Increasing Lung Cancer Screening Among Emergency Department Patients - LCS R01
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorUniversity of Rochester
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 50 - 80
≥ 20 pack-year smoking history
current smoker or quit within 15 years
English/Spanish speaking
Disqualifiers
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
Trial design
Design model
Factorial
Treatments tested in this trial
Basic Referral
BehavioralParticipants 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.
Facilitated Referral
BehavioralA 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.
Text Messaging
BehavioralParticipants receive a series of up to 9 theory informed text messages designed to increase awareness, motivation, and completion of lung cancer screening.
Treatment groups
1,036 Participants
are divided into 4 treatment groupsGroup A: Basic Referral (enhanced control arm)Active comparator 1 intervention
Group B: Basic Referral plus Text MessagingExperimental treatment 2 interventions
Group C: Facilitated ReferralActive comparator 1 intervention
Group D: Facilitated Referral plus Text MessagingExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 120 Days After EnrollmentSecondary outcomes
1
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.
Time frame
Up to 120 Days After Enrollment2
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.
Time frame
120 Days After Enrollment3
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.
Time frame
Up to 120 Days After Enrollment4
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.
Time frame
120 Days After EnrollmentLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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