Trial Outcomes & Findings for Implementing Effective, Collaborative Care for Schizophrenia (EQUIP-2) (NCT 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).

Recruitment status

COMPLETED

Study phase

Target enrollment

1067 participants

Primary outcome timeframe

1 year

Results posted on

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

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

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=5 Participants	54.5 years STANDARD_DEVIATION 9.5 • n=7 Participants	54.3 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants	39 Participants n=7 Participants	69 Participants n=5 Participants
Sex: Female, Male Male	359 Participants n=5 Participants	373 Participants n=7 Participants	732 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	10 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Black or African American	160 Participants n=5 Participants	195 Participants n=7 Participants	355 Participants n=5 Participants
Race (NIH/OMB) White	175 Participants n=5 Participants	180 Participants n=7 Participants	355 Participants n=5 Participants
Race (NIH/OMB) More than one race	11 Participants n=5 Participants	4 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	33 Participants n=5 Participants	19 Participants n=7 Participants	52 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	72 Participants n=5 Participants	28 Participants n=7 Participants	100 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	312 Participants n=5 Participants	380 Participants n=7 Participants	692 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	389 participants n=5 Participants	412 participants n=7 Participants	801 participants n=5 Participants
Duration with Schizophrenia, years	26.2 years STANDARD_DEVIATION 11.7 • n=5 Participants	25.8 years STANDARD_DEVIATION 12.7 • n=7 Participants	26.0 years STANDARD_DEVIATION 12.3 • n=5 Participants
Psychotropic medications by weight gain potential High Weight Gain Potential	70 participants n=5 Participants	65 participants n=7 Participants	135 participants n=5 Participants
Psychotropic medications by weight gain potential Moderate Weight Gain Potential	149 participants n=5 Participants	158 participants n=7 Participants	307 participants n=5 Participants
Psychotropic medications by weight gain potential Low Weight Gain Potential	96 participants n=5 Participants	92 participants n=7 Participants	188 participants n=5 Participants
Psychotropic medications by weight gain potential Unknown/Not Reported	74 participants n=5 Participants	97 participants n=7 Participants	171 participants n=5 Participants
Weight, kilograms	94.6 kilograms STANDARD_DEVIATION 20.4 • n=5 Participants	93.0 kilograms STANDARD_DEVIATION 20.1 • n=7 Participants	93.8 kilograms STANDARD_DEVIATION 20.2 • n=5 Participants
Body Mass Index	30.2 kg/m^2 STANDARD_DEVIATION 6.1 • n=5 Participants	29.9 kg/m^2 STANDARD_DEVIATION 6.5 • n=7 Participants	30.1 kg/m^2 STANDARD_DEVIATION 6.3 • n=5 Participants
Diagnosis of Diabetes Yes	120 participants n=5 Participants	118 participants n=7 Participants	238 participants n=5 Participants
Diagnosis of Diabetes No	269 participants n=5 Participants	294 participants n=7 Participants	563 participants n=5 Participants
Waist Circumference, centimeters	104.9 centimeters STANDARD_DEVIATION 16.3 • n=5 Participants	104.3 centimeters STANDARD_DEVIATION 15.7 • n=7 Participants	104.6 centimeters STANDARD_DEVIATION 16.0 • n=5 Participants
Psychotic Symptoms, Brief Psychiatric Rating Scale	2.3 units on a scale STANDARD_DEVIATION 1.3 • n=5 Participants	2.5 units on a scale STANDARD_DEVIATION 1.3 • n=7 Participants	2.4 units on a scale STANDARD_DEVIATION 1.3 • n=5 Participants
Negative Symptoms, Brief Psychiatric Rating Scale	1.5 units on a scale STANDARD_DEVIATION 0.8 • n=5 Participants	2.0 units on a scale STANDARD_DEVIATION 1.3 • n=7 Participants	1.8 units on a scale STANDARD_DEVIATION 0.8 • n=5 Participants
Functioning, Global Assessment of Functioning Scale Occupational Functioning	39.5 units on a scale STANDARD_DEVIATION 20.6 • n=5 Participants	38.2 units on a scale STANDARD_DEVIATION 16.8 • n=7 Participants	38.8 units on a scale STANDARD_DEVIATION 18.8 • n=5 Participants
Functioning, Global Assessment of Functioning Scale Social Functioning	53.4 units on a scale STANDARD_DEVIATION 14.1 • n=5 Participants	54.4 units on a scale STANDARD_DEVIATION 12.9 • n=7 Participants	53.9 units on a scale STANDARD_DEVIATION 13.5 • n=5 Participants
Functioning, Global Assessment of Functioning Scale Symptomatic Functioning	53.4 units on a scale STANDARD_DEVIATION 15.1 • n=5 Participants	50.2 units on a scale STANDARD_DEVIATION 13.8 • n=7 Participants	51.7 units on a scale STANDARD_DEVIATION 14.5 • n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Outcome measures

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 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.

Outcome measures

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 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).

Outcome measures

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 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.

Outcome measures

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

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

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

Phone: 310-268-3416

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place