Clinical trial NCT02029989: Point-of-Care Testing (POCT) Detection and Management of Metabolic Syndrome in Patients With Mental Illness
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?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperlipidemia
Diabetes
Hypertension
Keywords: 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
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Medica Foundation
First posted: 2014-01-08
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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.

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 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

Primary outcomes:
measure: Metabolic Syndrome (MetS)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Duluth
country: United States
facility: Human Development Center
state: Minnesota
Study officials:
References:
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 30;16(5):10.4088/PCC.14m01669. doi: 10.4088/PCC.14m01669. eCollection 2014.
citation: 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.