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Trial Title:
Integrating Telehealth to Advance Lung Cancer Screening
NCT ID:
NCT06638554
Condition:
Early Detection of Cancer
Telemedicine
Decision Making
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Intervention model description:
This study uses a sequential randomization design in which all eligible participants will
be randomized into one of two interventions at Stage 1 and then participants that do not
respond to Stage 1 interventions will be randomized to receive Stage 2 interventions
Primary purpose:
Health Services Research
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
Active Choice
Description:
The participant will be send a letter inviting them to complete a SDM visit either
in-person or via telehealth.
Arm group label:
Active Choice (Stage 1) + High Touch (Stage 2)
Arm group label:
Active Choice (Stage 1) + Low Touch (Stage 2)
Intervention type:
Behavioral
Intervention name:
Telehealth Only
Description:
The participant will be send a letter inviting them to complete a SDM visit via
telehealth only.
Arm group label:
Telehealth Only (Stage 1) + High Touch (Stage 2)
Arm group label:
Telehealth Only (Stage 1) + Low Touch (Stage 2)
Intervention type:
Behavioral
Intervention name:
Low Touch Strategy
Description:
Patient will be sent asynchronous text messaging reminders encouraging SDM for LCS using
framed messaging.
Arm group label:
Active Choice (Stage 1) + Low Touch (Stage 2)
Arm group label:
Telehealth Only (Stage 1) + Low Touch (Stage 2)
Intervention type:
Behavioral
Intervention name:
High Touch Strategy
Description:
Patient will be sent asynchronous text messaging reminders encouraging SDM for LCS using
framed messaging in combination with synchronous telephone-based digital care
coordination.
Arm group label:
Active Choice (Stage 1) + High Touch (Stage 2)
Arm group label:
Telehealth Only (Stage 1) + High Touch (Stage 2)
Summary:
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
50 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Pennsylvania
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Katharine Rendle, PhD,MSW,MPH
Phone:
215-349-5442
Email:
katharine.rendle@pennmedicine.upenn.edu
Contact backup:
Last name:
Hannah Toneff, MSW, MA
Phone:
267-882-3186
Email:
Hannah.Toneff@pennmedicine.upenn.edu
Investigator:
Last name:
Katharine Rendle, PhD,MSW,MPH
Email:
Principal Investigator
Investigator:
Last name:
Anil Vachani, MD
Email:
Principal Investigator
Start date:
July 9, 2024
Completion date:
January 31, 2027
Lead sponsor:
Agency:
Abramson Cancer Center at Penn Medicine
Agency class:
Other
Collaborator:
Agency:
National Institutes of Health (NIH)
Agency class:
NIH
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Abramson Cancer Center at Penn Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06638554
