Increasing Adherence to Lung Cancer Screening

Sponsor

Abramson Cancer Center at Penn Medicine (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05832008

Collaborator

National Comprehensive Cancer Network (Other), AstraZeneca (Industry)

1,400

Enrollment

Arms

18.4

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer Adherence, Patient	Behavioral: Patient Nudge Behavioral: Clinician Nudge	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1400 participants

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).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 (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Nov 10, 2024

Anticipated Study Completion Date :

Nov 10, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Clinician Nudge A pended order will prompt clinicians in this arm when a patient is due for lung cancer screening or diagnostic follow-up.	Behavioral: Clinician Nudge EHR-based Prompts - an EHR-based prompt that alerts a clinician if a patient is due for screening or diagnostic follow-up.
No Intervention: No Clinician Nudge 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.
Experimental: Patient Nudge Patients in this arm will receive messaging designed to increase awareness of the benefits of LCS and remind patients that they are due for screening or recommended follow-up care.	Behavioral: Patient Nudge Framed Messaging - brief persuasive messaging to increase awareness about the risks and benefits of lung cancer screening and completion of recommended follow-up sent to patients via text message.
No Intervention: No Patient Nudge Patients in this arm will receive usual care.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Reach [Initial measurement will occur 3 months after randomization]
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)

Other Outcome Measures

Rate of false-positive screens [6 months after LDCT date]
Defined as having a positive LDCT and no subsequent lung cancer diagnosis within 6 months of the LDCT date
Number of downstream imaging and diagnostic procedures [6 months after LDCT date]
Measured using EHR data
Number of lung cancer diagnoses [6 months after LDCT date]
Biopsy confirmed lung cancer diagnosis measured using EHR data

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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 2019-2022; 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 2019-2022;
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