Proactive Outreach and Shared Decision Making to Improve Lung Cancer Screening Rates Among Primary Care Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Thomas Jefferson University
- Enrollment
- 2,355
- Locations
- 1
- Primary Endpoint
- Time to screening with low dose computed tomography (LDCT)
Study Overview
Brief Summary
This trial studies how well proactive outreach and shared decision making works in improving lung cancer screening rates in primary care patients. Proactive outreach and shared decision making strategies may help to improve the detection of lung cancer at an earlier stage through screening.
Detailed Description
PRIMARY OBJECTIVES:
I. To compare the combined intervention group (Outreach Contact Group [OC]/Outreach Contact and Decision Counseling Group [OC-DCP]) versus the control usual care group (UC) with respect to time to screening with low dose computed tomography (LDCT).
SECONDARY OBJECTIVES:
I. To compare the combined intervention (OC/OC-DCP) and usual care (UC) groups with respect to the fraction of patients who are referred/scheduled for screening.
II. To compare the combined intervention (OC/OC-DCP) and usual care (UC) groups with respect to the proportion of the referred/scheduled patients who actually keep their screening appointment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 55 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Had a recent office visit with a primary care physician in one of the study practices.
- •History of smoking (current or former) in the electronic health record (EHR).
Exclusion Criteria
- •LDCT performed in the 12 months prior to study initiation according to EHR.
- •Diagnosis of lung cancer indicated in problem list in the EHR.
Arms & Interventions
Group 1 (usual care)
receive usual care
Intervention: Best Practice (Other)
Group II (outreach contact)
Patients receive educational materials in the mail about lung cancer screening with a cover letter from their physician. A week later, they receive a phone call from the study staff to assess their eligibility. Eligible and interested patients receive an office visit at the JLCSP for shared decision-making and possible lung cancer screening.
Intervention: Cancer Educational Materials (Behavioral)
Group II (outreach contact)
Patients receive educational materials in the mail about lung cancer screening with a cover letter from their physician. A week later, they receive a phone call from the study staff to assess their eligibility. Eligible and interested patients receive an office visit at the JLCSP for shared decision-making and possible lung cancer screening.
Intervention: Behavioral, Psychological or Informational Intervention (Other)
Group III (outreach + Decision Counseling Program)
Patients receive educational materials in the mail about lung cancer screening with a cover letter from their physician. A week later, they receive a phone call from the study staff to assess their eligibility. Patients then undergo a decision counseling session through a semi-structured Decision Counseling Program that includes a review of the mailed educational materials and completion of an interactive exercise intended to clarify personal preference related to screening options (to have LDCT or not to have LDCT). Patients interested in screening schedule an office visit at JLCSP for possible screening or are referred to their primary care physician for consultation.
Intervention: Cancer Educational Materials (Behavioral)
Group III (outreach + Decision Counseling Program)
Patients receive educational materials in the mail about lung cancer screening with a cover letter from their physician. A week later, they receive a phone call from the study staff to assess their eligibility. Patients then undergo a decision counseling session through a semi-structured Decision Counseling Program that includes a review of the mailed educational materials and completion of an interactive exercise intended to clarify personal preference related to screening options (to have LDCT or not to have LDCT). Patients interested in screening schedule an office visit at JLCSP for possible screening or are referred to their primary care physician for consultation.
Intervention: Behavioral, Psychological or Informational Intervention (Other)
Group III (outreach + Decision Counseling Program)
Patients receive educational materials in the mail about lung cancer screening with a cover letter from their physician. A week later, they receive a phone call from the study staff to assess their eligibility. Patients then undergo a decision counseling session through a semi-structured Decision Counseling Program that includes a review of the mailed educational materials and completion of an interactive exercise intended to clarify personal preference related to screening options (to have LDCT or not to have LDCT). Patients interested in screening schedule an office visit at JLCSP for possible screening or are referred to their primary care physician for consultation.
Intervention: Counseling (Other)
Outcomes
Primary Outcomes
Time to screening with low dose computed tomography (LDCT)
Time Frame: From the date of randomization to the date of screening (for those screened) or to the date of the review (for those not screened, "censored", assessed at 3 months
Will be assessed through a review of electronic health records data at the end of the study. The main analysis will compare the combined intervention group and the usual care group (Outreach Contact \[OC\]/OC-Decision Counseling Program \[DCP\] versus \[vs.\] usual care \[UC\]) with the Kaplan-Meier method and the log-rank test (stratified by practice). Further analyses will rely on Cox proportional hazards regression to explore the difference between OC and OC-DCP groups, as well as differences across practices and patient characteristics (age, gender, race, current vs. former smoking, etc.).
Secondary Outcomes
No secondary outcomes reported