Increasing Lung Cancer Screening Among Emergency Department Patients - LCS R01

Increasing Lung Cancer Screening Uptake Among Emergency Department Patients - LCS R01

This randomized clinical trial evaluates the effectiveness of text messaging and facilitated referral strategies to increase lung cancer screening uptake among emergency department patients who meet lung cancer screening eligibility criteria.

Study Overview

• Status: Not yet recruiting
• Conditions: Current Smoker; Lung Cancer Screening; Smoking History
• Intervention / Treatment: Behavioral: Basic Referral; Behavioral: Text Messaging; Behavioral: Facilitated Referral

Detailed Description

This randomized clinical trial will evaluate strategies to improve lung cancer screening uptake among emergency department patients who meet lung cancer screening eligibility criteria based on age and smoking history. Participants will be randomized using a 2 by 2 factorial design into one of four groups: basic referral, basic referral plus text messaging, facilitated referral, or facilitated referral plus text messaging.

The basic referral strategy includes verbal referral to the lung cancer screening program and primary care provider, if applicable, along with written contact information for the lung cancer screening program navigator. The facilitated referral strategy includes submission of a lung cancer screening requisition to the lung cancer screening program on behalf of the participant during the emergency department visit.

The text messaging intervention includes a series of theory informed messages designed to increase intention and motivation to complete lung cancer screening. Lung cancer screening uptake will be assessed at 120 days after enrollment using participant follow up and electronic health record review.

• Study Type: Interventional
• Enrollment (Estimated): 1036
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Peter Macdowell; Phone Number: 585-274-1509; Email: peter_macdowell@urmc.rochester.edu

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Age 50 - 80
• ≥ 20 pack-year smoking history
• current smoker or quit within 15 years
• English/Spanish speaking
• Registered in the Emergency Department as a patient

Exclusion Criteria:

• Non-English/Spanish
• Inability to provide consent (e.g. high clinical acuity, cognitive deficit)
• Lack of text-capable mobile phone and/or inability to use text function

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Basic Referral (enhanced control arm); Participants assigned to this arm will be notified that they are eligible and meet federal recommendations for lung cancer screening. They will be verbally referred to a lung cancer screening program and their primary care provider (if they have one) to discuss lung cancer screening. They will also be provided with written materials that include telephone contact information for the lung cancer screening program navigator. If contacted, the LCS Program Navigator will conduct a discussion, schedule a screening CT scan at one of the 8 regional American College of Radiology-designated lung cancer screening centers and arrange clinical follow-up as needed.	Behavioral: Basic Referral; Participants are verbally referred to the lung cancer screening program and their primary care provider if applicable. Written materials with contact information for the lung cancer screening program navigator are provided.
Experimental: Basic Referral plus Text Messaging; Participants assigned to this arm will receive the basic referral as described in the previous arm. In addition, they will receive a series of text messages, aimed at generating intention and motivation to get lung cancer screening. Patients will receive a total of 9 messages.	Behavioral: Basic Referral; Participants are verbally referred to the lung cancer screening program and their primary care provider if applicable. Written materials with contact information for the lung cancer screening program navigator are provided.; Behavioral: Text Messaging; Participants receive a series of up to 9 theory informed text messages designed to increase awareness, motivation, and completion of lung cancer screening.
Active Comparator: Facilitated Referral; Participants assigned to this arm will be notified that they are eligible and meet federal recommendations for lung cancer screening. Rather than the basic referral received in the arms above, a lung cancer screening requisition form will be submitted to the lung cancer screening program on behalf of the participant during their emergency department visit.	Behavioral: Facilitated Referral; A lung cancer screening requisition form is submitted to the lung cancer screening program on behalf of the participant during the emergency department visit. The screening program will contact the participant to discuss screening and schedule a low dose CT scan if appropriate.
Experimental: Facilitated Referral plus Text Messaging; Participants assigned to this arm will receive facilitated referral plus the series of text messages described above. Among these participants, contact with the lung cancer screening program is likely to occur after receipt of the initial text messages but prior to receipt of all text messages.	Behavioral: Text Messaging; Participants receive a series of up to 9 theory informed text messages designed to increase awareness, motivation, and completion of lung cancer screening.; Behavioral: Facilitated Referral; A lung cancer screening requisition form is submitted to the lung cancer screening program on behalf of the participant during the emergency department visit. The screening program will contact the participant to discuss screening and schedule a low dose CT scan if appropriate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants Who Complete Lung Cancer Screening Within 120 Days After Enrollment	Lung cancer screening uptake is defined as completion of a low dose computed tomography scan for lung cancer screening within 120 days after enrollment. Screening completion will be confirmed using electronic health record review, lung cancer screening program records, or participant self report obtained during follow up. The outcome is reported as the proportion of participants who complete screening.	Up to 120 Days After Enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants Who Participate in Shared Decision Making for Lung Cancer Screening Within 120 Days After Enrollment	Participation in shared decision making is defined as documentation of a shared decision making discussion regarding lung cancer screening or participant self report of completing such a discussion within 120 days after enrollment. The outcome is reported as the proportion of participants who participate in shared decision making.	Up to 120 Days After Enrollment
Frequency of Reported Barriers to Lung Cancer Screening at 120 Days	Barriers to lung cancer screening are assessed using participant responses to a structured questionnaire administered at follow up. The questionnaire includes items on transportation challenges, cost concerns, scheduling difficulties, and fear of screening results. The outcome is reported as the number and proportion of participants reporting each barrier.	120 Days After Enrollment
Acceptability of Emergency Department Based Lung Cancer Screening Interventions at 120 Days	Acceptability is assessed using participant responses to Likert scale questionnaire items evaluating the degree to which participants find the emergency department based lung cancer screening interventions acceptable. Each item is scored on a 5 point Likert scale ranging from 1 to 5, with higher scores indicating greater acceptability. The outcome is reported as summary scores based on participant responses.	Up to 120 Days After Enrollment
Appropriateness of Emergency Department Based Lung Cancer Screening Interventions at 120 Days	Appropriateness is assessed using participant responses to Likert scale questionnaire items evaluating the perceived fit and relevance of emergency department based lung cancer screening interventions. Each item is scored on a 5 point Likert scale ranging from 1 to 5, with higher scores indicating greater perceived appropriateness. The outcome is reported as summary scores based on participant responses.	120 Days After Enrollment
Frequency of Reported Facilitators to Lung Cancer Screening at 120 Days	Facilitators to lung cancer screening are assessed using participant responses to a structured questionnaire administered at follow up. The questionnaire includes items related to factors such as access to care, health literacy, prior healthcare engagement, and presence of a primary care provider. The outcome is reported as the number and proportion of participants reporting each facilitator.	120 Days After Enrollment

Collaborators and Investigators

• Sponsor: University of Rochester

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2031

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: April 28, 2026
• First Posted (Actual): May 5, 2026

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Smoking; Emergency Department; Lung Cancer Screening
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Behavior; Emergencies; Smoking
• Other Study ID Numbers: FP00007604

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Undecided

Drug and device information, study documents

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