Increasing Lung Cancer Screening Among Emergency Department Patients - LCS R01
28 april 2026 uppdaterad av: David Adler, University of Rochester
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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
1036
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Peter Macdowell
- Telefonnummer: 585-274-1509
- E-post: peter_macdowell@urmc.rochester.edu
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Undersökning
- Tilldelning: Randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: 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.
|
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.
|
|
Experimentell: 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.
|
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.
Participants receive a series of up to 9 theory informed text messages designed to increase awareness, motivation, and completion of lung cancer screening.
|
|
Aktiv komparator: 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.
|
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.
|
|
Experimentell: 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.
|
Participants receive a series of up to 9 theory informed text messages designed to increase awareness, motivation, and completion of lung cancer screening.
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Proportion of Participants Who Complete Lung Cancer Screening Within 120 Days After Enrollment
Tidsram: Up to 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Proportion of Participants Who Participate in Shared Decision Making for Lung Cancer Screening Within 120 Days After Enrollment
Tidsram: Up to 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
Tidsram: 120 Days After Enrollment
|
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
Tidsram: Up to 120 Days After Enrollment
|
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
Tidsram: 120 Days After Enrollment
|
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
Tidsram: 120 Days After Enrollment
|
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
|
Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 mars 2027
Primärt slutförande (Beräknad)
1 december 2030
Avslutad studie (Beräknad)
1 december 2031
Studieregistreringsdatum
Först inskickad
27 april 2026
Först inskickad som uppfyllde QC-kriterierna
28 april 2026
Första postat (Faktisk)
5 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
5 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
28 april 2026
Senast verifierad
1 april 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- FP00007604
Plan för individuella deltagardata (IPD)
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IPD-planbeskrivning
Undecided
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