Increasing Adherence to Lung Cancer Screening

Lung Cancer Clinical Trial

Official title:

Increasing Equitable Adherence to Annual Lung Cancer Screening and Diagnostic Follow-up

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05832008
• Other study ID #: UPCC 09522
• Secondary ID: 851056
• Status: Recruiting
• Phase: N/A
• Start date: October 18, 2023
• Est. completion date: November 10, 2024

Study information

• Verified date: November 2023
• Source: Abramson Cancer Center at Penn Medicine
• Contact: Katharine Rendle, PhD,MSW,MPH
• Phone: 215-349-5442
• Email: katharine.rendle[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Adherence, Patient
• Lung Cancer
• Lung Neoplasms

Intervention

Behavioral:
• Patient Nudge
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.
• Clinician Nudge
EHR-based Prompts - an pended order and message that alerts a clinician if a patient is due for screening or diagnostic follow-up.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine	AstraZeneca, National Comprehensive Cancer Network

Country where clinical trial is conducted

United States, 

Outcome

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