Integrating Telehealth to Advance Lung Cancer Screening (ITALCS)

Abramson Cancer Center at Penn Medicine

Status: Enrolling

Conditions: Early Detection of Cancer; Decision Making; Telemedicine

Treatments: Behavioral: High Touch Strategy; Behavioral: Active Choice; Behavioral: Telehealth Only; Behavioral: Low Touch Strategy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06638554

P50CA271338 (U.S. NIH Grant/Contract)

UPCC 04524

850376 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6,000 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Single Blind

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6,000 participants in 4 patient groups

Active Choice (Stage 1) + Low Touch (Stage 2)

Experimental group

Description:

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)

Treatment:

Behavioral: Low Touch Strategy

Behavioral: Active Choice

Active Choice (Stage 1) + High Touch (Stage 2)

Experimental group

Description:

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).

Treatment:

Behavioral: Active Choice

Behavioral: High Touch Strategy

Telehealth Only (Stage 1) + Low Touch (Stage 2)

Experimental group

Description:

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).

Treatment:

Behavioral: Low Touch Strategy

Behavioral: Telehealth Only

Telehealth Only (Stage 1) + High Touch (Stage 2)

Experimental group

Description:

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).

Treatment:

Behavioral: Telehealth Only

Behavioral: High Touch Strategy