Integrating Telehealth to Advance Lung Cancer Screening (ITALCS)

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.

Study Overview

• Status: Recruiting
• Conditions: Telemedicine; Decision Making; Early Detection of Cancer
• Intervention / Treatment: Behavioral: Active Choice; Behavioral: Low Touch Strategy; Behavioral: High Touch Strategy; Behavioral: Telehealth Only

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 6000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hannah Toneff, MSW, MA; Phone Number: 267-882-3186; Email: Hannah.Toneff@pennmedicine.upenn.edu
• Study Contact Backup: Name: Katharine Rendle, PhD; Phone Number: 215-349-5442; Email: katharine.rendle@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
      • Principal Investigator: Anil Vachani, MD
      • Contact: Katharine Rendle, PhD,MSW,MPH; Phone Number: 215-349- 5442; Email: katharine.rendle@pennmedicine.upenn.edu
      • Contact: Hannah Toneff, MSW, MA; Phone Number: 267-882-3186; Email: Hannah.Toneff@pennmedicine.upenn.edu
      • Principal Investigator: Katharine Rendle, PhD,MSW,MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Choice (Stage 1) + Low Touch (Stage 2); Participants in this arm will be offered the option via outreach letter to complete an SDM visit via telehealth or in-person (Stage 1) and if individuals do not schedule an SDM visit within 30 days (non-responders), they will receive asynchronous text messages alone (Stage 2)	Behavioral: Active Choice; The participant will be send a letter inviting them to complete a SDM visit either in-person or via telehealth.; Behavioral: Low Touch Strategy; Patient will be sent asynchronous text messaging reminders encouraging SDM for LCS using framed messaging.
Experimental: Active Choice (Stage 1) + High Touch (Stage 2); Participants in this arm will be offered the option via outreach letter to complete an SDM visit via telehealth or in-person (Stage 1) and if individuals do not schedule an SDM visit within 30 days (non-responders), they will receive asynchronous text messages in combination with synchronous digital care coordination (Stage 2).	Behavioral: Active Choice; The participant will be send a letter inviting them to complete a SDM visit either in-person or via telehealth.; Behavioral: High Touch Strategy; Patient will be sent asynchronous text messaging reminders encouraging SDM for LCS using framed messaging in combination with synchronous telephone-based digital care coordination.
Experimental: Telehealth Only (Stage 1) + Low Touch (Stage 2); Participants in this arm will be offered the option via outreach letter to complete an SDM visit via telehealth only (Stage 1) and if individuals do not schedule an SDM visit within 30 days (non-responders), they will receive asynchronous text messages alone (Stage 2).	Behavioral: Low Touch Strategy; Patient will be sent asynchronous text messaging reminders encouraging SDM for LCS using framed messaging.; Behavioral: Telehealth Only; The participant will be send a letter inviting them to complete a SDM visit via telehealth only.
Experimental: Telehealth Only (Stage 1) + High Touch (Stage 2); Participants in this arm will be offered the option via outreach letter to complete an SDM visit via telehealth only (Stage 1) and if individuals do not schedule an SDM visit within 30 days (non-responders), they will receive asynchronous text messages in combination with synchronous digital care coordination (Stage 2).	Behavioral: High Touch Strategy; Patient will be sent asynchronous text messaging reminders encouraging SDM for LCS using framed messaging in combination with synchronous telephone-based digital care coordination.; Behavioral: Telehealth Only; The participant will be send a letter inviting them to complete a SDM visit via telehealth only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shared decision making (SDM) for lung cancer screening (LCS)	Completion of an SDM visit (in person or telehealth) defined as any completed encounter that has documented SDM for LCS as indicated by 1) procedure code (G0296 or equivalent), or documentation of SDM conversation related to LCS in associated progress notes.	90 days after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Low-dose computed tomography (LDCT)	Completion of LDCT within 6 months of randomization date among individuals who complete SDM and are determined to be eligible for LCS.	6 months after randomization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fidelity to Shared Decision-Making	Completion of key components of SDM for LCS including: discussion of risks & benefits of LCS; use of decision aid; elicitation of patient preferences; tobacco cessation support	Up to 90 days after randomization
Fidelity to Digital Care Coordination	Completion of key components of digital care coordination including assessing digital needs and readiness, providing technological support, answering questions about security or safety, and helping to coordinate telehealth appointments.	Up to 90 days after randomization
Lung cancer diagnoses	Number of people diagnosed with lung cancer after randomization.	12 months after randomization
Reach: Text Message Delivery	The number of participants who are successfully delivered text messages divided by those who are sent text messages in Stage 2.	Up to 90 days after randomization
Reach: Digital Care Coordination	The number of participants who complete a digital care coordination visit divided by those contacted by the Digital Care Coordinator in Stage 2.	Up to 90 days after randomization
Reach: Scheduling	The number of participants who schedule an SDM visit divided by those who are sent initial outreach.	Up to 90 days after randomization
Timeliness	The number of days between randomization and SDM completion among subjects who complete SDM for LCS.	Up to 12 months after randomization

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Katharine Rendle, PhD, Abramson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: October 9, 2024
• First Submitted That Met QC Criteria: October 10, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: UPCC 04524; P50CA271338 (U.S. NIH Grant/Contract); 850376 (Other Identifier: Penn IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No