Treatment of Metabolic Syndrome in a Community Mental Health Center
- Conditions
- Serious Mental Illness
- Interventions
- Behavioral: LiaisonBehavioral: TAUBehavioral: IMBED
- Registration Number
- NCT01115114
- Brief Summary
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).
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 130
- 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
- Legally declared mentally incompetent (guardians will not be approached about study)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Liaison Liaison 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 as Usual (TAU) TAU Study Intervention 1 Treatment as usual (TAU) will be psychiatry follow-up at local Community Mental Health Clinic at least every 3 months. IMBED IMBED 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.
- Primary Outcome Measures
Name Time Method Utilization of Care 9 months We will compare the efficacy of IMBED, Liaison and Treatment as Usual for improving utilization of care. The primary outcome variables are time to contact with primary care practitioner, number of primary care visits, receiving appropriate medications, receiving appropriate labs, and receiving dietary and life style counseling.
- Secondary Outcome Measures
Name Time Method Metabolic Indicators 9 months We will compare the efficacy of IMBED, Liaison and Treatment as Usual for improving metabolic indicators. The targets are biological variables measured over time (triglycerides, glucose, blood pressure, HDL, BMI)
Trial Locations
- Locations (2)
University of Texas Health Science Center at San Antonio
🇺🇸San Antonio, Texas, United States
Center for Health Care Services
🇺🇸San Antonio, Texas, United States