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

Primary Purpose

Schizophrenia, Chronic Illness, Weight Gain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Collaborative Chronic Illness Care Model
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Schizophrenia focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Long Beach Healthcare System, Long Beach, CA
  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA
  • Overton Brooks VA Medical Center, Shreveport, LA
  • VA Southern Nevada Healthcare System, North Las Vegas, NV
  • James J. Peters VA Medical Center, Bronx, NY
  • Northport VA Medical Center, Northport, NY
  • Michael E. DeBakey VA Medical Center, Houston, TX
  • Central Texas Veterans Health Care System, Temple, TX

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Collaborative Chronic Illness Care Model

Usual Care

Arm Description

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.

Usual Care

Outcomes

Primary Outcome Measures

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).
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.
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).
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.

Secondary Outcome Measures

Full Information

First Posted
August 25, 2005
Last Updated
January 24, 2018
Sponsor
VA Office of Research and Development
Collaborators
University of California, Los Angeles, National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00137280
Brief Title
Implementing Effective, Collaborative Care for Schizophrenia (EQUIP-2)
Acronym
EQUIP-2
Official Title
Implementing Effective, Collaborative Care for Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
June 13, 2007 (Actual)
Primary Completion Date
March 5, 2010 (Actual)
Study Completion Date
May 31, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
Collaborators
University of California, Los Angeles, National Institute of Mental Health (NIMH)

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Masking Description
research assessors had minimal contact with staff involved in implementation
Allocation
Non-Randomized
Enrollment
1067 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Collaborative Chronic Illness Care Model
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual Care
Intervention Type
Behavioral
Intervention Name(s)
Collaborative Chronic Illness Care Model
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Effect of Care Model Implementation on Treatment Appropriateness: Weight Service Utilization
Description
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).
Time Frame
1 year
Title
The Effect of Care Model Implementation on Treatment Appropriateness: Patient Weight Outcomes
Description
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.
Time Frame
1 year
Title
The Effect of Care Model Implementation on Treatment Appropriateness: Supported Employment Utilization
Description
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).
Time Frame
1 year
Title
The Effect of Care Model Implementation on Treatment Appropriateness: Patient Employment Outcomes
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Stehle Young, MD MSHS
Organizational Affiliation
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Long Beach Healthcare System, Long Beach, CA
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
VA Greater Los Angeles Healthcare System, West Los Angeles, CA
City
West Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
Overton Brooks VA Medical Center, Shreveport, LA
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
VA Southern Nevada Healthcare System, North Las Vegas, NV
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
James J. Peters VA Medical Center, Bronx, NY
City
Bronx
State/Province
New York
ZIP/Postal Code
10468
Country
United States
Facility Name
Northport VA Medical Center, Northport, NY
City
Northport
State/Province
New York
ZIP/Postal Code
11768
Country
United States
Facility Name
Michael E. DeBakey VA Medical Center, Houston, TX
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Central Texas Veterans Health Care System, Temple, TX
City
Temple
State/Province
Texas
ZIP/Postal Code
76504
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18997159
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.
Results Reference
background
PubMed Identifier
18279505
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.
Results Reference
result
PubMed Identifier
20077148
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.
Results Reference
result
PubMed Identifier
20658320
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.
Results Reference
result
PubMed Identifier
23407006
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.
Results Reference
result
PubMed Identifier
24138608
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.
Results Reference
result
PubMed Identifier
28287773
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.
Results Reference
result

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

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