A Patient and Provider Intervention to Address Health Disparities in Lung Cancer Screening

A Multilevel Intervention to Address Health Disparities in Lung Cancer Screening

To test the impact of a multilevel intervention on primary (provider-patient communication, intentions, and knowledge) and secondary (screening referrals and completion) outcomes.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Behavioral: Provider Prompt & Patient Outreach and Education

Detailed Description

The proposed study will target two key levels of influence in the healthcare setting: provider and patient behavior in order to address disparities between African American and whites in lung screening awareness and utilization. Guided by NIH's Health Disparities Research Framework and building on the formative work conducted in the K99 phase, we will conduct a quasi-experimental study (pretest-posttest, with a nonequivalent control group) in partnership with four primary care clinics within the MedStar Health system in the R00 phase.

• Study Type: Interventional
• Enrollment (Estimated): 368
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Randi M Williams, PhD; Phone Number: (202) 687-7036; Email: rmw27@georgetown.edu

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20007
      • Recruiting
      • Medstar Health
      • Contact: Andrew Canning

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 50-80 years old;
• current cigarette smoker or quit within 15 years;
• a 20+ pack-year smoking history;
• non-adherent to lung screening (>13 months);
• English-speaking;
• scheduled for an upcoming clinic appointment (4 weeks - 8 weeks); and
• able and willing to provide meaningful consent and complete telephone interviews

Exclusion Criteria:

• Individuals with a history of lung cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Multilevel Intervention	Behavioral: Provider Prompt & Patient Outreach and Education; To target lack of provider-prompted discussion about lung screening, an electronic medical record (EMR) message will be sent to primary care providers prior to scheduled visits with screening-eligible patients to notify them of the patient's eligibility and to encourage discussion of the benefits and limitations of the test. To target patient-level knowledge about lung screening, an outreach specialist will educate screening-eligible patients about the benefits and limitations of the test prior to their visit.
No Intervention: Nonequivalent Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
provider-patient discussion	Discussion about lung screening with the provider ('did you have a discussion with your doctor about lung screening?')	1-week post-visit
lung cancer screening intentions	Screening intentions ('how likely is it that you will undergo lung screening in the next 6-months?')	1-week post-visit
lung cancer screening knowledge	Lung cancer screening knowledge measure	1-week post-visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
lung cancer screening referrals	Total number of lung screening orders captured via the electronic medical record	6-months
lung cancer screening completion rates	Total number of lung screening completions captured via the electronic medical record	6-months

Collaborators and Investigators

• Sponsor: Georgetown University

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: December 4, 2020
• First Submitted That Met QC Criteria: December 14, 2020
• First Posted (Actual): December 19, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: STUDY00003277

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No