This clinical trial tests the impact of a patient and provider multilevel intervention on lung cancer screening. Lung cancer is the leading cause of cancer-related deaths in the United States (US). Research has shown that low-dose computed tomography lung cancer screening reduced deaths due to lung cancer by 20%. The US Preventative Services Task Force recommends yearly lung cancer screening for high risk individuals. Despite this recommendation, less than 14% of eligible people undergo screening. Evidence suggests that insurance issues, access to care, lack of knowledge about early detection and patient preference are barriers to lung cancer screening. A patient and provider multilevel intervention may be an effective method to help people learn about lung cancer to improve awareness and increase lung cancer screenings.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04675476.
Locations matching your search criteria
United States
District of Columbia
Washington
MedStar Georgetown University HospitalStatus: Active
Contact: Randi M Williams
Phone: 202-687-7036
PRIMARY OBJECTIVES:
I. Evaluate the feasibility and acceptability of implementing the healthcare provider prompt in a primary care network.
II. Develop and pre-test the patient education component.
III. Test the impact of the multilevel intervention on primary and secondary outcomes.
IV. Evaluate the implementation outcomes (adoption, feasibility, acceptability, intervention fidelity).
OUTLINE: Participants are assigned to 1 of 4 AIMS.
AIM 1 (DEVELOPMENT): Providers complete an online survey over 15-20 minutes to assess existing electronic health record (EHR) system tools, strengths and gaps in the current system, preferences, and perceived usefulness of prompts for intervention development on study. Providers may also undergo a semi-structured interview over 30-40 minutes on study. Providers are then assigned to 1 of 2 groups based on clinic assignment.
GROUP 1 (PILOT): Providers recieve the health maintenance recommendation in the EHR for patients eligible for lung cancer screening as standard of care over 6 months on study.
GROUP 2 (PILOT): Providers recieve the health maintenance recommendation as well as the pre-visit EHR prompt delivered 24 hours before a clinical encounter with a screen-eligible patient over 6 months on study.
AIM 2 (REFINEMENT): Participants undergo a semi-structured telephone interview over 30-40 minutes to measure knowledge, health literacy, and information preferences regarding lung screening on study. Participants receive educational materials in different formats on lung cancer risk and screening and complete survey after interview and review of material for intervention refinement on study.
AIM 3 (IMPLEMENTATION): Participants are assigned to 1 of 2 groups based on clinic assignment:
GROUP 3 (INTERVENTION): Patients receive educational materials and participate in a phone based health education session over 15-20 minutes at least 1 week before upcoming provider appointment. Providers recieve an EHR prompt 48 hours before clinical encounter with patient on study.
GROUP 4 (USUAL CARE): Participants receive standard of care.
AIM 4 (EVALUATION): Stakeholders undergo an interview over 30 minutes pre-implementation and post-intervention.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationMedStar Georgetown University Hospital
Principal InvestigatorRandi M Williams
