UPCC 04524 Integrating Telehealth to Advance Lung Cancer Screening (ITALCS) (ITALCS)

Investigating Telehealth Strategies for Lung Cancer Screening

Enrolling By Invitation
50 years - 80 years
All
Phase N/A
6000 participants needed
1 Location

Brief description of study

The goal of this pragmatic trial is to learn if telehealth strategies can increase shared decision-making (SDM) for lung cancer screening (LCS). It will also learn about the equity of these strategies by conducting non-inferiority analysis by race and sex. The main questions it aims to answer are:

  1. Does patient outreach using synchronous and asynchronous telehealth strategies increase completion of SDM visits for LCS?
  2. Is the effectiveness of these telehealth strategies similar by race and sex?

The study uses a Sequential Multiple Assignment Randomized Trial (SMART) design and includes two stages of interventions. The first stage of intervention includes direct patient outreach with an invitation to schedule either a 1) telehealth SDM visit or 2) telehealth or in-person SDM visit. Participants that do not respond to the first stage interventions receive a text message reminder encouraging SDM visit completion with or without digital care coordination.

Detailed description of study

Annual lung cancer screening using low-dose computed tomography (LDCT) is associated with decreased lung cancer mortality but also with harms. As such, it is recommended, and required for reimbursement, that patients complete an shared decision-making visit (SDM) prior to screening to discuss potential risks and benefits in the context of patient values. Despite guidelines recommending screening and national insurance coverage of LDCT, uptake of SDM visits and subsequent LDCT is remarkably low. We aim to address these gaps by comparing the effectiveness of synchronous and asynchronous telehealth strategies on SDM visits and subsequent LDCT in a pragmatic trial using a Sequential Multiple Assignment Randomized Trial (SMART) design. The specific first stage strategies to be tested are: a) Active Choice Outreach (invitation to schedule a telehealth or in-person SDM visit) vs b) Telehealth Only Outreach (invitation to schedule a telehealth SDM visit). The specific second stage strategies (delivered only if participants do not respond to first stage interventions) are a) text message reminders encouraging SDM visit completion (low-touch) alone or b) in combination with phone-based digital care coordination (high-touch). We will also assess non-inferiority of strategies by race and sex to assess equity of effectiveness.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Early Detection of Cancer, Telemedicine, Decision Making
  • Age: 50 years - 80 years
  • Gender: All

Inclusion criteria:

Participants will be eligible if:

  1. are aged 50 to 80
  2. have a history of tobacco use indicated by either: Documented 20 pack-year or greater smoking history in their electronic health record (EHR); OR Self-report via structured survey
  3. currently smoke or formerly smoked cigarettes
  4. have no documented history of lung cancer
  5. have no documented history of lung cancer screening in the 24 months prior to study enrollment
  6. have completed at least one primary care visit at Penn Medicine in the 3 years prior to study enrollment.

Exclusion criteria:

Participants who do not meet inclusion criteria will not be eligible.

This study investigates the use of telehealth strategies to improve shared decision-making (SDM) visits for lung cancer screening (LCS). Lung cancer screening often involves low-dose computed tomography (LDCT), which can reduce lung cancer mortality but also carries risks. Patients are recommended to complete an SDM visit to discuss these risks and benefits. Despite guidelines and insurance coverage, participation in SDM visits and subsequent LDCT is low. This study aims to compare the effectiveness of synchronous (real-time) and asynchronous (not real-time) telehealth strategies in increasing SDM visits and LDCT uptake.

Participants will be involved in a Sequential Multiple Assignment Randomized Trial (SMART) design, which includes two stages of intervention. The first stage involves direct patient outreach, inviting them to schedule either a telehealth or in-person SDM visit. If participants do not respond, the second stage involves sending text message reminders, with or without additional digital care coordination. The study will also assess whether these telehealth strategies are equally effective across different races and sexes.

  • Who can participate: Participants aged 50 to 80 with a history of tobacco use, either documented in their electronic health record or self-reported, are eligible. They must currently smoke or be former smokers, have no history of lung cancer or lung cancer screening in the past 24 months, and have attended at least one primary care visit at Penn Medicine in the past 3 years.
  • Study details: Participants will be contacted for scheduling SDM visits either through telehealth or in-person. If they do not respond, they will receive text message reminders, potentially combined with phone-based digital care coordination. This study will evaluate the equity of these strategies by assessing their effectiveness across different races and sexes.
Updated on 29 May 2026. Study ID: 24-0561
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