Treatment of Metabolic Syndrome in a Community Mental Health Center
Primary Purpose
Serious Mental Illness
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TAU
IMBED
Liaison
Sponsored by
About this trial
This is an interventional health services research trial for Serious Mental Illness
Eligibility 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)
Sites / Locations
- Center for Health Care Services
- University of Texas Health Science Center at San Antonio
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Treatment as Usual (TAU)
IMBED
Liaison
Arm Description
Study Intervention 1 Treatment as usual (TAU) will be psychiatry follow-up at local Community Mental Health Clinic at least every 3 months.
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT01115114
First Posted
April 28, 2010
Last Updated
February 9, 2015
Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT01115114
Brief Title
Treatment of Metabolic Syndrome in a Community Mental Health Center
Official Title
Treatment of Metabolic Syndrome in a Community Mental Health Center
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Serious Mental Illness
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment as Usual (TAU)
Arm Type
Placebo Comparator
Arm Description
Study Intervention 1 Treatment as usual (TAU) will be psychiatry follow-up at local Community Mental Health Clinic at least every 3 months.
Arm Title
IMBED
Arm Type
Active Comparator
Arm 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.
Arm Title
Liaison
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
TAU
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
IMBED
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Liaison
Intervention Description
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.
Primary Outcome Measure Information:
Title
Utilization of Care
Description
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.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Metabolic Indicators
Description
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)
Time Frame
9 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn I Velligan, PhD
Organizational Affiliation
The University of Texas Health Science Center at San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Health Care Services
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
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Treatment of Metabolic Syndrome in a Community Mental Health Center
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