Trial Outcomes & Findings for Implementing Effective, Collaborative Care for Schizophrenia (EQUIP-2) (NCT NCT00137280)
NCT ID: NCT00137280
Last Updated: 2018-02-22
Results Overview
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).
COMPLETED
NA
1067 participants
1 year
2018-02-22
Participant Flow
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.
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.
Participant milestones
| Measure |
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
Continue with usual care
|
|---|---|---|
|
Overall Study
STARTED
|
389
|
412
|
|
Overall Study
COMPLETED
|
305
|
357
|
|
Overall Study
NOT COMPLETED
|
84
|
55
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Implementing Effective, Collaborative Care for Schizophrenia (EQUIP-2)
Baseline characteristics by cohort
| Measure |
Collaborative Chronic Illness Care Model
n=389 Participants
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
n=412 Participants
Continue with usual care
|
Total
n=801 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.0 years
STANDARD_DEVIATION 9.3 • n=99 Participants
|
54.5 years
STANDARD_DEVIATION 9.5 • n=107 Participants
|
54.3 years
STANDARD_DEVIATION 9.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
359 Participants
n=99 Participants
|
373 Participants
n=107 Participants
|
732 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
160 Participants
n=99 Participants
|
195 Participants
n=107 Participants
|
355 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
175 Participants
n=99 Participants
|
180 Participants
n=107 Participants
|
355 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
11 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
33 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
72 Participants
n=99 Participants
|
28 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
312 Participants
n=99 Participants
|
380 Participants
n=107 Participants
|
692 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
389 participants
n=99 Participants
|
412 participants
n=107 Participants
|
801 participants
n=206 Participants
|
|
Duration with Schizophrenia, years
|
26.2 years
STANDARD_DEVIATION 11.7 • n=99 Participants
|
25.8 years
STANDARD_DEVIATION 12.7 • n=107 Participants
|
26.0 years
STANDARD_DEVIATION 12.3 • n=206 Participants
|
|
Psychotropic medications by weight gain potential
High Weight Gain Potential
|
70 participants
n=99 Participants
|
65 participants
n=107 Participants
|
135 participants
n=206 Participants
|
|
Psychotropic medications by weight gain potential
Moderate Weight Gain Potential
|
149 participants
n=99 Participants
|
158 participants
n=107 Participants
|
307 participants
n=206 Participants
|
|
Psychotropic medications by weight gain potential
Low Weight Gain Potential
|
96 participants
n=99 Participants
|
92 participants
n=107 Participants
|
188 participants
n=206 Participants
|
|
Psychotropic medications by weight gain potential
Unknown/Not Reported
|
74 participants
n=99 Participants
|
97 participants
n=107 Participants
|
171 participants
n=206 Participants
|
|
Weight, kilograms
|
94.6 kilograms
STANDARD_DEVIATION 20.4 • n=99 Participants
|
93.0 kilograms
STANDARD_DEVIATION 20.1 • n=107 Participants
|
93.8 kilograms
STANDARD_DEVIATION 20.2 • n=206 Participants
|
|
Body Mass Index
|
30.2 kg/m^2
STANDARD_DEVIATION 6.1 • n=99 Participants
|
29.9 kg/m^2
STANDARD_DEVIATION 6.5 • n=107 Participants
|
30.1 kg/m^2
STANDARD_DEVIATION 6.3 • n=206 Participants
|
|
Diagnosis of Diabetes
Yes
|
120 participants
n=99 Participants
|
118 participants
n=107 Participants
|
238 participants
n=206 Participants
|
|
Diagnosis of Diabetes
No
|
269 participants
n=99 Participants
|
294 participants
n=107 Participants
|
563 participants
n=206 Participants
|
|
Waist Circumference, centimeters
|
104.9 centimeters
STANDARD_DEVIATION 16.3 • n=99 Participants
|
104.3 centimeters
STANDARD_DEVIATION 15.7 • n=107 Participants
|
104.6 centimeters
STANDARD_DEVIATION 16.0 • n=206 Participants
|
|
Psychotic Symptoms, Brief Psychiatric Rating Scale
|
2.3 units on a scale
STANDARD_DEVIATION 1.3 • n=99 Participants
|
2.5 units on a scale
STANDARD_DEVIATION 1.3 • n=107 Participants
|
2.4 units on a scale
STANDARD_DEVIATION 1.3 • n=206 Participants
|
|
Negative Symptoms, Brief Psychiatric Rating Scale
|
1.5 units on a scale
STANDARD_DEVIATION 0.8 • n=99 Participants
|
2.0 units on a scale
STANDARD_DEVIATION 1.3 • n=107 Participants
|
1.8 units on a scale
STANDARD_DEVIATION 0.8 • n=206 Participants
|
|
Functioning, Global Assessment of Functioning Scale
Occupational Functioning
|
39.5 units on a scale
STANDARD_DEVIATION 20.6 • n=99 Participants
|
38.2 units on a scale
STANDARD_DEVIATION 16.8 • n=107 Participants
|
38.8 units on a scale
STANDARD_DEVIATION 18.8 • n=206 Participants
|
|
Functioning, Global Assessment of Functioning Scale
Social Functioning
|
53.4 units on a scale
STANDARD_DEVIATION 14.1 • n=99 Participants
|
54.4 units on a scale
STANDARD_DEVIATION 12.9 • n=107 Participants
|
53.9 units on a scale
STANDARD_DEVIATION 13.5 • n=206 Participants
|
|
Functioning, Global Assessment of Functioning Scale
Symptomatic Functioning
|
53.4 units on a scale
STANDARD_DEVIATION 15.1 • n=99 Participants
|
50.2 units on a scale
STANDARD_DEVIATION 13.8 • n=107 Participants
|
51.7 units on a scale
STANDARD_DEVIATION 14.5 • n=206 Participants
|
PRIMARY outcome
Timeframe: 1 yearThe 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).
Outcome measures
| Measure |
Collaborative Chronic Illness Care Model
n=308 Participants
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
n=315 Participants
Continue with usual care
|
|---|---|---|
|
The Effect of Care Model Implementation on Treatment Appropriateness: Weight Service Utilization
|
73 participants
|
38 participants
|
PRIMARY outcome
Timeframe: 1 yearAnalysis 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.
Outcome measures
| Measure |
Collaborative Chronic Illness Care Model
n=273 Participants
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
n=332 Participants
Continue with usual care
|
|---|---|---|
|
The Effect of Care Model Implementation on Treatment Appropriateness: Patient Weight Outcomes
|
208.1 pounds
Standard Error .92
|
207.2 pounds
Standard Error .83
|
PRIMARY outcome
Timeframe: 1 yearThe 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).
Outcome measures
| Measure |
Collaborative Chronic Illness Care Model
n=194 Participants
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
n=212 Participants
Continue with usual care
|
|---|---|---|
|
The Effect of Care Model Implementation on Treatment Appropriateness: Supported Employment Utilization
|
32 participants
|
17 participants
|
PRIMARY outcome
Timeframe: 1 yearChi-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.
Outcome measures
| Measure |
Collaborative Chronic Illness Care Model
n=96 Participants
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
n=148 Participants
Continue with usual care
|
|---|---|---|
|
The Effect of Care Model Implementation on Treatment Appropriateness: Patient Employment Outcomes
|
14 competitive employment
|
12 competitive employment
|
Adverse Events
Collaborative Chronic Illness Care Model
Usual Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Alexander S. Young
Greater Los Angeles Veterans Healthcare Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place