Lung Cancer Clinical Trial
Official title:
Increasing Equitable Adherence to Annual Lung Cancer Screening and Diagnostic Follow-up
Investigators are conducting a pragmatic randomized trial testing the effectiveness of patient and clinician nudge strategies on adherence to lung cancer screening (LCS) & diagnostic follow-up across eligible primary care clinicians & patients. Following the trial, a subsample of patients & clinicians will be invited to one-time semi-structured interview & survey to identify individual & system-level factors that may restrict or enhance the impact of strategies.
Status | Recruiting |
Enrollment | 1400 |
Est. completion date | November 10, 2024 |
Est. primary completion date | November 10, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 80 Years |
Eligibility | Inclusion Criteria: Clinicians will be eligible if they: 1. are practicing primary care or specialty care physicians at a recruiting site within the University of Pennsylvania Health System; 2. care for patients who completed LCS via LDCT in 2019-2023; and 3. do not opt-out of study participation. Patients will be eligible if they: 1. are eligible for LCS based on 2021 US Preventive Services Task Force (USPSTF) population guidelines (aged 50-80; smoking history of 20-pack years; smoked within the last 15 years) 2. completed LCS via LDCT in 2019-2023; 3. have not been diagnosed with lung cancer; 4. meet criteria for non-adherence; 5. remain eligible for LCS during the trial enrollment period; and 6. receive LCS care from a clinician that has not opted-out of study participation Exclusion Criteria: Patients will be excluded if they: a) have a highly suspicious baseline LDCT (Lung-RADS 4B/X) given the presence of existing clinical pathways to ensure adherence in this group |
Country | Name | City | State |
---|---|---|---|
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Abramson Cancer Center at Penn Medicine | AstraZeneca, National Comprehensive Cancer Network |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Rate of false-positive screens | Defined as having a positive LDCT and no subsequent lung cancer diagnosis within 6 months of the LDCT date | 6 months after LDCT date | |
Other | Number of downstream imaging and diagnostic procedures | Measured using EHR data | 6 months after LDCT date | |
Other | Number of lung cancer diagnoses | Biopsy confirmed lung cancer diagnosis measured using EHR data | 6 months after LDCT date | |
Primary | Number of completed annual LCS in patients with a negative baseline screen (Lung Imaging Reporting and Data System (Lung-RADS) 1 or 2). | Number of completed low-dose computed tomography (LDCT) scans among adults who are due for annual screening based on evidence-based guidelines. | Initial measurement will occur 3 months after randomization | |
Primary | Number of completed recommended diagnostic follow-up scans or procedures in patients with a positive baseline screen (Lung-RADS 3 or 4a). | Completion of recommended diagnostic follow-up scans or procedures among adults with positive baseline LDCT scan. | Initial measurement will occur 3 months after randomization | |
Secondary | Reach | Reach defined by proportion of patients who receive patient nudges and by the proportion of patients whose clinician acts upon clinician nudge (i.e., signs pended orders) | Initial measurement will occur 3 months after randomization |
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