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Clinical Trials/NCT07264062
NCT07264062Enrolling By InvitationNot Applicable

Optimizing Care to Prevent Diabetes and Promote Cardiovascular Health Among Younger Adults With Severe Mental Illness

Kaiser Permanente2 sites in 1 country20,000 target enrollmentStarted: December 15, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Enrolling By Invitation
Enrollment
20,000
Locations
2
Primary Endpoint
Percent with completed hemoglobin A1c test within 6 months.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Exclusion Criteria

  • Not provided

Arms & Interventions

MetSense

Active Comparator

Participants will be managed by clinical pharmacists who are able to view the MetSense risk flag.

Intervention: MetSense Risk Flag (Behavioral)

Usual Care

Other

Participants will receive usual care. They will be managed by clinical pharmacists who are not able to view the MetSense risk flag.

Intervention: Usual Care (Other)

Outcomes

Primary Outcomes

Percent with completed hemoglobin A1c test within 6 months.

Time Frame: 6 months

Laboratory test completion

Secondary Outcomes

  • Percent with clinician evaluation of metabolic risk factors as documented in the electronic health record within 6 months.(6 months)
  • Percent with body mass index measurement within 6 months.(6 months)
  • Percent with prediabetes diagnosis within 6 months.(6 months)
  • Percent who attended a primary care visit within 6 months.(6 months)
  • Percent with metformin medication dispensed within 6 months.(6 months)
  • Average hemoglobin A1c value based on the final measurement in 6 months.(6 months)
  • Average body mass index based on the final measurement in 6 months.(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Esti Iturralde

Research Scientist I

Kaiser Permanente

Study Sites (2)

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