Chronic Illness, Psychotic Disorder, Schizophrenia, Weight Gain
Conditions
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
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.
Interventions
BEHAVIORALCollaborative 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.
Sponsors
University of California, Los Angeles
National Institute of Mental Health (NIMH)
VA Office of Research and Development
Study design
Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
research assessors had minimal contact with staff involved in implementation
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Effect of Care Model Implementation on Treatment Appropriateness: Weight Service Utilization | 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). |
| The Effect of Care Model Implementation on Treatment Appropriateness: Patient Weight Outcomes | 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. |
| The Effect of Care Model Implementation on Treatment Appropriateness: Supported Employment Utilization | 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). |
| The Effect of Care Model Implementation on Treatment Appropriateness: Patient Employment Outcomes | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 389 |
| Usual Care Continue with usual care | 412 |
| Total | 801 |
Baseline characteristics
| Characteristic | Usual Care | Total | Collaborative Chronic Illness Care Model |
|---|---|---|---|
| Age, Continuous | 54.5 years STANDARD_DEVIATION 9.5 | 54.3 years STANDARD_DEVIATION 9.4 | 54.0 years STANDARD_DEVIATION 9.3 |
| Body Mass Index | 29.9 kg/m^2 STANDARD_DEVIATION 6.5 | 30.1 kg/m^2 STANDARD_DEVIATION 6.3 | 30.2 kg/m^2 STANDARD_DEVIATION 6.1 |
| Diagnosis of Diabetes No | 294 participants | 563 participants | 269 participants |
| Diagnosis of Diabetes Yes | 118 participants | 238 participants | 120 participants |
| Duration with Schizophrenia, years | 25.8 years STANDARD_DEVIATION 12.7 | 26.0 years STANDARD_DEVIATION 12.3 | 26.2 years STANDARD_DEVIATION 11.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 28 Participants | 100 Participants | 72 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 380 Participants | 692 Participants | 312 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 4 Participants | 9 Participants | 5 Participants |
| Functioning, Global Assessment of Functioning Scale Occupational Functioning | 38.2 units on a scale STANDARD_DEVIATION 16.8 | 38.8 units on a scale STANDARD_DEVIATION 18.8 | 39.5 units on a scale STANDARD_DEVIATION 20.6 |
| Functioning, Global Assessment of Functioning Scale Social Functioning | 54.4 units on a scale STANDARD_DEVIATION 12.9 | 53.9 units on a scale STANDARD_DEVIATION 13.5 | 53.4 units on a scale STANDARD_DEVIATION 14.1 |
| Functioning, Global Assessment of Functioning Scale Symptomatic Functioning | 50.2 units on a scale STANDARD_DEVIATION 13.8 | 51.7 units on a scale STANDARD_DEVIATION 14.5 | 53.4 units on a scale STANDARD_DEVIATION 15.1 |
| Negative Symptoms, Brief Psychiatric Rating Scale | 2.0 units on a scale STANDARD_DEVIATION 1.3 | 1.8 units on a scale STANDARD_DEVIATION 0.8 | 1.5 units on a scale STANDARD_DEVIATION 0.8 |
| Psychotic Symptoms, Brief Psychiatric Rating Scale | 2.5 units on a scale STANDARD_DEVIATION 1.3 | 2.4 units on a scale STANDARD_DEVIATION 1.3 | 2.3 units on a scale STANDARD_DEVIATION 1.3 |
| Psychotropic medications by weight gain potential High Weight Gain Potential | 65 participants | 135 participants | 70 participants |
| Psychotropic medications by weight gain potential Low Weight Gain Potential | 92 participants | 188 participants | 96 participants |
| Psychotropic medications by weight gain potential Moderate Weight Gain Potential | 158 participants | 307 participants | 149 participants |
| Psychotropic medications by weight gain potential Unknown/Not Reported | 97 participants | 171 participants | 74 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 10 Participants | 13 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 195 Participants | 355 Participants | 160 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 15 Participants | 11 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 5 Participants | 4 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 19 Participants | 52 Participants | 33 Participants |
| Race (NIH/OMB) White | 180 Participants | 355 Participants | 175 Participants |
| Region of Enrollment United States | 412 participants | 801 participants | 389 participants |
| Sex: Female, Male Female | 39 Participants | 69 Participants | 30 Participants |
| Sex: Female, Male Male | 373 Participants | 732 Participants | 359 Participants |
| Waist Circumference, centimeters | 104.3 centimeters STANDARD_DEVIATION 15.7 | 104.6 centimeters STANDARD_DEVIATION 16 | 104.9 centimeters STANDARD_DEVIATION 16.3 |
| Weight, kilograms | 93.0 kilograms STANDARD_DEVIATION 20.1 | 93.8 kilograms STANDARD_DEVIATION 20.2 | 94.6 kilograms STANDARD_DEVIATION 20.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 389 | 0 / 412 |
| serious Total, serious adverse events | 0 / 389 | 0 / 412 |
Outcome results
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.
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Collaborative Chronic Illness Care Model | The Effect of Care Model Implementation on Treatment Appropriateness: Patient Employment Outcomes | 14 competitive employment |
| Usual Care | The Effect of Care Model Implementation on Treatment Appropriateness: Patient Employment Outcomes | 12 competitive employment |
p-value: 0.11Chi-squared
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.
Time frame: 1 year
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Collaborative Chronic Illness Care Model | The Effect of Care Model Implementation on Treatment Appropriateness: Patient Weight Outcomes | 208.1 pounds | Standard Error 0.92 |
| Usual Care | The Effect of Care Model Implementation on Treatment Appropriateness: Patient Weight Outcomes | 207.2 pounds | Standard Error 0.83 |
p-value: 0.03ANCOVA
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).
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Collaborative Chronic Illness Care Model | The Effect of Care Model Implementation on Treatment Appropriateness: Supported Employment Utilization | 32 participants |
| Usual Care | The Effect of Care Model Implementation on Treatment Appropriateness: Supported Employment Utilization | 17 participants |
p-value: <0.0195% CI: [1.22, 4.34]Regression, Logistic
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).
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Collaborative Chronic Illness Care Model | The Effect of Care Model Implementation on Treatment Appropriateness: Weight Service Utilization | 73 participants |
| Usual Care | The Effect of Care Model Implementation on Treatment Appropriateness: Weight Service Utilization | 38 participants |
p-value: <0.0195% CI: [1.47, 3.58]Regression, Logistic