Support and Outreach to Increase Screening for Lung Cancer in Patients With a History of Smoking

Официальное название

Provider Support and Patient Outreach in Lung Cancer Screening

Обзор

This clinical trial tests how well providing education improves screening for lung cancer in patients with a history of smoking. Screenings may help doctors find lung cancer sooner when it may be easier to treat. Education and counseling may be an effective method to help providers and patients learn about lung cancer screening. Providing education and decision counseling to providers and patients may increase lung cancer screening.

Подробное описание

PRIMARY OBJECTIVES:

I. Assess intervention impact on lung cancer screening (LCS). II. Assess intervention impact on shared decision making (SDM).

SECONDARY OBJECTIVES:

I. Identify mediators and moderators of LCS. II. Assess intervention implementation barriers and facilitators.

EXPLORATORY OBJECTIVES:

I. Assess intervention impact on:

Ia. LCS referral; Ib. Tobacco treatment services referral; Ic. Repeat annual LCS among participants with a normal initial screening result; Id. Follow-up diagnostic evaluation for participants with an abnormal screening result.

OUTLINE: In accordance with the 2X2 cluster randomized design, primary care practices along with providers initially are randomized to 1 of 2 groups. Then, patients within the practices are randomized to 1 of 2 groups.

PROVIDERS:

GROUP A: PROVIDER SUPPORT GROUP: Providers complete baseline and endpoint surveys once on study. Providers also undergo online educational activity on study. Participants undergo distance learning on study.

GROUP B: PROVIDER CONTROL GROUP: Participants complete baseline and endpoint surveys once on study.

PATIENTS:

GROUP A: PROVIDER SUPPORT + PATIENT OUTREACH GROUP: Providers receive support once on study. Patients undergo educational activity and SDM counseling once on study and complete baseline and endpoint surveys.

GROUP B: PROVIDER SUPPORT + PATIENT CONTROL GROUP: Providers receive support once on study. Patients receive usual care once on study and complete baseline and endpoint telephone surveys.

GROUP C: PROVIDER CONTROL + PATIENT OUTREACH GROUP: Providers receive usual care once on study. Patients undergo educational activity and SDM counseling once on study and complete baseline and endpoint surveys.

Group D: PROVIDER CONTROL + PATIENT CONTROL GROUP: Providers receive usual care once on study. Patients receive usual care once on study and complete baseline and endpoint telephone surveys.

Вмешательства

• Другое Survey Administration
  Complete survey
• Другое Educational Activity
  Undergo online shared decision making training and distance learning
• Другое Survey Administration
  Complete survey
• Другое Electronic Health Record Review
  Undergo electronic health record review
• Другое Educational Activity
  Undergo online shared decision making training and distance learning
• Другое Counseling
  Undergo shared decision making counseling
• Другое Survey Administration
  Complete survey
• Другое Electronic Health Record Review
  Undergo electronic health record review

Первичные конечные точки

• Completion of initial lung cancer screening (LCS) [Срок оценки: Within 4 months of randomization]

Вторичные конечные точки (4)

• Referral for LCS [Срок оценки: Up to 5 years]
• Tobacco cessation services [Срок оценки: Up to 5 years]
• Repeat annual lung cancer screenings within 11-16 months of original screening [Срок оценки: within 11-16 months of original screening]
• Diagnostic follow up after initial lung cancer screening [Срок оценки: Up to 4 months of screening]

Критерии участия

Критерии включения

• PRACTICE LEVEL:
• Primary care practice (family medicine, geriatrics, internal medicine) in one of the 4 participating health systems
• Practice using the main electronic medical record (EMR) of each system, in order to run appropriate patient recruitment reports
• Practice with at least 50% of practice providers (physicians and advanced care providers) consenting to participate
• PATIENT LEVEL:
• Have an office or telemedicine established patient visit scheduled with a primary care provider in one of the participating practices within next 14 to 25 days
• 50 to 77 years of age
• Have at least a 20-pack-year smoking history (based on self-report at baseline eligibility assessment)
• Currently smoke or have quit smoking within the past 15 years (based on self-report at baseline eligibility assessment)
• Able to communicate in English or Spanish (determined at baseline eligibility assessment)

Критерии исключения

• PATIENT OUTREACH:
• Any lung computed tomography (CT) or low-dose computed tomography (LDCT) scan in the past 11 months, current procedural terminology (CPT) Codes are as follows

• G0297 - LDCT screening
• 71250 - CT w/o contrast
• 71260 - CT w/ contrast
• 71270 - CT with and w/o contrast
• 71275 - CT angiography chest
• 78815 - Positron emission tomography computed tomography (PET CT) skull base to mid-thigh
• 78816 - PET CT whole body
• Prior history of lung cancer (The patient's problem list includes a problem with an international classification of diseases (ICD10) code of "Z85.118" or one beginning with "C34.", or by self-report at baseline eligibility assessment)
• Recent hospitalization (Admission date within the last 60 days listed in electronic health record (EHR), or by self-report at baseline eligibility assessment)
• Dementia (diagnosis codes F03.90 or F03.91) in EHR

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Четверное слепое

Основная цель

Скрининг

Центры проведения

США · 1 центр

• Sidney Kimmel Cancer Center at Thomas Jefferson University — Philadelphia

Идентификаторы

NCT: NCT05679349 · 22F.808 · R01CA258849 · JT 24704

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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