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| Name | Class |
|---|---|
| Medica Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extended Treatment Group | Experimental | 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 |
|
| Usual Treatment Group | Active Comparator | Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glucose and lipids | Device | Point-of-care (POCT) screening for diabetes and dyslipidemia. Glucose and Lipids |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Development Center | Duluth | Minnesota | 55812 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25667811 | Result | 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. | |
| 34000112 |
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Subjects were recruited at three community mental health sites in Minnesota site (Human Development Center - Duluth, MN; Range Mental Health Center - Hibbing, MN; Family Life Mental Health Center - Coon Rapids, MN; with subjects assigned to receive either pharmacist CMM services (PCS) or no pharmacist CMM services (NCS)/Control Group.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pharmacist Comprehensive Medication Management Service (PCS) | 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 Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia. Glucose and Lipids A1c Now®: Point-of-care (POCT) screening for diabetes Glycosylated Hemoglobin A1c Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension Blood Pressure and Heart Rate HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared QM2000 Circumference measuring tape: Measurement for Central Obesity Waist and Hip circumference Comprehensive Medication Management: Defined at http://www.pcpcc.org/guide/patient-health-through-medication-management |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Glycosylated Hemoglobin A1c | Device | Point-of-care (POCT) screening for diabetes Glycosylated Hemoglobin A1c |
|
|
| Blood Pressure and Heart Rate | Device | Point-of-care (POCT) screening for hypertension Blood Pressure and Heart Rate |
|
|
| Body mass index | Device | Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared |
|
|
| Waist and Hip circumference | Device | Measurement for Central Obesity Waist and Hip circumference |
|
|
| Comprehensive Medication Management | Behavioral |
|
|
| 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. |
| FG001 | No Comprehensive Medication Management Services (NCS) | Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia. Glucose and Lipids A1c Now®: Point-of-care (POCT) screening for diabetes Glycosylated Hemoglobin A1c Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension Blood Pressure and Heart Rate HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared QM2000 Circumference measuring tape: Measurement for Central Obesity Waist and Hip circumference |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pharmacist Comprehensive Medication Management Service (PCS) | 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 Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia. Glucose and Lipids A1c Now®: Point-of-care (POCT) screening for diabetes Glycosylated Hemoglobin A1c Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension Blood Pressure and Heart Rate HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared QM2000 Circumference measuring tape: Measurement for Central Obesity Waist and Hip circumference Comprehensive Medication Management: Defined at http://www.pcpcc.org/guide/patient-health-through-medication-management |
| BG001 | No Comprehensive Medication Management Services (NCS) | Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia. Glucose and Lipids A1c Now®: Point-of-care (POCT) screening for diabetes Glycosylated Hemoglobin A1c Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension Blood Pressure and Heart Rate HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared QM2000 Circumference measuring tape: Measurement for Central Obesity Waist and Hip circumference |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Subjects with Metabolic Syndrome based on Point of Care analyses | Metabolic syndrome was identified in 71.2% of the NCS group and in 85.2% of the PCS group. Data was not available for 7 subjects. This explains why the sum of this baseline measure does not equal the overall baseline participants. | Number | participants |
| |||||||||||||||
| Abdominal Obesity | Waist Circumference Risk (Males: > 40 inches, Females: > 35 inches) was 86.4% in the NCS group and 87.7% in the PCS Group. Data was not available for 4 subjects. This explains why the sum of this baseline measure does not equal the overall baseline participants. | Number | participants |
| |||||||||||||||
| Total Cholesterol Risk | Risk is defined as greater than 200 mg/dL was 41.7% in the NCS group and 38.6% in the PCS group. Data was not available for 3 subjects. This explains why the sum of this baseline measure does not equal the overall baseline participants. | Number | participants |
| |||||||||||||||
| Low Density Lipoprotein (LDL) Risk | Risk is defined as greater than 130 mg/dL was 24.5% in the NCS group and 25.5% in the PCS group. Data was not available for 20 subjects. This explains why the sum of this baseline measure does not equal the overall baseline participants. | Number | participants |
| |||||||||||||||
| Triglyceride Risk | Risk is defined as greater than 150 mg/dL was 54.2% in the NCS group and 42.1% in the PCS group. Data was not available for 4 subjects. This explains why the sum of this baseline measure does not equal the overall baseline participants. | Number | participants |
| |||||||||||||||
| High Density Lipoprotein (HDL) Risk | Risk is defined as: Males < 40 mg/dL; Females < 50 mg/dL was 75% in the NCS group and 73.3% in the PCS group. Data was not available for 7 subjects. This explains why the sum of this baseline measure does not equal the overall baseline participants. | Number | participants |
| |||||||||||||||
| Hypertension Risk | Risk is defined as blood pressures greater than 130 mmHg systolic and/or greater than 85 mmHg diastolic was 48.1% in the NCS group and 51.9% in the PCS group. Data was not available for 2 subjects. This explains why the sum of this baseline measure does not equal the overall baseline participants. | Number | participants |
| |||||||||||||||
| Diabetes Risk | Risk is defined as glycosylated hemoglobin A1c greater or equal to 6.5% was found in 10.3% of the NCS group and 12.5% of the PCS group. Data was not available for 6 subjects. This explains why the sum of this baseline measure does not equal the overall baseline participants. | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Number | percentage of participants | Baseline |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pharmacist Comprehensive Medication Management Service (PCS) | 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 Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia. Glucose and Lipids A1c Now®: Point-of-care (POCT) screening for diabetes Glycosylated Hemoglobin A1c Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension Blood Pressure and Heart Rate HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared QM2000 Circumference measuring tape: Measurement for Central Obesity Waist and Hip circumference Comprehensive Medication Management: Defined at http://www.pcpcc.org/guide/patient-health-through-medication-management | 0 | 60 | 0 | 60 | ||
| EG001 | No Comprehensive Medication Management Services (NCS) | Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia. Glucose and Lipids A1c Now®: Point-of-care (POCT) screening for diabetes Glycosylated Hemoglobin A1c Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension Blood Pressure and Heart Rate HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared QM2000 Circumference measuring tape: Measurement for Central Obesity Waist and Hip circumference | 0 | 60 | 0 | 60 |
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Limitations include: 1) Short time duration to achieve metabolic outcome goals, 2) Smaller than anticipated sample size, 3) High number of subjects lost to follow up after 12-months.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark E. Schneiderhan | UMN, College of Pharmacy | 8452540458 | meschnei@d.umn.edu |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D003920 | Diabetes Mellitus |
| D006973 | Hypertension |
| D024821 | Metabolic Syndrome |
| D012559 | Schizophrenia |
| D001714 | Bipolar Disorder |
| D050171 | Dyslipidemias |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D044882 | Glucose Metabolism Disorders |
| D004700 | Endocrine System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001794 | Blood Pressure |
| D006339 | Heart Rate |
| D015992 | Body Mass Index |
| D002360 | Carubicin |
| D054539 | Medication Therapy Management |
| C099588 | myotubularin |
| ID | Term |
|---|---|
| D055986 | Vital Signs |
| D010808 | Physical Examination |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006439 | Hemodynamics |
| D002320 | Cardiovascular Physiological Phenomena |
| D002943 | Circulatory and Respiratory Physiological Phenomena |
| D001837 | Body Weights and Measures |
| D001824 | Body Constitution |
| D000886 | Anthropometry |
| D008919 | Investigative Techniques |
| D010829 | Physiological Phenomena |
| D001699 | Biometry |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010593 | Pharmaceutical Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D054524 | Medicare Part D |
| D007356 | Insurance, Pharmaceutical Services |
| D007348 | Insurance, Health |
| D007341 | Insurance |
| D005381 | Financing, Organized |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D006278 | Medicare |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|