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Proactive Outreach and Shared Decision Making in Improving Lung Cancer Screening Rates in Primary Care Patients

Proactive Outreach and Shared Decision Making to Improve Lung Cancer Screening Rates Among Primary Care Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03929926
Enrollment
2355
Registered
2019-04-29
Start date
2019-06-19
Completion date
2024-05-01
Last updated
2025-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

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. III. To determine cost of implementing the OC and OC-DCP interventions. EXPLORATORY OBJECTIVES: I. To compare the two intervention groups (OC-DCP versus \[vs.\] OC) on the primary and secondary study endpoints (time to LDCT screening, proportion of patients referred/scheduled for screening, proportion of patients keeping their screening appointments, and cost). II. To assess the feasibility of patient eligibility review by providers in the OC and OC-DCP arms. III. To assess the difference in success in identifying eligible patients between arms. IV. To assess the difference in reaching referred patients between arms. OUTLINE: Patients are randomized to 1 of 3 groups. GROUP I (USUAL CARE): Patients receive usual care. 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 Jefferson Lung Cancer Screening Program (JLCSP) for shared decision-making and possible lung cancer screening. 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. After completion of study, patients are followed up for 90 days.

Interventions

OTHERBest Practice

receive usual care

Receive educational materials via mail

Receive shared decision making and lung cancer screening information

OTHERCounseling

Undergo decision counseling session

Sponsors

Thomas Jefferson University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
55 Years to 80 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Time to screening with low dose computed tomography (LDCT)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 monthsWill 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.).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026