Increasing Adherence to Lung Cancer Screening

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer; Adherence, Patient
• Intervention / Treatment: Behavioral: Patient Nudge; Behavioral: Clinician Nudge

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 Type: Interventional
• Enrollment (Estimated): 1400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jocelyn Wainwright, MS; Phone Number: 215-615-4226; Email: Jocelyn.Wainwright@pennmedicine.upenn.edu
• Study Contact Backup: Name: Katharine Rendle, PhD,MSW,MPH; Phone Number: 215-349-5442; Email: katharine.rendle@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
      • Contact: Hannah Toneff, MSW, MA; Phone Number: 267-882-3186; Email: hannah.toneff@pennmedicine.upenn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Abramson Cancer Center at Penn Medicine
• Collaborators: AstraZeneca; National Comprehensive Cancer Network
• Investigators: Principal Investigator: Katharine Rendle, PhD,MSW,MPH, University of Pennsylvania; Principal Investigator: Anil Vachani, MD, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2023
• Primary Completion (Estimated): November 10, 2024
• Study Completion (Estimated): November 10, 2024

Study Registration Dates

• First Submitted: March 23, 2023
• First Submitted That Met QC Criteria: April 14, 2023
• First Posted (Actual): April 27, 2023

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 10, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Adherence; Screening; Implementation science; Digital health; Nudge; Behavioral science
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: UPCC 09522; 851056 (Other Identifier: UPenn IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No