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| ID | Type | Description | Link |
|---|---|---|---|
| 851056 | Other Identifier | UPenn IRB |
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| Name | Class |
|---|---|
| National Comprehensive Cancer Network | NETWORK |
| AstraZeneca | INDUSTRY |
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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.
Investigators will conduct a pragmatic clinical trial with a 2 x 2 factorial design with clinicians that provide care to screening-eligible patients who are overdue for annual screening or diagnostic evaluation. The specific nudge strategies to be tested are: 1) gain-framed messaging delivered via text messaging to prompt patient adherence to LCS guidelines (patient nudges); and 2) electronic health record (EHR) prompts alerting clinicians when their patients are due for annual screening or diagnostic follow-up (clinician nudges). The rationale for this study is that changing external stimuli to encourage adherence to evidence-based LCS guidelines will increase early detection of lung cancer by removing individual and system-level barriers to identifying and prompting patients who are due for care. The central hypothesis is that the combination of patient and clinician strategies will have the greatest effect on increasing adherence because it will target multilevel determinants of lung cancer screening identified in our prior research including limited screening knowledge and suboptimal EHR design. The proposed strategies are designed to support equitable implementation across diverse settings and populations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinician Nudge + Patient Nudge | Experimental | An EHR-prompt (pended order) will prompt clinicians in this arm when a patient is due for lung cancer screening or diagnostic follow-up. Patients in this arm will receive messaging designed to increase awareness about the importance of annual screening and recommended follow-up |
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| Clinician Nudge Only | Experimental | Clinicians in this arm will not be prompted by a pended order when a patient is due for lung cancer screening or diagnostic follow-up. Patients will receive usual care. |
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| Patient Nudge Only | Experimental | Patients in this arm will receive messaging designed to increase awareness about the importance of annual screening and recommended follow-up. Clinicians will receive usual care. |
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| Usual care (no nudges) | No Intervention | Patients and clinicians in this arm will receive usual care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Nudge | Behavioral | Brief persuasive messaging to increase awareness about the importance of annual lung cancer screening and completion of recommended follow-up sent to patients via text message. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of downstream imaging and diagnostic procedures |
Inclusion Criteria:
Clinicians will be eligible if they:
Patients will be eligible if they:
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
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| Name | Affiliation | Role |
|---|---|---|
| Katharine Rendle, PhD,MSW,MPH | University of Pennsylvania | Principal Investigator |
| Anil Vachani, MD | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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At the start of the trial, clinicians who do not opt-out will be randomized to the intervention (clinician nudge) or control arm (no clinician nudge). Eligible patients will be randomized, stratified by clinician, to either the intervention (patient nudge) or control group (no patient nudge).
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| Clinician Nudge | Behavioral | EHR-based Prompts - an pended order and message that alerts a clinician if a patient is due for screening or diagnostic follow-up. |
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Measured using EHR data
| 6 months after LDCT date |
| Number of lung cancer diagnoses | Biopsy confirmed lung cancer diagnosis measured using EHR data | 6 months after LDCT date |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |