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Trial Title:
Increasing Adherence to Lung Cancer Screening
NCT ID:
NCT05832008
Condition:
Lung Cancer
Adherence, Patient
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
Screening
Nudge
Adherence
Implementation science
Behavioral science
Digital health
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Factorial Assignment
Intervention model description:
At the start of the trial, clinicians who do not opt-out will be randomized to the
intervention (clinician nudge) or control arm (no clinician nudge). Eligible patients
will be randomized, stratified by clinician, to either the intervention (patient nudge)
or control group (no patient nudge).
Primary purpose:
Health Services Research
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
Patient Nudge
Description:
Brief persuasive messaging to increase awareness about the importance of annual lung
cancer screening and completion of recommended follow-up sent to patients via text
message.
Arm group label:
Clinician Nudge + Patient Nudge
Arm group label:
Patient Nudge Only
Intervention type:
Behavioral
Intervention name:
Clinician Nudge
Description:
EHR-based Prompts - an pended order and message that alerts a clinician if a patient is
due for screening or diagnostic follow-up.
Arm group label:
Clinician Nudge + Patient Nudge
Arm group label:
Clinician Nudge Only
Summary:
Investigators are conducting a pragmatic randomized trial testing the effectiveness of
patient and clinician nudge strategies on adherence to lung cancer screening (LCS) &
diagnostic follow-up across eligible primary care clinicians & patients. Following the
trial, a subsample of patients & clinicians will be invited to one-time semi-structured
interview & survey to identify individual & system-level factors that may restrict or
enhance the impact of strategies.
Detailed description:
Investigators will conduct a pragmatic clinical trial with a 2 x 2 factorial design with
clinicians that provide care to screening-eligible patients who are overdue for annual
screening or diagnostic evaluation. The specific nudge strategies to be tested are: 1)
gain-framed messaging delivered via text messaging to prompt patient adherence to LCS
guidelines (patient nudges); and 2) electronic health record (EHR) prompts alerting
clinicians when their patients are due for annual screening or diagnostic follow-up
(clinician nudges). The rationale for this study is that changing external stimuli to
encourage adherence to evidence-based LCS guidelines will increase early detection of
lung cancer by removing individual and system-level barriers to identifying and prompting
patients who are due for care. The central hypothesis is that the combination of patient
and clinician strategies will have the greatest effect on increasing adherence because it
will target multilevel determinants of lung cancer screening identified in our prior
research including limited screening knowledge and suboptimal EHR design. The proposed
strategies are designed to support equitable implementation across diverse settings and
populations.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
Clinicians will be eligible if they:
1. are practicing primary care or specialty care physicians at a recruiting site within
the University of Pennsylvania Health System;
2. care for patients who completed LCS via LDCT in 2019-2023; and
3. do not opt-out of study participation.
Patients will be eligible if they:
1. are eligible for LCS based on 2021 US Preventive Services Task Force (USPSTF)
population guidelines (aged 50-80; smoking history of 20-pack years; smoked within
the last 15 years)
2. completed LCS via LDCT in 2019-2023;
3. have not been diagnosed with lung cancer;
4. meet criteria for non-adherence;
5. remain eligible for LCS during the trial enrollment period; and
6. receive LCS care from a clinician that has not opted-out of study participation
Exclusion Criteria:
Patients will be excluded if they:
a) have a highly suspicious baseline LDCT (Lung-RADS 4B/X) given the presence of existing
clinical pathways to ensure adherence in this group
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:
Hannah Toneff, MSW, MA
Phone:
267-882-3186
Email:
hannah.toneff@pennmedicine.upenn.edu
Start date:
October 18, 2023
Completion date:
November 10, 2024
Lead sponsor:
Agency:
Abramson Cancer Center at Penn Medicine
Agency class:
Other
Collaborator:
Agency:
National Comprehensive Cancer Network
Agency class:
Other
Collaborator:
Agency:
AstraZeneca
Agency class:
Industry
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/NCT05832008
