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

This study has been completed.
Sponsor:
Collaborator:
Medica Foundation
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT02029989
First received: September 30, 2013
Last updated: May 16, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention
Hyperlipidemia
Diabetes
Hypertension
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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: 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?

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Metabolic Syndrome (MetS) [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    Detect the percentage of subjects on antipsychotic agents who met MetS criteria established by the National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP-III) and National Heart Lung and Blood Institute (NHLBI) using glucose/lipid and glycosylated A1c capillary blood testing and compare test results in subjects with or without pre-existing MetS and/or related metabolic conditions at baseline.


Secondary Outcome Measures:
  • Comprehensive Medication Management (CMM) Service [ Time Frame: Baseline, 6 months, and 12 months ] [ Designated as safety issue: Yes ]
    Evaluate pharmacist provided comprehensive medication management (CMM) services ability to: (a) identify and reduce the number of drug therapy related problems (i.e., need for additional medications, non-adherence, unnecessary drug therapy problems, etc.) and increase primary care follow-up visits in the past 12 months compared to controls; (b) Reduce the odds of metabolic syndrome by increasing the number of subjects achieving treatment goals for dyslipidemia, hypertension, and diabetes based POCT analyses and the criteria established by the American Diabetes Association (ADA) 2013, National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III, and Joint National Committee 7 (JNC-7) at the end of 12-months compared to controls.

  • Sustainability of Cholestech LDX ® Glucose/Lipid and Glycosylated Hemoglobin A1c Now® Testing [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Assess sustainability by comparing third party payor reimbursements for Cholestech LDX ® glucose/lipid and glycosylated hemoglobin A1c Now® tests to the actual cost of laboratory testing over a 12 month duration in community mental health clinic settings.


Enrollment: 121
Study Start Date: February 2010
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Cholestech LDX ® by Inverness Medical www.cholestech.com
Device: Glycosylated Hemoglobin A1c

Point-of-care (POCT) screening for diabetes

Glycosylated Hemoglobin A1c

Other Name: A1c Now® by Bayer HealthCare
Device: Blood Pressure and Heart Rate

Point-of-care (POCT) screening for hypertension

Blood Pressure and Heart Rate

Other Name: 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 Name: HealthOMeter® 500KL
Device: Waist and Hip circumference

Measurement for Central Obesity

Waist and Hip circumference

Other Name: QM2000 Circumference measuring tape
Behavioral: Comprehensive Medication Management
Defined at http://www.pcpcc.org/guide/patient-health-through-medication-management
Other Name: 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 Name: Cholestech LDX ® by Inverness Medical www.cholestech.com
Device: Glycosylated Hemoglobin A1c

Point-of-care (POCT) screening for diabetes

Glycosylated Hemoglobin A1c

Other Name: A1c Now® by Bayer HealthCare
Device: Blood Pressure and Heart Rate

Point-of-care (POCT) screening for hypertension

Blood Pressure and Heart Rate

Other Name: 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 Name: HealthOMeter® 500KL
Device: Waist and Hip circumference

Measurement for Central Obesity

Waist and Hip circumference

Other Name: QM2000 Circumference measuring tape

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02029989

Locations
United States, Minnesota
Family Life Mental Health Center
Coon Rapids, Minnesota, United States, 55433
Human Development Center
Duluth, Minnesota, United States, 55805
Range Mental Health Center
Hibbing, Minnesota, United States, 55746
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Medica Foundation
Investigators
Principal Investigator: Mark E Schneiderhan, PharmD University of Minnesota, College of Pharmacy, Duluth
  More Information

No publications provided

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02029989     History of Changes
Other Study ID Numbers: 090M72212
Study First Received: September 30, 2013
Results First Received: April 15, 2014
Last Updated: May 16, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Metabolic Syndrome
Antipsychotics
Schizophrenia
Bipolar Disorder
Diabetes
Dyslipidemia
Hyperlipidemia
Hypertension
Obesity
Medication Therapy Management
MTM
Pharmacist
Comprehensive Medication Management
CMM
Health Disparity
Monitoring
Point of Care Testing
Chronic Persistent Mental Illness

Additional relevant MeSH terms:
Hyperlipidemias
Hypertension
Metabolic Syndrome X
Syndrome
Cardiovascular Diseases
Disease
Dyslipidemias
Glucose Metabolism Disorders
Hyperinsulinism
Insulin Resistance
Lipid Metabolism Disorders
Metabolic Diseases
Pathologic Processes
Vascular Diseases
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 29, 2014