Integrating Telehealth to Advance Lung Cancer Screening
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Active Choice, Telehealth Only, Low Touch Strategy, High Touch Strategy.
- Who it may be relevant to
- Registry conditions: Early Detection of Cancer, Telemedicine, Decision Making. Basic parameters: 50 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
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.
Interventions
- Behavioral Active Choice
The participant will be send a letter inviting them to complete a SDM visit either in-person or via telehealth. - Behavioral Telehealth Only
The participant will be send a letter inviting them to complete a SDM visit via telehealth only. - Behavioral Low Touch Strategy
Patient will be sent asynchronous text messaging reminders encouraging SDM for LCS using framed messaging. - 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.
Primary outcome measures
- Shared decision making (SDM) for lung cancer screening (LCS) [Time frame: 90 days after randomization]
Secondary outcome measures (1)
- Low-dose computed tomography (LDCT) [Time frame: 6 months after randomization]
Eligibility criteria
Inclusion criteria
Participants will be eligible if:
- are aged 50 to 80
- 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
- currently smoke or formerly smoked cigarettes
- have no documented history of lung cancer
- have no documented history of lung cancer screening in the 24 months prior to study enrollment
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Single blind
- Primary purpose
- Health services research
Study locations
United States · 1 center
- University of Pennsylvania — Philadelphia
Identifiers
NCT: NCT06638554 · UPCC 04524 · P50CA271338 · 850376