Lung Cancer Screening Protocol

Lung Cancer Screening Clinical Trial

— I-STEP  

Official title:

I-STEP: Increasing Screening Through Engaging Primary Care Providers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03958253
• Other study ID #: 201811093
• Status: Completed
• Phase: N/A
• Start date: April 22, 2019
• Est. completion date: March 31, 2021

Study information

• Verified date: April 2021
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 193
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 exclusion criteria for the study

Related Conditions & MeSH terms

• Lung Cancer Screening
• Lung Neoplasms

Intervention

Other:
• Toolbox 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

Locations

Country	Name	City	State
United States	Southern Illinois Healthcare	Carbondale	Illinois
United States	Decatur Memorial Hospital	Decatur	Illinois
United States	Sarah Bush Lincoln Health System	Mattoon	Illinois
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	BJC HealthCare, Barnes-Jewish St. Peters Hospital	Saint Peters	Missouri
United States	CoxHealth	Springfield	Missouri
United States	Memorial Health System	Springfield	Illinois

Sponsors (7)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of initial low-dose CT (LDCT) scan screenings per month per screening center	-Screening will be defined as completed initial screen for lung cancer	Completion of study (estimated to be 21 months)
Secondary	Number of primary care providers who refer at least two patients per month for LDCT		Completion of study (estimated to be 21 months)
Secondary	Percent of patients referred who are screen-eligible	Defined as the number of screen-eligible patients divided by the total of screening procedures performed	Completion of study (estimated to be 21 months)
Secondary	Percent of patients referred who complete screening	Defined as the number of patients referred for screening divided by the total number of screening procedures performed.	Completion of study (estimated to be 21 months)

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine