Serious Mental Illness, Type 2 Diabetes
Conditions
Keywords
serious mental illness, type 2 diabetes, diabetes prevention, prediction model, clinical decision support
Brief summary
People with serious mental illness have high risk for type 2 diabetes due to multiple risk factors, including the metabolic side effects of psychotropic medications that are used to treat these conditions. Type 2 diabetes is preventable through lifestyle and pharmacological interventions, but many people with serious mental illness do not receive regular screening for type 2 diabetes risk. In many health care settings, clinical pharmacists are increasingly managing patients with serious mental illness and have expertise in monitoring the metabolic side effects of psychotropic medications. This study evaluates the feasibility and acceptability of using a diabetes prediction model that is based on electronic health record data (the MetSense risk flag) to alert clinical pharmacists about patients who are at high diabetes risk, prompting these clinicians to prioritize diabetes risk management services.
Detailed description
MetSense is a clinical decision support tool that is being developed to help clinicians prioritize diabetes risk management services for patients with serious mental illness who have high diabetes risk. This study seeks to evaluate the feasibility, acceptability, and preliminary effectiveness of using the MetSense risk flag to prompt further evaluation of metabolic risk factors and to prioritize other diabetes risk management services, including diabetes risk screening, care coordination with patients' primary care physicians, and pharmacological management of diabetes risk. In this pragmatic, cluster-randomized trial, patients with serious mental illness will be allocated to 1 of 2 trial arms based on which clinical pharmacist manages their care. The clinical pharmacists will be randomized to view the MetSense risk flag (intervention arm) or to not view the MetSense risk flag (control arm, i.e., usual care). The primary outcome is completion of hemoglobin A1c laboratory testing. The study will also examine differences in clinician evaluation of metabolic risk factors, body mass index measurement, prediabetes diagnosis, diabetes diagnosis, primary care visits, metformin medication dispensing, hemoglobin A1c result, body mass index result, and clinician-reported acceptability and feasibility.
Interventions
BEHAVIORALMetSense Risk Flag
The MetSense risk flag alerts the clinician if the patient has high diabetes risk and prompts additional diabetes risk management.
OTHERUsual Care
Participants will receive usual care.
Sponsors
Kaiser Permanente
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
2-arm pragmatic cluster-randomized pilot feasibility trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 or older * Diagnosed with schizophrenia, another psychotic disorder, or bipolar disorder * Included in a clinical pharmacist population management program for serious mental illness within Kaiser Permanente Northern California
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent with completed hemoglobin A1c test within 6 months. | 6 months | Laboratory test completion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent with clinician evaluation of metabolic risk factors as documented in the electronic health record within 6 months. | 6 months | Electronic health record documentation via smartphrase |
| Percent with body mass index measurement within 6 months. | 6 months | Body mass index recorded in the electronic health record |
| Percent with prediabetes diagnosis within 6 months. | 6 months | Diagnosis documented in the electronic health record |
| Percent who attended a primary care visit within 6 months. | 6 months | Visit documented in the electronic health record |
| Percent with metformin medication dispensed within 6 months. | 6 months | Dispensing based on pharmacy records |
| Average hemoglobin A1c value based on the final measurement in 6 months. | 6 months | Laboratory value |
| Average body mass index based on the final measurement in 6 months. | 6 months | Value recorded in the electronic health record |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREsti Iturralde, PhD
KPNC Division of Research
Outcome results
None listed