Proactive Outreach and Shared Decision Making in Improving Lung Cancer Screening Rates in Primary Care Patients
Clinicaltrials.gov identifier recruitment status First Posted Last update posted
NCT03929926 Recruiting April 29, 2019 February 11, 2021

study description
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.

Condition or Disease: Lung Cancer
Intervention/treatment: Other: Counseling
Other: Best Practice
Behavioral: Cancer Educational Materials
Other: Behavioral, Psychological or Informational Intervention
Phase: N/A
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.


study design
Study Type: Interventional
Estimated Enrollment : 3000 participants
Intervention Model : Parallel Assignment
Masking: None (Open Label) ()
Primary Purpose: Screening
Official Title: Proactive Outreach and Shared Decision Making to Improve Lung Cancer Screening Rates Among Primary Care Patients
Actual Study Start Date: June 2019
Estimated Primary Completion Date: June 2021
Estimated Study Completion Date: June 2021

Arms and interventions
Arm Intervention/treatment
Active Comparator: Group 1 (usual care)
receive usual care
Other: Best Practice
receive usual care
Experimental: 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.
Behavioral: Cancer Educational Materials
Receive educational materials via mail

Other: Behavioral, Psychological or Informational Intervention
Receive shared decision making and lung cancer screening information
Experimental: 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.
Behavioral: Cancer Educational Materials
Receive educational materials via mail

Other: Behavioral, Psychological or Informational Intervention
Receive shared decision making and lung cancer screening information

Other: Counseling
Undergo decision counseling session
outcome measures
Primary Outcome Measures: 1. 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.).

Eligibility Criteria
Ages Eligible for Study: 55 to 80 Years (Adult, Older Adult)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
Criteria

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.


Contacts and Locations
Contacts

Contact: Ronald Myers 215-503-4085 Ronald.Myers@jefferson.edu

Locations
United States, Pennsylvania Sidney Kimmel Cancer Center at Thomas Jefferson University Philadelphia
Sponsors and Collaborators
Thomas Jefferson University
Investigator
Principal Investigator : Ronald Myers Sidney Kimmel Cancer Center at Thomas Jefferson University
More Information
Responsible Party : Thomas Jefferson University
ClinicalTrials.gov Identifier : NCT03929926     
Other Study ID Numbers : 18G.752
First Posted : April 29, 2019
Last Update Posted : February 11, 2021
Last Verified : February 2021
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms :
Lung Neoplasms