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

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?

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Diabetes; Hyperlipidemia
• Intervention / Treatment: 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

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Duluth, Minnesota, United States, 55812
      • Human Development Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: Medica Foundation
• Investigators: Principal Investigator: Mark E Schneiderhan, PharmD, University of Minnesota, College of Pharmacy, Duluth

Publications and helpful links

General Publications

• Schneiderhan ME, Shuster SM, Davey CS. Twelve-month prospective randomized study of pharmacists utilizing point-of-care testing for metabolic syndrome and related conditions in subjects prescribed antipsychotics. Prim Care Companion CNS Disord. 2014 Oct 30;16(5):10.4088/PCC.14m01669. doi: 10.4088/PCC.14m01669. eCollection 2014.
• Schneiderhan ME, Li X. Observed Sex Differences in Cardiometabolic Indices in Patients on Antipsychotics: Secondary Analyses of a 12-Month Multicenter, Randomized, Controlled Trial. Prim Care Companion CNS Disord. 2021 Apr 8;23(2):19m02493. doi: 10.4088/PCC.19m02493.

Study record dates

Study Major Dates

• Study Start: February 1, 2010
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): February 1, 2012

Study Registration Dates

• First Submitted: September 30, 2013
• First Submitted That Met QC Criteria: January 7, 2014
• First Posted (Estimated): January 8, 2014

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Diabetes; Schizophrenia; Obesity; Dyslipidemia; Hypertension; Monitoring; Metabolic Syndrome; Bipolar Disorder; Hyperlipidemia; Health Disparity; Pharmacist; Antipsychotics; Point of Care Testing; Medication Therapy Management (MTM); Chronic Persistent Mental Illness; Comprehensive Medication Management (CMM)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Lipid Metabolism Disorders; Dyslipidemias; Hypertension; Metabolic Syndrome; Hyperlipidemias; Hyperlipoproteinemias; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Chrysarobin
• Other Study ID Numbers: 090M72212

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO