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

Thomas Jefferson University

Status: Completed

Conditions: Lung Cancer

Treatments: Other: Best Practice; Behavioral: Cancer Educational Materials; Other: Counseling; Other: Behavioral, Psychological or Informational Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03929926

18G.752

JT 13384 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,355 patients

Sex: All

Ages: 55 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,355 participants in 3 patient groups

Group 1 (usual care)

Active Comparator group

Description:

receive usual care

Treatment:

Other: Best Practice

Group II (outreach contact)

Experimental group

Description:

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.

Treatment:

Other: Behavioral, Psychological or Informational Intervention

Behavioral: Cancer Educational Materials

Group III (outreach + Decision Counseling Program)

Experimental group

Description:

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.

Treatment:

Other: Behavioral, Psychological or Informational Intervention

Other: Counseling

Behavioral: Cancer Educational Materials