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Lung Cancer Screening Protocol (I-STEP)

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ClinicalTrials.gov Identifier: NCT03958253
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : July 23, 2019
Sponsor:
Collaborators:
BJC HealthCare, Barnes-Jewish St. Peters Hospital
Decatur Memorial Hospital
Memorial Health System
Sarah Bush Lincoln Health System
Southern Illinois Healthcare
Cox Health Systems
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Lung Cancer Screening Other: Toolbox for Lung Cancer Screening Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
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
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: I-STEP: Increasing Screening Through Engaging Primary Care Providers
Actual Study Start Date : April 22, 2019
Estimated Primary Completion Date : January 31, 2021
Estimated Study Completion Date : January 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

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




Primary Outcome Measures :
  1. Number of initial low-dose CT (LDCT) scan screenings per month per screening center [ Time Frame: Completion of study (estimated to be 21 months) ]
    -Screening will be defined as completed initial screen for lung cancer


Secondary Outcome Measures :
  1. Number of primary care providers who refer at least two patients per month for LDCT [ Time Frame: Completion of study (estimated to be 21 months) ]
  2. Percent of patients referred who are screen-eligible [ Time Frame: Completion of study (estimated to be 21 months) ]
    Defined as the number of screen-eligible patients divided by the total of screening procedures performed

  3. Percent of patients referred who complete screening [ Time Frame: Completion 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03958253


Contacts
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Contact: Aimee S James, Ph.D., MPH 314-454-8300 aimeejames@wustl.edu
Contact: Graham A Colditz, M.D., DrPH 314-454-7940 colditzg@wustl.edu

Locations
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United States, Illinois
Southern Illinois Healthcare Recruiting
Carbondale, Illinois, United States, 62901
Contact: Jennifer Badiu    618-985-3333 ext 68301      
Contact: Justin Walker    618-985-3333 ext 68302      
Decatur Memorial Hospital Recruiting
Decatur, Illinois, United States, 62526
Contact: Dave Overlot    217-876-2341    daveo@dmhhs.org   
Contact: Jeri Ann Higgins    217-876-2338    jerih@dmhhs.org   
Sarah Bush Lincoln Health System Recruiting
Mattoon, Illinois, United States, 61938
Contact: Colleen Swick    217-258-4147    cswick@sblhs.org   
Contact: Stacia Goings    217-238-452    sgoings@sblhs.org   
Memorial Health System Recruiting
Springfield, Illinois, United States, 62702
Contact: Linda Jones, DNS    217-788-7002    jones.linda@mhsil.com   
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Aimee S James, Ph.D., MPH    314-454-8300    aimeejames@wustl.edu   
Contact: Graham A Colditz, M.D., DrPH    314-454-7940    colditzg@wustl.edu   
BJC HealthCare, Barnes-Jewish St. Peters Hospital Recruiting
Saint Peters, Missouri, United States, 63376
Contact: Dareld LaBeau    636-916-9163    dareld.labeau@bjc.org   
Contact: Ellen Brennan    636-916-7098    ellen.brennan@bjc.org   
CoxHealth Recruiting
Springfield, Missouri, United States, 65802
Contact: Chris Schulze    417-528-7541 ext 24370    chris.schulze@coxhealth.com   
Contact: Jackie Muenks    417-269-0512    jackie.muenks@coxhealth.com   
Sponsors and Collaborators
Washington University School of Medicine
BJC HealthCare, Barnes-Jewish St. Peters Hospital
Decatur Memorial Hospital
Memorial Health System
Sarah Bush Lincoln Health System
Southern Illinois Healthcare
Cox Health Systems
Investigators
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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

Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03958253     History of Changes
Other Study ID Numbers: 201811093
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code
Time Frame: Beginning in 3 months and ending 5 years following article publication
Access Criteria: Proposals should be directed to aimeejames@wustl.edu. To gain access, data requestors will need to sign a data access agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases