Treatment of Metabolic Syndrome in a Community Mental Health Center - Full Text View

Purpose

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).

Condition	Intervention
Serious Mental Illness	Behavioral: TAU Behavioral: IMBED Behavioral: Liaison

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research
Official Title:	Treatment of Metabolic Syndrome in a Community Mental Health Center

Resource links provided by NLM:

MedlinePlus related topics: Mental Disorders Mental Health Metabolic Syndrome

U.S. FDA Resources

Further study details as provided by The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:

Utilization of Care [ Time Frame: 9 months ] [ Designated as safety issue: No ]
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:

Metabolic Indicators [ Time Frame: 9 months ] [ Designated as safety issue: No ]
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)

Estimated Enrollment:	150
Study Start Date:	January 2009
Estimated Study Completion Date:	September 2012
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
No Intervention: Treatment as Usual (TAU) Study Intervention 1 Treatment as usual (TAU) will be psychiatry follow-up at local Community Mental Health Clinic at least every 3 months.	Behavioral: TAU A medical assistant will provide feedback on and educational materials describing the meaning of lab values to individuals identified as needing follow-up for metabolic syndrome, and will provide educational materials regarding healthy eating and exercise. The psychiatrist will recommend that the individual contact a primary care physician to follow-up on out of range values, and alter behaviors (over eating, being sedentary) to help improve health.
Active Comparator: 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.	Behavioral: IMBED After identifying individuals through routine screening that need medical follow-up for metabolic syndrome, these individuals will be scheduled to see the on site primary care provider. Rapid scheduling (within 2 weeks) will be attempted. Patients will be seen by the primary care provider monthly or as needed as determined per patient. The primary care provider will prescribe medications for metabolic syndrome, discuss the patient with psychiatry staff and recommend follow-up appointments for physical problems based upon recommended guidelines and clinical judgment of necessity and urgency. Referral to a specialist will be made according to standard primary care practice guidelines. During the Metabolic Syndrome Clinic, if individuals bring up other medical conditions, they will be referred for treatment of these conditions to an outside primary care provider.
Active Comparator: 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.	Behavioral: Liaison Patients will be seen by the MCM bi-weekly or as needed as determined per patient. The MCM will discuss findings of the labs with the patient, work to get the individual an appointment with a primary care doctor, get releases of information to discuss treatment coordination between the primary care and psychiatric teams, obtain necessary records from primary care, and communicate findings to the treating psychiatrist. The MCM will also assist the patient in getting to primary care appointments by providing bus passes or other transportation, and with obtaining medications prescribed by the primary care provider. This may necessitate enrolling the patient in specific care plans as needed.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01115114

Locations

United States, Texas
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Center for Health Care Services
San Antonio, Texas, United States, 78207

Sponsors and Collaborators

The University of Texas Health Science Center at San Antonio

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Dawn I Velligan, PhD

University of Texas Health Science Center at San Antonio

More Information

No publications provided

Responsible Party:	The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:	NCT01115114 History of Changes
Other Study ID Numbers:	HSC20090135H, 5R24MH072830
Study First Received:	April 28, 2010
Last Updated:	May 8, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Mental Disorders
Metabolic Syndrome X
Insulin Resistance

Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 23, 2013