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Lung Cancer Screening Protocol

I-STEP: Increasing Screening Through Engaging Primary Care Providers

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03958253
Acronym
I-STEP
Enrollment
193
Registered
2019-05-21
Start date
2019-04-22
Completion date
2021-03-31
Last updated
2021-04-08

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

Conditions

Lung Cancer Screening

Brief summary

The successful implementation of lung cancer screening across diverse setting requires working with the community and primary care practices. Collaborating across diverse community-based sites will employ local knowledge and culture in the understanding of the health problem and identifying and implementing solutions that are appropriate for all partners (patients, primary care, referral centers). Enhanced, culturally-competent communication with patients at high risk for lung cancer can narrow inequities in screening awareness, referral, and utilization, as well as improve lung cancer outcomes across diverse patients and communities. Promoting partnerships among physicians, staff, and patients; creating routines; and tailoring materials to each clinician's situation have been show to increase the proportion of patients receiving screening.

Interventions

OTHERToolbox for Lung Cancer Screening

-Toolbox of evidence-based elements that a primary care or referral site could implement to address known barriers to screening and referral, as well as required elements for screening. These elements will be designed to be adaptable to the unique needs and screening processes of the participating practices. * Patient education materials * Primary care practice educational materials * Pack-years/eligibility calculator * Local referral process guide * Smoking cessation materials and support * Shared decision-making guide * LDCT best practice guidelines

Sponsors

BJC HealthCare, Barnes-Jewish St. Peters Hospital
CollaboratorUNKNOWN
Decatur Memorial Hospital
CollaboratorUNKNOWN
Memorial Health System
CollaboratorOTHER
Sarah Bush Lincoln Health System
CollaboratorUNKNOWN
Southern Illinois Healthcare
CollaboratorUNKNOWN
Cox Health Systems
CollaboratorOTHER
Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SCREENING
Masking
NONE

Intervention model description

This is a stepped wedge cluster randomized trial in which the intervention condition (toolbox) is sequentially assigned to participating hospitals (screening centers) in 6 clusters at different time-delays and where pre-intervention data serves as the control. By the end of the study, all clusters have been exposed to the intervention and each cluster has provided data for the control and intervention conditions. Independent samples of primary care providers are enrolled at each period within a cluster, thus, it is a repeated cross-sectional study. The order of the entry into the intervention phase is randomized based on levels of readiness

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* To be eligible to participate in the trial, screening centers have to be existing members of the BJC Collaborative. * Primary Care Providers have to have a referral relationship with the screening center; serve adult patients who may be screening-eligible, and are willing to interact with the referral site to implement referral for LDCT.

Exclusion criteria

There are not any

Design outcomes

Primary

MeasureTime frameDescription
Number of initial low-dose CT (LDCT) scan screenings per month per screening centerCompletion of study (estimated to be 21 months)-Screening will be defined as completed initial screen for lung cancer

Secondary

MeasureTime frameDescription
Number of primary care providers who refer at least two patients per month for LDCTCompletion of study (estimated to be 21 months)
Percent of patients referred who are screen-eligibleCompletion of study (estimated to be 21 months)Defined as the number of screen-eligible patients divided by the total of screening procedures performed
Percent of patients referred who complete screeningCompletion of study (estimated to be 21 months)Defined as the number of patients referred for screening divided by the total number of screening procedures performed.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026