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Набор скоро начнётся NCT07599943

Population Health Management -Increase Lung Cancer Screening in Community Health Centers (LungSMART)

Без фазы С лечением Lung Cancer

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: Text Messages (TM+), Chatbot (CA), Video (VID), Reactive Patient Navigation (RPN).
Кому может быть актуально
Состояния в реестре: Lung Cancer. Базовые параметры: 50 лет — 80 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
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Официальное название

Population Health Management Approaches to Increase Lung Cancer Screening in Community Health Centers - LungSMART UH3 Clinical Trial

Обзор

The long-term goal of Lung Sequential Multiple Assignment Randomized Trial (LungSMART) Utah is to increase the reach of Low-Dose Computed Tomography (LDCT) screening for lung cancer (hereafter referred to as Lung Cancer Screening or LCS) at scale in low-resource healthcare settings.

Подробное описание

LungSMART is a Sequential Multiple Assignment Randomized Trial (SMART) conducted in Utah Community Health Centers (CHCs). The SMART design is structured in two sequential stages: Stage 1 aims to increase uptake of Lung Cancer Screening (LCS) eligibility assessment, while Stage 2 aims to increase LCS completion.

In Stage 1, the Eligibility Assessment Stage, LungSMART Utah uses Azara, a population health management software, to identify potentially eligible patients from participating CHCs. Patients who are enrolled in the study will be randomized to digital health interventions and connected with a centralized hub (Hub) for eligibility assessment and shared decision making (SDM) with a qualified registered nurse (RN).

In Stage 2, the LCS Completion Stage, participants referred for LCS receive access to a Chatbot and are randomized to receive reactive (patient needs to request navigation) vs proactive (navigator proactively calls the patient) patient navigation (PN) delivered via telehealth by a community health worker (CHW) at the Hub to address logistical barriers and hesitancy in completing LCS.

Вмешательства

  • Поведенческое Text Messages (TM+)
    A message informs the participants that a Registered Nurse (RN) from the Hub will call them about shared decision making (SDM) and LCS.
  • Поведенческое Chatbot (CA)
    Access to a chatbot for frequently asked questions about LCS
  • Поведенческое Video (VID)
    An educational video about LCS
  • Поведенческое Reactive Patient Navigation (RPN)
    RPN to help complete the LCS appointment. RPN requires the participant to initiate the PN request
  • Поведенческое Proactive Patient Navigation (PPN)
    Proactive patient navigation to help complete the LCS appointment. PPN does not require the participant to initiate the PN request and instead is a proactive call to the participant.

Первичные конечные точки

  • Stage 1: Completion of eligibility assessment [Срок оценки: up to 18 weeks]
  • Stage 2: Completion of LCS [Срок оценки: up to 30 weeks]
Вторичные конечные точки (7)
  • Cost-effectiveness: Incremental Cost [Срок оценки: up to 30 weeks]
  • Cost-effectiveness: Incremental Effectiveness [Срок оценки: up to 30 weeks]
  • Proportion of patients who engage with interventions [Срок оценки: up to 18 weeks]
  • Proportion of patients who reply opting out of receiving interventions [Срок оценки: up to 30 weeks]
  • Proportion of patients who complete SDM [Срок оценки: up to 18 weeks]
  • Proportion of patients who request to speak with a patient navigator [Срок оценки: up to 30 weeks]
  • Proportion of patients who speak with a patient navigator [Срок оценки: up to 30 weeks]

Критерии участия

Критерии включения

  • Is currently a patient at participating CHCs
  • Speak English or Spanish
  • Current or former tobacco smoker
  • Male or Female
  • Age 50-80
  • Electronic health records indicate they have not opted out of receiving text contact from the clinic
  • Has a phone that can receive text messages

Критерии исключения

  • Persons with lung cancer or who have previously participated in a Shared Decision Making discussion with a health provider regarding lung cancer or have completed LCS.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Последовательный дизайн
Маскирование
Открытое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • Huntsman Cancer Institute/University of Utah — Salt Lake City

Идентификаторы

NCT: NCT07599943 · HCI190012 · 1UG3CA287109-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗