Lung Cancer Screening
Conditions
Brief summary
This study will assess the impact of centralized outreach on lung cancer screening completion among individuals served by Federally Qualified Health Centers.
Detailed description
This will be a two-arm, parallel, pragmatic randomized controlled trial (RCT) to evaluate the effectiveness of a centralized patient outreach strategy in increasing lung cancer screening (LCS) completion among populations served by Federally Qualified Health Centers (FQHCs). This study will randomize individuals potentially eligible for LCS (50-80 years, current or past smokers) to receive centralized patient outreach in addition to usual care (outreach arm) and usual care alone (usual care arm). Individuals assigned to the outreach arm will receive centralized patient outreach from the Lung screening team through a letter followed by up to three attempts of telephone contact. Individuals assigned to the usual care arm will not receive any contact during the study period and the referral for LCS will be made at the treating physician's discretion.
Interventions
BEHAVIORALCentralized patient outreach for lung cancer screening
Centralized patient outreach for lung cancer screening will be conducted by the lung screening team and will consist of a letter followed by telephone contact. One week following the mail invitation, a senior patient coordinator (SPC) will make telephone contact with individuals to pre-screen eligibility determination based on pack-year smoking history. Up to three telephone contact attempts will be made within two weeks.
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Adults aged 50 to 80 years * Current or past smokers * Individuals without a recorded LDCT scan within the past year * Individuals without a prior lung cancer diagnosis * Active patients of Ryan Health * Individuals with a mailing address in the New York City area and a phone number on file
Exclusion criteria
* Individuals aged less than 50 or above 80 years * Individuals without smoking history * Individuals with a recorded LDCT scan within the past year * Individuals with a prior lung cancer diagnosis * Individuals without a mailing address in the New York City area or a phone number on file * Individuals served by one of Ryan Health clinics where the centralized patient outreach was developed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of individuals completing low-dose CT (LDCT) within 15 months of randomization. | Within 15 months of randomization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LDCT scan findings: Lung Imaging Reporting and Data System (Lung-RADS) | Within 15 months of randomization | Proportion of individuals with Lung-RADS 1, 2, 3, and 4 |
| LDCT incident findings | Within 15 months of randomization | Proportion of individuals with incident findings on LDCT (including moderate to severe coronary artery calcification, lung-mediastinal findings, moderate to severe emphysema, and abdominal findings) |
| Follow-up care | Within 6 months after screening | Proportion of individuals receiving a biopsy or lung cancer treatment |
| Average costs of implementing centralized outreach per individual | Within 15 months of randomization | — |
Countries
United States
Outcome results
None listed