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Набор по приглашению NCT07264062

MetSense Pilot and Feasibility

Без фазы С лечением Serious Mental Illness Type 2 Diabetes

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: MetSense Risk Flag, Usual Care.
Кому может быть актуально
Состояния в реестре: Serious Mental Illness, Type 2 Diabetes. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • KPNC Division of Research — Pleasanton

Публикации

  • 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

Идентификаторы

NCT: NCT07264062 · 1850120-11 · K23MH126078

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗