Facilitation of Information eXchange for Shared Decision Making for Lung Cancer Screening

Обзор

The goal of this pilot clinical trial is to learn whether the patient and provider support program, called FIX-SDM, helps patients and providers engage in shared decision-making for lung cancer screening during primary care visits and increases the number of patients who complete lung cancer screening. The investigators will also assess the acceptability of the support program and the feasibility of the study protocol to prepare for a future large-scale trial. The main questions this trial aims to answer are: * Does the patient and provider support increase the number of patients who complete lung cancer screening? * Does the patient and provider support help patients and health care providers engage more in shared decision-making and improve the quality of the patient's decision regarding lung cancer screening? * Is the study protocol feasible? The investigators will compare the patient and provider support program to usual care to see if the support increases the number of patients who complete lung cancer screening. Primary care provider participants will: * Receive the provider support session and educational materials, or follow usual practice * Answer a baseline survey and a follow-up survey in 6 months * Answer additional survey questions regarding the acceptability of the provider support session if they receive it Patient participants will * Receive a smoking history survey, a decision aid, and text messages about lung cancer screening prior to the primary care visit, or receive usual care * Complete the baseline survey and two follow-up surveys, one right after the primary care visit and another 3 months after the visit.

Подробное описание

Facilitation of Information eXchange for Shared Decision Making (FIX-SDM) for lung cancer screening is a multi-strategy implementation program designed to help patients eligible for lung cancer screening and their primary care providers (PCPs) prepare for shared decision-making (SDM). The investigators will conduct a cluster-randomized pilot study of FIX-SDM plus the standard electronic alert (e-alert) notification of a patient's possible lung cancer screening eligibility (FIX-SDM arm), compared with the standard e-alert notification alone (usual care comparison arm).

The investigators hypothesized that, compared to the usual care comparison arm, more patients in the FIX-SDM arm will complete lung cancer screening 3 months after the primary care visit. This study will also provide feasibility data and preliminary results to help prepare for a future large-scale trial.

Вмешательства

• Поведенческое FIX-SDM
  Primary care providers (PCPs) will receive a support session and educational materials, in addition to the standard electronic alert (e-alert) notification of a patient's possible lung cancer screening eligibility implemented within the healthcare system. Patients receive a smoking history survey, a decision aid, and text messages about lung cancer screening prior to the primary care visit.
• Поведенческое Usual Care
  PCPs will receive the standard e-alert notification implemented within the healthcare system (usual practice). Patients will receive the usual care

Первичные конечные точки

• Completion of Lung Cancer Screening (LCS) within 3 months [Срок оценки: 3 months after the index visit]

Вторичные конечные точки (12)

• Completion of LCS within 6 months [Срок оценки: 6 months after the index visit]
• LCS order [Срок оценки: 3 and 6 months after the index visit]
• LCS appointment [Срок оценки: 3 and 6 months after the index visit]
• Patient-reported LCS discussion [Срок оценки: Within 10 days after the index visit]
• Content of LCS discussion [Срок оценки: Within 10 days after the index visit]
• Patient perceived quality of LCS discussion [Срок оценки: Within 10 days after the index visit]
• Patient-reported shared decsion making (SDM) for LCS [Срок оценки: Within 10 days after the index visit.]
• Patient knowledge of LCS [Срок оценки: Within 10 days after the index visit.]
• Patient decisional conflict [Срок оценки: Within 10 days after the index visit and 3 months after the index visit]
• Patient acceptability of FIX-SDM [Срок оценки: Within 10 days after the index visit.]
• Patient decision satisfaction [Срок оценки: 3 months after the index visit]
• Patient decision regret [Срок оценки: 3 months after the index visit]

Критерии участия

Primary care provider (PCP) participants:

Критерии включения

• PCPs (physicians or advanced practitioners)
• Who practice in general internal medicine or family medicine clinics in UMass Memorial Health
• Who care for more than 5 potentially LCS-eligible patients in their practice Exclusion criteria
• Participation in the previous study to co-develop the provider intervention (to avoid bias)

Patient participants

Критерии включения

• Adults between the ages of 50 and 77
• Meets criteria for Lung Cancer Screening (LCS) (Current eligibility includes: An individual who currently smokes or quit smoking within 15 years with at least a 20 pack-year smoking history)
• Has a smartphone with texting capability
• English-speaking
• Has a scheduled PCP visit in the next \~3-6 weeks from study enrollment with one of the PCP participants enrolled in the study

Критерии исключения

• Prior LCS
• Chest CT within the last 12 months
• History of lung cancer
• Active cancer requiring treatment
• Supplemental oxygen use
• Pregnancy
• Participation in the previous study to co-develop the patient intervention (to avoid bias)

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

Скрининг

Центры проведения

США · 1 центр

• University of Massachusetts Chan Medical School — Worcester

Идентификаторы

NCT: NCT07517692 · STUDY00001107 · 5K08CA283304

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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