Clinical trial NCT03958253: Lung Cancer Screening Protocol
Official title: I-STEP: Increasing Screening Through Engaging Primary Care Providers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer Screening
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: BJC HealthCare, Barnes-Jewish St. Peters Hospital
name: Decatur Memorial Hospital
name: Memorial Health System
name: Sarah Bush Lincoln Health System
name: Southern Illinois Healthcare
name: Cox Health Systems
First posted: 2019-05-21
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
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
Primary purpose: 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.


Eligibility 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

Primary outcomes:
measure: Number of initial low-dose CT (LDCT) scan screenings per month per screening center
timeFrame: Completion of study (estimated to be 21 months)
Secondary outcomes:
measure: Number of primary care providers who refer at least two patients per month for LDCT
timeFrame: Completion of study (estimated to be 21 months)
measure: Percent of patients referred who are screen-eligible
timeFrame: Completion of study (estimated to be 21 months)
measure: Percent of patients referred who complete screening
timeFrame: Completion of study (estimated to be 21 months)
Other outcomes:
Locations:
city: Carbondale
country: United States
facility: Southern Illinois Healthcare
state: Illinois
city: Decatur
country: United States
facility: Decatur Memorial Hospital
state: Illinois
city: Mattoon
country: United States
facility: Sarah Bush Lincoln Health System
state: Illinois
city: Springfield
country: United States
facility: Memorial Health System
state: Illinois
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Saint Peters
country: United States
facility: BJC HealthCare, Barnes-Jewish St. Peters Hospital
state: Missouri
city: Springfield
country: United States
facility: CoxHealth
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Aimee S James, Ph.D., MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Graham A Colditz, M.D., DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.