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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

Tracking Information
First Submitted Date  ICMJE May 17, 2019
First Posted Date  ICMJE May 21, 2019
Last Update Posted Date July 23, 2019
Actual Study Start Date  ICMJE April 22, 2019
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 17, 2019)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03958253 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2019)
  • 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) ]
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lung Cancer Screening Protocol
Official Title  ICMJE I-STEP: Increasing Screening Through Engaging Primary Care Providers
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Lung Cancer Screening
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Other: Toolbox for Lung Cancer Screening
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 4, 2019)
180
Original Estimated Enrollment  ICMJE
 (submitted: May 17, 2019)
160
Estimated Study Completion Date  ICMJE January 31, 2021
Estimated Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
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
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03958253
Other Study ID Numbers  ICMJE 201811093
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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.
Responsible Party Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE
  • 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  ICMJE
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
PRS Account Washington University School of Medicine
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP