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

• ClinicalTrials.gov Identifier: NCT00137280
• Recruitment Status: Completed
• First Posted: August 29, 2005
• Results First Posted: October 15, 2014
• Last Update Posted: February 22, 2018
• Sponsor: VA Office of Research and Development
• Collaborators: University of California, Los Angeles; National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Schizophrenia; Chronic Illness; Weight Gain; Psychotic Disorder	Behavioral: Collaborative Chronic Illness Care Model	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1067 participants
• Allocation: Non-Randomized
• Intervention Model: Factorial Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: research assessors had minimal contact with staff involved in implementation
• Primary Purpose: Health Services Research
• Official Title: Implementing Effective, Collaborative Care for Schizophrenia
• Actual Study Start Date: June 13, 2007
• Actual Primary Completion Date: March 5, 2010
• Actual Study Completion Date: May 31, 2011

Arms and Interventions

Arm	Intervention/treatment
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.	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.
No Intervention: Usual Care; Usual Care

Outcome Measures

Primary Outcome Measures :

1. 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).
2. 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.
3. 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).
4. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, California

VA Long Beach Healthcare System, Long Beach, CA

Long Beach, California, United States, 90822

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

West Los Angeles, California, United States, 90073

United States, Louisiana

Overton Brooks VA Medical Center, Shreveport, LA

Shreveport, Louisiana, United States, 71101

United States, Nevada

VA Southern Nevada Healthcare System, North Las Vegas, NV

Las Vegas, Nevada, United States, 89106

United States, New York

James J. Peters VA Medical Center, Bronx, NY

Bronx, New York, United States, 10468

Northport VA Medical Center, Northport, NY

Northport, New York, United States, 11768

United States, Texas

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, United States, 77030

Central Texas Veterans Health Care System, Temple, TX

Temple, Texas, United States, 76504

Sponsors and Collaborators

VA Office of Research and Development

University of California, Los Angeles

National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Alexander Stehle Young, MD MSHS; VA Greater Los Angeles Healthcare System, West Los Angeles, CA

More Information

Publications of Results:

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 1:27-31. 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.

Other Publications:

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.

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT00137280
• Other Study ID Numbers: MNT 03-213; P30MH082760 ( U.S. NIH Grant/Contract )
• First Posted: August 29, 2005
• Results First Posted: October 15, 2014
• Last Update Posted: February 22, 2018
• Last Verified: January 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:

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

Additional relevant MeSH terms:

Weight Gain; Chronic Disease; Schizophrenia; Mental Disorders; Psychotic Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Body Weight Changes; Body Weight; Disease Attributes; Pathologic Processes