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| ID | Type | Description | Link |
|---|---|---|---|
| P30MH082760 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of California, Los Angeles | OTHER |
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Collaborative Chronic Illness Care Model | Experimental | 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 | No Intervention | Usual Care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Collaborative Chronic Illness Care Model | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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. |
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Inclusion Criteria:
Clinicians and Managers:
Patients:
Exclusion Criteria:
None
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Stehle Young, MD MSHS | VA Greater Los Angeles Healthcare System, West Los Angeles, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Long Beach Healthcare System, Long Beach, CA | Long Beach | California | 90822 | United States | ||
| VA Greater Los Angeles Healthcare System, West Los Angeles, CA |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18997159 | Background | 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. | |
| 18279505 | Result | 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. |
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Patients were excluded if they did not meet inclusion criteria, refused to participate, or were not approached about participation. Staff were excluded if they refused to participate.
Patients were selected randomly from the population of individuals with schizophrenia receiving care at VA mental health clinics. All clinicians and managers at mental health clinics were selected.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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research assessors had minimal contact with staff involved in implementation
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| 1 year |
| West Los Angeles |
| California |
| 90073 |
| United States |
| Overton Brooks VA Medical Center, Shreveport, LA | Shreveport | Louisiana | 71101 | United States |
| VA Southern Nevada Healthcare System, North Las Vegas, NV | Las Vegas | Nevada | 89106 | United States |
| Northport VA Medical Center, Northport, NY | Northport | New York | 11768 | United States |
| James J. Peters VA Medical Center, Bronx, NY | The Bronx | New York | 10468 | United States |
| Michael E. DeBakey VA Medical Center, Houston, TX | Houston | Texas | 77030 | United States |
| Central Texas Veterans Health Care System, Temple, TX | Temple | Texas | 76504 | United States |
| 20077148 | Result | 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. |
| 20658320 | Result | 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. |
| 23407006 | Result | 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. |
| 24138608 | Result | 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. |
| 28287773 | Result | 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. |
| Usual Care |
Continue with usual care |
| COMPLETED |
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| NOT COMPLETED |
|
People with schizophrenia
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Usual Care | Continue with usual care |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Duration with Schizophrenia, years | Mean | Standard Deviation | years |
| |||||||||||||||
| Psychotropic medications by weight gain potential | Participants are only counted in one category; Participants are counted in the highest weight gain potential category. | Number | participants |
| |||||||||||||||
| Weight, kilograms | Mean | Standard Deviation | kilograms |
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| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
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| Diagnosis of Diabetes | Number | participants |
| ||||||||||||||||
| Waist Circumference, centimeters | Mean | Standard Deviation | centimeters |
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| Psychotic Symptoms, Brief Psychiatric Rating Scale | The Brief Psychiatric Rating Scale includes a number of scales that measure domains of psychopathology. Item scores and scale scores range from 1 (none) to 7 (extremely severe). The psychotic symptoms scale measures severity of psychosis. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Negative Symptoms, Brief Psychiatric Rating Scale | The Brief Psychiatric Rating Scale includes a number of scales that measure domains of psychopathology. Item scores and scale scores range from 1 (none) to 7 (extremely severe). The negative symptoms scale measures severity of negative symptoms. | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Functioning, Global Assessment of Functioning Scale | The Global Assessment of Functioning Scale consists of three scales: occupational functioning, social functioning, and symptomatic functioning. Each scale ranges from 1 (worst possible functioning) to 100 (superior functioning). | Mean | Standard Deviation | units on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Number | participants | 1 year |
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| 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. | Posted | Least Squares Mean | Standard Error | pounds | 1 year |
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| 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). | Posted | Number | participants | 1 year |
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| 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. | Posted | Number | competitive employment | 1 year |
|
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 389 | 0 | 389 | ||
| EG001 | Usual Care | Continue with usual care | 0 | 412 | 0 | 412 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Alexander S. Young | Greater Los Angeles Veterans Healthcare Center | 310-268-3416 | alexander.young@va.gov |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D002908 | Chronic Disease |
| D015430 | Weight Gain |
| D011618 | Psychotic Disorders |
| D000092862 | Psychological Well-Being |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Moderate Weight Gain Potential |
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| Low Weight Gain Potential |
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| Unknown/Not Reported |
|
| No |
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| Social Functioning |
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| Symptomatic Functioning |
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