Lung Cancer Screening Protocol (I-STEP)

I-STEP: Increasing Screening Through Engaging Primary Care Providers

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer Screening
• Intervention / Treatment: Other: Toolbox for Lung Cancer Screening

• Study Type: Interventional
• Enrollment (Actual): 193
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Carbondale, Illinois, United States, 62901
      • Southern Illinois Healthcare
    • Decatur, Illinois, United States, 62526
      • Decatur Memorial Hospital
    • Mattoon, Illinois, United States, 61938
      • Sarah Bush Lincoln Health System
    • Springfield, Illinois, United States, 62702
      • Memorial Health System
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
    • Saint Peters, Missouri, United States, 63376
      • BJC HealthCare, Barnes-Jewish St. Peters Hospital
    • Springfield, Missouri, United States, 65802
      • CoxHealth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Lung Cancer Screening Toolbox; WU Staff will train local screening staff using a train-the-trainer model three months prior to the intervention and will provide technical assistance on an ongoing basis.; During the 3 hour train-the-trainer session, the selected staff from the referral sites will learn about the program, receive an orientation to the toolbox elements, and discuss how to adapt the elements of the toolbox to their referral sites.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of primary care providers who refer at least two patients per month for LDCT		Completion of study (estimated to be 21 months)
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)
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)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: Memorial Health System; Cox Health Systems; BJC HealthCare, Barnes-Jewish St. Peters Hospital; Decatur Memorial Hospital; Sarah Bush Lincoln Health System; Southern Illinois Healthcare
• Investigators: Principal Investigator: Aimee S James, Ph.D., MPH, Washington University School of Medicine; Principal Investigator: Graham A Colditz, M.D., DrPH, Washington University School of Medicine

Publications and helpful links

General Publications

• Salazar AS, Sekhon S, Rohatgi KW, Nuako A, Liu J, Harriss C, Brennan E, LaBeau D, Abdalla I, Schulze C, Muenks J, Overlot D, Higgins JA, Jones LS, Swick C, Goings S, Badiu J, Walker J, Colditz GA, James AS. A stepped-wedge randomized trial protocol of a community intervention for increasing lung screening through engaging primary care providers (I-STEP). Contemp Clin Trials. 2020 Apr;91:105991. doi: 10.1016/j.cct.2020.105991. Epub 2020 Mar 14.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2019
• Primary Completion (Actual): March 31, 2021
• Study Completion (Actual): March 31, 2021

Study Registration Dates

• First Submitted: May 17, 2019
• First Submitted That Met QC Criteria: May 17, 2019
• First Posted (Actual): May 21, 2019

Study Record Updates

• Last Update Posted (Actual): April 8, 2021
• Last Update Submitted That Met QC Criteria: April 6, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 201811093

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Practice level and screening center aggregate numbers may be made available to investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose
• IPD Sharing Time Frame: Beginning in 3 months and ending 5 years following article publication
• IPD Sharing Access Criteria: Proposals should be directed to aimeejames@wustl.edu. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No