Clinical trial NCT05832008: Increasing Adherence to Lung Cancer Screening
Official title: Increasing Equitable Adherence to Annual Lung Cancer Screening and Diagnostic Follow-up
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Adherence, Patient
Keywords: Screening
Nudge
Adherence
Implementation science
Behavioral science
Digital health
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: National Comprehensive Cancer Network
name: AstraZeneca
First posted: 2023-04-27
Enrollment: 800
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
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

Brief 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.

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

Primary outcomes:
measure: Number of completed annual LCS in patients with a negative baseline screen (Lung Imaging Reporting and Data System (Lung-RADS) 1 or 2).
timeFrame: Initial measurement will occur 3 months after randomization
measure: Number of completed recommended diagnostic follow-up scans or procedures in patients with a positive baseline screen (Lung-RADS 3 or 4a).
timeFrame: Initial measurement will occur 3 months after randomization
Secondary outcomes:
measure: Reach
timeFrame: Initial measurement will occur 3 months after randomization
Other outcomes:
measure: Rate of false-positive screens
timeFrame: 6 months after LDCT date
measure: Number of downstream imaging and diagnostic procedures
timeFrame: 6 months after LDCT date
measure: Number of lung cancer diagnoses
timeFrame: 6 months after LDCT date
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Katharine Rendle, PhD,MSW,MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania
name: Anil Vachani, MD
role: PRINCIPAL_INVESTIGATOR
References: