Medical Center, Houston, TX	Houston	Texas
United States	VA Southern Nevada Healthcare System, North Las Vegas, NV	Las Vegas	Nevada
United States	VA Long Beach Healthcare System, Long Beach, CA	Long Beach	California
United States	Northport VA Medical Center, Northport, NY	Northport	New York
United States	Overton Brooks VA Medical Center, Shreveport, LA	Shreveport	Louisiana
United States	Central Texas Veterans Health Care System, Temple, TX	Temple	Texas
United States	VA Greater Los Angeles Healthcare System, West Los Angeles, CA	West Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
VA Office of Research and Development	National Institute of Mental Health (NIMH), University of California, Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (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. — View 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. — View 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: 10.1111/14 — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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