Treatment of Metabolic Syndrome in a Community Mental Health Center

The University of Texas System (UT)

Status: Completed

Conditions: Serious Mental Illness

Treatments: Behavioral: IMBED; Behavioral: Liaison; Behavioral: TAU

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01115114

5R24MH072830 (U.S. NIH Grant/Contract)

HSC20090135H

Details and patient eligibility

About

The purpose of this study is to learn if patients being treated with second generation antipsychotics and with clinically meaningful elevations/levels in any metabolic syndrome elements will have better access to medical treatment more quickly if they are randomized to one of the following conditions: 1) a primary care provider located in the community mental health center where mental health treatment is provided (IMBED), 2) a medical care manager to help coordinate treatment with an outside primary care provider (Liaison) or 3) the standard practice of advising the patient to see a primary care doctor (Treatment as Usual).

Full description

Individuals will be identified for participation based upon baseline laboratory values obtained at the local Community Mental Health Clinic (CMHC) as part of the standard monitoring procedures for individuals on Second Generation Antipsychotics (SGAs). Following randomization, a research assistant will be assigned to obtain information on primary care provider visits, medications and lab tests conducted outside of the CMHC using a signed release for from the patient. Variables collected include: date and time of all physician or practitioner visits, type of practitioner, all medication prescriptions, and all laboratory values and vital signs related to metabolic syndrome parameters. Data will be put into an access data base for analysis. Data from private pharmacies will be obtained using a separate signed consent form.

Enrollment: 130 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and Females 18 years and older
• Active CMHC consumers
• Currently taking an atypical antipsychotic
• Identified as having clinically meaningful elevations/levels in metabolic indicators; i.e. fasting blood glucose (≥ 110), HDL ≤ 40mg/dl for males or ≤ 50mg/dl for females, blood pressure (≥ 130/85)
• Able to give informed consent
• Recipient of private or publicly-financed health insurance that includes medication coverage

Exclusion criteria

• Legally declared mentally incompetent (guardians will not be approached about study)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 3 patient groups, including a placebo group

Treatment as Usual (TAU)

Placebo Comparator group

Description:

Study Intervention 1 Treatment as usual (TAU) will be psychiatry follow-up at local Community Mental Health Clinic at least every 3 months.

Treatment:

Behavioral: TAU

IMBED

Active Comparator group

Description:

Study Intervention 2 A Primary Care Provider (PCP) will be located within the community mental health clinic one day weekly to specifically run a Metabolic Syndrome Clinic.

Treatment:

Behavioral: IMBED

Liaison

Active Comparator group

Description:

Study Intervention 3 A Medical Case Manager(MCM) will be assigned to a patient who is identified on the basis of routine screening to need medical follow-up for metabolic syndrome.

Treatment:

Behavioral: Liaison