Treatment of Metabolic Syndrome in a Community Mental Health Center

Serious Mental Illness Clinical Trial

Official title:

Treatment of Metabolic Syndrome in a Community Mental Health Center

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01115114
• Other study ID #: HSC20090135H
• Secondary ID: 5R24MH072830
• Status: Completed
• Phase: N/A
• First received: April 28, 2010
• Last updated: February 9, 2015
• Start date: January 2009
• Est. completion date: January 2014

Study information

• Verified date: February 2015
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: January 2014
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Mental Disorders
• Metabolic Syndrome X
• Serious Mental Illness

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Center for Health Care Services	San Antonio	Texas
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Utilization of Care	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.	9 months	No
Secondary	Metabolic Indicators	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)	9 months	No