Increasing Adherence to Lung Cancer Screening

Study Overview
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Brief Summary
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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
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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.

Official Title
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Increasing Equitable Adherence to Annual Lung Cancer Screening and Diagnostic Follow-up

Conditions
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Lung Cancer, Adherence, Patient

Intervention / Treatment
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* Behavioral: Patient Nudge
* Behavioral: Clinician Nudge


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinicians will be eligible if they: are practicing primary care or specialty care physicians at a recruiting site within the University of Pennsylvania Health System; care for patients who completed LCS via LDCT in 2019-2023; and do not opt-out of study participation. Patients will be eligible if they: 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) completed LCS via LDCT in 2019-2023; have not been diagnosed with lung cancer; meet criteria for non-adherence; remain eligible for LCS during the trial enrollment period; and 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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional 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).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clinician Nudge + Patient Nudge<br>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<br>* 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.<br>Behavioral: Clinician Nudge<br>* EHR-based Prompts - an pended order and message that alerts a clinician if a patient is due for screening or diagnostic follow-up.<br>|
| Experimental: Clinician Nudge Only<br>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<br>* EHR-based Prompts - an pended order and message that alerts a clinician if a patient is due for screening or diagnostic follow-up.<br>|
| Experimental: Patient Nudge Only<br>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<br>* 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.<br>|
| No Intervention: Usual care (no nudges)<br>Patients and clinicians in this arm will receive usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of completed annual LCS in patients with a negative baseline screen (Lung Imaging Reporting and Data System (Lung-RADS) 1 or 2). | Number of completed low-dose computed tomography (LDCT) scans among adults who are due for annual screening based on evidence-based guidelines. | Initial measurement will occur 3 months after randomization | 
| Number of completed recommended diagnostic follow-up scans or procedures in patients with a positive baseline screen (Lung-RADS 3 or 4a). | Completion of recommended diagnostic follow-up scans or procedures among adults with positive baseline LDCT scan. | Initial measurement will occur 3 months after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reach | Reach defined by proportion of patients who receive patient nudges and by the proportion of patients whose clinician acts upon clinician nudge (i.e., signs pended orders) | Initial measurement will occur 3 months after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Screening, Nudge, Adherence, Implementation science, Behavioral science, Digital health