Increasing Adherence to Lung Cancer Screening

NCT ID: NCT05832008

Last Updated: 2026-01-27

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 825 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-18
• Study Completion Date: 2026-06-01

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.

Conditions

Lung Cancer; Adherence, Patient

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Patient Nudge

Intervention Type: BEHAVIORAL

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.

Clinician Nudge

Intervention Type: BEHAVIORAL

EHR-based Prompts - an pended order and message that alerts a clinician if a patient is due for screening or diagnostic follow-up.

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.

Group Type: EXPERIMENTAL

Clinician Nudge

Intervention Type: BEHAVIORAL

EHR-based Prompts - an pended order and message that alerts a clinician if a patient is due for screening or diagnostic follow-up.

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.

Group Type: EXPERIMENTAL

Patient Nudge

Intervention Type: BEHAVIORAL

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.

Usual care (no nudges)

Patients and clinicians in this arm will receive usual care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Comprehensive Cancer Network

NETWORK

Sponsor Role: collaborator

AstraZeneca

INDUSTRY

Sponsor Role: collaborator

Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role: lead

Responsible Party

Katharine Rendle

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katharine Rendle, PhD,MSW,MPH

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Anil Vachani, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

UPCC 09522

Identifier Type: -

Identifier Source: org_study_id

851056

Identifier Type: OTHER

Identifier Source: secondary_id