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Enrolling by invitation NCT07264062

MetSense Pilot and Feasibility

No phase Interventional Serious Mental Illness Type 2 Diabetes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MetSense Risk Flag, Usual Care.
Who it may be relevant to
Registry conditions: Serious Mental Illness, Type 2 Diabetes. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Behavioral MetSense Risk Flag
    The MetSense risk flag alerts the clinician if the patient has high diabetes risk and prompts additional diabetes risk management.
  • Other Usual Care
    Participants will receive usual care.

Primary outcome measures

  • Percent with completed hemoglobin A1c test within 6 months. [Time frame: 6 months]
Secondary outcome measures (7)
  • Percent with clinician evaluation of metabolic risk factors as documented in the electronic health record within 6 months. [Time frame: 6 months]
  • Percent with body mass index measurement within 6 months. [Time frame: 6 months]
  • Percent with prediabetes diagnosis within 6 months. [Time frame: 6 months]
  • Percent who attended a primary care visit within 6 months. [Time frame: 6 months]
  • Percent with metformin medication dispensed within 6 months. [Time frame: 6 months]
  • Average hemoglobin A1c value based on the final measurement in 6 months. [Time frame: 6 months]
  • Average body mass index based on the final measurement in 6 months. [Time frame: 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • KPNC Division of Research — Pleasanton

Publications

  • Iturralde E, Fazzolari L, Shia M, Slama N, Leang J, Awsare S, Nguyen LT. Closing the Care Gap for People with Severe and Persistent Mental Illness: Collaborative Care, Telehealth, and Clinical Pharmacy. NEJM Catal Innov Care Deliv. 2022 May;3(5):10.1056/CAT.21.0417. doi: 10.1056/CAT.21.0417. PMID 36569369
  • Iturralde E, Fazzolari L, Slama NE, Alexeeff SE, Sterling SA, Awsare S, Koshy MT, Shia M. Telehealth Collaborative Care Led by Clinical Pharmacists for People With Psychosis or Bipolar Disorder: A Propensity Weighted Comparison With Usual Psychiatric Care. J Clin Psychiatry. 2024 Jan 29;85(1):23m14917. doi: 10.4088/JCP.23m14917. PMID 38301189

Identifiers

NCT: NCT07264062 · 1850120-11 · K23MH126078

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗