Point-of-Care Testing (POCT) Detection and Management of Metabolic Syndrome in Patients With Mental Illness

Study Overview
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Brief Summary
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The study was a 12-month, multi-centered, quasi-experimental design to assess point-of-care (POCT) screening/monitoring of subjects on antipsychotic agents for metabolic syndrome. Subjects were also randomized to either an Extended Treatment Group (ETG) defined by receiving comprehensive medication management (CMM) pharmacist interventions or a Usual Treatment Group (UTG) receiving no CMM interventions. All subjects were recruited from three community mental health clinic settings in Minnesota.

Detailed Description
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It is well recognized that patients on antipsychotic agents with mental illness continue to be affected by a severe health disparity due to lack of adequate metabolic monitoring.1-7 A major healthcare concern is the life-expectancy decrease of  25 years for patients with illnesses such as schizophrenia as compared with the general population. Equally concerning is that patients with severe persistent mental illness (SPMI) continue to have inadequate integration of care between psychiatry and medicine. Because of the difficulty getting patients to primary care or hospital based laboratories, the use of capillary blood, point-of-care tests (POCT) to monitor glucose and lipids in addition to vital signs and other anthropometric measurements in community mental health centers might prove beneficial. It is highly likely that this advanced level of screening in the mental health setting may lead to identifying new metabolic abnormalities or improved treatment with careful monitoring of previously diagnosed metabolic syndrome, diabetes, and/or hypertension in antipsychotic treated patients. It is hypothesized that if metabolic abnormalities are identified; then providing pharmacist CMM consultative services would reduce medication related problems by improving medication adherence, coordination of care between psychiatry and primary care, and outcomes in metabolic indices.

Official Title
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Can Point-of-care Testing (POCT) and Assistance From Comprehensive Medication Management (CMM) Pharmacists Improve Early Detection and Management of Metabolic Syndrome in Patients Treated With Antipsychotic Medications?

Conditions
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Hyperlipidemia, Diabetes, Hypertension

Intervention / Treatment
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* Device: Glucose and lipids
* Device: Glycosylated Hemoglobin A1c
* Device: Blood Pressure and Heart Rate
* Device: Body mass index
* Device: Waist and Hip circumference
* Behavioral: Comprehensive Medication Management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English speaking Age 18-64 Competent to understand and make medical choices independently Exclusion Criteria: Currently or previously seen by a CMM pharmacist

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extended Treatment Group<br>Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference and Comprehensive Medication Management | Device: Glucose and lipids<br>* Point-of-care (POCT) screening for diabetes and dyslipidemia. Glucose and Lipids<br>* Other names: Cholestech LDX ® by Inverness Medical www.cholestech.com;Device: Glycosylated Hemoglobin A1c<br>* Point-of-care (POCT) screening for diabetes Glycosylated Hemoglobin A1c<br>* Other names: A1c Now® by Bayer HealthCare;Device: Blood Pressure and Heart Rate<br>* Point-of-care (POCT) screening for hypertension Blood Pressure and Heart Rate<br>* Other names: Omron ® Ultra Premium blood pressure monitor Model HEM-790IT;Device: Body mass index<br>* Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared<br>* Other names: HealthOMeter® 500KL;Device: Waist and Hip circumference<br>* Measurement for Central Obesity Waist and Hip circumference<br>* Other names: QM2000 Circumference measuring tape;Behavioral: Comprehensive Medication Management<br>* Defined at http://www.pcpcc.org/guide/patient-health-through-medication-management<br>* Other names: CMM, Medication Therapy Management, MTM;|
| Active Comparator: Usual Treatment Group<br>Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference | Device: Glucose and lipids<br>* Point-of-care (POCT) screening for diabetes and dyslipidemia. Glucose and Lipids<br>* Other names: Cholestech LDX ® by Inverness Medical www.cholestech.com;Device: Glycosylated Hemoglobin A1c<br>* Point-of-care (POCT) screening for diabetes Glycosylated Hemoglobin A1c<br>* Other names: A1c Now® by Bayer HealthCare;Device: Blood Pressure and Heart Rate<br>* Point-of-care (POCT) screening for hypertension Blood Pressure and Heart Rate<br>* Other names: Omron ® Ultra Premium blood pressure monitor Model HEM-790IT;Device: Body mass index<br>* Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared<br>* Other names: HealthOMeter® 500KL;Device: Waist and Hip circumference<br>* Measurement for Central Obesity Waist and Hip circumference<br>* Other names: QM2000 Circumference measuring tape;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic Syndrome (MetS) | compare test results in subjects between the PCS and NCS groups, with or without pre-existing MetS and/or related metabolic conditions at baseline | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MTM, Antipsychotics, Schizophrenia, Bipolar Disorder, Diabetes, Dyslipidemia, Hyperlipidemia, Hypertension, Obesity, Medication Therapy Management, Pharmacist, Comprehensive Medication Management, Metabolic Syndrome, CMM, Health Disparity, Monitoring, Point of Care Testing, Chronic Persistent Mental Illness