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This study will assess the impact of centralized outreach on lung cancer screening completion among individuals served by Federally Qualified Health Centers.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Outreach arm | Experimental | Individuals in the outreach arm will receive centralized patient outreach for lung cancer screening in addition to usual care. |
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| Usual care arm | No Intervention | Individuals in the usual care arm will receive usual care and will not receive any outreach contacts (mail or telephone) within 15 months after randomization. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Centralized patient outreach for lung cancer screening | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of individuals completing low-dose CT (LDCT) within 15 months of randomization. | Within 15 months of randomization |
| Measure | Description | Time Frame |
|---|---|---|
| LDCT scan findings: Lung Imaging Reporting and Data System (Lung-RADS) | Proportion of individuals with Lung-RADS 1, 2, 3, and 4 | Within 15 months of randomization |
| LDCT incident findings | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jialin Mao, MD, PhD | Weill Medical College of Cornell University | Principal Investigator |
| Bradley B Pua, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine | New York | New York | 10065 | United States |
De-identified data collected during the trial.
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1 year after publication until 6 years after publication
Researchers who propose a methodologically sound proposal and receive IRB approval
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| Within 15 months of randomization |
| Follow-up care | Proportion of individuals receiving a biopsy or lung cancer treatment | Within 6 months after screening |
| Average costs of implementing centralized outreach per individual | Within 15 months of randomization |