Increasing Lung Cancer Screening Uptake Among Emergency Department Patients

University of Rochester

Status: Begins enrollment this month

Conditions: Screening Compliance; Lung Cancer (Diagnosis); Lung Cancer; Lung Cancer Diagnosis

Treatments: Behavioral: Basic Referral (enhanced control arm); Behavioral: Facilitated referral and text messaging

Study type: Interventional

Funder types: Other

Identifiers

NCT07287085

FP 9214

Details and patient eligibility

About

The objective of the proposed clinical trial is to determine if we can increase LCS among ED patients using a combination of facilitated referral to an LCS program plus text message reminders to get screened. Step 1 of the approach is to identify participants that are eligible for LCS. Step 2 is to randomize eligible study participants between two study arms: (1) basic referral for LCS (i.e.

verbal referral with written materials), and (2) facilitated referral for LCS (i.e. submission of a requisition to LCS program by staff) plus a subsequent series of text messages aimed at generating intention and motivation to get screened. The investigators' preliminary work showed this approach was feasible in the ED setting. The proposed study will build on this preliminary work with the goal of having a significant positive impact on LCS uptake.

A total of 300 individuals eligible for LCS will be recruited from a high-volume urban ED, randomized between study arms, and followed-up at 120 days to assess interval LCS uptake. The Specific Aims of the proposed project are, (1) Compare LCS uptake between the two study arms, (2) Identify predictors of individuals that are not up-to-date with LCS at the time of enrollment, and (3) Evaluate study participant feedback on (a) barriers and facilitators to getting screened and (b) acceptability and appropriateness of ED-based promotion of LCS. The study team is at the forefront of developing ED-based interventions to promote cancer screening. This project leverages the universal access setting of the ED to identify individuals at greatest risk for lung cancer and get them screened. A scalable ED-based intervention that increases LCS uptake would save lives.

Enrollment: 349 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 50 - 80
• ≥ 20 pack-year smoking history
• current smoker or quit within 15 years
• English speaking
• Current patient in URMC involved Emergency Department

Exclusion criteria

• Non-English
• Inability to provide consent (e.g. high clinical acuity, cognitive deficit)
• Lack of text-capable mobile phone and/or inability to use text function
• Not being a patient in URMC involved Emergency Department There are no restrictions for gender, racial and ethnic origins.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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349 participants in 2 patient groups

Basic Referral (enhanced control arm)

Active Comparator group

Description:

Participants assigned to Arm 1 will be referred to the UR Medicine LCS Program and their primary care provider (if they have one) to discuss LCS. They will also be provided with written materials that include telephone contact information for the LCS Program Navigator.

Treatment:

Behavioral: Basic Referral (enhanced control arm)

Facilitated Referral + Text Messaging

Experimental group

Description:

For participants assigned to Arm 2, an LCS requisition form will be submitted to the UR Medicine LCS Program on behalf of the participant during their ED visit. The participant's primary care provider (if they have one) will be CC'd on the requisition. Participants will be instructed that the LCS program will reach out to them to discuss LCS and, if decided upon, schedule screening. An LCS Program Navigator will call the participant by phone, conduct a shared decision-making discussion, and schedule the screening CT scan (assuming eligibility is confirmed and the discussion results in the participant's decision to schedule screening). In addition, participants in Arm 2 will receive a series of text messages, grounded in the TPB, SDT, and HBM aimed at generating intention and motivation to get LCS.

Treatment:

Behavioral: Facilitated referral and text messaging