Hyperlipidemia, Diabetes, Hypertension
Conditions
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
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.
Interventions
Point-of-care (POCT) screening for diabetes and dyslipidemia. Glucose and Lipids
Point-of-care (POCT) screening for diabetes Glycosylated Hemoglobin A1c
Point-of-care (POCT) screening for hypertension Blood Pressure and Heart Rate
Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared
Measurement for Central Obesity Waist and Hip circumference
Defined at http://www.pcpcc.org/guide/patient-health-through-medication-management
Sponsors
Study design
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metabolic Syndrome (MetS) | Baseline | compare test results in subjects between the PCS and NCS groups, with or without pre-existing MetS and/or related metabolic conditions at baseline |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 60 |
| 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 | 60 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Change of location | 2 | 3 |
| Overall Study | Death | 0 | 1 |
| Overall Study | Lost to Follow-up | 9 | 7 |
| Overall Study | Physician Decision | 2 | 0 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
| Overall Study | Withdrawal: Fear of needles | 1 | 0 |
Baseline characteristics
| Characteristic | Total | No Comprehensive Medication Management Services (NCS) | Pharmacist Comprehensive Medication Management Service (PCS) |
|---|---|---|---|
| Abdominal Obesity | 101 participants | 51 participants | 50 participants |
| Age, Continuous | 42.9 years STANDARD_DEVIATION 11.3 | 43.5 years STANDARD_DEVIATION 10.62 | 42.32 years STANDARD_DEVIATION 11.95 |
| Diabetes Risk | 13 participants | 6 participants | 7 participants |
| High Density Lipoprotein (HDL) Risk | 89 participants | 45 participants | 44 participants |
| Hypertension Risk | 52 participants | 25 participants | 27 participants |
| Low Density Lipoprotein (LDL) Risk | 25 participants | 12 participants | 13 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 4 Participants | 4 Participants |
| Race (NIH/OMB) White | 104 Participants | 53 Participants | 51 Participants |
| Sex: Female, Male Female | 71 Participants | 35 Participants | 36 Participants |
| Sex: Female, Male Male | 49 Participants | 25 Participants | 24 Participants |
| Subjects with Metabolic Syndrome based on Point of Care analyses | 88 participants | 42 participants | 46 participants |
| Total Cholesterol Risk | 47 participants | 25 participants | 22 participants |
| Triglyceride Risk | 56 participants | 32 participants | 24 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 60 | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 |
Outcome results
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
Time frame: Baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pharmacist Comprehensive Medication Management Service (PCS) | Metabolic Syndrome (MetS) | 85.2 percentage of participants |
| No Comprehensive Medication Management Services (NCS) | Metabolic Syndrome (MetS) | 71.2 percentage of participants |