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

Hypertension Clinical Trial

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02029989
• Other study ID #: 090M72212
• Status: Completed
• Phase: N/A
• Start date: February 2010
• Est. completion date: February 2012

Study information

• Verified date: April 2024
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Hyperlipidemia
• Hyperlipidemias
• Hyperlipoproteinemias
• Hypertension
• Metabolic Syndrome

Intervention

Device:
• Glucose and lipids
Point-of-care (POCT) screening for diabetes and dyslipidemia. Glucose and Lipids
• Glycosylated Hemoglobin A1c
Point-of-care (POCT) screening for diabetes Glycosylated Hemoglobin A1c
• Blood Pressure and Heart Rate
Point-of-care (POCT) screening for hypertension Blood Pressure and Heart Rate
• Body mass index
Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared
• Waist and Hip circumference
Measurement for Central Obesity Waist and Hip circumference

Behavioral:
• Comprehensive Medication Management
Defined at http://www.pcpcc.org/guide/patient-health-through-medication-management

Locations

Country	Name	City	State
United States	Human Development Center	Duluth	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	Medica Foundation

Country where clinical trial is conducted

United States, 

References & Publications (2)

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/P — View Citation

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 3 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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