Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 50 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
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)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Clinician Nudge + Patient Nudge
An EHR-prompt (pended order) will prompt clinicians in this arm when a patient is due for lung cancer screening or diagnostic follow-up. Patients in this arm will receive messaging designed to increase awareness about the importance of annual screening and recommended follow-up
  • Behavioral: Patient Nudge
    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.
  • Behavioral: Clinician Nudge
    EHR-based Prompts - an pended order and message that alerts a clinician if a patient is due for screening or diagnostic follow-up.
Experimental
Clinician Nudge Only
Clinicians in this arm will not be prompted by a pended order when a patient is due for lung cancer screening or diagnostic follow-up. Patients will receive usual care.
  • Behavioral: Clinician Nudge
    EHR-based Prompts - an pended order and message that alerts a clinician if a patient is due for screening or diagnostic follow-up.
Experimental
Patient Nudge Only
Patients in this arm will receive messaging designed to increase awareness about the importance of annual screening and recommended follow-up. Clinicians will receive usual care.
  • Behavioral: Patient Nudge
    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.
No Intervention
Usual care (no nudges)
Patients and clinicians in this arm will receive usual care.

Recruiting Locations

University of Pennsylvania
Philadelphia, Pennsylvania 19104
Contact:
Hannah Toneff, MSW, MA
267-882-3186
hannah.toneff@pennmedicine.upenn.edu

More Details

NCT ID
NCT05832008
Status
Recruiting
Sponsor
Abramson Cancer Center at Penn Medicine

Study Contact

Katharine Rendle, PhD,MSW,MPH
215-349-5442
katharine.rendle@pennmedicine.upenn.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.